chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pallor, Pruritus, Swelling face
Clinical narrative: slight elevated heart rate; was white as a ghost; itching; face also swelled; This is a spontaneous report from a contactable consumer (patient's mother).  A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec2020, the patient experienced: slight elevated heart rate, was white as a ghost, itching, face also swelled; which were all assessed as non-serious. The clinical course was reported as follows:  The patient's mother stated that her daughter was a grown woman and did not know that the she was calling Pfizer. The patient's mother stated that her daughter had the COVID vaccine on a Wednesday (as reported), and the patient was kept for 15 minutes after the administration. The patient's mother stated that her daughter had a slightly elevated heart rate, and her daughter's husband said that she was white as a ghost. The patient's mother stated that her daughter also experienced itching, that did require antihistamines. The patient's mother stated that her daughter called the hospital, and they just said that they will make a note of it. The patient's mother stated that as a parent, she was slightly worried about her daughter getting the second dose; however, she was more concerned about her daughter getting COVID.  The patient's mother also stated that her daughter's face also swelled after getting the vaccine, but that her daughter did not have any closing of the throat. The patient did have to go to get antihistamines. The patient's doctors did not tell the patient that she needed to pre-medicate with antihistamines next time. The patient underwent lab tests and procedures which included heart rate: slightly elevated in Dec2020.  Therapeutic measures were taken as a result of itching. The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red itchy rash at injection site; Red itchy rash at injection site; Red itchy rash at injection site; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), intramuscular (left arm) on 22Dec2020 15:15 at single dose for Covid-19 immunization. The patient's medical history included Intracranial HTN (intracranial hypertension) and known allergies: PCN (Penicillin). Concomitant medication included acetazolamide sodium (DIAMOX), topiramate (TOPAMAX), and Multivitamin. The patient previously took Augmentin, tetracycline, and Ceclor and experienced drug allergy. The patient did not 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 red itchy rash at injection site on 26Dec2020. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph node in R armpit. Tender to touch and swollen; swollen lymph node in R armpit. Tender to touch and swollen; This is a spontaneous report from a contactable healthcare professional.  A 30-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 1284), intramuscular on the right arm on 21Dec2020 at 20:30 at a single dose for Covid-19 immunization.  Medical history included depression, infertility, and acid reflux.  Concomitant medications included omeprazole, fluoxetine hydrochloride (PROZAC), magnesium, and melatonin. The patient previously took trazodone and experienced allergies.  The patient experienced swollen lymph node in right (R) armpit, tender to touch and swollen on 26Dec2020. There was no treatment received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination has not tested for COVID-19. Outcome of the events was recovering.  The reporter assessed the events as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: heart rate spiked; difficult to catch breath; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 (at the age of 39-years-old) at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis, depression, acid reflux, and COVID-19 (prior to vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications, within two weeks prior to vaccination, included sertraline (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), liothyronine sodium (T3), and levothyroxine sodium (T4). The patient experienced heart rate spiked and difficult to catch breath on 20Dec2020. The events were reported as non-serious. The clinical course was reported as follows: In Dec2020, the heart rate spiked to 194 when running outside and it was difficult to catch breath, so the patient ran/walked the 3 mile route. The heart rate spiked to 183 during a strength training workout and to 148 during a low impact weight training, which is unusual for the patient (as reported). The patient did not receive any treatment for the events. The clinical outcome of heart rate spiked and difficult to catch breath was recovered in Dec2020. 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: Arthralgia, Chills, Headache, Pain in extremity
Clinical narrative: Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Nausea, Pain
Clinical narrative: Injection site soreness; Headache; Nausea; Body aches; stiffness in neck and shoulder area; Muscle soreness; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscularly on 21Dec2020 at 09:00 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included pre-diabetes, previous liver failure from ciprofloxacin (CIPRO) in 2019, 3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017. Known allergies included Ciprofloxacin. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Metformin, Spironolactone, Sertraline. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness, Headache, Nausea, body aches, muscle soreness and stiffness in neck and shoulder area on 22Dec2020 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered with sequel in Dec2020 (also reported as Recovered with lasting effects). The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; Headache; Nausea; Body aches; stiffness in neck and shoulder area; Muscle soreness; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscularly on 21Dec2020 at 09:00 AM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included pre-diabetes, previous liver failure from ciprofloxacin (CIPRO) in 2019, 3 septoplasty due to recurrent sinus infections and nasal cysts in 2016 and 2017. Known allergies included Ciprofloxacin. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Metformin, Spironolactone, Sertraline. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness, Headache, Nausea, body aches, muscle soreness and stiffness in neck and shoulder area on 22Dec2020 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered with sequel in Dec2020 (also reported as Recovered with lasting effects). The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable nurse (patient's wife).  A 73-year-old male patient received bnt162b2 (BNT162B2) at single dose on 28Dec2020 for Covid-19 immunisation, because he was a physician.  Medical history included prostate cancer receiving radiation and having bowel issues and diarrhoea. The patient's concomitant medications were not reported.  The patient experienced diarrhea in Dec2020 after receiving the vaccine. He had prostate cancer and was receiving radiation so it was normal for him to have diarrhea. The nurse state it was not a good source to confirm if diarrhea is from COVID-19 Vaccine. She has not a chance to talk to her husband about his experiences. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Achiness; Runny nose; Sore Arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (friend of patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 20Dec2020 once by injection in the left arm at single dose for COVID-19 immunization. The patient medical history included already had COVID last November (unspecified year). No concomitant medications. Reporter confirmed that she spoke with her coworker (patient) who also had a runny nose and achiness, along with a sore arm on 21Dec2020. These only lasted 1-2 days for patient. She was also scheduled to receive the second dose on 10Jan2021. Investigation Assessment was not reported. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL) and dextromethorphan hydrobromide; guaifenesin; paracetamol; pseudoephedrine hydrochloride (DAYQUIL). The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on my face around my side of my nose and same on both sides; This is a spontaneous report from a contactable other hcp (patient). This 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 29Dec2020 12:00pm for Covid-19 immunisation. Medical history included asthma, eggs chicken penicillin. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), omeprazole (PROTONIX [OMEPRAZOLE]), budesonide, formoterol fumarate (SYMBICORT).   The patient stated that experienced: swelling on my face around my side of my nose and same on both sides on 29Dec2020 21:00 with outcome of unknown. No treatment required. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 post the vaccination.   Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nasal congestion
Clinical narrative: still not feeling well; I feel a little run down; little of bit congestion; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported he felt a little run down and little of bit congestion and asked 'if he is still not feeling well should he get the second dose'. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry eye, Dry mouth, Energy increased, Irritability
Clinical narrative: Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization.  The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D).  The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Rash, Sleep disorder, Thinking abnormal
Clinical narrative: Initial reaction: rash on chest; muscle, joint pain; muscle, joint pain; urge to run; inability to sleep; Irritable mood; Muscle spasms; dry eyes; Dry mouth; brain fog, inability to multitask; This is a spontaneous report from a contactable nurse. A 58-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number: EJ1685; intramuscular in left arm on 18Dec2020 at 14:45 (at the age of 58 years-old) as a single dose for COVID-19 immunization.  The vaccine was given in a hospital. The patient did not receive any other vaccines in the past 4 weeks. Medical history included asthma, mitral valve prolapse and an allergy to latex. Concomitant medication included calcium (CALCIUM), metoprolol (METOPROLOL), magnesium (MG [MAGNESIUM]), ergocalciferol (VIT D).  The patient previously took penicillin and experienced an allergy. The patient did not receive any other vaccines in the past 4 weeks. She did take other medications (concomitant) in the past 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. In Dec2020, at 14:45, the patient experienced rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth, brain fog, and an inability to multitask after 1 week following COVID-19 vaccine. The patient was not hospitalized for the events and no treatment was administered. The outcome of the events: rash on chest followed by muscle, joint pain, urge to run, inability to sleep, irritable mood, muscle spasms, dry eyes, dry mouth. brain fog, inability to multitask, was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Vaccination site pain, Vomiting
Clinical narrative: Arm more sore than with flu shot; Woke up very nauseous; light headed; achy; Threw up twice; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 30Dec2020 at 19:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and peanut allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: montelukast sodium (SINGULAIR), fluticasone propionate/salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020 at 05:00, the patient experienced arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice. No treatment was given for these events. The clinical outcome of arm more sore than with flu shot, woke up very nauseous, light headed, achy, and threw up twice was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loss of her sense of taste and smell; loss of her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient herself). A 53-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Since 29Dec2020, the patient had a loss of her sense of taste and smell that was unresolved. The patient wanted to know if this was a known side effect. The patient was not recovered from the events.  Information on the batch/lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Muscular weakness, Paraesthesia
Clinical narrative: Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vertigo, Vomiting
Clinical narrative: severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'.  The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling jittery, Headache, Insomnia, Nervousness
Clinical narrative: Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00  as a single dose,  for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300,  the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00  as a single dose,  for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300,  the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Nerve compression, Vaccination site pain
Clinical narrative: couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient.  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination.  Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg  of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Productive cough
Clinical narrative: Productive cough; Swollen lymph nodes on neck; Severe body aches; Chills; Minor headache; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: Ek5730, via an unspecified route of administration on 29Dec2020 at 13:30 (at the age of 34 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included fibromyalgia, anxiety disorder, and allergy to amoxicillin from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included omeprazole 40mg and duloxetine 120 mg, both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 29Dec2020 at 18:30, the patient experienced severe body aches, chills, minor headache, and swollen lymph nodes on neck. On 30Dec2020, the patient experienced productive cough. The patient did not receive treatment for the events. The clinical outcome of body aches, chills, minor headache, swollen lymph nodes on neck, and productive cough was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sick; flu; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was sick (illness) and had flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick (illness) (unknown latency) and had flu (influenza) (few weeks) following the administration of INFLUENZA VACCINE.  It was reported that, the flu shot always made the patient sick. The patient stopped taking it 11 years ago when got the flu a few weeks after getting the shot, haven't taken it since and haven't been sick since, will never take it again.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was sick all winter; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was sick all winter (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick all winter (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient I had the flu shot two years in a row a few years back. The patient was sick all winter both times also reported that, (never again. The patient won't be vaccinated for anything ever again).   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician in the united States.  This case involves a 2 months old female patient who was given the first dose of dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (product preparation issue, same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves male patient of unknown age, who had tiny red spot at the injection site (vaccination site erythema), after receiving PENTACEL. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination, before he turned 3 (years / months unspecified). On an unknown date, the patient developed a non-serious tiny red spot at the injection site (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Case details: Patient's mother reported that QUADRACEL vaccine for her 5-year-old son who needs his 5th dose of DTAP and to satisfy his school requirements, now he needs his 5th dose of the polio vaccine, as well, because he got his 4th dose before he turned 3. On speaking with the health department where they do have vaccine but the nurse said the QUADRACEL was not approved, at least not by her, for a 5th dose. So, wanted to know, is it approved for a 5th dose of Dtap plus polio and is it safe. Question number 1. Question number 2 is: Is it possible to help her locate it somewhere closer, instead of having to go to another facility, which was a 2-hour drive away. Called every pediatrician, every family doctor, every pharmacy and she can think of in the area and everyone orders through one particular pharmacy and for some reason, on their computers are unable to order QUADRACEL whether that's due to manufacturer restrictions. She doesn't know if there's a pharmacy (unintelligible) like contract. Everyone in town seems to give KINRIX, which she doesn't want to give to her son and want to give him QUADRACEL because she know, in the past, he's tolerated PENTACEL really, really well and want to stick with what works for his body and, like, want to spend money and buy and pay for QUADRACEL vaccine and just running into a million brick walls trying to get it. So, if she could be helped, so she will be appreciative. No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reports, the outcome was not reported for the event vaccination site erythema. There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: it is not recommended to give to a two month old, with no AE; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 23-Dec-2020.  This case involves a 2 months old male patient for whom it was reported that it was not recommended to give to a two month old, (product administered to patient of inappropriate age), while he received quadrivalent influenza vaccine (Influenza Quadrival A-B Vaccine).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (Tet Tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel); Hepatitis B Vaccine and Rotavirus Vaccine.  On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine (lot UT7102JA) via intramuscular route in the left vastus lateralis for prophylactic vaccination, who was 2 months old (product administered to patient of inappropriate age).  It was a case of potential medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: HEADACHE   FATIGUE AND CHILLS
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vertigo, Vomiting
Clinical narrative: Headaches, severe vertigo, vomiting, tired, chills
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, swollen, warm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever 101.9 , Headache, Body aches, Chills
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Myalgias Headache Arthralgias
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: uncontrollable chills, headache, fatigue, body aches, nausea
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Terrible chills, body aches, fever 101.9 , HA , nausea.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient states arm which vaccination was given became red and sore 3 days after vaccination. It them became large, softball size, red, hot, swollen, and itchy. She states it lasted 10 days and is now resolving with bactroban ointment.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Left arm deltoid sore at injection site, tiredness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Nausea, Tachycardia
Clinical narrative: Nausea, tachycardia and elevated blood pressure.   O2 at 100%, BP at 167/114 pulse 135 patient resolved within 10 minutes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: pain all over the body, swelling of neck, axilla and arm, pain on left side of arm.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Joint range of motion decreased, Pain in extremity, Periarthritis
Clinical narrative: SEVERE HEADACHES LASTING A FEW HOURS AND ACUTE PAIN IN ARM WITH FROZEN SHOULDER UNABLE TO LIFT ARM
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: SEVERE HEADACHES LASTING A FEW HOURS AND ACUTE PAIN IN ARM WITH FROZEN SHOULDER UNABLE TO LIFT ARM
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Joint range of motion decreased, Pain in extremity, Periarthritis
Clinical narrative: Pt had severe headache that started at 7:30pm after receiving the Covid vaccine and lasted for about 3.5 hours. It resolved after he took Tylenol. He also had pain at the injection site with reduced range of motion. Full range of motion came back 1/6 at 8 AM.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt had severe headache that started at 7:30pm after receiving the Covid vaccine and lasted for about 3.5 hours. It resolved after he took Tylenol. He also had pain at the injection site with reduced range of motion. Full range of motion came back 1/6 at 8 AM.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Moderna COVID-19 Vaccine EUA - rash at injection site one week post-injection in left upper arm
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain in extremity
Clinical narrative: Right arm soreness, Stomach bug and exhaustion for 3 days after the 1st dose of the vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Eye pain, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Woke up with a golf ball sized bullseye, swollen, red, itchy, sore, and hot to the touch.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching and rash
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Ophthalmological examination, Physical examination, Rash
Clinical narrative: Three days 1st dose of  Pfizer vaccine I developed moderate headache and malaise. Six days later  I developed a maculo-vesicular itchy, non painful rash on my R forehead.  I visited an Immediate Care office (started valacyclovir) and I was seen the same day by a retina specialist ophthalmologist (started prednisone 60 mg/day). I'm doing much better.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash maculovesicular, Rash pruritic
Clinical narrative: Three days 1st dose of  Pfizer vaccine I developed moderate headache and malaise. Six days later  I developed a maculo-vesicular itchy, non painful rash on my R forehead.  I visited an Immediate Care office (started valacyclovir) and I was seen the same day by a retina specialist ophthalmologist (started prednisone 60 mg/day). I'm doing much better.