chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon.  The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021.  The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon.  The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021.  The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage
Clinical narrative: broken blood vessel in left eye/It might have happened after the 1st dose too; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a broken blood vessel in left eye and stated that it was not going away. The outcome of event was not resolved.  Information about batch/lot number has been requested. Further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Memory impairment, Mental impairment
Clinical narrative: I am having serious like mental problem/my cousin have the same reaction as well what I have; I started having really bad forgetfulness and anxiety; It is just crippling anxiety and ridiculous forgetfulness/my cousin have the same reaction as well what I have; I can't function/my cousin have the same reaction as well what I have; I feel like it is dangerous, I can't even run my business right now/my cousin have the same reaction as well what I have; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She messed the 3 hair colors that she has never done in most 20 years of coloring hair and she can't remember anything. She got crippling anxiety, she said she got her second shot and then on day 4 after her second shot all the symptoms gone away then she got better." On an unspecified date the patient experienced having serious like mental problem, her cousin had the same reaction as well what she had, she started having really bad forgetfulness and anxiety; it was just crippling anxiety and ridiculous forgetfulness/her cousin had the same reaction as well what she had, she could not function/her cousin had the same reaction as well what she, she felt like it was dangerous, she could not even run her business right now/her cousin have the same reaction as well what she had. The outcome of the events was unknown.  Information on batch/ lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021557392 same drug/AE, different patient
Age: 49.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Humerus fracture, Pain in extremity, Upper limb fracture
Clinical narrative: I have a broken shoulder and my humerus bone broke; I have a broken shoulder and my humerus bone broke; May be just felt a little bit of a sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unknown route of administration on 05May2021 as 2 nd dose, single for Covid-19 immunization. The patient received co suspect Ibuprofen (IBUPROFEN) 800 mg in the morning (Batch/Lot number: not reported), Paracetamol (TYLENOL) 1000 mg (around 12 took Tylenol 1000 mg) (Batch/Lot number was not reported) via an unknown route of administration on an unknown date for an unknown indication. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unknown date as SINGLE for Covid-19 immunization and experienced no adverse event.  On an unknown date, the patient experienced to have a broken shoulder and humerus bone broke and may be just felt a little bit of a sore arm. It was reported that patient had been hearing multiple news conferences about aspirin and ibuprofen when receive Pfizer vaccinations as it lowers the dose of vaccination. It was reported that patient was informed not to take Ibuprofen and Tylenol whatsoever and patient had been taking it all long like Ibuprofen 800 mg in the morning and then Tylenol 1000 mg around 12  and patient did not felt the first vaccine even the second vaccine patient did not feel nothing. May be just felt a little bit of a sore arm other than that nothing and patient do not feel protected. The outcome of the events was unknown.    No follow-up attempts were possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She has already had covid 19, Both have had the first covid vaccine; She has already had covid 19, Both have had the first covid vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose bnt162b2 (Pfizer Covid 19 Vaccine, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was asking if she needs to get the second dose of the covid vaccine if she has already had covid 19 in the past. Patient had covid-19 and patient had the first covid vaccine on an unspecified date. Patient concerned about side effects. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blindness, Movement disorder
Clinical narrative: Loss of vision; pain down back; impaired ability to move; This is a spontaneous report received from a contactable consumer, the patient. A female patient (over 50) of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced loss of vision, pain down back after second injection and impaired ability to move. The patient was tested for MS after all symptoms came back negative. Outcome of the event was unknown.  Follow up attempts needed. Further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: Pulmonary embolism; Two massive bilateral clots; This is a spontaneous report received from a contactable physician (patient). A 75 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 23Feb2021 (Lot Number: EL9204) as single dose for covid-19 immunization. Medical history included, chronic obstructive pulmonary disease (COPD), history of cancers. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 74 years old, administered in arm left on 02Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. The patient experienced pulmonary embolism on 19Apr2021, two massive bilateral clots on 19Apr2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for all events for 6 days. The patient underwent lab tests and procedures which included Nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of pulmonary embolism, two massive bilateral clots and included Heparin and Xarelta. The outcome of the events was recovered with Seroquel in 2021.; Sender's Comments: Based on the temporal relation, the association between pulmonary embolism, thrombosis and vaccination with BNT162B2 cannot be completely ruled out. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. 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: Investigation, Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (nephew) reported that. A 30-years-old male patient received first dose of bnt162b2 (Pfizer covid vaccine, Solution for injection, Lot number was not reported),via an unspecified route of administration, administered in Arm on an unspecified date as 1st dose, single for covid-19 immunization. Medical history included allergy (to an unknown medication). The patient's concomitant medications were not reported. On an unknown date the patient experienced passed out. It was reported that the patient suddenly passed out and was rushed to the hospital after the first dose of the Pfizer covid vaccine. The patient is healthy and has an allergy to an unknown medication. The patient went to get the shot and then passed out. The patient passed out at the facility where he received the vaccine and was then rushed to the hospital and hospitalized. The caller is unsure when this event happened or the dates that the patient was hospitalized. The patient was released from the hospital the same day he was admitted. The caller mentions that the patient did not eat anything the day of the vaccine, prior to receiving the vaccine. The reporter asked Should the patient get the second dose of the vaccine. Is there any data on not eating all day and if that was an issue. The hospital ran all sorts of test on the patient and everything was fine. He had one shot he had one. And reporter wondering about getting the second one. The reporter stated, Okay, so I have a question about the Pfizer vaccine, so his 30 year old pretty much healthy nephew took the Pfizer vaccine and he passed out and they took him to the hospital (not clarified further if hospitalized or not, hence not captured in event tab) and ran bunch of test, he was fine, but he didn't eat all day. Do they have any data that shows if you don't eat all day you could have that kind of a reaction? Because the thing you know if is going to end up in the hospital I hate for him to have a second one you know what I mean, but if it is related to him not eating then that's another story. Well, I am wondering if they had data on anyone who had not eaten all day and whether or not there were reactions of that. Reporter was sure they tested every possibility when they tested this Pfizer vaccine. The patient underwent lab tests and procedures which included investigation: everything was fine. The event's seriousness was captured as hospitalized and medically significant. The clinical outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Pulmonary thrombosis
Clinical narrative: Blood clots in lung and leg; Blood clots in lung and leg; Dizziness; Weakness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Apr2021 16:00 (Batch/Lot Number: EW0162) as 2nd dose, single dose for COVID-19 immunization. The patient received the first dose of COVID-19 vaccine on 08Apr2021 17:45 left arm for COVID-19 immunization. Medical history included fibromyalgia and had covid-19 prior to vaccination. Concomitant medications included gabapentin; ethinylestradiol, norgestimate (ORTHO-CYCLEN); and diclofenac sodium (DICLOFENAC SODIUM); all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 05:00, the patient had blood clots in lung and leg, dizziness, weakness, headache (still after a month) and shortness of breath. As a result of the events, the patient visited doctor or other healthcare professional and has been to the emergency room. The events required hospitalization and was considered a life-threatening illness (immediate risk of death from the event). The patient was hospitalized for two days. The patient was put on blood thinners as treatment for the events. The patient has not recovered from the events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots in lung and leg; Blood clots in lung and leg; Dizziness; Weakness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Apr2021 16:00 (Batch/Lot Number: EW0162) as 2nd dose, single dose for COVID-19 immunization. The patient received the first dose of COVID-19 vaccine on 08Apr2021 17:45 left arm for COVID-19 immunization. Medical history included fibromyalgia and had covid-19 prior to vaccination. Concomitant medications included gabapentin; ethinylestradiol, norgestimate (ORTHO-CYCLEN); and diclofenac sodium (DICLOFENAC SODIUM); all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Apr2021 05:00, the patient had blood clots in lung and leg, dizziness, weakness, headache (still after a month) and shortness of breath. As a result of the events, the patient visited doctor or other healthcare professional and has been to the emergency room. The events required hospitalization and was considered a life-threatening illness (immediate risk of death from the event). The patient was hospitalized for two days. The patient was put on blood thinners as treatment for the events. The patient has not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: she had very adverse reactions for three days in which she had to call off work and was on deaths door; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 18Apr2021, as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received the first dose of the Pfizer Covid-19 vaccine on 18Apr2021 and she is scheduled to receive the second dose tomorrow. She "had very adverse reactions for three days" in which she had to call off work and was "on deaths door. She stated that it has been over 4 weeks since she had the vaccine due to being uncertain if she was going to receive the second dose. She was originally scheduled on Mother's Day for her second injection. She was asking that, since it has been more than 3 weeks apart, is it even worth it to get the shot. She already spoke with her HCP and she is adamant about caller receiving the second dose. The outcome of the event was unknown.  Follow up are needed. Information about batch/Lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: She felt like if she was going to faint; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 19May2021 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient received the first dose of the Pfizer BioNtech Covid-19 vaccine on19MAY2021. A little bit ago, today she felt like if she was going to faint, she would like to know if this could be a side-effect from the vaccine.the outcome of the event was unknown.   Information on the lot/ batch number has been requested. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Pain in extremity, SARS-CoV-2 antibody test, Underdose
Clinical narrative: quite a bit of bleeding after the second dose; if the dose was lost in the bleeding or if the dose was given incorrectly; pain in the arm; tired; This is a spontaneous report from a contactable consumer (daughter). A 67-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot: not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of blood compared to the first time, pain in the arm, tired on an unspecified date. Reporter stated that her father takes blood thinners and experienced quite a bit of bleeding after the second dose. She says he thinks the dose might have leaked out with the blood. She thinks he should have gotten the same amount as her mom. They both had antibody tests completed and her mother had a good antibody result, but her father did not. Reporter asked, Does that have to do with the bleeding afterward. Was the dose not properly stored. She thinks it has to do with the way the dose was administered. Does he need to get a third dose of the vaccine. In case the second dose was given improperly is it safe to get a third dose. Was the dose not properly stored. What would it take for him to get a third dose. Response was "that I don't know if the dose was lost in the bleeding or if the dose was given incorrectly. I could not say if the dose was properly stored or not and referred caller to the vaccination provider to discuss". She stated her father had the following side effects: pain in the arm, tired after the first dose no. No side effects after the second dose other than the bleeding. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This is a spontaneous report from a contactable consumer (patient's child). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) via unspecified route on left arm single dose for COVID-19 immunization on 27Mar2021 12:45 at 57-year-old. Medical history included high blood pressure, ongoing hospitalization. There were no concomitant medications. The patient had an ischemic stroke on 30Apr2021 12:45; reported as serious due to life threatening illness (immediate risk of death from the event), prolonged hospitalization (vaccine received during existing hospitalization), and disability or permanent damage. Emergency room/department or urgent care visited. The patient was hospitalized for 7 days. The patient was treated for a stroke, currently in rehab. Outcome of the event was resolved with sequelae in 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive since the 2 doses; tested positive since the 2 doses; This is a spontaneous report from a Pfizer sponsored program.  A non-contactable consumer reported that a female patient (his relative) of an unknown age received the 1st and 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on unknown dates at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. It was reported that the patient tested positive on an unknown date. The reporting consumer asked how can his relative tested positive since the 2 doses of vaccines were already taken. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: faint; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (caregiver) reported for a 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got fainted (syncope) (medically significant). Reporter considered the event as serious. Caller is asking if there would be a component that would cause her daughter to faint a few minutes after getting the first dose of the Pfizer BioNTech Covid-19 Vaccine. Caller wanted to know if fainting is a reported side effect after getting the first shot of the Pfizer BioNTech Covid-19 Vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swelled after first shot; This is a spontaneous report was received from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications of the patient were not reported. It was unknown if, patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or since the vaccination, has the patient been tested for COVID-19 or not. On an unspecified date, patient experienced lymph nodes were swollen and patient was hospitalized for the same. Patient received unspecified treatment for the event. Outcome of the event was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021.  It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event 'Patient went to sleep and died within 12 hours of vaccination' was fatal.   Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cerebrovascular accident, Muscular weakness, Neck pain
Clinical narrative: stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; right arm, soreness in arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm/ with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; General body weakness; This is a spontaneous report received from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 91-year-old, via an unspecified route of administration, administered in arm right on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included arthritis. Known allergies: amoxicillin. Concomitant medication included verapamil HCL; furosemide, potassium chloride (LASIX + K); colecalciferol (VIT.D3); magnesium oxide (MAGOX); atorvastatin calcium; warfarin. The patient previously received the first dose of BNT162B2 on 28Jan2021 at the age of 91-year-old for COVID-19 Immunisation, no issues whatsoever. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021 on 24Feb2021 02:00, right arm, soreness in arm on 21Feb2021  , neck and shoulder pain began along with weakness in right arm on 21Feb2021, general body weakness on 21Feb2021. Adverse events resulted in emergency room/department or urgent care, hospitalization (in 2021 for 3 days), life threatening, disability or permanent damage.  It was unknown whether treatment received for the events. The patient underwent lab tests and procedures which included Covid test type post vaccination: blood test: negative in 2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; right arm, soreness in arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm/ with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; General body weakness; This is a spontaneous report received from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 91-year-old, via an unspecified route of administration, administered in arm right on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included arthritis. Known allergies: amoxicillin. Concomitant medication included verapamil HCL; furosemide, potassium chloride (LASIX + K); colecalciferol (VIT.D3); magnesium oxide (MAGOX); atorvastatin calcium; warfarin. The patient previously received the first dose of BNT162B2 on 28Jan2021 at the age of 91-year-old for COVID-19 Immunisation, no issues whatsoever. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021 on 24Feb2021 02:00, right arm, soreness in arm on 21Feb2021  , neck and shoulder pain began along with weakness in right arm on 21Feb2021, general body weakness on 21Feb2021. Adverse events resulted in emergency room/department or urgent care, hospitalization (in 2021 for 3 days), life threatening, disability or permanent damage.  It was unknown whether treatment received for the events. The patient underwent lab tests and procedures which included Covid test type post vaccination: blood test: negative in 2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 11:00 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation (age at vaccination was of 60 years). Medical history included rheuatoid arthritis, surgical asplenia. Patient also allergic to Pineapple. No other vaccine was recieved by the patient in four weeks. The patient received other concomitant medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 14:30 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation (age at vaccination was of 60 years). On 21May2021 12:15, the patient experienced short of breath, increasing difficulty breathing, anaphylaxis, in order hoarseness, voice sounds like laryngitis, in order hoarseness, voice sounds like laryngitis, lips tingling, eyes swelling, wheezing, dizziness. Patient took 50mg Benadryl at 12:30 with no relief and went to ER. The ER (emergency room) diagnosed anaphylaxis and started treatment at 13:37. EpiPen, famotidine (Pepsid), SoluMedrol PF was given as treatment. Patient recovered with lasting effects. No covid prior vaccination was reported. Patient was not tested for covid post vaccination. Outcome of all events was recovered with sequelae.  Follow up attempts are needed. Further information has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Passed away from a Pulmonary Embolism; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 39 years old, on 11Mar2021 (Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history included wolff-parkinson-white syndrome from an unknown date to 15Mar2021. The patient was diagnosed with this later in life, but was told he probably had it his entire life it just hadn't caused any issues for him. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously got the flu vaccine for immunization every year with no issues. The patient passed away from a pulmonary embolism on 15Mar2021. The patient was not hospitalized prior to his death.  He died from the pulmonary embolism in his sleep. The reporter denied any medications, labs, testing, or treatments for her husband relevant to these events. The patient died on 15Mar2021. There was a private autopsy performed and they said that the Pfizer Covid Vaccine was one of the contributing factors to the patient's death. The autopsy said the vaccine was a contributing factor. The reporter stated she told them since they said it was the pulmonary embolism that killed him, then that's what it should say. The Medical Examiner was saying that the science for the vaccine is so new, they just don't have the data that they need.; Reported Cause(s) of Death: Pulmonary embolism
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received an expired dose of Ipol with no reported AE; Initial information regarding an unsolicited valid non-serious case was received on 12-May-2021 from a Other Health Care Professional via Agency (Reference number- 00598493) and transmitted to Sanofi on 12-May-2021  This case involves a 4 year-old female patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination  On 29-Mar-2021, the patient received third dose 0.5 mL of suspect IPV (VERO) (lot R1B251M and expiry date 13-Mar-2021) via an subcutaneous route at the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, Product storage error
Clinical narrative: 57 year old male patient inadvertently administered an expired dose of Typhim Vi with no reported adverse event; Initial information received on 18-May-2021 regarding an unsolicited valid non-serious case received from a physician via other health care professional.  This case involves a 57 year old male patient who was inadvertently administered an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE (YELLOW FEVER) for Immunisation; and POLIO VACCINE (POLIO VACCINE) for Immunisation.  On 17-May-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A25 and expiry date: 11-May-2021) (prefilled syringe) via an intramuscular route in the right upper arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: 11 year old male patient administered expired dose of menactra with no reported adverse event; Initial information received on 18-May-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old male patient who was administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation.  On 21-Apr-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6576AA and expiry date: 04-Apr-2021) (Frequency once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: severe reaction to the flu vaccine/flu vaccine caused the allergic reaction; arms swelled up, hot to the touch; arms swelled up, hot to the touch; breathing issues; medically fragile; Initial information regarding an unsolicited valid serious case received from a Consumer/non-hcp (healthcare professional) via Information (Reference number- 00609408) and transmitted on 20-May-2021  This case involves a 12 years old male patient who experienced severe reaction to the flu vaccine/flu vaccine caused the allergic reaction (hypersensitivity), arms swelled up (peripheral swelling), hot to the touch (skin warm), breathing issues (dyspnoea) and medically fragile (asthenia), while receiving vaccine INFLUENZA VACCINE.  The patient's medical history included a genetic abnormality.   The patient's past medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.  On an unknown date in year 2009, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in year 2009, the patient developed a serious severe reaction to the flu vaccine (hypersensitivity), arms swelled up (peripheral swelling), hot to the touch (skin warm), breathing issues (dyspnoea) and medically fragile (asthenia), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  Laboratory data was not reported.  The reported stated that they received a letter  confirming that the flu vaccine caused the allergic reaction. At this time, the caller would like to know if it is safe for patient (now 24 years of age) to receive the Covid-19 vaccine.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovered from all the events on an unknown date.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a 12 years old male patient who experienced hypersensitivity, peripheral swelling, skin warm, dyspnoea and asthenia, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. The patient's medical history included genetic abnormality. The patient's concomitant medication, medical condition at time of vaccination and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: I developed what is known as the ?COVID arm? rash about 12 days after my first dose of Moderna. I had one smaller rash at the exact injection site and another much larger rash a few inches below that. Both rashes were red, itchy, slightly painful, and warm to the touch. I am treating it with Benadryl, which has helped relieve the itchiness.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site reaction
Clinical narrative: I developed what is known as the ?COVID arm? rash about 12 days after my first dose of Moderna. I had one smaller rash at the exact injection site and another much larger rash a few inches below that. Both rashes were red, itchy, slightly painful, and warm to the touch. I am treating it with Benadryl, which has helped relieve the itchiness.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Electrocardiogram normal, Red blood cell sedimentation rate increased, Troponin increased
Clinical narrative: Patient developed left sided chest pain that lasted for approximately 12 hours.  It then improved but she still had it with lifting heavy objects.  Was seen in clinic.  Went home and has follow-up with Pediatric Cardiology tomorrow.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I have had occasional brief chest pains, like a painful tightness around my heart that lasts a couple seconds at a time.  They have been random and infrequent enough I have not done anything about it (also, I am currently uninsured), but v-safe suggested I should submit a VAERS report of it anyway.  Obviously I cannot be entirely sure it is related, but it is not something I have experienced before.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Sleep disorder
Clinical narrative: Woke in the middle of the night to soft, itchy, quarter-sized lump under the skin around injection site ten days after vaccination.  Persistent when scratched.  No obvious inflammation observant to the eye but can be observed by touch.