chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dyspnoea, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: shortness of breath; facial swelling; angioedema; swollen tongue and lips; swollen tongue and lips; This is a spontaneous report from a contactable pharmacist. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 03Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 55-year-old. Medical history included ongoing hypertension, cirrhosis, obesity, prediabetes, allergies to Lisinopril, adhesive tape and Silicones. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lisinopril; acetaminophen; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); gabapentin from 03Aug2021 to an unspecified stop date; hydrochlorothiazide; levothyroxine; metformin; oxycodone; venlafaxine. On 04Aug2021, the patient presented to the hospital with shortness of breath and facial swelling. At the ED, he was found to have angioedema with swollen tongue and lips. Patient was currently intubated with mechanical ventilation. Pt is currently sedated and being treated with decadron, Benadryl and famotidine. The patient was hospitalized from 04Aug2021 to 05Aug2021. The outcome of events was not recovered. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19; Since the vaccination, it was unknown if the patient been tested for COVID-19. The case was reported as serious with seriousness criteria of hospitalization, life threatening.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dry mouth, Dry throat, Dysphagia
Clinical narrative: at around 3:00PM I took my temperature and it was100.4F; dry mouth (a bit hard to swallow).; Woke up sweating; Woke up sweating and then turned to chills.; Had light headedness; body aches; dry throat (a bit hard to swallow); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) via an unspecified route of administration in the left arm on 04Aug2021 at 13:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccination. Concomitant medications included vitamin d nos (VITAMIN D) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. On 05Aug2021 at 01:00, the patient woke up with sweating and then turned to chills, had light headedness, body aches and dry mouth/throat (a bit hard to swallow), these continued throughout the day. On 05Aug2021 at 15:00, the patient experienced fever of 101.4 Fahrenheit. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, chills, light headedness, body aches, dry mouth/throat and fever were not recovered at the time of this report.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: at around 3:00PM I took my temperature and it was100.4F; dry mouth (a bit hard to swallow).; Woke up sweating; Woke up sweating and then turned to chills.; Had light headedness; body aches; dry throat (a bit hard to swallow); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) via an unspecified route of administration in the left arm on 04Aug2021 at 13:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccination. Concomitant medications included vitamin d nos (VITAMIN D) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. On 05Aug2021 at 01:00, the patient woke up with sweating and then turned to chills, had light headedness, body aches and dry mouth/throat (a bit hard to swallow), these continued throughout the day. On 05Aug2021 at 15:00, the patient experienced fever of 101.4 Fahrenheit. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, chills, light headedness, body aches, dry mouth/throat and fever were not recovered at the time of this report.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Dry mouth, Dry throat
Clinical narrative: at around 3:00PM I took my temperature and it was100.4F; dry mouth (a bit hard to swallow).; Woke up sweating; Woke up sweating and then turned to chills.; Had light headedness; body aches; dry throat (a bit hard to swallow); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) via an unspecified route of administration in the left arm on 04Aug2021 at 13:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccination. Concomitant medications included vitamin d nos (VITAMIN D) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. On 05Aug2021 at 01:00, the patient woke up with sweating and then turned to chills, had light headedness, body aches and dry mouth/throat (a bit hard to swallow), these continued throughout the day. On 05Aug2021 at 15:00, the patient experienced fever of 101.4 Fahrenheit. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, chills, light headedness, body aches, dry mouth/throat and fever were not recovered at the time of this report.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: at around 3:00PM I took my temperature and it was100.4F; dry mouth (a bit hard to swallow).; Woke up sweating; Woke up sweating and then turned to chills.; Had light headedness; body aches; dry throat (a bit hard to swallow); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FA7485) via an unspecified route of administration in the left arm on 04Aug2021 at 13:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccination. Concomitant medications included vitamin d nos (VITAMIN D) for unknown indication on unknown date and unknown if ongoing. The patient had no known allergies. On 05Aug2021 at 01:00, the patient woke up with sweating and then turned to chills, had light headedness, body aches and dry mouth/throat (a bit hard to swallow), these continued throughout the day. On 05Aug2021 at 15:00, the patient experienced fever of 101.4 Fahrenheit. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sweating, chills, light headedness, body aches, dry mouth/throat and fever were not recovered at the time of this report.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Electrocardiogram normal, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: arm started shaking (seizure like); He was unconscious; body went stiff; He was pale and freaked out; started shaking; This is a spontaneous report from a contactable consumer (patient's mother) reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EWO196) via an unspecified route of administration in arm left on 04Aug2021 15:00 (at the age of 12-year-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medications included melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported. 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 had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination was 0.1 mg of melatonin/ day before bed. On 04Aug2021 15:15, the patient experienced that he walked off to the area where he was supposed to wait for 15 min after his vaccine was administered. He sat down, and after 1 minute of sitting his arm and body went stiff and arm started shaking (seizure like) and his head collapsed. He was unconscious. Reporter supported him and yelled for help, 911 was called. Reporter and bystander laid patient on the floor and he regained consciousness after some time (1min). He was pale and freaked out, but his answers were coherent. Arm and body had no more seizures. Very scary and unexpected. Ambulance was called and patient underwent a bunch of tests for his heart at the hospital. Reporter queried if patient was recommend that if he gets a second shot scheduled in 3 weeks. Reporter was worried that this could have been allergic reaction causing anaphylaxis, and worried that it can be worse with the second injection. Queried to recommend if they should go with it or not. No treatment was received. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events was unknown.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Posture abnormal, Seizure like phenomena, Tremor
Clinical narrative: arm started shaking (seizure like); He was unconscious; body went stiff; He was pale and freaked out; started shaking; This is a spontaneous report from a contactable consumer (patient's mother) reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EWO196) via an unspecified route of administration in arm left on 04Aug2021 15:00 (at the age of 12-year-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medications included melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported. 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 had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination was 0.1 mg of melatonin/ day before bed. On 04Aug2021 15:15, the patient experienced that he walked off to the area where he was supposed to wait for 15 min after his vaccine was administered. He sat down, and after 1 minute of sitting his arm and body went stiff and arm started shaking (seizure like) and his head collapsed. He was unconscious. Reporter supported him and yelled for help, 911 was called. Reporter and bystander laid patient on the floor and he regained consciousness after some time (1min). He was pale and freaked out, but his answers were coherent. Arm and body had no more seizures. Very scary and unexpected. Ambulance was called and patient underwent a bunch of tests for his heart at the hospital. Reporter queried if patient was recommend that if he gets a second shot scheduled in 3 weeks. Reporter was worried that this could have been allergic reaction causing anaphylaxis, and worried that it can be worse with the second injection. Queried to recommend if they should go with it or not. No treatment was received. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events was unknown.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Seizure, Tremor
Clinical narrative: arm started shaking (seizure like); He was unconscious; body went stiff; He was pale and freaked out; started shaking; This is a spontaneous report from a contactable consumer (patient's mother) reported for a 12-year-old male patient (reporter's son). A 12-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EWO196) via an unspecified route of administration in arm left on 04Aug2021 15:00 (at the age of 12-year-old) as dose 1, single for COVID-19 immunization. Medical history included none. Concomitant medications included melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported. 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 had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination was 0.1 mg of melatonin/ day before bed. On 04Aug2021 15:15, the patient experienced that he walked off to the area where he was supposed to wait for 15 min after his vaccine was administered. He sat down, and after 1 minute of sitting his arm and body went stiff and arm started shaking (seizure like) and his head collapsed. He was unconscious. Reporter supported him and yelled for help, 911 was called. Reporter and bystander laid patient on the floor and he regained consciousness after some time (1min). He was pale and freaked out, but his answers were coherent. Arm and body had no more seizures. Very scary and unexpected. Ambulance was called and patient underwent a bunch of tests for his heart at the hospital. Reporter queried if patient was recommend that if he gets a second shot scheduled in 3 weeks. Reporter was worried that this could have been allergic reaction causing anaphylaxis, and worried that it can be worse with the second injection. Queried to recommend if they should go with it or not. No treatment was received. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Aleve for fever. I have been experiencing chronic heavy nose bleeds three to five times a week every since the second vaccination that I received on June 9, 2021. Yesterday, August 5, 2021, I was at w; Aleve for fever. I have been experiencing chronic heavy nose bleeds three to five times a week every since the second vaccination that I received on June 9, 2021. Yesterday, August 5, 2021, I was at w; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 18May2021 (Batch/Lot Number: ER8731) at the age of 30-year-old as single dose for COVID-19 immunization. Medical history included fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included naproxen sodium (ALEVE) taken for fever. On 18May2021 at 14:30, the patient experienced fever, chronic heavy nose bleeds three to five times a week every since the second vaccination that received on 09Jun2021.The patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on right arm on 09Jun2021 at 14:30 (Batch/Lot NumberL: ER8731) at the age of 30-year-old as single dose for COVID-19 immunization. As reported: " Yesterday, August 5, 2021, I was at work when the worst one began to date. My mask was full of blood, my clothes covered in blood, blood was all of the work floor at my job from my work station leading to another part of the building. These nose bleeds did not begin until the same day hours after I was administered a second vaccine dose on June, 9, 2021. I have tried to report this to Health Department, but the representatives on  the phone were rude and hung up. This health department administered both vaccines that I have received of Pfizer." The adverse event resulted in emergency room/department or urgent care. Treatment was not received. The outcome of events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Antinuclear antibody, Balance disorder, Blood thyroid stimulating hormone, Dizziness
Clinical narrative: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ehrlichia test, Feeling abnormal, Immunology test, Metabolic function test, Parasite blood test
Clinical narrative: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroxine free, Visual impairment
Clinical narrative: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Balance disorder, Dizziness, Feeling abnormal, Visual impairment
Clinical narrative: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: She had another covid 19 test done that resulted this afternoon positive; she developed cold symptoms; She had another covid 19 test done that resulted this afternoon positive; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 02Aug2021 10:20 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient stated that she had a covid 19 test done on Saturday that was negative on 31Jul2021. Yesterday at 10:20 AM she received her 2nd dose of the Pfizer BioNtech covid 19 vaccine, overnight she developed cold symptoms on 02Aug2021. She had another covid 19 test done that resulted this afternoon positive on 03Aug2021. She wanted to know if the vaccine could give a false positive. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: She had another covid 19 test done that resulted this afternoon positive; she developed cold symptoms; She had another covid 19 test done that resulted this afternoon positive; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 02Aug2021 10:20 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient stated that she had a covid 19 test done on Saturday that was negative on 31Jul2021. Yesterday at 10:20 AM she received her 2nd dose of the Pfizer BioNtech covid 19 vaccine, overnight she developed cold symptoms on 02Aug2021. She had another covid 19 test done that resulted this afternoon positive on 03Aug2021. She wanted to know if the vaccine could give a false positive. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: She had another covid 19 test done that resulted this afternoon positive; she developed cold symptoms; She had another covid 19 test done that resulted this afternoon positive; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 02Aug2021 10:20 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient stated that she had a covid 19 test done on Saturday that was negative on 31Jul2021. Yesterday at 10:20 AM she received her 2nd dose of the Pfizer BioNtech covid 19 vaccine, overnight she developed cold symptoms on 02Aug2021. She had another covid 19 test done that resulted this afternoon positive on 03Aug2021. She wanted to know if the vaccine could give a false positive. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: many of my other problems stopped. weakness, pain , brain fogs, digestive...Second shot just fine but the good stuff; many of my other problems stopped. weakness, pain , brain fogs, digestive...Second shot just fine but the good stuff; many of my other problems stopped. weakness, pain , brain fogs, digestive...Second shot just fine but the good stuff; many of my other problems stopped. weakness, pain , brain fogs, digestive...Second shot just fine but the good stuff; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old patient of an unspecified gender 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 on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history included dercums. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 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 and experienced arm got sore. The patient experienced many of my other problems stopped. Weakness, pain, brain fogs, digestive. Second shot just fine but the good stuff didn't come back on an unspecified date. Patient stated, I am 75yrs, have a rare disease, DERCUMS, for info if unaware see withheld research doc, it is progressive with no cure. It's a doozie Last winter I sent an email to the CDC about your shot as this virus would send those of us with DD straight to heaven, we are so compromised. Nice note back, stating they were comfortable with the Pfizer shot. 90% OF US WANTED THE SHOT. The 2 I know of that got the virus before the shot was available, they are both lucky to be alive, however, both have now got the Delta strain. both very sick. Enter the reason I call withheld You know the old saying out of the horses mouth to get answers. I want answers you can't give probably. how much protection will we have against Delta, are you thinking about a booster, what added things do we look for in Delta anything diff. This is info I wanted to take back to the people who are really scared, and a heads up to all. I will move on to the shot, gladly fill in any further questions as needed, TOOK ALMOST A YR. to get it and I had to go to the hospital for that. Let me say because of this DD I keep my immune system pretty strong with herbs and fruits. First shot was great, arm got sore, no swelling or side effects. EXCEPT I felt great, many of my other problems stopped. weakness, pain, brain fogs, digestive. Lasted just over 2 weeks then poof. others but not enough for Dr. H. but she was interested. Second shot just fine but the good stuff didn't come back. no more room, those w/ strong imm. didn't get sick from shot. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, Vaccination site erythema, Vaccination site pain
Clinical narrative: UTI; pneumonia; This is a spontaneous report received from a contactable consumer (patient). An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jul2021 at her house as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced UTI and pneumonia. The patient was due for her second shot on 28Jul2021, however she had to went to the hospital for events. She was now located at a rehab facility about one mile away from her house and was told to call (#) to schedule her second dose. She was called to got her second dose scheduled and requested the dose be administered at the facility. She was told she could received the dose and could call to have it schedule. The events caused in hospitalization. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Urinary tract infection
Clinical narrative: UTI; pneumonia; This is a spontaneous report received from a contactable consumer (patient). An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jul2021 at her house as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced UTI and pneumonia. The patient was due for her second shot on 28Jul2021, however she had to went to the hospital for events. She was now located at a rehab facility about one mile away from her house and was told to call (#) to schedule her second dose. She was called to got her second dose scheduled and requested the dose be administered at the facility. She was told she could received the dose and could call to have it schedule. The events caused in hospitalization. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain injury, Hyperhidrosis, Loss of personal independence in daily activities, Myocardial infarction, Pain
Clinical narrative: Hair feels very sticky after washing it and drying it/Hair is sticky and hard; discoloration of her hair; Loss of her hair/Losing Hair; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 72 years) as single for covid-19 immunization along with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8737 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 72 years) as single for covid-19 immunization. Medical history included covid-19 from 03Oct2020 to an unknown date. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN, 50MCG) taken for thyroid from 1986 and ongoing once a day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date of Mar2021 the patient experienced that her hair feels very sticky after washing it and drying it. Patient also reports. loss and discoloration of her hair. Caller states all this happened after receiving the vaccine. patient further questioned that about anyone reported this side effects. On unspecified date of 2021 the patient underwent lab tests and procedures which included Nutrition Panel and metabolic function test both with unknown result. The outcome of the events was not recovered.  Follow-up attempts are needed. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Hair feels very sticky after washing it and drying it/Hair is sticky and hard; discoloration of her hair; Loss of her hair/Losing Hair; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 72 years) as single for covid-19 immunization along with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8737 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 72 years) as single for covid-19 immunization. Medical history included covid-19 from 03Oct2020 to an unknown date. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN, 50MCG) taken for thyroid from 1986 and ongoing once a day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date of Mar2021 the patient experienced that her hair feels very sticky after washing it and drying it. Patient also reports. loss and discoloration of her hair. Caller states all this happened after receiving the vaccine. patient further questioned that about anyone reported this side effects. On unspecified date of 2021 the patient underwent lab tests and procedures which included Nutrition Panel and metabolic function test both with unknown result. The outcome of the events was not recovered.  Follow-up attempts are needed. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Hair colour changes, Hair disorder, Investigation, Metabolic function test
Clinical narrative: Hair feels very sticky after washing it and drying it/Hair is sticky and hard; discoloration of her hair; Loss of her hair/Losing Hair; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 72 years) as single for covid-19 immunization along with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8737 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 29Mar2021 (at the age of 72 years) as single for covid-19 immunization. Medical history included covid-19 from 03Oct2020 to an unknown date. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN, 50MCG) taken for thyroid from 1986 and ongoing once a day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date of Mar2021 the patient experienced that her hair feels very sticky after washing it and drying it. Patient also reports. loss and discoloration of her hair. Caller states all this happened after receiving the vaccine. patient further questioned that about anyone reported this side effects. On unspecified date of 2021 the patient underwent lab tests and procedures which included Nutrition Panel and metabolic function test both with unknown result. The outcome of the events was not recovered.  Follow-up attempts are needed. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Inappropriate schedule of product administration, Neuropathy peripheral, Pain
Clinical narrative: After receiving the first shot I started having a pain in my right calf and hamstring muscle.; After receiving the first shot I started having a pain in my right calf and hamstring muscle.; I had not been doing any heavy exercise other than walking.; It was hard to walk because my right leg felt heavy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0176), via an unspecified route of administration, administered in Arm Right on 03May2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies of Penicillin and COVID-19 (Prior to vaccination the patient diagnosed with COVID-19). Concomitant medications included finasteride at 5 mg, daily and metoprolol at 25 mg, daily taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after receiving the first shot patient started having a pain in his right calf and hamstring muscle. Like a pulled muscle. patient had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy on 06May2021 01:00 AM. Patient got the second shot almost 8 weeks later and now both legs are acting like I have peripheral Neuropathy. patient having a hard time just walking and it is very painful. Patient visited a physician office. Therapeutic measures were taken as a result of Pain in extremity, Muscle strain, Gait disturbance and Limb discomfort. The outcome of the events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Limb discomfort, Muscle strain, Pain in extremity
Clinical narrative: After receiving the first shot I started having a pain in my right calf and hamstring muscle.; After receiving the first shot I started having a pain in my right calf and hamstring muscle.; I had not been doing any heavy exercise other than walking.; It was hard to walk because my right leg felt heavy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0176), via an unspecified route of administration, administered in Arm Right on 03May2021 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Known allergies of Penicillin and COVID-19 (Prior to vaccination the patient diagnosed with COVID-19). Concomitant medications included finasteride at 5 mg, daily and metoprolol at 25 mg, daily taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after receiving the first shot patient started having a pain in his right calf and hamstring muscle. Like a pulled muscle. patient had not been doing any heavy exercise other than walking. It was hard to walk because his right leg felt heavy on 06May2021 01:00 AM. Patient got the second shot almost 8 weeks later and now both legs are acting like I have peripheral Neuropathy. patient having a hard time just walking and it is very painful. Patient visited a physician office. Therapeutic measures were taken as a result of Pain in extremity, Muscle strain, Gait disturbance and Limb discomfort. The outcome of the events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test normal, Chest X-ray normal, Electrocardiogram normal, Feeding disorder
Clinical narrative: the reaction started with a rush like I was going to faint.; feel a surge or flush of heat followed by my heart racing/each day I'd be woken by the surge/flush and all symptoms repeating; feel a surge or flush of heat followed by my heart racing/Palpitations; anxiety; inability to eat; my insides felt like they were being squeezed; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER 8733 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 11:30 AM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included colitis ulcerative. The patient previously took Tramadol, Pseudoephedrine, Dextromethorphan, and Keflex which had known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 6208 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13Mar2021 at 12:45 PM (age at vaccination: 64 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medication included mesalamine. 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. The patient reported that on 19Apr2021 at 12:15 PM, (2 weeks to the day after her 2nd shot), the reaction started with a rush like I was going to faint. For 11 days following her body would feel a surge or flush of heat followed by her heart racing, palpitations, anxiety, inability to eat, her insides felt like they were being squeezed. This lasted for the most part, the entire day. When it subsided, she felt normal, but each day she would be woken by the surge/flush and all symptoms repeating. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment clonazepam to control the palpitations. Outcome of the event the reaction started with a rush like I was going to faint was recovered on an unspecified date and for all other events, it was recovered on 30Apr2021 at 12:15.  Follow-up attempts are completed. No further information is expected.