chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchiness across body; Itchiness  at injection site; sore swollen throat.; Swollen throat; Spine pain; Back inflammation; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: unknown) via an unspecified route of administration in the arm left on 10Apr2021 at 16:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included seizures (temporal limbic/parietal), tourettism (Tourettes Bipolar), post-traumatic stress disorder (Ptsd Seizures), asperger's disorder, obsessive-compulsive disorder, autism, social anxiety disorder (Social anxiety), panic attacks, claustrophobia (Severe claustrophobia), migraine, psychosis, pre-diabetes (hyperglycemic), prostatitis (Prosttitus), irritable bowel syndrome, neuropathy (Severe neuropathy), syncope vasovagal, fainting, dizzy, fever, lower back extra vertebra fused to L5, issues heart condition, loose joints syndrome (high risk break/sprain disorder i.e. elderly youth syndrome), ulcer (issues with ulcers: spicy, citrus, soda, allergy to garlic flavoured cigs), milk allergy, allergy to plants (citrus, hemp, weed, corn), allergy to nuts (walnuts, almonds, cashews), allergy to meat (beef, pork), allergy to vegetable (onion, garlic, carrots), allergy to animal (elm mold, ragweed dog, cat goose) and allergy to all forms of perfume and cologne most forms of incense vape fluids near-lethal allergy to some forms of flavoured cigarettes (throat seals, blackout, cannot breathe). Concomitant medications included buspirone 5 mg, doxycycline and diclofenac sodium (DYCLO). The patient previously took cyclobenzaprine (seizure hiccups, severe fever), meloxicam (seizures, severe suicidal depression, severe fever), diclofenac (seizures, severe fever), gabapentin /neurontin (seizure spasms and convulsive diarrhea), omeprazole (seizure hiccups, severe constipation, stomach pain) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 17:15, the patient experienced itchiness across body, itchiness at injection site, sore throat, swollen throat, spine pain and back inflammation. Therapeutic measures were taken as a result of events and included treatment with itch cream, ice packs, pain medication. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itchiness across body, itchiness at injection site, sore throat, swollen throat, spine pain and back inflammation was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Arm and neck pain; Neck pain; Fever; Chills; Nausea; This is a spontaneous case received from a contactable consumer (patient). This is the first of two reports. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the right arm on 09Mar2021 at 12:00 PM (at the age of 42-year-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included one kidney, lost left kidney to cancer, mitral valve prolapse and left ventricle blockage on heart. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unknown indication. The patient previously took tetracycline on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 12:00, the patient experienced arm and neck pain instantly after first shot. On an unknown date in Mar2021, the patient experienced fever, chills and nausea. It was unknown whether any therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021413382 same patient, different drug(dose)/events
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Dysphagia, Myalgia, Neck pain
Clinical narrative: the muscle on the right side of my neck was sore to the point where it hurt to swallow; the muscle on the right side of my neck was sore to the point where it hurt to swallow; the soreness is worse, feels like a burning sensation on the right side of my neck; neck is tender to the touch and movement; dry cough; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. A 29-years-old non pregnant female patient received (not pregnant at the time of vaccination) bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6198) (at the age of 29-years-old) as dose 1, single for covid-19 immunisation. The patient medical history reported as none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date in Mar2021, about a week after her first injection the patient noticed that the muscle on the right side of her neck was sore to the point where it hurt to swallow. She originally thought she was sleeping on her pillow wrong. However, the soreness was worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat do help the pain throughout the day. The patient received treatment of advil for the events muscle soreness, swallowing difficulty, burning sensation and neck pain. The patient underwent lab tests and procedures which included nasal swab test (sars-cov-2 test): negative on 07Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: the muscle on the right side of my neck was sore to the point where it hurt to swallow; the muscle on the right side of my neck was sore to the point where it hurt to swallow; the soreness is worse, feels like a burning sensation on the right side of my neck; neck is tender to the touch and movement; dry cough; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. A 29-years-old non pregnant female patient received (not pregnant at the time of vaccination) bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6198) (at the age of 29-years-old) as dose 1, single for covid-19 immunisation. The patient medical history reported as none. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date in Mar2021, about a week after her first injection the patient noticed that the muscle on the right side of her neck was sore to the point where it hurt to swallow. She originally thought she was sleeping on her pillow wrong. However, the soreness was worse, feels like a burning sensation on the right side of her neck. The dry cough does make this worse and her neck is tender to the touch and movement. Advil and heat do help the pain throughout the day. The patient received treatment of advil for the events muscle soreness, swallowing difficulty, burning sensation and neck pain. The patient underwent lab tests and procedures which included nasal swab test (sars-cov-2 test): negative on 07Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Gastric dilatation, Pain
Clinical narrative: Joint pain; severe stomach pain; Right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch; Diarrhea; throwing up; hurting/pain; stomach is distended; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender 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 05Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included magnesium taken for an unspecified indication. The patient had previously received first 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 1, single for COVID-19 immunization. On 06Apr2021 after the second dose of vaccination, the patient experienced joint pain. On an unspecified date in Apr2021, severe stomach pain, right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch, diarrhea, throwing up, hurting/pain and stomach was distended. It was reported that, the patient stated had second dose of Pfizer vaccine on Monday and Tuesday woke up. Patient thought in the late afternoon, patient had severe joint pain which was like there when woke up. Next day patient took some magnesium, took two teaspoons of the magnesium supplement last night with Smarter and woke up in the middle of the night with severe stomach pain and it went throughout the morning and then it continued to start get little better but patient stomach was distended and right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch. Patient have been putting ice pack, cold water bottle. Patient have been putting frozen thing on stomach to get reduce the pain. Patient have diarrhea and throwing up. Patient stated about the COVID-19 vaccine shot and the side effects and the combination as of yesterday with magnesium supplement. The outcome of all events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Joint pain; severe stomach pain; Right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch; Diarrhea; throwing up; hurting/pain; stomach is distended; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender 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 05Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included magnesium taken for an unspecified indication. The patient had previously received first 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 1, single for COVID-19 immunization. On 06Apr2021 after the second dose of vaccination, the patient experienced joint pain. On an unspecified date in Apr2021, severe stomach pain, right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch, diarrhea, throwing up, hurting/pain and stomach was distended. It was reported that, the patient stated had second dose of Pfizer vaccine on Monday and Tuesday woke up. Patient thought in the late afternoon, patient had severe joint pain which was like there when woke up. Next day patient took some magnesium, took two teaspoons of the magnesium supplement last night with Smarter and woke up in the middle of the night with severe stomach pain and it went throughout the morning and then it continued to start get little better but patient stomach was distended and right underneath breast the ribcage area was painful and where it meet in the center was painful to the touch. Patient have been putting ice pack, cold water bottle. Patient have been putting frozen thing on stomach to get reduce the pain. Patient have diarrhea and throwing up. Patient stated about the COVID-19 vaccine shot and the side effects and the combination as of yesterday with magnesium supplement. The outcome of all events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: my left arm are broke out into rash and my forearm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in left arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included metoprolol, one tablet a day, 50mg, orally taking about from 5 years for high blood pressure; amlodipine, 2.5 mg, one tablet a day, orally just started this at the same time when took Pfizer injection for high blood pressure. Reporter have got first shot of Pfizer injection on left arm are broke out into rash and forearm and then after patient got the second injection the first injection was in the first of the month last month and the last injection was on the 26th and patient got injected in the opposite arm and that broke up in rash. Patient still have the rash and want to see primary doctor and he suggested see a dermatologist. The patient had rash on both of arms. The patient have an appointment on 13th of this month to see a dermatologist. The patient had a reaction to the drug. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: hands and fingers started hurting and swelling with knots on the joints; hands and fingers started hurting and swelling with knots on the joints; hands and fingers started hurting and swelling with knots on the joints; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6198), via unspecified route of administration, in right arm on 17Feb2021 at 11:30 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included pacemaker (Cardiac pacemaker insertion), partial removal of thyroid and neuroendrocrine cancer (had neuroendrocrine cancer in 2013). The concomitant medication of the patient included Levothyroxine 75mcg, and metoprolol succinate ER Tab 25mg within two weeks of vaccination. 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 and since the vaccination the patient was not tested for COVID-19. Allergies to medications, food, or other products were reported as None.On 18Feb2021 at 05:00 the patient experienced hands and fingers started hurting and swelling with knots on the joints. Patient stated that her thumbs were especially bad where patient even had a hard time getting dressed. Patient didn't think much about it having anything to do with the COVID vaccine. Patient stated that she never had this problem with her hands and it was interfering with daily activities. Patient stated that her hand was bothering her. Patient was not able to open anything. Patient had trouble picking up things and drop them. Patient had hard time to pull pants up or button the shirts. The hands of the patient were ache constantly. The patient did not receive any treatment for the reported events. The patient had the physician office visit for the reported events. Patient received the dose 2 of BNT162B2 on 10March2021 at 11:30 AM in right arm with lot number EN620Y. The outcome for all the reported events was not recovered.  No follow up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Eye pruritus, Headache, Hypoaesthesia
Clinical narrative: right side of her face was swollen and rugged; right side of her face was swollen and rugged; eyes were itchy; inside of her nose felt a little itchy and numb; inside of her nose felt a little itchy and numb; headache; lethargic; throat started swelling; pale; legs were shaking; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included swelling (something similar happened to her 10 years ago) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that on 12Apr2021, the patient experienced after 10 minutes she had a small headache and was feeling lethargic. After 30 minutes her throat started swelling / picking up, so they went back to the clinic. One hour later, she was very pale, and her legs were shaking. On 13Apr2021, the patient experienced right side of her face was swollen and rugged, eyes were itchy, inside of her nose felt a little itchy and numb. He gave her some leftover Cetirizine Hydrochloride for the swelling which was in a small region but very swollen. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure was 120/75 which was normal, temperature was 98 Fahrenheit (which was normal), oxygen was 98%. Therapeutic measures were taken as a result of events includes 2 pills of Benadryl with an unknown strength. It was stated that, she slept the whole day and the whole night due to the Benadryl and some leftover Cetirizine Hydrochloride. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oxygen saturation, Pallor, Pharyngeal swelling, Pruritus
Clinical narrative: right side of her face was swollen and rugged; right side of her face was swollen and rugged; eyes were itchy; inside of her nose felt a little itchy and numb; inside of her nose felt a little itchy and numb; headache; lethargic; throat started swelling; pale; legs were shaking; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included swelling (something similar happened to her 10 years ago) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that on 12Apr2021, the patient experienced after 10 minutes she had a small headache and was feeling lethargic. After 30 minutes her throat started swelling / picking up, so they went back to the clinic. One hour later, she was very pale, and her legs were shaking. On 13Apr2021, the patient experienced right side of her face was swollen and rugged, eyes were itchy, inside of her nose felt a little itchy and numb. He gave her some leftover Cetirizine Hydrochloride for the swelling which was in a small region but very swollen. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure was 120/75 which was normal, temperature was 98 Fahrenheit (which was normal), oxygen was 98%. Therapeutic measures were taken as a result of events includes 2 pills of Benadryl with an unknown strength. It was stated that, she slept the whole day and the whole night due to the Benadryl and some leftover Cetirizine Hydrochloride. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Skin fissures, Swelling face
Clinical narrative: right side of her face was swollen and rugged; right side of her face was swollen and rugged; eyes were itchy; inside of her nose felt a little itchy and numb; inside of her nose felt a little itchy and numb; headache; lethargic; throat started swelling; pale; legs were shaking; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included swelling (something similar happened to her 10 years ago) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that on 12Apr2021, the patient experienced after 10 minutes she had a small headache and was feeling lethargic. After 30 minutes her throat started swelling / picking up, so they went back to the clinic. One hour later, she was very pale, and her legs were shaking. On 13Apr2021, the patient experienced right side of her face was swollen and rugged, eyes were itchy, inside of her nose felt a little itchy and numb. He gave her some leftover Cetirizine Hydrochloride for the swelling which was in a small region but very swollen. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure was 120/75 which was normal, temperature was 98 Fahrenheit (which was normal), oxygen was 98%. Therapeutic measures were taken as a result of events includes 2 pills of Benadryl with an unknown strength. It was stated that, she slept the whole day and the whole night due to the Benadryl and some leftover Cetirizine Hydrochloride. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 62-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 62, via an unspecified route of administration, in right arm, on Apr 7, 2021, single dose, for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing (diagnosed probably in 1985, but does not know the exact date). Concomitant medications included losartan 100 mg tablet, one time daily for high blood pressure, start and stop date not reported. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On Apr 7, 2021, patient experienced headache, body ache, combination of fever and chills. The patient reported she was trying to report an adverse event after having the COVID-19 vaccine yesterday (Apr 7, 2021). She was having an adverse reaction and trying to report the adverse event triggered by the vaccine. The outcome of the events: not resolved. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: tongue was swollen; This is a spontaneous report from a Pfizer sponsored program  via non-contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tongue was swollen. It was reported that patient tongue was swollen after first dose and the second dose of vaccine was coming up. Reporter wonders if patient should get 2nd dose. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Headache; Joint ache; Muscle ache; Warmth, swelling, & redness at injection site, which remains, but improving.; Warmth, swelling, & redness at injection site, which remains, but improving.; Warmth, swelling, & redness at injection site, which remains, but improving.; This is a spontaneous report from a non-contactable consumer (patient herself). This is first of two reports.  A 66-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8729, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 07Apr2021 19:45 (Age at vaccination 66-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Medical history included Known allergies sulfa , factor v leiden carrier from an unknown date and unknown if ongoing Leiden Factor V. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included warfarin, ascorbic acid (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D3), vitamin b complex (VITAMIN B [VITAMIN B COMPLEX]), diphenhydramine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pseudoephedrine and experienced drug allergy, first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8729, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 17Mar2021 (Age at vaccination 66-years-old) as dose 1, single for covid-19 immunization and experienced myalgia, arthralgia, headache. On 08Apr2021 at 02:00, the patient experienced head, joint and muscle aches worse than first injection, very painful for first 24 hours then slowly diminished and almost gone, about 65 hours later. The patient also experienced warmth, swelling and redness at injection site which remained, but was improving. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Headache; Joint ache; Muscle ache; Warmth, swelling, & redness at injection site, which remains, but improving.; Warmth, swelling, & redness at injection site, which remains, but improving.; Warmth, swelling, & redness at injection site, which remains, but improving.; This is a spontaneous report from a non-contactable consumer (patient herself). This is first of two reports.  A 66-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8729, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 07Apr2021 19:45 (Age at vaccination 66-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Medical history included Known allergies sulfa , factor v leiden carrier from an unknown date and unknown if ongoing Leiden Factor V. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included warfarin, ascorbic acid (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D3), vitamin b complex (VITAMIN B [VITAMIN B COMPLEX]), diphenhydramine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pseudoephedrine and experienced drug allergy, first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8729, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 17Mar2021 (Age at vaccination 66-years-old) as dose 1, single for covid-19 immunization and experienced myalgia, arthralgia, headache. On 08Apr2021 at 02:00, the patient experienced head, joint and muscle aches worse than first injection, very painful for first 24 hours then slowly diminished and almost gone, about 65 hours later. The patient also experienced warmth, swelling and redness at injection site which remained, but was improving. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: my torso, arms, neck, and face began to itch/the same symptoms began; this time a rash appeared; my hands swelled twice the normal size; This is a spontaneous report from a non-contactable consumer (patient). This female consumer (patient) reported that: A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 10Apr2021 09:00 (38-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history included sulfur allergy and allergy to beauty products (Sulfur of all types in medications, foods, health and beauty products) from an unspecified date and unknown if ongoing. Concomitant medications included calcium (CALCIUM); vitamin d nos (VITAMIN D NOS); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 20Mar2021 09:00 (38-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunization and experienced pruritus and peripheral swelling. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient received other medications in two weeks. On 10Apr2021 17:00 after the second dose of vaccination, the patient experienced my torso, arms, neck, and face began to itch/the same symptoms began, this time a rash appeared and my hands swelled twice the normal size. The patient received treatment for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Headache, Hyperhidrosis
Clinical narrative: feeling clammy; sweaty; High fever of 105 degrees when I woke up the following morning. Fever persisted all day and night averaging around 103 degrees; Body aches; headache; chills; This is a spontaneous report from contactable consumer (patient) reported for herself that:  A 42-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 09Apr2021 11:30 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 42 years). Facility where the most recent COVID-19 vaccine was administered Information: Hospital The patient past medical history included Lupus from an unknown date and unknown if ongoing. There were no allergies to medications, food and other products. The concomitant medication was none. The patient previously treated with BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 20Mar2021 06:30 AM (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 10Apr2021, the patient experienced High fever of 105 degrees when she woke up the following morning fever persisted all day and night averaging around 103 degrees. Body aches, headache and chills. After 48 hours after the shot on 11Apr2021 she woke up feeling clammy and sweaty for about 10 hours. The patient underwent lab tests and procedures which included body temperature: 105 (High fever of 105 degrees when I woke up the following morning) and  body temperature: 103 (Fever  persisted all day and night averaging  around 103 degrees) on 10Apr2021. No treatment was reported. The outcome for the event fever, Body aches, headache and chills recovered on unspecified date in 2021 and feeling clammy and sweaty recovered on 11Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feeling clammy; sweaty; High fever of 105 degrees when I woke up the following morning. Fever persisted all day and night averaging around 103 degrees; Body aches; headache; chills; This is a spontaneous report from contactable consumer (patient) reported for herself that:  A 42-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 09Apr2021 11:30 (Batch/Lot Number: ER8729) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 42 years). Facility where the most recent COVID-19 vaccine was administered Information: Hospital The patient past medical history included Lupus from an unknown date and unknown if ongoing. There were no allergies to medications, food and other products. The concomitant medication was none. The patient previously treated with BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 20Mar2021 06:30 AM (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks. On 10Apr2021, the patient experienced High fever of 105 degrees when she woke up the following morning fever persisted all day and night averaging around 103 degrees. Body aches, headache and chills. After 48 hours after the shot on 11Apr2021 she woke up feeling clammy and sweaty for about 10 hours. The patient underwent lab tests and procedures which included body temperature: 105 (High fever of 105 degrees when I woke up the following morning) and  body temperature: 103 (Fever  persisted all day and night averaging  around 103 degrees) on 10Apr2021. No treatment was reported. The outcome for the event fever, Body aches, headache and chills recovered on unspecified date in 2021 and feeling clammy and sweaty recovered on 11Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Insomnia, Lethargy
Clinical narrative: Arm became very heavy; Became lethargic; Became drowsy; My hands were shaking (could not hold glass); Fever: within 24 hours fever shot to 103.2; Extreme pain in my joints like my entire bone structure was about to collapse; unable to sleep due to pain; Headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 65-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN4199, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 09:00 (at the age of 65 years) as dose 2, single for covid-19 immunization in hospital. Medical history included osteoporosis, osteoarthritis, Hashimoto thyroiditis and known allergies all from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included alendronate sodium (ALENDRONATE SODIUM) tablet and levothyroxine sodium (SYNTHROID) both were taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6201, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:00 (at the age of 65 years) as dose 1, single for covid-19 immunization and experienced Pain and swelling for about 3days at injection location. After exactly one week she took Alendronate Sodium within the hour the injection location swelled up into a hard ball with intense itching. This lasted several days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced arm became very, became lethargic, became drowsy, my hands were shaking (could not hold glass), and on an unspecified date in Mar2021, the patient experienced fever, within 24 hours fever shot to 103.2, unable to sleep due to pain, headaches, extreme pain in my joints like my entire bone structure was about to collapse. It was reported that, after 3 hours of vaccination arm became very heavy, became lethargic and drowsy. By the evening my hands were shaking (could not hold glass), fever: within 24 hours fever shot to 103.2 - responded well to Tylenol. For 48 hours experienced extreme pain in my joints like her entire bone structure was about to collapse- unable to sleep due to pain, severe headaches etc. Patient was asking had anyone else reported interaction with Alendronate sodium (unspecified if she experienced). Having had this reaction when could I restart taking it safely? No treatment was received for the event. Clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pyrexia, Somnolence, Tremor
Clinical narrative: Arm became very heavy; Became lethargic; Became drowsy; My hands were shaking (could not hold glass); Fever: within 24 hours fever shot to 103.2; Extreme pain in my joints like my entire bone structure was about to collapse; unable to sleep due to pain; Headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 65-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN4199, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 09:00 (at the age of 65 years) as dose 2, single for covid-19 immunization in hospital. Medical history included osteoporosis, osteoarthritis, Hashimoto thyroiditis and known allergies all from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included alendronate sodium (ALENDRONATE SODIUM) tablet and levothyroxine sodium (SYNTHROID) both were taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6201, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:00 (at the age of 65 years) as dose 1, single for covid-19 immunization and experienced Pain and swelling for about 3days at injection location. After exactly one week she took Alendronate Sodium within the hour the injection location swelled up into a hard ball with intense itching. This lasted several days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced arm became very, became lethargic, became drowsy, my hands were shaking (could not hold glass), and on an unspecified date in Mar2021, the patient experienced fever, within 24 hours fever shot to 103.2, unable to sleep due to pain, headaches, extreme pain in my joints like my entire bone structure was about to collapse. It was reported that, after 3 hours of vaccination arm became very heavy, became lethargic and drowsy. By the evening my hands were shaking (could not hold glass), fever: within 24 hours fever shot to 103.2 - responded well to Tylenol. For 48 hours experienced extreme pain in my joints like her entire bone structure was about to collapse- unable to sleep due to pain, severe headaches etc. Patient was asking had anyone else reported interaction with Alendronate sodium (unspecified if she experienced). Having had this reaction when could I restart taking it safely? No treatment was received for the event. Clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: tiredness; fever; nausea; This is a spontaneous report from a Pfizer-sponsored program  via contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced tiredness, fever and nausea. It was reported that the reporter on behalf of his companion inquired how long does the patient have to wait until she can see her physician. Asked if the patient needs to wait for 7 days. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: I got bruise in my arm; This is a spontaneous report from a contactable Reporter (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6207, expiration date: 30Jul2021), via an unspecified route, administered in right arm on 20Mar2021 (at the age of 68 years) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after his vaccine nine six days after, he got a question as he got bruise in his arm for the vaccination. His next vaccination was on Saturday (10Apr2021) at 1:30. He asked was that ok if he go or he need to cure the bruise, or it would go away. He said, I do not know I need to wait until the bruise goes away or can I get it anyway if I have in my arm the bruise. Reporter stated, this is going to be 2nd one, I am going to get on Saturday 10Apr2021 at 1:30 I have appointment. The patient did not receive treatment for adverse event. The outcome of event was unknown.  QR Comment: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts were possible. No further information was expected.