chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chest tightness; Shortness of breath; Fever; Fatigue; Muscle and joint pain; Muscle and joint pain; Brain fog; nausea; headache; costochondritis; random pain in both upper extremities; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 35-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ew0153), via an unspecified route of administration, administered in Arm Right on 23Mar2021 13:30 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6207), via an unspecified route of administration, administered in Arm Right on 13Apr2021 13:30 (both doses at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity (ADD), asthma, intervertebral disc degeneration from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN), beclometasone dipropionate (QVAR) Inhaler, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced, on 13Apr2021 16:30, chest tightness, shortness of breath, fever, fatigue, muscle and joint pain, brain fog, nausea, headache that persisted until 17Apr2021 and costochondritis pain began 16Apr2021 and diagnosed on 20Apr2021, and is still persisting along with intermittent brain fog, fatigue, and random pain in both upper extremities. Treatment was received for the events as Albuterol, ibuprofen, declined oral prednisone. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was reported as not recovered.  No follow-up attempt are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Heart rate, Tachycardia, Vertigo, Vomiting
Clinical narrative: had a tachycardia episode that lasted 10 minutes with a BPM of 214; vertigo; vomiting; Due to the spinning and imbalance I could not get out of bed for 8 days; Due to the spinning and imbalance I could not get out of bed for 8 days; This is a spontaneous report from a contactable consumer (patient) or other non healthcare professional. A 63 year old non-pregnant female patient received bnt162b2 (Solution for injection, Age at Vaccination: 63 years), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 08:30 (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included tachycardia from an unknown date and unknown if ongoing , hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) 75mcg taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). No other vaccine in four weeks. The patient previously took macrodantin and experienced allergies, flagyl [metronidazole] and experienced allergies. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination. The patient experienced vertigo, vomiting, due to the spinning and imbalance she could not get out of bed for 8 days on 02Apr2021. She had a tachycardia episode that lasted 10 minutes with a BPM (beats per minute) of 214 on 13Apr2021 (on day 21 after the vaccine). On day 9 following the vaccine she awakened with acute vertigo and vomiting. She was prescribed Zofran and had to take it every 6 hours to stop the vomiting. This went on for 10 days. It was now day 28 after the vaccine and she was still experiencing vertigo though it has greatly improved. She was now able to walk though cannot yet drive. The patient underwent lab tests and procedures which included heart rate of 214 on 13Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with Zofran, meclazine and Tylenol. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Feeling abnormal, Heart rate
Clinical narrative: Paralysis of the hands from throwing up/ paralysis; Sweats; Chills; Diarrhea; woke up feeling off; not hungry; ended up throwing up; slept all day; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in the right arm on 24Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. Patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in the left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks of the COVID vaccine. Concomitant medications included bupropion hcl (WELLBUTRIN), escitalopram (LEXAPRO), and Whey Protein. On 25Apr2021 at 08:00 AM, 16 hours after second shot, patient woke up feeling off, not hungry, ended up throwing up, no fever, slept all day. Around 8:30 pm, he went to bed, got back up and threw up, sweats, chills, diarrhea, paralysis of the hands from throwing up, heart rate (HR) was 98, O2 level 98. Wife got patient back into bed. Patient stated that other than the paralysis this is exactly how COVID hit him for 14 days of non stop vomiting. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Oxygen saturation, Paralysis, Vomiting
Clinical narrative: Paralysis of the hands from throwing up/ paralysis; Sweats; Chills; Diarrhea; woke up feeling off; not hungry; ended up throwing up; slept all day; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in the right arm on 24Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. Patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in the left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks of the COVID vaccine. Concomitant medications included bupropion hcl (WELLBUTRIN), escitalopram (LEXAPRO), and Whey Protein. On 25Apr2021 at 08:00 AM, 16 hours after second shot, patient woke up feeling off, not hungry, ended up throwing up, no fever, slept all day. Around 8:30 pm, he went to bed, got back up and threw up, sweats, chills, diarrhea, paralysis of the hands from throwing up, heart rate (HR) was 98, O2 level 98. Wife got patient back into bed. Patient stated that other than the paralysis this is exactly how COVID hit him for 14 days of non stop vomiting. The clinical outcome of the events was not recovered. The patient was not tested for COVID post vaccination.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Rash, Rash macular
Clinical narrative: This is a spontaneous report from a contactable other hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9810), via an unspecified route of administration in arm left on 03Mar2021 at 15:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included RA, Waldenstrom Macroglobulinemia, osteoporosis, scoliosis, glaucoma, osteoarthritis, nerve damage, herpes, atherosclerosis. The patient known allergies were reported as Cipro family of antibiotics. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9819), via an unspecified route of administration in arm left on 10Feb2021 at 13:15 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 08Mar2021 at 00:00, the patient experienced serious itching on my torso, stomach, neck, face, head, armpits, and back. / some kind of pruritus, rash/harsher rash, red dots and this has lasted and gotten worse since the shot. The patient reported that went to dermatologist, who said to use Cerave cream for 2 weeks, then Triamcinolone 2 weeks, plus hydroxozine. Some kind of pruritus, she said. Nothing had helped (it's not shingles, and skin has a red tinge, like mild rash, sometimes red dots and harsher rash, sometimes not). She knew the mast cells are working overtime with a hystamine response, but her oncologist doesn't know if the vaccine kicked it off. But this had lasted and gotten worse since the shot. The events resulted in physician office visit. The outcome of the events was reported as not resolved.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; Numbness and Tingling in hands feet and face.; This is a spontaneous report from a non-contactable consumer (the patient). A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- Ew0161) via an unspecified route of administration, in the left arm, on 20Apr2021 at 13:30 (at the age of 37-year-old), as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on and unspecified date, as single dose, for COVID-19 immunization. On 20Apr2021 at 14:00, patient experienced adverse event Numbness and Tingling in hands feet and face. Patient did not receive any treatment for events. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Breath sounds abnormal, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: borderline atypical arrhythmia; Coarse lung sounds; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Apr2021 at 13:00 (Lot Number: EW0170, unknown expiration; at the age of 61 years old) as dose 2, single for COVID-19 immunisation. Medical history included bacterial pneumo and walking pneumo. No known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER8727) on 31Mar2021 at 13:00 in the left arm at the age of 61 years old for COVID-19 immunization. No other vaccine in four weeks. The patient experienced coarse lung sounds, shortness of breath, and borderline atypical arrhythmia on 22Apr2021 (11 hours after vaccination). Diagnostic tests included chest x-ray and ECG on unspecified dates with unknown results. The events resulted in emergency room/department or urgent care visit and doctor or other healthcare professional office/clinic visit. The patient received Flonase as treatment for the events. The patient has no COVID prior to vaccination and was tested for COVID post vaccination via nasal swab on 23Apr2021 with negative result. The patient is recovering from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: borderline atypical arrhythmia; Coarse lung sounds; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Apr2021 at 13:00 (Lot Number: EW0170, unknown expiration; at the age of 61 years old) as dose 2, single for COVID-19 immunisation. Medical history included bacterial pneumo and walking pneumo. No known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER8727) on 31Mar2021 at 13:00 in the left arm at the age of 61 years old for COVID-19 immunization. No other vaccine in four weeks. The patient experienced coarse lung sounds, shortness of breath, and borderline atypical arrhythmia on 22Apr2021 (11 hours after vaccination). Diagnostic tests included chest x-ray and ECG on unspecified dates with unknown results. The events resulted in emergency room/department or urgent care visit and doctor or other healthcare professional office/clinic visit. The patient received Flonase as treatment for the events. The patient has no COVID prior to vaccination and was tested for COVID post vaccination via nasal swab on 23Apr2021 with negative result. The patient is recovering from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: still feel fatigued; nausea; soreness in my left arm (injection site) as well - and oddly my right arm too - especially day 2 post; was accompanied by excruciating chest pains and the body pains were unbearable.; vomited for a couple hours with chills and sweats; vomited for a couple hours with chills and sweats; vomited for a couple hours with chills and sweats; Awful body aches and a massive headache followed.; Awful body aches and a massive headache followed...; experienced soreness in my left arm (injection site) as well - and oddly my right arm too - especially day 2 post; gestational_period: 22; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 at 12:30 hours (Batch/Lot Number: EW0172) as DOSE 2, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history was not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 12:30 PM (Batch/Lot Number: EW0150) as DOSE 1, SINGLE (at the age of 36-years-old) for COVID-19 immunisation. Concomitant medications included prenatal vitamins and vitamin D. The night of the vaccine, on 23Apr2021, the patient woke up around 1:00 AM & vomited for a couple hours with chills and sweats. Awful body aches and a massive headache followed. Only somewhat comfort the patient could find was with a cold compress on her forehead and running baths for the body aches. The patient then started feeling a bit better, had a nap and woke up to more vomiting early evening (about 29 hours after vaccine) but was accompanied by excruciating chest pains and the body pains were unbearable. The patient almost went to the hospital but called a family friend/nurse and decided to wait it out a bit and it eventually passed. The next day, the patient woke up with an appetite/feeling better but then the body aches and nausea (not vomiting) returned that afternoon/spent the rest of that day in bed. On26Apr2021, 4 days post vaccine injection, the patient still feel fatigued and a bit achy. The patient also reported definitely experienced soreness in my left arm (injection site) as well - and oddly my right arm too - especially day 2 post (on 24Apr2021). The patient reported she was pregnant while taking bnt162b2. The patient's last menstrual date was 18Nov2020. The patient was 22 Weeks pregnant at the onset of the event. The patient was due to deliver on 24Aug2021. The patient received no treatment for the adverse events. The patient did not have COVID prior to vaccination and had not COVID tested post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events on an unspecified date in 2021. The clinical outcome for the event gestational_period: 22 was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: I started "spotting"./bleeding became a bit heavier; strong stabbing cramps.; I was not due for my next period until May 10th as I had just finished my last cycle the week prior; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), via an unspecified route of administration, administered in left arm on 24Apr2021 10:45 (at the age of 43-year-old) as dose 2, single dose for COVID-19 immunisation was public health clinic. Medical history included hashimoto's disease and hypothyroidism from unspecified date and unknown if ongoing. Concomitant medication received within 2 weeks of vaccination included levothyroxine and vitamins nos (DAILY VITAMINS). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in right arm on 18Mar2021 (at the age of 43-year-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient received second dose on Saturday (24Apr2021 at 10:45) and on Sunday on 25Apr2021, afternoon she started "spotting". By Sunday evening (20:00), the bleeding became a bit heavier. She was not due for her next period until 10May2021 as she had just finished her last cycle the week prior. This was extremely unusual for her as she had always been very regular and never spot between periods. Today (Monday) on 26Apr2021, the bleeding continues to be moderate, however, she was now experiencing strong stabbing cramps (at the time of report). This was also highly unusual as my history of periods had been very moderate without much cramping. Menstrual changes were not listed as a possible side-effect of this vaccine and she saw that other women are reporting the same or similar issues. This was very clearly a side effect of the vaccine, at least for her. The patient did not receive treatment for the events. Outcome of the evets was not resolved.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: numb his hands were numb, and his one leg is numb; Pain in arm; This is a spontaneous report from a contactable consumer (brother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot, Expiration date and NDC number: Unknown), via an unspecified route of administration in left shoulder on 21Apr2021 (at the age of 21-year-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date in Apr2021, the patient experienced numb his hands were numb, and his one leg is numb. The reporter stated as, "my brother he was started numb his hands were numb, and his one leg is numb, and yesterday night he was even feeling pain in his arm but he just took a sleep because we couldn't contact anyone it was closed so he slept and today morning the pain was gone but the numbness was still there, so it was kind of change because none of us had this reaction". No investigation assessment reported. Outcome of the event pain in arm was recovered and another event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Period started normally after vaccine but lasted for nine days. Normal period is only three days.; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient) reported that: A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 13:00 (Batch/Lot Number: Ew0151) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Period started normally after vaccine but lasted for nine days. Normal period is only three days on 17Apr2021. No treatment was received. Patient did not have Covid prior vaccination and also patient did not Covid tested post vaccination. There was no other vaccine in four weeks. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling hot, Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: had "COVID arm; delayed cutaneous hypersensitivity; It presented as a reddish area of skin, slightly raised, roughly 4-x-7-inches.; Not as itchy as some describe, but definitely a rash-like appearance with the oval shape; I experienced only mild discomfort in the affected the area.; It felt warm to the touch; sensitive but in a sore way,; This is a spontaneous report from a contactable Consumer or other non HCP (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263), via an unspecified route of administration on Left arm on 04Feb2021 02:30 PM (age at vaccination: 67 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other. The patient medical history included Glaucoma and Hair loss and had no known allergies. Device Date was reported as 26Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Concomitant medications within 2 weeks of vaccination included bimatoprost (LUMIGAN) taken for Glaucoma from an unknown date and Finasteride (PROSCAR) taken for Hair loss from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3246), via an unspecified route of administration on Left arm on 13Jan2021 02:30 PM (at the age of 67 years) as dose1, single for COVID-19 immunization. On 07Feb2021 12:00 PM, In reaction to my 2nd dose, I had "COVID arm" or delayed cutaneous hypersensitivity. This appeared 3 to 4 days after the 2nd dose was administered. It lasted for 4 to 5 days. It presented as a reddish area of skin, slightly raised, roughly 4x7 inches. Not as itchy as some describe, but definitely a rash-like appearance with the oval shape.  I experienced only mild discomfort in the affected the area. It felt warm to the touch, sensitive but in a sore way, as if the inoculation site soreness was simply wider and more diffused than usual. My concern was that this might have been a subcutaneous injection rather than injection into the muscle. I now realize "COVID arm" is what this was. It's a relief because I believe now that I've got the full protection of the second dose. Since the vaccination, the patient has been tested for COVID-19. The lab tests included test: SARS-CoV-2 test (nasal swab), result: Negative((#) COVID-19 Combo)on 14Mar2021. Treatment received as a result of events was reported as no. The outcome of Not as itchy as some describe was recovered on 2021, while the outcome of the other events was recovered on Feb2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensitisation, Vaccination site pain
Clinical narrative: had "COVID arm; delayed cutaneous hypersensitivity; It presented as a reddish area of skin, slightly raised, roughly 4-x-7-inches.; Not as itchy as some describe, but definitely a rash-like appearance with the oval shape; I experienced only mild discomfort in the affected the area.; It felt warm to the touch; sensitive but in a sore way,; This is a spontaneous report from a contactable Consumer or other non HCP (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9263), via an unspecified route of administration on Left arm on 04Feb2021 02:30 PM (age at vaccination: 67 years) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Other. The patient medical history included Glaucoma and Hair loss and had no known allergies. Device Date was reported as 26Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Concomitant medications within 2 weeks of vaccination included bimatoprost (LUMIGAN) taken for Glaucoma from an unknown date and Finasteride (PROSCAR) taken for Hair loss from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3246), via an unspecified route of administration on Left arm on 13Jan2021 02:30 PM (at the age of 67 years) as dose1, single for COVID-19 immunization. On 07Feb2021 12:00 PM, In reaction to my 2nd dose, I had "COVID arm" or delayed cutaneous hypersensitivity. This appeared 3 to 4 days after the 2nd dose was administered. It lasted for 4 to 5 days. It presented as a reddish area of skin, slightly raised, roughly 4x7 inches. Not as itchy as some describe, but definitely a rash-like appearance with the oval shape.  I experienced only mild discomfort in the affected the area. It felt warm to the touch, sensitive but in a sore way, as if the inoculation site soreness was simply wider and more diffused than usual. My concern was that this might have been a subcutaneous injection rather than injection into the muscle. I now realize "COVID arm" is what this was. It's a relief because I believe now that I've got the full protection of the second dose. Since the vaccination, the patient has been tested for COVID-19. The lab tests included test: SARS-CoV-2 test (nasal swab), result: Negative((#) COVID-19 Combo)on 14Mar2021. Treatment received as a result of events was reported as no. The outcome of Not as itchy as some describe was recovered on 2021, while the outcome of the other events was recovered on Feb2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inflammation, Limb injury, Loss of personal independence in daily activities
Clinical narrative: she does not have range of motion and can't use it; Fever; chills; Itching; ended up having severe pains in her left arm and shoulder; ended up having severe pains in her left arm and shoulder; shoulder injury; her arm is severely inflamed; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8737; Expiration Date: Jul2021), via an unspecified route of administration in the arm left on 20Apr2021 10:30 as dose 1, single (at the age of 54-years-old) for covid-19 immunization. Medical history included ongoing hypertension from 2016 and covid-19. Patient family history was none. Concomitant medication included atenolol taken for hypertension from 2016. On 20Apr2021, she had the first dose of the vaccine and got the complications of fever, chills and itching and everything and these symptoms lasted three days and were completely resolved. Reportedly, after that she ended up having severe pains in her left arm and shoulder so in morning she ended up in the emergency room where the HCP said it could be a shoulder injury related to the vaccine administration and the acronym is SIRVA. The pain began on 20Apr2021 at nighttime and became worse on 21Apri2021. Her arm was severely inflamed and she did not had range of motion and could not use it. she was prescribed with prednisone 20mg and she had been taking three tablets daily for three days. The HCP also prescribed Volsarten 1 percent topical gel for pain and she has to rub it on her shoulder. Patient not yet had the 2nd dose of the Pfizer COVID Vaccine. Reportedly, the indication of the Pfizer COVID vaccine was that earlier in January, she, her husband and her daughter got the covid virus and it was pretty bad and had covid for two weeks straight and got over that and reportedly, her mother had a stroke. She went to the emergency room in morning because the pain was so unbearable and she was doing the over-the-counter CVS brand acetaminophen 500mg and CVS brand ibuprofen and that stuff was not helping her since last night, stated she knew this reported event was something more than how she was treating herself, also stated acetaminophen has lot 8JE2070C, expiry date Oct2021. Patient stated the Ibuprofen was 800 mg and she does not see any lot number on the bottle and did not. Patient did not receive any additional vaccines on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events pyrexia, chills and pruritus was recovered and for rest of events it was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: she does not have range of motion and can't use it; Fever; chills; Itching; ended up having severe pains in her left arm and shoulder; ended up having severe pains in her left arm and shoulder; shoulder injury; her arm is severely inflamed; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8737; Expiration Date: Jul2021), via an unspecified route of administration in the arm left on 20Apr2021 10:30 as dose 1, single (at the age of 54-years-old) for covid-19 immunization. Medical history included ongoing hypertension from 2016 and covid-19. Patient family history was none. Concomitant medication included atenolol taken for hypertension from 2016. On 20Apr2021, she had the first dose of the vaccine and got the complications of fever, chills and itching and everything and these symptoms lasted three days and were completely resolved. Reportedly, after that she ended up having severe pains in her left arm and shoulder so in morning she ended up in the emergency room where the HCP said it could be a shoulder injury related to the vaccine administration and the acronym is SIRVA. The pain began on 20Apr2021 at nighttime and became worse on 21Apri2021. Her arm was severely inflamed and she did not had range of motion and could not use it. she was prescribed with prednisone 20mg and she had been taking three tablets daily for three days. The HCP also prescribed Volsarten 1 percent topical gel for pain and she has to rub it on her shoulder. Patient not yet had the 2nd dose of the Pfizer COVID Vaccine. Reportedly, the indication of the Pfizer COVID vaccine was that earlier in January, she, her husband and her daughter got the covid virus and it was pretty bad and had covid for two weeks straight and got over that and reportedly, her mother had a stroke. She went to the emergency room in morning because the pain was so unbearable and she was doing the over-the-counter CVS brand acetaminophen 500mg and CVS brand ibuprofen and that stuff was not helping her since last night, stated she knew this reported event was something more than how she was treating herself, also stated acetaminophen has lot 8JE2070C, expiry date Oct2021. Patient stated the Ibuprofen was 800 mg and she does not see any lot number on the bottle and did not. Patient did not receive any additional vaccines on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events pyrexia, chills and pruritus was recovered and for rest of events it was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Unusual monthly period/bright red blood/Numerous & large blood clots; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8737) via an unknown route of administration in the left arm on 02Apr2021 at 10:45 (at 46-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa from an unknown date. Concomitant medications were not reported. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in 4 weeks. On 02Apr2021 at 11:00 the patient experienced unusual monthly period, numerous and large blood clots, and bright red blood. The patient received no treatment for the events. The clinical outcome of the event was recovered in Apr2021. Since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: spotting(showing small amounts of menstrual blood); I got my period even though it was only day 10 of my cycle; I bled heavily for 5 days; I am anxious about when my period will happen again; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 17Apr2021 17:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization in public health clinic/facility. It was reported that, patient had other vaccine on same date. No other vaccine was administered in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have known allergies. Medical history included premenstrual dysphoric disorder. The patient concomitant medications were not reported. On 18Apr2021, the patient experienced spotting (showing small amounts of menstrual blood), she got her period even though it was only day 10 of her cycle, she bled heavily for 5 days, she was anxious about when her period will happen again. The day after the vaccine, she began spotting (showing small amounts of menstrual blood). The next day, she got her period even though it was only day 10 of her cycle. She tracked her menstrual cycle on the clue app, and she do not have irregular periods. She bled heavily for 5 days. This was extremely unusual for her. She was anxious about when my period will happen again and if it will be triggered by the second dose. No treatment was given for the events. The events were considered as non-serious by the reporter. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea
Clinical narrative: Abdominal cramping; frequent bathroom trips, loose stool (bristol 6); chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) on 26Apr2021 10:00 at dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613) on 05Apr2021 10:00 at dose 1, single, both the doses via an unspecified route of administration, administered in arm right (at the age of 25-year-old) for covid-19 immunisation. Medical history included generalized anxiety disorder, depression, adhd, trichotillomania. Patient had no Known allergies. Concomitant medications included escitalopram (ESCITALOPRAM); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); cetirizine hydrochloride (ZYRTEC ALLERGY) all taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Patient did not have other vaccine in four weeks. On 26Apr2021 10:15 the patient experienced Abdominal cramping, frequent bathroom trips, loose stool (bristol 6), chills. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Feeding disorder, Gastrointestinal pain, Pain
Clinical narrative: A lot of body aches.; had to be in bed for 2 days; digestive system pain; couldn't eat much; This is a spontaneous report from a contactable consumer. A contactable 66-year-old female patient (consumer) reported for herself, that she received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 (Age 66-Year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Historical Vaccine included BNT162B2 taken as first dose on 19Feb2021 (Age 66-Year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The concomitant medications included denosumab (PROLIA) taken for osteoporosis from Jan2021 and ongoing and sumatriptan succinate (IMITREX) taken for an unspecified indication from an unspecified start date and ongoing at unknown dose, monthly (once every two months). After the second shot, the patient experienced a lot of body aches and had to be in bed for 2 days in 2021. Also, the patient had digestive system pain and could not eat much in 2021. It all lasted for 2 days and on third day felt on. The patient did not receive any treatment for any events. The outcome of the events was reported as not recovered.  No follow-up attempts are needed.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Severe chest pain in the the middle of my chest lasting more than five minutes. The first episode was just a minute long, second was more than 5 minutes; Day following chest is tight; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 49-year-old adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 13:30 (at the age of 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication(s) included Salbutamol (ALBUTEROL HFA); Fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and Escitalopram oxalate (LEXAPRO), all taken for an unspecified indication, start and stop date were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8T34), via an unspecified route of administration, administered in Arm Left on 03Apr2021 at 01:15 PM (at the age of 49-year-old) as single dose for covid-19 immunisation and experienced swollen lymph nodes. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On 26Apr2021 at 07:00 AM, the patient experienced severe chest pain in the middle of my chest lasting more than five minutes. The first episode was just a minute long, second was more than 5 minutes. The clinical details of the events as follows: Severe chest pain in the middle of my chest lasting more than five minutes. The first episode was just a minute long, second was more than 5 minutes. She was checked for heart and blood clot, none found. Day following chest was tight like when she had COVID last year. She stated it may not be related, but wanted to report in case, as there was not another reason, she can tie to this. She had reactions 48 hours after first dose with need for inhaler and swollen lymph nodes. AE resulted in Emergency room/department or urgent care. AE treatment included Emergency room, work up for heart concern. The patient outcome of the events was Resolved with Sequel (lasting effects).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Experienced numbness in index & middle finger distal phalanx as well as redness; Experienced numbness in index & middle finger distal phalanx as well as redness/right ear was hot and red; Swelling of hypothenar & palm at the base of the index finger.; Index finger was still numb/tingly; Right ear was hot and red; This is a spontaneous report received from a contactable consumer (Patient). A 45-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), Solution for injection, via an unspecified route of administration, administered in Arm Right on 09Apr2021 14:00 (at the age of 45-year-old) as single dose for covid-19 immunisation. Medical history included sulfa drugs allergy, neomycin allergy and milk allergy. Concomitant medications included venlafaxine hydrochloride (VENLAFAXINE HYDROCHLORIDE), cranberry (CRANBERRY), loratadine (LORATADINE), ergocalciferol (VIT D). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. On 10Apr2021 at 07:30, the patient experienced numbness in index and middle finger distal phalanx as well as redness and swelling of hypothenar and palm at the base of the index finger. Started the day after the 1st vaccination. Right ear was hot and red on the day after the vaccination as well. Swelling and redness stopped 2 days after vaccination. Middle finger was numb for 1 week. Index finger was still numb/tingly. No treatment was received to treat adverse events. The outcome of event experienced numbness in index and middle finger distal phalanx as well as redness, right ear was hot and red and Index finger was still numb/tingly was not recovered, experienced numbness in index and middle finger distal phalanx as well as redness/right ear was hot, red and swelling of hypothenar and palm at the base of the index finger was recovered on 11-Apr-2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Epistaxis, Hypertension
Clinical narrative: Severe nosebleeds started.; extremely high blood pressure 180/110; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received second dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 15:00 PM as dose 2, single for covid-19 immunisation. Medical history included high cholesterol and recently resolved prolactin tumor on pituitary from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took hydrochlorothiazide and experienced drug allergy. The patient previously received first dose of bnt162b2 (Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 PM as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 17Apr2021 20:30 PM patient experienced Severe nosebleeds started. Got the first one Saturday evening, 3 days after 2nd dose. Then 3 more severe bleeds Monday the 19th, 5 days after second does. Required nasal packing. Only one prior incident, 7 or 8 years ago, not a bleed of this magnitude. I also have extremely high blood pressure 180/110 and just started meds. BP was creeping up but not to this amount prior to vaccine. The patient received treatment with nasal packing, now on BP meds. AE resulted in emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab test include Blood pressure: 180/110 unknown unit on 17Apr2021. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.