chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Facial paralysis, Feeding disorder, Herpes zoster, Neuralgia
Clinical narrative: ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Skin lesion
Clinical narrative: ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: received the Covid 19 vaccine/then tested positive for the virus/symptomatic; received the Covid 19 vaccine/then tested positive for the virus/symptomatic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose as Covid 19 vaccine. Medical history and concomitant medications were not reported. It was reported that the patient received the Covid 19 vaccine on 17Dec2020 and then tested positive for the virus on an unspecified date. She was scheduled to have the second vaccine on 07Jan2021, but she was not able to go to work because she's still symptomatic. She would like to know if there's an extension to the 21 days since she has the virus now. The outcome of the events was unknown.  Information about Lot/Batch number is requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Diarrhoea, Headache, Hypersensitivity
Clinical narrative: developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Periorbital swelling, Swelling face, Urinary tract infection
Clinical narrative: developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: felt a rush of dizziness to my head / felt a little lightheaded all day; heart started racing over 150 bpm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140), via an unspecified route of administration in the left arm on 04Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included overweight and elevated cholesterol. The patient had no known allergies to medications, food, or other products. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 04Jan2021 08:00, the patient felt a rush of dizziness to her head a few minutes after receiving the injection and then her heart started racing over 150 bpm. It calmed down after a few minutes although she have felt a little lightheaded all day. No treatment was received for the adverse event. The events were considered non-serious by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vaccination site haemorrhage, Vaccination site injury
Clinical narrative: at the injection site, there is a small hole in it and it is still bleeding; at the injection site, there is a small hole in it and it is still bleeding; severe headache/headache is a pain; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient verbalized, "I received the vaccine 2 and 1/2 weeks ago. At the injection site, there is a small hole in it and it is still bleeding. Is this a common side effect? I had a severe headache the next day, and it seemed to get less than the past week and 1/2 to 2 weeks it's back again, a constant headache. I've been taking Tylenol but doesn't seem to go away. I did go get a COVID test to make sure and that should be back in a few days. It's weird that the injection site is still bleeding and with the headaches. The injection site hole healed up. I couldn't see the injection a week afterwards but it opened up again and continuous bleeding here and there again. It doesn't look infected, doesn't look red. The headache is a pain." The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on an unspecified date. Therapeutic measures were taken as a result of severe headache that included Tylenol. Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Nerve compression, Product administered at inappropriate site
Clinical narrative: doesn't have full function of left shoulder; nerve entrapment from the incorrect administration; The person who injected the vaccine into the joint space and not the deltoid; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 21Dec and the person who injected the vaccine into the joint space and not the deltoid. The patient stated that she doesn't have full function of left shoulder because of nerve entrapment from the incorrect administration and asked if she is able to get the other dose somewhere other than her deltoid muscle. Clinical outcome of the events was unknown.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: vomited; diarrhea; a severe headache; severe muscle pain; severe fatigue like being "beat up in a bar"; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot and expiry not reported), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Dec2020, patient experienced a severe headache, severe muscle pain and severe fatigue; further reported as like being "beat up in a bar" for over 1 week. It was also reported that the patient vomited and experienced diarrhea on an unspecified date. The patient was also inquiring if there is difference between the symptoms in dose 1 and 2. Outcome of events was unknown.  Information of lot and batch number has been requested.; Sender's Comments: Based on the available information and known BNT162B2 vaccine safety profile, a causal relationship between events severe headache, severe muscle pain and severe fatigue and BNT162B2 vaccine cannot be excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, SARS-CoV-2 test negative
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Facial paresis, Immunoglobulin therapy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, SARS-CoV-2 test negative
Clinical narrative: Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy.  Started high dose Prednisone and Valtex.  Received IVIG infusion on 1/6/21 and 1/7/21.  Mild improvement 1/11/21.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Facial paresis, Immunoglobulin therapy
Clinical narrative: Woke up 1/4/21 with right sided facial weakness consistent with Bell's Palsy.  Started high dose Prednisone and Valtex.  Received IVIG infusion on 1/6/21 and 1/7/21.  Mild improvement 1/11/21.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: Tested positive with covid 19 with symptoms; Tested positive with covid 19 with symptoms; This is a spontaneous report from a contactable healthcare professional.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I received the covid 19 vaccine on 22Dec; was supposed to have 2nd dose on 12Jan2021. Tested positive with covid 19 on 01Jan2021 with symptoms. I want to know how long I need to wait to get the second dose".The outcome of the events was unknown.   Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (10 days in this case) of first dose administration, a causal relationship between event "Tested positive with covid 19 with symptoms" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Investigation, Pain
Clinical narrative: difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received covid vaccine then contracted covid-19, 9 days after getting the vaccine; received covid vaccine then contracted covid-19, 9 days after getting the vaccine; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on Dec2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  It was stated, "received covid vaccine then contracted covid-19, 9 days after getting the vaccine, should he get his 2nd dose which is on Friday? Tested positive on the 30th, received monoclonal antibody infusion on the 31st. Any information regarding this?". The outcome of the event was unknown.   Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (9 days in this case) after first dose administration, a causal relationship between event "received covid vaccine then contracted covid-19" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Facial asymmetry, Facial paralysis
Clinical narrative: Bell's palsy/Face was turning side ways; This is a spontaneous report from a contactable nurse.  A female patient of unspecified age received BNT162B2 (reported as "Covid-19 Vaccine, manufacturer: Unspecified", Batch/lot number: not provided) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. A woman received a Covid vaccine. She did not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning sideways. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incident or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported event Bell's Palsy and BNT162B2 vaccine cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Head discomfort, Muscle spasms, Musculoskeletal discomfort, Nasal congestion
Clinical narrative: Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown.  Information on lot/batch number for the product has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paranasal sinus discomfort, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown.  Information on lot/batch number for the product has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed with COVID, all three had COVID symptoms; memory care patients received Pfizer-BioNTech covid vaccine, and then were diagnosed; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is first of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004747 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is second of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is 3rd of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is limited information reported, it is possible patient would have taken only single dose,  a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004747 same reporter/product/event, different patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mouth swelling, Oral discomfort, Swelling face
Clinical narrative: cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint stiffness, Myalgia, Vaccination site pain
Clinical narrative: Slight pain at the injection site; sore/tender muscles on the left side of the body (mainly shoulder & neck); soreness/stiffness in left hip; soreness/stiffness in left hip; fatigue; This is a spontaneous report from a contactable pharmacist, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1284) solution for injection intramuscular in the left arm on 31Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01Jan2021, the patient experienced slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. No treatment was provided for the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue. The outcome of the events slight pain at the injection site, sore/tender muscles on the left side of the body (mainly shoulder & neck), some soreness/stiffness in left hip, and fatigue was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had a positive test for COVID; had a positive test for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician who reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient had a PCR COVID-19 swab performed on 23Dec2020 which returned positive on 26Dec2020. The action taken in response to the event for bnt162b2 was not applicable. Outcome of the event was unknown.  Information for lot number has been requested in follow up activity.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingling; This is a spontaneous report from a non-contactable Nurse, the patient. This male patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and tingling from the shoulder to the feet on the side the injection was given. The clinical outcome of the events numbness and tingling was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable pharmacist via Pfizer Sales Representative. A 25-year-old male patient (nurse) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown as did not have this information), via an unspecified route of administration in Dec2020 (reported as received either 17Dec2020 or 18Dec2020) at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. One of the reporter's employees (patient) got the COVID-19 Vaccine. Ended up testing positive for COVID probably due to patient care. Patient was taking care of two to three people who were not positive for COVID while in the hospital, but tests came up as positive. Patient developed symptoms in Dec2020 and tested positive for COVID on 24Dec2020. Patient received COVID-19 Vaccine either 17Dec2020 or 18Dec2020. Began coughing three to four days after vaccination in Dec2020. Rapid test was negative in Dec2020. On 24Dec2020, the M20 test came back as positive for COVID. Only other symptom patient experienced was loss of taste and smell in Dec2020. Had been a stressful situation for the patient. The outcome of the events was unknown.  Information on the Lot/ Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: M
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable pharmacist via Pfizer Sales Representative. A 25-year-old male patient (nurse) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown as did not have this information), via an unspecified route of administration in Dec2020 (reported as received either 17Dec2020 or 18Dec2020) at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. One of the reporter's employees (patient) got the COVID-19 Vaccine. Ended up testing positive for COVID probably due to patient care. Patient was taking care of two to three people who were not positive for COVID while in the hospital, but tests came up as positive. Patient developed symptoms in Dec2020 and tested positive for COVID on 24Dec2020. Patient received COVID-19 Vaccine either 17Dec2020 or 18Dec2020. Began coughing three to four days after vaccination in Dec2020. Rapid test was negative in Dec2020. On 24Dec2020, the M20 test came back as positive for COVID. Only other symptom patient experienced was loss of taste and smell in Dec2020. Had been a stressful situation for the patient. The outcome of the events was unknown.  Information on the Lot/ Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: myalgias; Headache; nausea; chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, intramuscularly on 17Dec2020 at 10:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) from an unspecified date, for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Dec2020 at 16:30, the patient experienced headache, nausea, chills, myalgias. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the headache, nausea, chills, myalgias was resolved on an unspecified date in 2020.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Encephalitis, Intensive care
Clinical narrative: encephalitis; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient was allergic to UTI(urinary tract infection) infection medication (i.e. sulfamethoxazole, trimethoprim etc.). Concomitant medications were not reported. The patient got encephalitis and was put in the ICU(intensive care unit) after getting vaccinated, led to hospitalization. Outcome of event was unknown. Information about lot/batch number has been requested.