chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye disorder, Fatigue, Pain, Pain in extremity
Clinical narrative: Coughing; Tired; Achy; Right arm was sore; Sudden eye floaters; There were floaters in her eyes described as "black spidery floater" moving around her eyes.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0196) via an unspecified route of administration, administered in arm right on 24Jun2021 15:15 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization at clinic. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0178) via an unspecified route of administration, administered in arm right on 03Jun2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization and experienced sore/achy arm for about 24 hours and ice helped. The patient previously took morphine [morphine sulfate] and compazine [prochlorperazine edisylate] and experienced allergic reactions. Patient reported that she had medical reactions to different medications. On 24Jun2021 at 16:00 (within an hour of vaccination), patient right arm was sore and there were floaters in her eyes described as "black spidery floater" moving around her eyes and was definitely changed the perception out of that eye. "One big floater is kind a dark not easy to spot. On 25Jun2021, it was reported that patient was tired and achy and on an unspecified date patient had cough. None of the AE require a visit to emergency room or physician office. Patient was asking if there were reported similar reactions after the second dose and if so, is it something that gets away quickly and was asking if this will dissipate soon or should she see her eye doctor. Further stated that she looked up generic side effects online and it is mentioned in different places. The outcome of the events vitreous floaters and eye disorder was not recovered whereas, outcome for remaining events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Coughing; Tired; Achy; Right arm was sore; Sudden eye floaters; There were floaters in her eyes described as "black spidery floater" moving around her eyes.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0196) via an unspecified route of administration, administered in arm right on 24Jun2021 15:15 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization at clinic. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0178) via an unspecified route of administration, administered in arm right on 03Jun2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization and experienced sore/achy arm for about 24 hours and ice helped. The patient previously took morphine [morphine sulfate] and compazine [prochlorperazine edisylate] and experienced allergic reactions. Patient reported that she had medical reactions to different medications. On 24Jun2021 at 16:00 (within an hour of vaccination), patient right arm was sore and there were floaters in her eyes described as "black spidery floater" moving around her eyes and was definitely changed the perception out of that eye. "One big floater is kind a dark not easy to spot. On 25Jun2021, it was reported that patient was tired and achy and on an unspecified date patient had cough. None of the AE require a visit to emergency room or physician office. Patient was asking if there were reported similar reactions after the second dose and if so, is it something that gets away quickly and was asking if this will dissipate soon or should she see her eye doctor. Further stated that she looked up generic side effects online and it is mentioned in different places. The outcome of the events vitreous floaters and eye disorder was not recovered whereas, outcome for remaining events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: hives all over body; headaches; Chills; muscle aches; pain; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 14-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiry Date was not provided), via an intramuscular route of administration, administered in left arm, on 21May2021 at 14:30 (age at vaccination was 14 Years) as dose 1, single for COVID-19 immunization. Relevant medical history included Chronic migraines (Occipital nerve block (02Nov2020) from 08Aug2021 to ongoing, Anxiety, ADHD and EDS and eczema from 04Jan2020 to ongoing. Patient had known allergies with dairy Products. Concomitant medications included Lisdexamfetamine mesilate (VYVANSE) for ADHD, Desvenlafaxine for Anxiety, Botulinum toxin type A (BOTOX) for Migraine (Every 3 mo), Desvenlafaxine succinate monohydrate (PRISTIQ) (100mg), Norethisterone acetate (NORETHINDRONE [NORETHISTERONE ACETATE]) (5mg) and Ketorolac tromethamine (TORADOL) (15.75mg). The patient did not receive any other vaccines in four weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. The vaccine was not administered at Military Facility. On 22May2021, patient experienced Chills, muscle aches, pain, fatigue and headaches and on 23May2021, patient experienced hives all over body. It was reported that the patient started having bouts of hives within 2 days after her first dose of the COVID-19. It was not realized they were hives, because she has had skin issues in the past. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for event Chronic Hives with Singular 10mg and Zertec 10mg. The outcome of hives all over body was recovered on an unspecified day in 2021 while for remaining events outcome was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over body; headaches; Chills; muscle aches; pain; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 14-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiry Date was not provided), via an intramuscular route of administration, administered in left arm, on 21May2021 at 14:30 (age at vaccination was 14 Years) as dose 1, single for COVID-19 immunization. Relevant medical history included Chronic migraines (Occipital nerve block (02Nov2020) from 08Aug2021 to ongoing, Anxiety, ADHD and EDS and eczema from 04Jan2020 to ongoing. Patient had known allergies with dairy Products. Concomitant medications included Lisdexamfetamine mesilate (VYVANSE) for ADHD, Desvenlafaxine for Anxiety, Botulinum toxin type A (BOTOX) for Migraine (Every 3 mo), Desvenlafaxine succinate monohydrate (PRISTIQ) (100mg), Norethisterone acetate (NORETHINDRONE [NORETHISTERONE ACETATE]) (5mg) and Ketorolac tromethamine (TORADOL) (15.75mg). The patient did not receive any other vaccines in four weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. The vaccine was not administered at Military Facility. On 22May2021, patient experienced Chills, muscle aches, pain, fatigue and headaches and on 23May2021, patient experienced hives all over body. It was reported that the patient started having bouts of hives within 2 days after her first dose of the COVID-19. It was not realized they were hives, because she has had skin issues in the past. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for event Chronic Hives with Singular 10mg and Zertec 10mg. The outcome of hives all over body was recovered on an unspecified day in 2021 while for remaining events outcome was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I experience swelling under my left arm; This is a spontaneous report from a contactable consumer (Patient).  A 38-year-old patient of an unspecified gender received BNT162B2 (Pfizer/BioNTech COVID-19 Formulation: Solution for injection, Batch/Lot Number: EL8982 Expiration Date: Unknown) via an unspecified route of administration, administered in Upper Left Arm on 14Jan2021 at 16:30 (at the age of 38-year-old) as dose 1 single for covid-19 immunization.  Patients Medical history and concomitant medications were not reported. After receiving first dose patient experienced swelling under left arm in Jan2021.Patient received 2nd dose (31Jan2021), 4-6 hours later patient  had headache, body aches, low grade fever, severe swelling under left arm, pain in arm to include fingers and fatigue. These symptoms persisted until 04Feb2021. An outcome of an event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Electrocardiogram normal, Feeling abnormal, Headache
Clinical narrative: both of us feel pretty bad for 3days; Severe headache; Joint pain; Chills; Nausea; he is in terrible shape; This is a spontaneous report from a contactable consumer or other non hcp (wife). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0217, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 23Jun2021 (at the age of 76 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history includes chronic obstructive pulmonary disease, Heart problems and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; tamsulosin (TAMSULOSIN) taken for an unspecified indication, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for an unspecified indication, start and stop date were not reported; hydralazine (HYDRALAZINE) taken for blood pressure measurement, start and stop date were not reported; clarithromycin (CLAVIX [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine prior to vaccination. On an unspecified date reporter stated, I am calling concerning my husband, my husband and I had the Pfizer vaccine Wednesday, and both of us feel pretty bad for 3days, he is in terrible shape, he is got severe headache, joint pain, chills, nausea. He is gone out of house on day since Wednesday, since last two day he haven't gone out of the house. As a treatment the patient received Tylenol for the events. The patient underwent lab tests and procedures which included electrocardiogram normal results unknown on Feb2021 He just had a heart procedure, magnetic resonance imaging results as unknown on Feb2021 MRI of back because of the accident. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Malaise, Nausea
Clinical narrative: both of us feel pretty bad for 3days; Severe headache; Joint pain; Chills; Nausea; he is in terrible shape; This is a spontaneous report from a contactable consumer or other non hcp (wife). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0217, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 23Jun2021 (at the age of 76 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history includes chronic obstructive pulmonary disease, Heart problems and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; tamsulosin (TAMSULOSIN) taken for an unspecified indication, start and stop date were not reported; levetiracetam (LEVETIRACETAM) taken for an unspecified indication, start and stop date were not reported; hydralazine (HYDRALAZINE) taken for blood pressure measurement, start and stop date were not reported; clarithromycin (CLAVIX [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine prior to vaccination. On an unspecified date reporter stated, I am calling concerning my husband, my husband and I had the Pfizer vaccine Wednesday, and both of us feel pretty bad for 3days, he is in terrible shape, he is got severe headache, joint pain, chills, nausea. He is gone out of house on day since Wednesday, since last two day he haven't gone out of the house. As a treatment the patient received Tylenol for the events. The patient underwent lab tests and procedures which included electrocardiogram normal results unknown on Feb2021 He just had a heart procedure, magnetic resonance imaging results as unknown on Feb2021 MRI of back because of the accident. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Computerised tomogram, Pain, Rash, Urine analysis
Clinical narrative: Just broke down in a rash all over; Area was sores in pain; I started hurting in like next day; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0180) via an unspecified route of administration, administered in left arm (left shoulder) on 25Jun2021 10:30 in the morning (at the age of 60-years-old)) as dose 2, single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0177) via an unspecified route of administration, administered in upper left arm on 04Jun2021 10:00 in the morning (at the age of 60-years-old)) as dose 1, single dose for covid-19 immunization and experienced no adverse events. The patient's medical history included diabetes, blood pressure high and cholesterol from an unknown date and unknown if ongoing. Consumer stated that prior to vaccination she had an IV when she had CT scan. They just call it a contrast. When probed if the consumer has received any other vaccine 4 weeks prior to COVID shot, consumer stated as she had another one, and also stated had two injections. Patient confirmed that the 2 injections consumer is mentioning about are Pfizer covid vaccine. The patient's concomitant medications included metformin 850mg (METFORMIN) one, twice a day taken for diabetes, lisinopril (LISINOPRIL) 10 mg, once daily taken for hypertension and atorvastatin (ATORVASTATIN) 10 mg, once a day taken for cholesterol and start and stop date were not reported. On 25Jun2021, the patient experienced just broke down in a rash all over, area was sores in pain and started hurting in like next day. Patient stated that after the vaccine, it was the 25Jun, around 10 to 10:30 in morning, she started hurting in like next day. Patient concerned that everything was fine with the first vaccine but since yesterday (second shot) just had broke down in a rash all over. Consumer stated that she needs to get a cure to get rid of this rash and she still have a rash all over and she doesn't understand what was going on and why she was breaking out in rash. The patient underwent lab tests and procedures which included blood sugar and urine analysis results unknown on unspecified date, computerised tomogram (CT scan) on 21Jun2021 but not yet received results and patient stated will receive it on monday. It was reported investigation assessment as yes and antibody test to platelets factor iv was no. No treatment received for the events. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just broke down in a rash all over; Area was sores in pain; I started hurting in like next day; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0180) via an unspecified route of administration, administered in left arm (left shoulder) on 25Jun2021 10:30 in the morning (at the age of 60-years-old)) as dose 2, single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0177) via an unspecified route of administration, administered in upper left arm on 04Jun2021 10:00 in the morning (at the age of 60-years-old)) as dose 1, single dose for covid-19 immunization and experienced no adverse events. The patient's medical history included diabetes, blood pressure high and cholesterol from an unknown date and unknown if ongoing. Consumer stated that prior to vaccination she had an IV when she had CT scan. They just call it a contrast. When probed if the consumer has received any other vaccine 4 weeks prior to COVID shot, consumer stated as she had another one, and also stated had two injections. Patient confirmed that the 2 injections consumer is mentioning about are Pfizer covid vaccine. The patient's concomitant medications included metformin 850mg (METFORMIN) one, twice a day taken for diabetes, lisinopril (LISINOPRIL) 10 mg, once daily taken for hypertension and atorvastatin (ATORVASTATIN) 10 mg, once a day taken for cholesterol and start and stop date were not reported. On 25Jun2021, the patient experienced just broke down in a rash all over, area was sores in pain and started hurting in like next day. Patient stated that after the vaccine, it was the 25Jun, around 10 to 10:30 in morning, she started hurting in like next day. Patient concerned that everything was fine with the first vaccine but since yesterday (second shot) just had broke down in a rash all over. Consumer stated that she needs to get a cure to get rid of this rash and she still have a rash all over and she doesn't understand what was going on and why she was breaking out in rash. The patient underwent lab tests and procedures which included blood sugar and urine analysis results unknown on unspecified date, computerised tomogram (CT scan) on 21Jun2021 but not yet received results and patient stated will receive it on monday. It was reported investigation assessment as yes and antibody test to platelets factor iv was no. No treatment received for the events. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast swelling, Lymphadenopathy, Nervousness, Peripheral swelling
Clinical narrative: Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Fever 100.6 degrees; I am Nervous and worried getting the second dose; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiration Date: Aug2021) dose 1 via an unspecified route of administration, administered in left deltoid on 25Jun2021 as dose 1, single for COVID-19 immunization (at the age of 46-year-old). The patient medical history included hypothyroid from an unspecified date. Concomitant medication included levothyroxine, liothyronine (NP THYROID) 30 mg for unspecified indication, start and stop date was not reported. On 26Jun2021, the patient experienced swelling in lymph node left side where received the vaccine from her left side neck down to breast and then arm pit, fever 100.6 degrees, nervous and worried getting the second dose. The patient stated that, I received Pfizer first dose on 25Jun2021, and I think that I am having unusual reactions to the Pfizer vaccine (unspecified vaccine), It was yesterday on 26Jun2021. For unusual reactions, Nurse stated, swelling in the lymph node on the left side where I received the vaccine from my left side neck down to breast and then my arm pit and also fever like 100.6 degrees. Patient stated, I have another date about getting the second dose of Pfizer, I am nervous. I am scheduled for the second dose I think it is July, don't remember. I am worried getting the second dose. My husband also received with me the first dose of Pfizer and he is fine (why) only I have the adverse reactions. On 26Jun2021, the patient underwent lab tests and procedures which included fever: 100.6 Fahrenheit. Reporter seriousness for the event was unspecified. The outcome of all the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Fever 100.6 degrees; I am Nervous and worried getting the second dose; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; Swelling in lymph node left side where received the vaccine from my left side neck down to breast and then arm pit; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiration Date: Aug2021) dose 1 via an unspecified route of administration, administered in left deltoid on 25Jun2021 as dose 1, single for COVID-19 immunization (at the age of 46-year-old). The patient medical history included hypothyroid from an unspecified date. Concomitant medication included levothyroxine, liothyronine (NP THYROID) 30 mg for unspecified indication, start and stop date was not reported. On 26Jun2021, the patient experienced swelling in lymph node left side where received the vaccine from her left side neck down to breast and then arm pit, fever 100.6 degrees, nervous and worried getting the second dose. The patient stated that, I received Pfizer first dose on 25Jun2021, and I think that I am having unusual reactions to the Pfizer vaccine (unspecified vaccine), It was yesterday on 26Jun2021. For unusual reactions, Nurse stated, swelling in the lymph node on the left side where I received the vaccine from my left side neck down to breast and then my arm pit and also fever like 100.6 degrees. Patient stated, I have another date about getting the second dose of Pfizer, I am nervous. I am scheduled for the second dose I think it is July, don't remember. I am worried getting the second dose. My husband also received with me the first dose of Pfizer and he is fine (why) only I have the adverse reactions. On 26Jun2021, the patient underwent lab tests and procedures which included fever: 100.6 Fahrenheit. Reporter seriousness for the event was unspecified. The outcome of all the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Pallor, Tachycardia
Clinical narrative: Dizziness/lightheadedness; pallor; shaking; headache; vomiting; ringing in ears; shortness of breath; tachycardia; This is a spontaneous report from a contactable consumer (patient's parent). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in Left arm on 25Jun2021 at 12:00 as dose 1, single (at the age of 15-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. Since the vaccination, patient was not tested for COVID-19. There were no known allergies. The patient received no other medications in two weeks of vaccination. The patient received no other vaccine in four weeks of vaccination. The patient's medical history and concomitant medications were none. On 26Jun2021, at 01:00, the patient experienced dizziness/lightheadedness, pallor, shaking, headache, vomiting, ringing in ears, shortness of breath and tachycardia. The patient didn't receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vomiting
Clinical narrative: Dizziness/lightheadedness; pallor; shaking; headache; vomiting; ringing in ears; shortness of breath; tachycardia; This is a spontaneous report from a contactable consumer (patient's parent). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in Left arm on 25Jun2021 at 12:00 as dose 1, single (at the age of 15-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. Since the vaccination, patient was not tested for COVID-19. There were no known allergies. The patient received no other medications in two weeks of vaccination. The patient received no other vaccine in four weeks of vaccination. The patient's medical history and concomitant medications were none. On 26Jun2021, at 01:00, the patient experienced dizziness/lightheadedness, pallor, shaking, headache, vomiting, ringing in ears, shortness of breath and tachycardia. The patient didn't receive any treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy
Clinical narrative: she got her first Pfizer COVID shot and has had joint pain ever since; had knee and ankle problems that are now exasperated; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 51-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0181) (at the age of 51 years old), dose 1 via an unspecified route of administration, administered in arm left on 08Jun2021 as dose 1, single for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing seasonal allergies that she has had since age 12. She had a tetanus booster. She got the chills. Her husband had to put blankets on her and lay on her. It was when she was 27 years old. She did not have NDC, lot, and expiry for the Tetanus booster. They did not give that information to her. Because she was adopted, she had no medical history. The patient's concomitant medications were not reported. It was reported that a couple of weeks ago she got her first COVID shot and on 11Jun2021 has had joint pain ever since. She already had knee and ankle problems that was exasperated in 2021. Her left elbow and left wrist were bad and that was the arm she got it in. Her right elbow and right wrist were fine and those were the only joint, as well as her hips, that were not bothering her on an unspecified date. She had not changed anything. The only thing different was getting the shot. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No vaccination prior four weeks. The outcome for the event of she got her first Pfizer COVID shot and has had joint pain ever since was not recovered. The outcome for the event of had knee and ankle problems that are now exasperated was unknown.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastrointestinal disorder, Hunger, Nausea, Vaginal haemorrhage
Clinical narrative: vaginal bleeding; She has been having nausea; Feels hungry; she has intestinal issues here and there which is unusual for her; stomach feels queasy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 03Jun2021 (Age at vaccination 59-years-old), as dose 2, single for COVID-19 immunization. Medical history included muscle strain from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN) taken for muscle strain start and stop date were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 13May2021 (Age at vaccination 59-years-old), as dose 1, single for covid-19 immunization. In Jun2021, the patient was feels hungry, she had intestinal issues here and there which was unusual for her, stomach feels queasy. On 14Jun2021, the patient had been having nausea. On 21Jun2021, the patient experienced vaginal bleeding. Caller was calling about the Pfizer Covid-19 Vaccine. She wanted to call to see if some of the symptoms she was having has anything to do with the Covid shot. She does not know if they can or could not. This was unusual for her. She had been having nausea. She was fine but then it was after the last vaccination. 03Jun2021 was her second one. It was not at first and she was fine. It started the week of 14Jun2021 so about a week and a half after her shot. She started feeling nauseous and that is not usual for her. On 21Jun2021 she started having vaginal bleeding which she had not had in years. Just the one day. Nausea, she was still having today. It was about the same. It comes and goes and she still feels hungry but her stomach feels queasy and she has intestinal issues here and there which is unusual for her. Caller stated that was all of her symptoms and she did not know if she should call or if she should not but she thought she would call just to see. No treatment was received for the events. Clinical outcome of the events She has been having nausea, feels hungry was not recovered. Outcome of the event vaginal bleeding was recovered on 21Jun2021. Outcome of the events she has intestinal issues here and there which was unusual for her and stomach feels queasy was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Condition aggravated, Insomnia, Pain
Clinical narrative: has thrown up today; fever; chills; Fever chills was reported as worsened.; body ache; she couldn't sleep; This is a spontaneous report received from a contactable consumer (patient's mother).  A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0196), via an unspecified route of administration in arm left on 27Jun2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included migraine since an unknown date. Concomitant medication included topiramate (TOPIRAMATE) 25mg, 2 tablet by mouth at bedtime, nortriptyline (NORTRIPTYLINE) and meloxicam (MELOXICAM) 15mg 1 tab by mouth daily taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 15:00, the consumer reported that the patient received the 1st dose of Pfizer Covid Vaccine yesterday and experienced fever, chills, body ache, and has thrown up today on28Jun2021. Consumer wanted to know if these symptoms were normal for her daughter's age. Consumer wanted to know how long will her daughter's symptoms last and when will her daughter function normally again. The patient was vaccinated yesterday with the covid vaccine and she was having a fever now, she has been giving her Tylenol. The fever started late last night, as well as chills and she couldn't sleep. She did throw up a few minutes ago. Her daughter only threw up today, it was just one episode today. The First Dose was yesterday 27Jun2021 between 12:30 and 12:45 during the day. The fever and chills started yesterday around 3PM. On an unknown date, the patient underwent lab tests and procedures which included Temperature: 100.9 Fahrenheit. The patient received treatment for adverse events. Her temperature was higher but she feels the same, no chills today, the temperature was rising even with the Tylenol. The Last taken temperature was 100.9F, it was taken today an hour and a half ago. The outcome of events fever, chills and fever chills was reported as worsened. was not recovered and unknown for events body ache, has thrown up today, she couldn't sleep.  Follow-up (28Jun2021): This is a follow-up spontaneous report received from a contactable consumer (patient's mother). This report is not related to study or programme. No new events added.   Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: has thrown up today; fever; chills; Fever chills was reported as worsened.; body ache; she couldn't sleep; This is a spontaneous report received from a contactable consumer (patient's mother).  A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0196), via an unspecified route of administration in arm left on 27Jun2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included migraine since an unknown date. Concomitant medication included topiramate (TOPIRAMATE) 25mg, 2 tablet by mouth at bedtime, nortriptyline (NORTRIPTYLINE) and meloxicam (MELOXICAM) 15mg 1 tab by mouth daily taken for an unspecified indication, start and stop date were not reported. On 27Jun2021 15:00, the consumer reported that the patient received the 1st dose of Pfizer Covid Vaccine yesterday and experienced fever, chills, body ache, and has thrown up today on28Jun2021. Consumer wanted to know if these symptoms were normal for her daughter's age. Consumer wanted to know how long will her daughter's symptoms last and when will her daughter function normally again. The patient was vaccinated yesterday with the covid vaccine and she was having a fever now, she has been giving her Tylenol. The fever started late last night, as well as chills and she couldn't sleep. She did throw up a few minutes ago. Her daughter only threw up today, it was just one episode today. The First Dose was yesterday 27Jun2021 between 12:30 and 12:45 during the day. The fever and chills started yesterday around 3PM. On an unknown date, the patient underwent lab tests and procedures which included Temperature: 100.9 Fahrenheit. The patient received treatment for adverse events. Her temperature was higher but she feels the same, no chills today, the temperature was rising even with the Tylenol. The Last taken temperature was 100.9F, it was taken today an hour and a half ago. The outcome of events fever, chills and fever chills was reported as worsened. was not recovered and unknown for events body ache, has thrown up today, she couldn't sleep.  Follow-up (28Jun2021): This is a follow-up spontaneous report received from a contactable consumer (patient's mother). This report is not related to study or programme. No new events added.   Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: could hardly stand up; was extremely tired; bad headache; body aches; joint aches; Nausea; Vomiting, Threw up 3 times; light headed; very sleepy; freezing cold, chills; freezing cold, chills; hips hurt; very disoriented; This is a spontaneous report from a contactable consumer (patient's parent) reported for a patient. This is report 2 of 3. A 19-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0177, Expiration date: unknown) intramuscular, administered in upper right arm on 24May2021 at 10:30 am (age at vaccination was 19 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient's family medical history relevant to adverse events was unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) intramuscular, administered in upper left arm on 03May2021 at 10:30 am (age at vaccination was 18 years) as dose 1, single for COVID-19 immunization. The patient was a healthy kid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24May2021 at 22:00 pm, the patient had the worst reaction of a bad headache, body aches, joint aches, nausea, vomiting, threw up 3 times, hips hurt, very disoriented, freezing cold, chills and was light headed for 24 hours, she was just a mess for 24 hours. She was very sleepy. This was after the 2nd dose of the COVID 19 Vaccine. The patient received vaccine at 10:30 am on Monday and was at work by 11:30 am. She came around 19:00 pm on 24May2021 that evening and was freezing cold, also had chills and was tired. Within 4-5 hours she started feeling something. The reporter didn't think that the patient had nausea straight away but all happened on 24May2021 and by 22:00 pm had all symptoms. After going to bed, patient talked about throwing up and was very disoriented and thought she had to go to work. She got up the next morning, went to work, and was home within 30 minutes, she could hardly stand up at work on 25May2021 at 07:30 am. She came home around 07:30 am with body aches, joint aches, her hips hurt, a bad headache, was extremely tired, nauseas, and had chills. She never ran a temp though. The patient had Tylenol about every 6 hours during that time. Started off with 1 since she was so small but the reporter thought it was bad she was giving patient two and was probably giving her the extra strength so her guess was 500mg. The patient woke up on Wednesday 26May2021 and felt perfectly fine. So, 48 hours from vaccination time she felt fine. She stopped experiencing all symptoms and felt perfectly fine by 26May2021 at 08:00 am and recovered completely. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was resolved on 26May2021 at 8:00 am.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from an Agency (manufacturer control number: US-AMGEN-USASL2021097487). This case was split from master case 2021808247 for taking COVID-19 experienced itching all over.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose (unknown dose number) for COVID-19 immunization. Medical history and family history was not reported. Concomitant medications included: Etanercept (ENBREL) on an unknown date in 2006 (15 years ago prior to this report). On an unknown date, the patient had itching all over. The patient did not receive any treatment for event. Outcome of event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, White blood cell count
Clinical narrative: fatigue; This is a spontaneous report from a Pfizer- sponsored program Support Program. A contactable  reporter reported for a female patient that: A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Patient also took palbociclib (IBRANCE), (Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date to an unspecified date, at 125 mg for Malignant neoplasm of unspecified site of unspecified female breast. The patient medical history and concomitant medications were not reported. The patient experienced fatigue on an unspecified date. Patient further stated that during patient side effect follow up call, patient reported an improvement in her previously reported side effects. Symptoms included: Nausea, fatigue, and abnormal white count. She reports an improvement with fatigue after dietary changes and a medication prescribed by her doctor. She noted that she did feel fatigue after her second dose of COVID-19 vaccine, but otherwise with the medication she noted improvement in her fatigue. Finally, her white count on follow up labs was appropriate to continue therapy. The patient underwent lab tests and procedures which included white blood cell count: abnormal on an unspecified date. Patient received treatment for the events. Outcome of event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Cardiac disorder, Hypoaesthesia, Swelling face
Clinical narrative: Felt like someone was squeezing my heart; Heart felt like pressure, left side center chest, felt like someone kept squeezing my heart; Felt like someone was squeezing my heart/ Heart felt like pressure, left side center chest; Had some facial numbness; Bottom of my nose and my above my lip the moustache area felt kind of numb and puffy but it didn't look puffy; My nose and my above my lip the moustache are a felt kind of numb and puffy but it didn't look puffy; This is a spontaneous case received from contactable consumer (patient). A 47-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0181) via an unspecified route of administration, administered in left arm (left shoulder) on 28Jun2021 at 20:30 (age at vaccination 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included allergies and breathing difficulty. Concomitant medications included nasal steroid spray for allergies and breathing, and some multivitamins. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration, administered in left arm (left shoulder) on 07Jun2021 at 20:30 for COVID-19 immunization and experienced facial numbness. Family medical history related to adverse event included, consumer reported that his mother gets anaphylactic shock from bee sting or something. Prior vaccinations within 4 weeks were reported as none. On an unspecified date in Jun2021, the patient reported that he had some facial numbness; bottom of his nose and above his lip the moustache area felt kind of numb and puffy, but it didn't look puffy. On 28Jun2021 at 21:15, the patient reported that, he felt like someone was squeezing his heart; Heart felt like pressure, left side center chest, felt like someone kept squeezing his heart. The patient did not receive any treatment for the event. The outcome of the event (Had some facial numbness; Bottom of my nose and my above my lip the moustache area felt kind of numb and puffy but it didn't look puffy) was recovered on an unspecified date in Jun2021 and event (Felt like someone was squeezing my heart; Heart felt like pressure, left side center chest, felt like someone kept squeezing my heart) was recovered on 28Jun2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: DTAP, MMR
Symptoms: Autism spectrum disorder, Injury
Clinical narrative: autism; was injured physically; This spontaneous report was received from a consumer (patient's father) via Pfizer and refers to a male patient who was 18 years old at the time of the report. The patient's historical condition, concomitant medications, allergies or drug reactions were not reported. In approximately 2004 (reported as "16 or 17" years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis and/or diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (dose, route of administration, lot # and expiration date was not reported for both vaccines). On an unknown date, in approximately 2004 (reported as "16 or 17 years ago" and "within 36 hours"), the patient was injured physically. On an unknown date, the patient experienced autism (also reported as current condition, however the given dates, type of event an context of the report indicated that it could be an event). The outcome of autism spectrum disorder was considered as not recovered/not resolved. The outcome of unspecified physical injury was unknown. It was additionally reported, that "health-wise on autism portion, his son is pretty healthy". The causality assessment was unknown.  Upon internal review, the event of autism was considered to be medically significant.