chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: severe headache; Muscle aches; Chills; feeling tired and rundown; This is a spontaneous report from a contactable other healthcare professional (HCP)(patient). A 50-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on right arm single dose for COVID-19 immunization on 07Jan2021, 12:00PM, at 50-year-old. Medical history included: asthma. Known allergies reported as: Latex, penicillin. Concomitant medication was not reported. No other vaccine received in four weeks. The patient did not have COVID prior vaccination. The patient had muscle aches, chills, severe headache, feeling tired and rundown; all on 08Jan2021, 04:00 am. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event severe headache and BNT162B2 (PFIZER-BIONTECH COVID-19 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Flank pain, Injection site pain, Skin warm
Clinical narrative: woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not 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.
Sex: M
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a contactable consumer (patient's spouse). A 65-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get his second dose on 16Jan2021 (reported as "this coming Saturday"), but in the meantime the patient came down with a bladder infection and was taking Cipro 250 mg twice a day. He started on 09Jan2021 (reported as the past Saturday night) and finishes on 7am on 16Jan2021 Saturday, the day of the second vaccine. The reporter did not know if the patient should take it that day or wait or move the vaccine a few days out. He would still be in the 19-23 day (window). The reporter didn't know if it would fight off the COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the Covid vaccine 19Dec2020/then became Covid positive; exposed to Covid/Covid positive; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2) 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.  The patient received the covid vaccine on 19Dec2020 /then became covid positive. The patient underwent lab tests and procedures which included Sars-Cov-2 test: positive on  unknown date.  Information on the Batch/Lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730; expiration date not provided), intramuscular (anatomical location: arm left) on 19Dec2020 at single dose, then second dose intramuscular (anatomical location: not provided) on 09Jan2021 (lot number and expiration date not provided) at single dose for COVID-19 immunisation. Patient is not pregnant. Medical history was reported as none. Concomitant medications included sumatriptan, escitalopram oxalate (LEXAPRO), and ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL), also reported as Woman's Balance. The patient did not receive other vaccine in four weeks. The patient has no known allergies. The patient has no COVID prior vaccination. On 27Dec2020, the patient experienced severe burning sensation in mid-abdominal, nausea, and chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit. It was reported that patient received anti-nausea prescription and loperamide (IMODIUM AD) as treatment for the events. Patient was not COVID tested post vaccination. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.    A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Dec2020 at a single dose for COVID-19 immunization.  Ongoing medical history included Alzheimer's Disease, encephalopathy, hypertension, acute kidney failure, urinary retention and recent urinary tract infection (UTI), all from an unspecified date.  Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN), bisacodyl (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), loperamide (MANUFACTURER UNKNOWN), ondansetron (MANUFACTURER UNKNOWN), senna alexandrina (SENNA PLUS), vitamin d3 (MANUFACTURER UNKNOWN).  The patient had no known drug allergies. The patient experienced death on 30Dec2020.  The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020.  The patient died on 30Dec2020, at approximately 2:00 AM.   It was unknown if an autopsy was performed.  It was unknown if the event was related to the suspect drug, the administrator marked as natural causes.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Fatigue, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypothermia, SARS-CoV-2 test
Clinical narrative: Hypothermia 95.7 - 96.1F; chills; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1685/expiration date) via an unspecified route of administration on 11Jan2021 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included negative PCR nasal swab on 15Dec2020. Concomitant medications were not reported. The patient received the vaccine in a hospital. She did not receive other vaccines within 4 weeks prior to COVID vaccine. She was not diagnosed with COVID-19 prior vaccination and was tested for COVID-19 since vaccination (PCR, unknown result). The patient experienced Hypothermia 95.7 - 96.1F and chills on 12Jan2021. No treatment was received for the events. The outcome of the event was recovered. The reporter assessed the events as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  hypothermia and chills  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Cough, Dizziness, Erythema
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The 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. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The 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. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The 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. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The 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. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Facial pain, Lymphadenopathy
Clinical narrative: swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Flushing, Heart rate increased, Hypersensitivity, Malaise
Clinical narrative: allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; 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 reported events cannot be 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; 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 reported events cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She was tested positive even though she got the vaccine; She was tested positive even though she got the vaccine; This is a spontaneous report received from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported that a female patient of an unspecified age received BNT162B2 (reported as COVID-19 Vaccine, Batch/lot number: Unknown), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The Nurse was calling on behalf of the patient, the patient got Covid test back in Dec2020 and in last week of Dec2020 she received a positive Covid test. So she got the Covid vaccine back in Dec2020 and then a couple of weeks later which was last week of Dec2020 she got a Covid test and then she was tested positive even though she got the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between event "tested positive even though she got the vaccine" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Headache, Rhinorrhoea, Vertigo
Clinical narrative: vertigo; runny nose; headache; joint pain; extreme fatigue; Initial information was received on 14-Jan-2021 regarding an unsolicited valid serious case received from a other health professional in United States.  This case involved a 42 year old female patient who experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue  (fatigue), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced vertigo, runny nose (rhinorrhoea), headache, joint pain (arthralgia) and extreme fatigue  (fatigue), unknown latency following the administration of INFLUENZA VACCINE.   Seriousness criteria for all event was assessed as medically significant as per reporter.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as not resolved for all the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 42 year old female patient who experienced vertigo, runny nose, headache, joint pain and extreme fatigue after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, concomitant medications, patient's medical condition at time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: her last flu shot, got made her sick; Initial information was received on 14-Jan-2021 regarding an unsolicited valid serious case received from a consumer.  This case involved a 74 year old female patient for whom her last flu shot, got made her sick (illness) was reported, while she received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.  At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient for whom her last flu shot, got made her sick (illness) was reported, unknown latency following the administration of INFLUENZA VACCINE.   The patient was hospitalized (caused or prolinged) for this event.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an 74 years old female patient who reported sickness after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. At the time of event the patient had ongoing pulmonary arterial hypertension. Moreover, concomitant medications and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 43.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient had received a first dose of G9, he missed the scheduled time for his second dose.; No additional AE details; This spontaneous report was received from a pharmacist via a company Representative referring to a 43 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. The patient missed the scheduled time for his second dose (inappropriate schedule of product administration). No additional adverse event (AE) details or product quality complaint (PQC).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Incorrect route of product administration, Pain
Clinical narrative: she feels that possibly the vaccine was administered incorrectly, "Wrong Route of Administration"; had a worser AE with the second dose with sore arm; possible fever; sweating; tiredness; body aches; shivering; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in August 2020, refer case US2020AMR249123).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. In December 2020, the patient experienced pain in arm, fever, sweating, tiredness, general body pain and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, sweating, tiredness, general body pain, shivering and wrong route of administration were unknown.   It was unknown if the reporter considered the pain in arm, fever, sweating, tiredness, general body pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the second dose of the Shingrix vaccine in her left arm and she felt that possibly the vaccine was administered incorrectly, wrong route of administration. The patient stated she had a worse adverse with the second dose with sore arm, shivering, body aches, tiredness, sweating and possible fever. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215496:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020AMR249184:same reporter US-GLAXOSMITHKLINE-US2020AMR249123:same patient (1st dose)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: she feels that possibly the vaccine was administered incorrectly, "Wrong Route of Administration"; had a worser AE with the second dose with sore arm; possible fever; sweating; tiredness; body aches; shivering; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in August 2020, refer case US2020AMR249123).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. In December 2020, the patient experienced pain in arm, fever, sweating, tiredness, general body pain and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, sweating, tiredness, general body pain, shivering and wrong route of administration were unknown.   It was unknown if the reporter considered the pain in arm, fever, sweating, tiredness, general body pain and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the second dose of the Shingrix vaccine in her left arm and she felt that possibly the vaccine was administered incorrectly, wrong route of administration. The patient stated she had a worse adverse with the second dose with sore arm, shivering, body aches, tiredness, sweating and possible fever. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215496:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020AMR249184:same reporter US-GLAXOSMITHKLINE-US2020AMR249123:same patient (1st dose)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction
Clinical narrative: tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 5th January 2021, the patient received the 2nd dose of Shingrix. On 5th January 2021, immediately after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's mother. It was reported that the patient just got his booster (second) Shingrix dose and felt tired but was better at the time of reporting. The reporter did not consent to follow-up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021001347:same reporter US-GLAXOSMITHKLINE-US2021001354:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: deathly ill; Initial information regarding this unsolicited valid non-serious social media case received from a consumer  and transmitted to Sanofi on 15-Jan-2021.  The case involved a patient who was deathly ill (illness), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly ill (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: Fever the for two days after with injection site soreness that progressed to muscle insertion site. Then 6 days later mild fever again with marked axillary lymph node swelling and soreness around. Swelling took 2.5 days to resolve.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initially sore arm at injection site. Approx 24 hrs later arm still sore but also red, swollen and warm to touch in 1 and 1/2? diameter circle around injection site. still warm red swollen 3.5 days after injection.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Vomiting
Clinical narrative: 1/14/2021 2am-chills & body aches 4am- chills & body aches 9am- body aches/fatigue  11am- slight chills/body aches/fatigue 12am-2pm- body aches/fatigue 2pm- nauseous/body aches/fatigue 4pm- vomiting/body aches/fatigue 6pm-7am- nauseous/body aches/fatigue/headache 1/15/2021 7am-12pm- fatigue 6pm-9am- nauseous/fatigue  9am-9pm- nauseous/fatigue  1/16/2021  7am-9pm: nauseous/fatigue  1/17/2020  no symptoms
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Epinephrine, Fear, Speech disorder, Throat tightness
Clinical narrative: Approximately 15 minutes after receiving the vaccination the patient began to feel a tightness in the throat and difficulty speaking with a sense of anxiety and fright.  The EMT and paramedic summoned me and after arriving at the observation area  and ascertaining the patient's symptoms i asked the medic to administer the .3ml of epinephrine via EpiPen which he then did. Responding paramedics then arrived and took over assessment and treatment of the patient.  An ambulance had previously been called and the patient remained stable with slight improvement in the sense that she became less anxious and frightened.  She exhibited no urticaria or angioedema.  Vital signs included initial B/P of 183/95 with improvement to 176/76 and 99% pulse ox .  Patient was transported to hospital and per daughter was released about 2 hours later.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: About 3 days later started getting not headaches but a sharp pain in and around left temple region.  Pain is sharp, like a stab, but first 2-3 days of the pain, it last a few seconds to a few minutes and nothing for the day, occasionally I might have the incident 2-3 times in a day.  But today 01/21/2021, the pain around 4pm, lasted longer, about 2 hours but on and off, not constant. At midnight, the pain seems to have stopped.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches,fever,chills,headach
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Chromaturia, Full blood count, Malaise, Metabolic function test
Clinical narrative: 15 hours after vaccine administration pt experienced sore arm, body aches, feeling feverish (did not check temp) and feeling generally quite unwell. This improved approximately 11 hours after it started. 12 hours later she noted cola colored urine. Was evaluated today and urine improving in color and now a light pink color. Urine positive for protein and blood. Menses did finish a few days ago. CBC, CMP, ESR results pending.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Protein urine present, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: 15 hours after vaccine administration pt experienced sore arm, body aches, feeling feverish (did not check temp) and feeling generally quite unwell. This improved approximately 11 hours after it started. 12 hours later she noted cola colored urine. Was evaluated today and urine improving in color and now a light pink color. Urine positive for protein and blood. Menses did finish a few days ago. CBC, CMP, ESR results pending.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: 15 hours after vaccine administration pt experienced sore arm, body aches, feeling feverish (did not check temp) and feeling generally quite unwell. This improved approximately 11 hours after it started. 12 hours later she noted cola colored urine. Was evaluated today and urine improving in color and now a light pink color. Urine positive for protein and blood. Menses did finish a few days ago. CBC, CMP, ESR results pending.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Full blood count abnormal, Gallbladder disorder
Clinical narrative: Pt had sudden onset abdominal pain necessitating visit to emergency room.  He was diagnosed with gallbladder attack.  He did not have previous history of gallbladder disease but US imaging did show thickened gallbladder.   He was treated with zofran, morphine and IV fluids and discharged home.  2 days later  he had diarrhea x 24 hours (day 4 after shot)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Flushing
Clinical narrative: Reports: feeling flushed and anxious, "didn't hydrate enough prior to vaccine" vitals obtained / stable, po hydration, rest, monitor x 30 minutes symptoms improve/ subside released from facility to home
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antiallergic therapy, Antibiotic therapy, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: 8 days after injection, injection site got red, hot, inflamed. I wasn't sure what was going on so I went to Immediate Care on 01/12/21 where they put me on antibiotics and an antihistamine. I followed up with primary care on 01/15/21. By then my arm was almost back to normal. He told me to stop taking the antibiotics and antihistamines and report the reaction. I did as instructed and by 01/17/21 the redness, warmth and swelling had returned. I restarted the antihistamines and my arm has gone back down to normal.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: 8 days after injection, injection site got red, hot, inflamed. I wasn't sure what was going on so I went to Immediate Care on 01/12/21 where they put me on antibiotics and an antihistamine. I followed up with primary care on 01/15/21. By then my arm was almost back to normal. He told me to stop taking the antibiotics and antihistamines and report the reaction. I did as instructed and by 01/17/21 the redness, warmth and swelling had returned. I restarted the antihistamines and my arm has gone back down to normal.