chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis, Vaccination site scar
Clinical narrative: Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further).  The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got covid 13Apr2021; Covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received the bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 (Batch/Lot number was not reported) (received at the age of 20-years-old) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot number was not reported) (received at the age of 20-years-old)  as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines within four weeks prior to receiving the Pfizer vaccine. Medical history included known allergy to tree nuts. She has no other medical history. She had no covid prior to vaccination. She was not pregnant at the time of vaccination and adverse events. There were no concomitant medications. It was reported that patient got covid on 13Apr2021. The patient was tested for covid post vaccination. She had undergone a nasal swab on 13Apr2021 and the result was positive. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the reported  COVID  infection as documented by a positive nasal swab in the context of a vaccine failure is possible.  The case will be assessed further upon receipt of additional information.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: Caller reports no additional AE or PQC.; a patient was administered a dose of PROQUAD on 4/15/2021 that had a labeled expiry of 4/6/2021; This spontaneous report has been received from a nurse, referring about a 5-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.  On 15-APR-2021 the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rHA), at a dose of 0.5 milliliter (mL) and lot number S031705; that had a labeled expiry of 06-APR-2021 (expired product administered), for prophylaxis (frequency, route of administration or anatomical location were not provided).  The caller reported there were no temperature excursions related to the dose and no additional adverse events were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Dysacusis, Hypoacusis
Clinical narrative: hearing loss; muffled hearing; echoing in ear; it got worse; This is a spontaneous report from a contactable consumer. This 26-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (Batch/Lot Number: EIM0162) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 (lot number= ER8727) on 22Mar2021 at 02:45PM on right arm and experienced ringing and pulsing in left ear. The patient's concomitant medications were not reported.  After second shot on 13Apr2021, the patient reported "it got worse, hearing loss, muffled hearing and echoing in ear"  with outcome of not recovered.  Therapeutic measures were taken as a result of reported events included over the counter medications. The patient was not tested positive for COVID post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haemorrhage, Pain, Somnolence
Clinical narrative: tired; it was spotting like bleeding it looks like bleeding; I had prompt pain/ body ache; I had Spotting; I have gone to menopause; my cycle has stopped; slept; I felt chill; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 57-years-old) in Arm right on 10Apr2021 (Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included high blood pressure and menopause. Concomitant medications included losartan potassium and hydrochlorothiazide; both taken for hypertension, paracetamol (TYLENOL) taken for prophylaxis ("before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain"), and unspecified vitamins; start and stop dates were not reported. The patient experienced "it was spotting like bleeding it looks like bleeding" on 11Apr2021, "I felt chill" on 10Apr2021, "I had prompt pain/ body ache" on 11Apr2021, "I had spotting; I have gone to menopause; my cycle has stopped" on 11Apr2021, "slept" on 11Apr2021, "tired" on 12Apr2021. Patient stated, "I am calling I had the Pfizer vaccine (Covid-19 Vaccine) on Saturday on April the 10th and everything was great probably about I would say about 45 minutes after I got the vaccine I felt chill and then the next day, on Sunday the 11th I had prompt pain and I had spotting (before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain for say). Actually I am a 57 years old woman and I have gone to menopause and my cycle has stopped. On Sunday I had body ache. Most of the day I took it easy and I slept but then next day tired beside that is the only kind of adverse reaction I had. It just trigger emergently it is it's good for everybody if you have any kind of symptoms or whatever you let you informed it's good to be informed. I got the vaccine on 10th got it on Saturday I had this spotting on 11th was sleepy on 11 and was tired on 12th too. And when I say spotting it is like it was having like cycle not, wasn't heavy it was spotting like bleeding it looks like bleeding." No treatment received for events. The outcome of the events was unknown. The event "it was spotting like bleeding it looks like bleeding" was considered as serious (medically significant). Schedule date of second vaccination was on 01May2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: tired; it was spotting like bleeding it looks like bleeding; I had prompt pain/ body ache; I had Spotting; I have gone to menopause; my cycle has stopped; slept; I felt chill; This is a spontaneous report from a contactable consumer (patient).  A 57-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 57-years-old) in Arm right on 10Apr2021 (Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included high blood pressure and menopause. Concomitant medications included losartan potassium and hydrochlorothiazide; both taken for hypertension, paracetamol (TYLENOL) taken for prophylaxis ("before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain"), and unspecified vitamins; start and stop dates were not reported. The patient experienced "it was spotting like bleeding it looks like bleeding" on 11Apr2021, "I felt chill" on 10Apr2021, "I had prompt pain/ body ache" on 11Apr2021, "I had spotting; I have gone to menopause; my cycle has stopped" on 11Apr2021, "slept" on 11Apr2021, "tired" on 12Apr2021. Patient stated, "I am calling I had the Pfizer vaccine (Covid-19 Vaccine) on Saturday on April the 10th and everything was great probably about I would say about 45 minutes after I got the vaccine I felt chill and then the next day, on Sunday the 11th I had prompt pain and I had spotting (before I took the vaccine I took some Tylenol (Treatment) so I would not really in a pain for say). Actually I am a 57 years old woman and I have gone to menopause and my cycle has stopped. On Sunday I had body ache. Most of the day I took it easy and I slept but then next day tired beside that is the only kind of adverse reaction I had. It just trigger emergently it is it's good for everybody if you have any kind of symptoms or whatever you let you informed it's good to be informed. I got the vaccine on 10th got it on Saturday I had this spotting on 11th was sleepy on 11 and was tired on 12th too. And when I say spotting it is like it was having like cycle not, wasn't heavy it was spotting like bleeding it looks like bleeding." No treatment received for events. The outcome of the events was unknown. The event "it was spotting like bleeding it looks like bleeding" was considered as serious (medically significant). Schedule date of second vaccination was on 01May2021.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Colitis microscopic, Stool analysis
Clinical narrative: Bowel movements 4 to 5 times a day (loose and uncontrollable); diagnosis of lymphocytic colitis; This is a spontaneous report from a contactable consumer (patient who is a financial advisor). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONETCH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 14Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included cholesterol. The patient's concomitant medication included atorvastatin for cholesterol. The patient had alerted the CDC but not heard anything from them. So, the patient had his second Pfizer vaccine shot on 14Feb2021 and on 16Feb2021, the patient began having issues where he was going in bowel movements 4 to 5 times a day and sometimes loose and sometime uncontrollable. When this all started, the patient was in another state and he came home 2 weeks later. The patient called his doctors and maybe it could've happened due to the vaccine. They ordered the patient to undergo a number of tests in 2021. There were no issues with any of the stool samples, no infection or anything crazy in that regard. For blood work, the patient didn't know specifically what they had done but all was within normal ranges. During that, the patient received the diagnosis of lymphocytic colitis, which is a new response and he was wondering if the company had heard of it from the vaccine. No treatment was received for the event. The patient was recovering from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Loss of consciousness, Migraine
Clinical narrative: Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered.    Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout  and   the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information.  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: Dehydration, Diarrhoea, Fatigue, Feeding disorder, Nausea
Clinical narrative: felt like she was actually dying, and she has been close to dying; Severe nausea and vomiting/severe nausea unable to eat without vomiting for 24 hours; Severe nausea and vomiting; unable to eat without vomiting for 24 hours; fatigue; Severe and uncontrollable diarrhea; got really severely dehydrated; moderate fevers; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ER8731) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 17Apr2021, the patient experienced severe nausea and vomiting- vomited every 5 to 10 minutes for 12 hours, severe nausea unable to eat without vomiting for 24 hours, fatigue so severe. She had Severe and uncontrollable diarrhea- more than 12 times in 12 hours- almost constant. She felt like she was actually dying, and she has been close to dying. She got really severely dehydrated. She also had moderate fevers. It's been days and she have not recovered. All of the events experience occurred on 17Apr2021. The patient did not received any treatment for all of the events. The patient was not pregnant. The patient does not have COVID prior vaccination and the patient has not been tested for COVID post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Pyrexia, Vomiting
Clinical narrative: felt like she was actually dying, and she has been close to dying; Severe nausea and vomiting/severe nausea unable to eat without vomiting for 24 hours; Severe nausea and vomiting; unable to eat without vomiting for 24 hours; fatigue; Severe and uncontrollable diarrhea; got really severely dehydrated; moderate fevers; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Lot Number: ER8731) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 17Apr2021, the patient experienced severe nausea and vomiting- vomited every 5 to 10 minutes for 12 hours, severe nausea unable to eat without vomiting for 24 hours, fatigue so severe. She had Severe and uncontrollable diarrhea- more than 12 times in 12 hours- almost constant. She felt like she was actually dying, and she has been close to dying. She got really severely dehydrated. She also had moderate fevers. It's been days and she have not recovered. All of the events experience occurred on 17Apr2021. The patient did not received any treatment for all of the events. The patient was not pregnant. The patient does not have COVID prior vaccination and the patient has not been tested for COVID post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test/Got infected with covid 19 and was symptomatic; COVID-19 confirmed by positive COVID-19 test Got infected with covid 19 and was symptomatic; This is a spontaneous report from a contactable nurse (patient)    A 27-years-old non pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 04Feb2021 08:00 (Batch/Lot Number: El9262) as SINGLE DOSE, dose 1 intramuscular, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot Number: El0142) as single dose for covid-19 immunization.  Medical history included peanut allergy. The facility in which the vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications.  On 18Apr2021, at 23:00, The patient experienced covid-19 confirmed by positive covid-19 test/got infected with covid 19 and was symptomatic .The patient underwent  Lab tests include SARS-CoV-2 test (PCR test Nasal Swab) on 18Apr2021 results positive, SARS-CoV-2 test (Nasal swab) on 19Apr2021 results positive. Treatment was given for the events.  The clinical outcome of the events was recovering
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: does not know if this is considered a anaphylactic reaction; her heart rate rapidly increased, and it got up to 160; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history included food allergy. Concomitant medications were not reported. On 19Apr2021, shortly after the vaccination, the patient's heart rate rapidly increased, up to 160. Her heartbeat also increased in intensity. The patient did not have any skipped heart beats. The patient's baseline heart rate was 65-72. The reporter did not know if it was considered an anaphylactic reaction and queried whether this was a full anaphylactic reaction. Within half an hour, the patient's heart rate was down to 95 to 100. The rest of the day, the patient rested, drank fluids, and had no stimulants. Today (20Apr2021), the patient's heart rate was back to her baseline at 65 to 70. The reporter preformed an electrocardiogram on the patient on an unspecified date, and it showed normal sinus rhythm. The reporter asked if the patient should get the second dose of the vaccine. The clinical outcome of anaphylactic reaction was unknown, while of "her heart rate rapidly increased, and it got up to 160" was resolved on 20Apr2021.   Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylactic reaction cannot be excluded.  The case will be reassessed if additional information becomes available.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 2nd dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 04Feb2021 at 15:10 (at the age of 87-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL8982) on 14Jan2021 at 14:50 as a single dose in the arm for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced arm hurt a little. The event was reported as non-serious. The outcome of arm hurt a little was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of TENIVAC with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Reference number- 00572564) and transmitted to Sanofi on 22-Apr-2021.  This case involves a female patient with age 65 or above who was administered with 0.5 mL expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 21-Apr-2021.   Medical history, past medical treatment(s), past vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if there is a grace period?   At the time of reporting, the patient experienced no specific adverse event.   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.
Sex: M
Vaccine: FLU3
Symptoms: Chemotherapy, Haemorrhage, Immune thrombocytopenia, Oral mucosal blistering, Platelet count decreased
Clinical narrative: an episode of idiopathic thrombocytopenic purpura (ITP); bleed out; getting blisters in the mouth; Initial information received on 26-Apr-2021 regarding an unsolicited valid serious case from a consumer.  This case involves male patient (in his early 60s in 2011) who experienced an episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia), getting blisters in the mouth (oral mucosal blistering) and bleed out (haemorrhage), after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) were given to the patient.  In Nov-2011, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot UT473AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient reported that the he only had the lot number and no other identifiers of the vaccine and that the provider told the consumer that he had a Sanofi vaccine.  In 2011, the patient developed a serious episode of idiopathic thrombocytopenic purpura (ITP) (immune thrombocytopenia) (one week latency), described as getting blisters in the mouth (oral mucosal blistering) (one week latency), had a platelet count of 1000 from 190000 the week prior and being a bleed out (haemorrhage) (one week latency). These events were assessed as medically significant. The patient was in inpatient hospitalization and reported that a week before the vaccine he had a physical and his platelet count then was 190000. The patient remained in the hospital for 4 weeks.  The patient was treated with chemotherapy to get the immune system on track, while he was in the hospital.  The patient recovered from all the reported events on an unknown date.  It was reported that he was now looking into getting the COVID-19 (coronavirus disease) vaccine but was informed that the COVID-19 vaccine should not be given if someone experienced ITP after receiving a vaccine with the same ingredients as the Covid-19 vaccine; that the consumer did not get the high dose in 2011. Reported that he does not have good site and was needing to transfer the phone to the spouse to type in a website for him. There was no more information for this report due to the consumer not having the information.; Sender's Comments: This case involves male patient who had immune thrombocytopenia, oral mucosal blistering and haemorrhage, a week after vaccination with FLUZONE. The time to onset is compatible. Platelet count of the patient was 1000 from 190000 (the week prior before the vaccination). However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Near death experience
Clinical narrative: It nearly killed me; The patient received influenza vaccine and Fluad Quadrivalent; This spontaneous case was received on 26-Apr-2021 from other non-health professional (consumer) via Media Communication (reference number: SEQW21-01242) and concerned female patient, of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location; not reported) as prophylactic vaccination. The batch number was not reported.   On an unknown date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, anatomical location and route of administration: not reported) (explicitly coded as 'Extra dose administered') as prophylactic vaccination. The batch number was not reported.  On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent and Fluad Quadrivalent, it nearly killed the patient (as reported).    The outcome of the event 'near death experience' was unknown.   The reporter assessed the event as related to Fluad Quadrivalent and influenza virus vaccine polyvalent.  The event of 'near death experience' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A patient of an unreported age was vaccinated with Fluad Quadrivalent. On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent. On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent and Fluad Quadrivalent, it nearly killed the patient (as reported). Causality is unassessable for near death experience due unclear information regarding event, temporal relationship, medical history and diagnostic findings. Extra dose administered is assessed as not related per company's conventions.; Reporter's Comments: It nearly killed the patient.; Sender's Comments: A patient of an unreported age was vaccinated with Fluad Quadrivalent. On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent. On an unknown date, unknown amount of time after receiving influenza virus vaccine polyvalent and Fluad Quadrivalent, it nearly killed the patient (as reported). Causality is unassessable for near death experience due unclear information regarding event, temporal relationship, medical history and diagnostic findings. Extra dose administered is assessed as not related per company's conventions.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itching at different parts of the body , started at the back of right hand, then at left side on the back, back of left leg, left upper arm with rashes, then rashes started to appear at back  of left leg as well.  By the time I got to be seen by the nurse practitioner, redness was observed by the nurse spreading from the back of right hand to right arm. Blood pressure was 126/86 which is high for me. After 15 min of being given Benadryl, itching stopped. BP rechecked, 107/73 and I was sent home.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Per CDC guidelines, if a patient has an allergy or contraindication to any of the components of the mRNA COVID-19 vaccines,  the Johnson & Johnson COVID-19 vaccine may be given as a 'dose 2', so long as it is at least 28 days from the first dose of the mRNA vaccine.  Vaccine was given before consent form was fully reviewed.  Patient stated she is getting Johnson & Johnson as dose 2 because her first dose of Moderna was administered 2/2021 so her second dose of Moderna was "missed."  This reason is not CDC supported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Dizziness
Clinical narrative: Dizziness, Weakness. EMTs observed blood pressure, offered to take to hospital but patient refused
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever, 4 does of Motrin, relieved after 20 hours
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Loss of consciousness, Nausea, Pain
Clinical narrative: I waited the 15 minutes after the shot like they asked. About half an hour after I got the shot I started feeling a touch woozy.  I was driving home and had started moving my arm around some to work out the soreness.  A few minutes later I got really nauseated and started fading out of it.  I pulled over, put my  car in park, and put my hazards on. I passed out for 5-10 minutes. It was not just falling asleep but actually going unconscious. When I woke up I was covered in sweat and was very nauseated.   I had a friend come pick me up (obviously it was unsafe for me to drive). I have continued to feel a little woozy and nauseated (about three hours now after the injection). I also have cold sweats come on and off and I feel very tired.   I was well hydrated, not hungry (had eaten semi-recently), and well rested when I went to get the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Rash vesicular
Clinical narrative: After 2nd dose of Shingrix on April 30: Headache, fever, joint pain and body aches started within 24 hours of injection and has persisted over the last 6 days. Today (May 5) a blister rash has appeared on the outside of right thigh.  Started Acyclovir 1,000 3x day.    Important to note: 1st injection of Shingrix resulted in similar symptoms and a shingles rash on the inside roof of mouth a few weeks after dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Chest X-ray, Computerised tomogram thorax
Clinical narrative: Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now.  Flu like symptoms, diarrhea,dizziness, very weak.  Short of breath, low pulse o2.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Influenza like illness, Myalgia
Clinical narrative: Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now.  Flu like symptoms, diarrhea,dizziness, very weak.  Short of breath, low pulse o2.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test negative
Clinical narrative: Since my 2nd shot, I have had very painful achy joints and muscles, it has been 2 and a half weeks now.  Flu like symptoms, diarrhea,dizziness, very weak.  Short of breath, low pulse o2.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe full body aches, severe headaches, 103.6 temp for at least 12 hours, severe fatigue. Patient has a better temp after 24 hrs from shot but still has the other symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Disorientation, Feeling abnormal, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Patient initially felt discomfort throughout her body and was unease. At this time, two Diphenhydramine 25mg tablets were given to the patient orally. Then five minutes later, patient had slight syncope. Then three minutes later, patient complained of discomfort in the throat area. Then 2 minutes later patient expressed pain and tightness in the throat area and was disoriented. At this point, one Epinephrine injection of 0.3mg was given intramuscularly in upper outer thigh area and 911 was called. Patient was monitored closely until Emergency Paramedics arrived.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Throat tightness
Clinical narrative: Patient initially felt discomfort throughout her body and was unease. At this time, two Diphenhydramine 25mg tablets were given to the patient orally. Then five minutes later, patient had slight syncope. Then three minutes later, patient complained of discomfort in the throat area. Then 2 minutes later patient expressed pain and tightness in the throat area and was disoriented. At this point, one Epinephrine injection of 0.3mg was given intramuscularly in upper outer thigh area and 911 was called. Patient was monitored closely until Emergency Paramedics arrived.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She felt really dizzy. She was still awake. She had to be laid down on the floor. We called 911 and they took her to the ambulance and she was fine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Entire left bicep sore for 2 days (no redness, swelling or rash). 8 days after vaccination left bicep still experiencing surges of mild to moderate pain at injection site.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pruritus
Clinical narrative: Patient reported a slight itch on the top of his pallet in his mouth.  It went away after a while.  After a 12 hour follow up the patient is fine and the itch has gone away.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Pt experienced a localized injection size reaction, started with a quarter size red bump and progressed to a welt as large as a fist. The patch was red and hot to the touch and itchy. The pt was referred to primary care for further evaluation, and recommendation as to whether pt should receive the second dose in the series.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: My face went numb for several hours a day and a half after injection.  I also had extreme fatigue, headaches, and pain and swelling at the injection site for 7+ days.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Headache body ache large red swollen lump at injection and. Overall weakness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache body ache large red swollen lump at injection and. Overall weakness
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Started hearing ring noise in my right ear on 04.26.21 that's persisting to this day of submitting the report.  I have gone to a walkin clinic and they refered me to an ENT. They're booked until mid June. No treatment , just trying to eat clean , anti-inflammatory
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I noticed both my ears started ringing within about 2 hours of getting the shot.  I mentioned it to several people and reported it on the app recommended by the hospital.  It had been constant and has only decreased in intensity occasionally but always returns to the baseline level within an hour. There has been no significant improvement.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Insomnia, Tinnitus
Clinical narrative: Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it might be allergy related he gave me Flonase.  I have had no relief and experience insomnia, anxiety, dizziness and tinnitus 24/7.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: 04/29/2021 PM-Queasy stomach, very sore arm at injection site, headache 04/30/2021 AM-Headache/chills all night.  Fever 101 about 9AM. Queasy stomach, very tired..  Continued through day.  Did not retake temperature but may have increased. headache beg an to ease overnight 4/30-5/1 05/01/2021-Light headache AM.  Queasy stomach and fatigue all day. 05/02/2021 to 05/03/2021-All symptoms gone except fatigue which continued through 5/3/21
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 04/29/2021 PM-Queasy stomach, very sore arm at injection site, headache 04/30/2021 AM-Headache/chills all night.  Fever 101 about 9AM. Queasy stomach, very tired..  Continued through day.  Did not retake temperature but may have increased. headache beg an to ease overnight 4/30-5/1 05/01/2021-Light headache AM.  Queasy stomach and fatigue all day. 05/02/2021 to 05/03/2021-All symptoms gone except fatigue which continued through 5/3/21
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on majority of stomach and inner right arm,  itching  -took Benadryl 25mg 5/5/2021 10pm
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fall, Head injury, Movement disorder, Swelling face
Clinical narrative: Patient was administered Janssen COVID 19 vaccine by a nurse conducting an on site clinic. The patient was seated for about 5 minutes into her mandatory 15 minute waiting period when she fell face first off the chair & onto the floor. The nurse detected no movement & administered an Epipen. 911 was called. After the Epipen administration the patient "woke" & was able to answer questions. She was given ice to apply to a bump on her forehead & napkins for her bloody nose. EMT arrived & she was assessed & transported to the hospital.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on head- 5 days subsequent to the second dose of Moderna Vaccine
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache
Clinical narrative: I noticed some chest tightness. Nothing bad but noticeable and was there for a few minutes and started to go away. I later have had random chest pains in different areas that would last a few minutes. I also noticed some light headaches
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nothing yet, unable to reach patient 2 hours after vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site discomfort, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: 1h after the vaccination, I had the usual arm pain which lasted for a few days and then completely cleared away (next day I also had fever 37.5-38 C, fatigue, and muscle pain).  However, 8 days after the vaccination, on Friday 30th of April 2021, I woke up in pain: my arm was hurting again and this time I could not find a position on how to keep my arm and not feel pain. I eventually fell asleep but the arm pain at injection site persisted for days. Today (5th of May), five days after the second I still feel some discomfort in the shot area which sometimes goes above the pain threshold.   I did read about people having delayed arm pain, especially with the Moderna vaccine, which is a some kind of delayed antibody reaction. But I did not read about people having both just-after-shot pain and delayed pain and I do not know if I should take the second dose while my arm still hurts from the first does (I have my second shot in 2 weeks). Should I wait for no pain? Should I do it in the other arm? Could you please advise?  Probably nothing, but just to mention everything I know: one contributing factor could be that I went to the gym the previous day of receiving the vaccine and worked my shoulders - I was already a bit sore when I got the vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: 1h after the vaccination, I had the usual arm pain which lasted for a few days and then completely cleared away (next day I also had fever 37.5-38 C, fatigue, and muscle pain).  However, 8 days after the vaccination, on Friday 30th of April 2021, I woke up in pain: my arm was hurting again and this time I could not find a position on how to keep my arm and not feel pain. I eventually fell asleep but the arm pain at injection site persisted for days. Today (5th of May), five days after the second I still feel some discomfort in the shot area which sometimes goes above the pain threshold.   I did read about people having delayed arm pain, especially with the Moderna vaccine, which is a some kind of delayed antibody reaction. But I did not read about people having both just-after-shot pain and delayed pain and I do not know if I should take the second dose while my arm still hurts from the first does (I have my second shot in 2 weeks). Should I wait for no pain? Should I do it in the other arm? Could you please advise?  Probably nothing, but just to mention everything I know: one contributing factor could be that I went to the gym the previous day of receiving the vaccine and worked my shoulders - I was already a bit sore when I got the vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient reports excessive arm stiffness, unable to use injection arm for 13 days post-vaccination. Patient reported to pharmacy staff at second appointment, arm had recovered at that time.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Pain, Peripheral swelling, Pruritus
Clinical narrative: from the second day after vaccination -> itchy, swollen, aching feet and fingers, hard to walk (does not pass). On the third day -> chills, cold as with a fever (has passed).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: from the second day after vaccination -> itchy, swollen, aching feet and fingers, hard to walk (does not pass). On the third day -> chills, cold as with a fever (has passed).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test negative
Clinical narrative: 3 days after receiving the Pfizer SARS-CoV-2 vaccine, pt developed Bell's Palsy on the left side of his face. This has not remitted despite standard treatment (prednisone and valacyclovir).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Involuntary shaking of the arms and legs.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Laboratory test normal, Lung infiltration, Oedema
Clinical narrative: SOB began within 24hrs of receiving second vaccine dose on 03/31/2021. Scheduled appt with PCP for 4/27/2021. Up to that date she continued to experience SOB.  Unable to breath in supine position. Had to sleep in chair. Developed 4+ pitting edema in lower extremities. On 4/27/2021 the PCP sent patient to Hospital ER. Patient was admitted to cardiac floor.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sleep disorder, X-ray abnormal
Clinical narrative: SOB began within 24hrs of receiving second vaccine dose on 03/31/2021. Scheduled appt with PCP for 4/27/2021. Up to that date she continued to experience SOB.  Unable to breath in supine position. Had to sleep in chair. Developed 4+ pitting edema in lower extremities. On 4/27/2021 the PCP sent patient to Hospital ER. Patient was admitted to cardiac floor.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: having fever for 5 days
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Nausea
Clinical narrative: pt felt nauseous so got up to go near a trash can to vomit and he fell on the floor.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed my period. 2 days late. That's never happened before and I'm 46 years old. I had my usual premenstrual symptoms at the right time but no period... just spotting
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain, Pyrexia
Clinical narrative: Approximately 6 hours after receiving the vaccine, I got a fever and body aches. This lasted for approximately 24 hours. I am pregnant and my due date is 9/25/21.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: I got shingles on my back and on two places in the chest with extreme pain going all the way into my left foot.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever that started at around 9 PM, about 12 hours after injection. It reached 101.6 degrees Farhenheit. Body aches started shortly after the fever along with chills. About an hour or two into the fever I got a headache and also felt slightly nauseous. About 5 hours after side effects appeared I was able to fall asleep after taking some Tylenol PM. Woke up around 8 or 9 am with most of the side effects gone except for body aches. My body was sore for the rest of the day but now all side effects are gone.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Red spot at injection site appeared. Bump with hot to touch and soreness at the red area. Soreness of arm went away after a couple days prior to red spot appearing and soreness to touch. Ongoing no treatment given. I will wait and see how long it lasts, it?s been about 1 day.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Patient says went into hospital within 24 hour as was told she had a heart attack