chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: second day post vaccine woke w/102.2/ fever fever broke by day 3; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first single dose of BNT162B2 (Pfizer, lot number: ett9899, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 30Dec2020 11:00 for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included osteoarthritis bilateral knees. The patient was not pregnant. Concomitant medication include amoxicillin, clavulanate potassium (AUGMENTIN), ascorbic acid (VITAMIN C ACID), meloxicam, and calcium carbonate (CAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications within two weeks. On 31Dec2020 22:00, the first day after vaccine, patient developed chills and the worst headache of her life along with fatigue. On 01Jan2021, second day post vaccine, she woke with 102.2 fever; chills were gone, headache mild, fatigue present. The fever broke by day 3 (02Jan2021). No treatment was provided for the events. The events were considered as non-serious by the reporter. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. The patient recovered from the fever on 02Jan2021, chills recovered on 31Dec2020, while outcome of headache and fatigue was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: heart rate in the 120's which last 15 minutes while at rest; Left arm deep aching; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EL1284), via an unspecified route of administration in the left arm on 30Dec2020 12:00 at a single dose for COVID-19 immunization at the hospital. Medical history included pulmonary embolism (PE's x 2) and left nephrectomy for kidney cancer (CA). Concomitant medications included apixaban (ELIQUIS), losartan and hctz. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020 18:00, the patient experienced heart rate in the 120's which lasted 15 minutes while at rest and left arm deep aching for 2 days. Outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Hyperhidrosis, Myalgia, Nasal congestion
Clinical narrative: Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse.  A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal dryness, Pain, Pain in extremity
Clinical narrative: Congestion; Nostrils are really like dry inside; back was hurting; Body ache; Muscle ache; Sweats; Body fatigue; Sore in arm; This is a spontaneous report from a contactable nurse.  A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included sertraline hydrochloride (ZOLOFT) as an antidepressant therapy. On 28Dec2020, patient was sore in her arm. On 29Dec2020, the next day patient woke up, she had body fatigue and muscle aches and had the sweats and was fine the next day. On 30Dec2020, Wednesday, the patient's back was hurting and has a body ache. And on 01Jan2021, patient stated she was like super congested. There was no back ache or anything but just has a really bad congestion and stated her nostrils were like really dry inside. Therapeutic measures were taken as a result of congestion, nostrils were like dry inside with spray nose with normal saline and the use of a humidifier. The patient recovered from the event, back pain; has not recovered from the events, congested and nostrils were like really dry; and outcome of all other events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours; This is a spontaneous report from a contactable other health care professional. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Dec2020 11:30 at single dose, at left arm for COVID-19 immunization.  Medical history included arthritis. On 31Dec2020 21:30, it was reported that the patient experienced some muscle soreness around injection site. Started about 10 hours after injection and lasted about 24 hours. The patient did not receive treatment for the event. The outcome of the event was recovered.   Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Migraine, Nausea, SARS-CoV-2 test
Clinical narrative: bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue.  She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort, Tongue haemorrhage, Tremor, Vomiting
Clinical narrative: bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue.  She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient's arm hurt (pain at injection site); This is a spontaneous report from a Pfizer sponsored program "from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient's arm hurt (pain at injection site). Clinical outcome of the adverse event was unknown at time of this report.   Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left upper arm on 02Jan2021 13:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced itching on 02Jan2021 with outcome of not recovered. The patient got the COVID vaccine on 02Jan2021 around 1 o'clock. That evening (5-6 hours after getting) the vaccine she started itching and has been itching since then. The itching is on her body, back, and stomach. She has been itching since, it comes and goes. Itching worsened. It also worsens in the evening, night, and morning. As treatment the patient took a baby loratadine (CLARITIN).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Migraine, Nausea
Clinical narrative: Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Swelling
Clinical narrative: All of a sudden I got flushed in the face; Swelling; This is a spontaneous report from a contactable consumer. A 74-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284), via an unspecified route of administration on 03Jan2021 16:04 at single dose for COVID-19 immunization. The patient's medical history was not reported. It was reported that patient is taking an unspecified blood thinner. The patient reported "My first Covid-19 Pfizer and had not any symptoms or any problems but all of a sudden got flushed in the face, and started little tiny bit of a swelling on an unspecified date and no problem it is already gone away. The outcome of the events was recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Back pain, Nausea, Pain
Clinical narrative: Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke.  The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke.  The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine a week ago. It was reported that the patient had a migraine today and wants to know if there's any side effects of any medication or reactions to migraine medication she is taking at onset of migraines only. She wanted to know if she could take it. The outcome of the event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Lymphadenopathy, Myalgia, SARS-CoV-2 test
Clinical narrative: I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 31Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dairy and infection. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) on 10Dec2020 for immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 01Jan2021 06:00, the patient woke up with chills and low grade fever. These were same symptoms as when she had the actual infection. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious by the reporter.  The following information on the batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; aches; fatigue; injection site soreness for 5 days; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), intramuscular on left arm on 18Dec2020 16:30 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included birth control medication (unspecified) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. On 19Dec2020 at 09:00 AM, patient experienced fever, aches, fatigue, injection site soreness for 5 days and loss of appetite. No treatment was received for the reported adverse events. Since the vaccination, the patient has not been tested for Covid-19. The outcome of the events was recovered.   Information about lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: He is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. He has been participating in the clinical trial for the COVID-19 vaccine and he has been calling his clinical trial site since Tuesday with no response. The patient was not feeling well on an unspecified date. Therapeutic measure was taken as a result of the event and included treatment with ibuprofen (ADVIL). Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after receiving the COVID Vaccine; tested positive for COVID after receiving the COVID Vaccine; This is a spontaneous report from a contactable other HCP from a Pfizer-sponsored Program Pfizer First Connect. A female patient (sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), 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. Caller stated that her sister tested positive for COVID after receiving the COVID Vaccine. Caller stated that her sister is a respiratory therapist and she has it (COVID) at the same time as the caller. Caller's sister tested positive at the same time as the caller on 01Jan2021. Caller's sister received the COVID Vaccine from a different facility from the caller. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Ocular hyperaemia
Clinical narrative: Red blood vessels in eyes, worse in left eye; watery eyes; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the right arm on 29Dec2020 08:15 at a single dose for COVID-19 immunization. The patient's medical history included mild von willebrand's, situational anxiety, allergies to penicillin, and Visian ICL surgery in August. The patient was not pregnant. Concomitant medications included calcium carbonate, famotidine, magnesium hydroxide (PEPCID COMPLETE), ethinylestradiol, etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA), and hydroxyzine. 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 and had not been tested for COVID-19 since the vaccination. On 31Dec2020 07:00, the patient experienced red blood vessels in eyes, worse in left eye. She also had watery eyes. No pain. No treatment was received for the adverse events. Outcome of the events was recovered with sequel. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; slight headache; This is a spontaneous report from a contactable Other-HCP (patient). A 31-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Bl1284), intramuscular at Left arm on 04Jan2021 16:45 at single dose for covid-19 immunization.  The COVID-19 vaccine was administered at Hospital. Medical history included narcolepsy, cataplexy, anxiety.   Concomitant medication included oxybate sodium (XYREM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), doxepin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021, received injection 2 hours later at 07:30 PM, the patient experienced nausea and slight headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she received vaccine was getting sore and very heavy.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 04Jan2021 morning at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine this morning (04Jan2021) and complained arm where she received vaccine was getting sore and very heavy. The events took place after use of product. She took Tylenol and stated that she feels better. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm is achy after getting the vaccine; This is a spontaneous report from non-contactable consumer(patient) via Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (lot number unknown), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was achy after getting the vaccine on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Palpitations
Clinical narrative: palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received.  It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Muscular weakness, Tremor
Clinical narrative: muscle spasming; muscle spasming or twitching; shaking; my muscles are weak; This is a spontaneous report from a contactable nurse (reporting for herself). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history was none. Concomitant medications were not reported. The patient started having like muscle spasming or twitching and like shaking a little bit like her muscles were weak on an unspecified date. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the third of 3 reports, reporting for one of the colleagues. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Registered nurse calling regarding the COVID 19 vaccine. She was wondering if people were reporting if they got their periods early? She got her period two weeks early and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021002844 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable physician reported for a patient.  A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer product, lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced hives that began 24 hours post the first dose of the BNT162B2 vaccine. It resolved with one dose of Claritin. No other symptoms at all. The outcome of the event was resolved. Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness x 3-4 hours until after eating a full meal; This is a spontaneous report from a contactable nurse (patient).  A 31-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number EK9231), intramuscular on 29Dec2020 16:30 at single dose on left arm for COVID-19 immunization.  Medical history was none. The patient's concomitant medications included OTC Vitamins/Supplements.  No allergies to medications, food, or other products. The patient experienced lightheadedness x 3-4 hours until after eating a full meal on 29Dec2020 16:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: period two weeks early; This is Spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is a 2nd of 3 reports. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Registered nurse calling regarding the COVID 19 vaccine. She is wondering if people were reporting if they got their periods early? She got her period two weeks early. Mentions she also has two colleagues who had that as well. States she does not have information to provide for her colleagues and declined to report regarding her colleagues. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021002844 same reporter/drug/AE, different patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization.  Medical history included Hypothyroid. She was not pregnant. There were no known allergies.  Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient).  A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization.  Medical history included Hypothyroid. She was not pregnant. There were no known allergies.  Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: muscle pain; cough; fever/have high fever above 102; injection site pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on right arm on 28Dec2020 17:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient reported she experienced symptoms like fever, injection site pain on 28Dec2020 (also reported as 09Dec2020, for clarification), muscle pain on an unknown date, and cough in Jan2021. She had high fever above 102 on 29Dec2020, one day after the vaccination and on the 5th day she started to cough. Patient did not receive any treatment for the events. Outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Feeling hot, Headache, Malaise
Clinical narrative: Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself.  A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself.  A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: chills; not feeling well; This is a spontaneous report from non-contactable nurse.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration and date at a SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  On an unknown date (the day after the vaccine), the patient had chills and not feeling well. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Nasal congestion
Clinical narrative: felt congested; worried; This is a spontaneous report from a non-contactable nurse. A patient of unspecified age and gender started to received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Jan201, the patient felt congested and worried. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; headache; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry unknown), via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches and headache on an unknown date.  The outcome of the events was unknown.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines; This is a spontaneous report from a non-contactable consumer.  A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache; it was specified that this health care worker who received the vaccine was happy to get a headache like she normally does with other vaccines. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician.  A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered.  The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fever 101; myalgias; arthralgias; headache; injection site pain; This is a spontaneous report from a contactable physician.  A 35-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular in the left arm on 22Dec2020 16:00 at single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergy to Sulfa and amoxicillin; clavulanic acid (AUGMENTIN). The patient had concomitant medications. On 23Dec2020 04:0 the patient experienced fever 101, myalgias, arthralgias, headache and injection site pain with outcome of recovered.  The patient received paracetamol (TYLENOL) and Ibuprofen as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none.  The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown  Information on batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none.  The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown  Information on batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Neck developed a rash; This is a spontaneous report from a non-contactable consumer (patient). A 25-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EH9899) via an unspecified route of administration in right arm on 18Dec2020 20:30 single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No allergies to medications, food, or other products reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced neck developed a rash on 20Dec2020 20:00 with outcome of unknown.    No follow-up attempts are possible. No further information is expected.