chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pharyngeal swelling, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Fullness/swollen sensation of throat with mild lymphadenopathy; Fullness/swollen sensation of throat with mild lymphadenopathy; This is a spontaneous report from a contactable healthcare professional.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in Jan2021 as first single dose for COVID-19 immunization.  Medical history included COVID prior to vaccination from an unknown date. No known allergies were noted.  The patient's concomitant medications were not reported.  The patient experienced fullness/swollen sensation of throat with mild lymphadenopathy in Jan2021 with outcome of recovered on an unspecified date in 2021.  The patient underwent lab tests and procedures which included blood test/ antibody positive in May2020 and Nasal Swab/ PCR negative in Nov2020.  There were no treatments given for the events. The clinical outcome of events was recovered on an unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Eye disorder
Clinical narrative: My eye, right eye, it started to blow up and a big black spot is coming in front of it, especially when I went to the bathroom and put on the light and that eye was totally blinded; It is happening every time I go to the bathroom or turn on the lights in the room or if I look up towards the ceiling, it starts showing me these two big black bubbles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 08Feb2021 at a single dose for COVID-19 immunisation. Medical history included ongoing macular degeneration (the patient had in the past, actually quite a number of years, macular degeneration on that same eye). Concomitant medications were not reported. The patient had the vaccine and on the 8th of this month (not clarified), that was five or six days ago the patient really went well for both the days and both injections. But on Friday, two days ago, it began a little bit on Thursday evening but on Friday the patient noticed that the right eye started to blow up and a big black spot is coming in front of it, especially when the patient went to the bathroom and put on the light and that eye was totally blinded and then when the patient dabbed it with water and things and dried it up, it started to come back. It was happening every time, going to the bathroom or turning on the lights in the room or looking up towards the ceiling, it started showing these two big black bubbles. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion, Feeling hot, Oral herpes, Pain in extremity
Clinical narrative: bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination.  On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site haemorrhage
Clinical narrative: bled at the injection site; bruised; there are little fever blisters on the arm; her arm also felt hot; her arm was hurting; water bubble appear on my arm with fever; fever; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EN6200), via an unspecified route of administration on 16Feb2021 at 09:15 (at the age of 66-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient was not tested for COVID-19 post vaccination.  On 16Feb2021 at 22:00 the patient experienced bled at the injection site; arm is bruised, states there are little fever blisters on the arm, the arm was hurting and the arm felt hot (clarified the whole arm) on 16Feb2021; and water bubble appeared on the arm with fever "later on" on an unknown date in Feb2021. The patient was treated for the bled at injection site, arm felt hot and pain in arm which included cold ice pack and ibuprofen. The events did not require a physician visit or hospitalization. The clinical outcome of the event bled at injection site was recovered on 16Feb2021, the bruising and fever blisters at injection site was recovering, feeling hot and pain in arm was not recovered, water bubble and fever was unknown.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very mild headache; This is a spontaneous report from a contactable consumer (the patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 16Feb2021 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 27Jan2021 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunization. On 17Feb2021 13:00, the patient experienced a very mild headache. The patient was still able to focus at work. He had not needed to take any headache medicine yet. The clinical outcome of very mild headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable physician (patient's wife). This physician reported similar events for two patients. This is the first of two reports. A 64-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced dizziness (non-serious) starting in the morning. The clinical outcome of the event, dizziness, was not recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021173289 same drug/reporter/event and different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 21Jan2021 15:00 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included magnesium, cannabidiol, and docusate sodium (COLACE). The patient experienced extreme muscle cramps in both legs on an unspecified date after the first shot. The patient underwent lab tests and procedures which included nasal swab: negative both on 15Feb2021 and 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, White blood cell count
Clinical narrative: 2days after second dose I broke out into a extremely itchy rash over most of my body; This is a spontaneous report from a contactable Consumer. This consumer reported for self that the 65-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand Pfizer), via an unspecified route of administration from 16Feb2021 14:00 on left arm at single dose for covid-19 immunization.  Medical history included Chemo for breast cancer 6 years ago. Concomitant medication included metoprolol (METOPROLOL) ER100mg, vitamin d3 (VITAMIN D3), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multi vitamin. The patient previously took first dose of bnt162b2 (COVID 19, brand Pfizer) on 26Jan2021 03:00 PM, on Left arm for covid-19 immunization. No reaction with first dose. The patient experienced "2days after second dose i broke out into a extremely itchy rash over most of my body" (medically significant) on 18Feb2021 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included white blood cell count: remains low on unknown date. Therapeutic measures were taken as a result of 2days after second dose i broke out into a extremely itchy rash over most of my body (rash). She is not pregnant. No other vaccine in four weeks. Treatment received. "Claritin helps a little but it is not subsiding. It's been four days since I had the shot". No covid prior vaccination. No covid tested post vaccination. None known allergies.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Nausea
Clinical narrative: Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a non-contactable consumer reported for herself. An 87-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 05Feb2021 10:30AM on right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced severe gas bloating, stomach cramps, nausea, feeling very weak on 07Feb2021 with outcome of not recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was unknown. The case was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dysphagia, Investigation, Swollen tongue
Clinical narrative: pain in chest through back; tongue swelled up; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number EL9764/EL9264), via an unspecified route of administration in the right arm on 01Feb2021 09:45 at a single dose for covid-19 immunization. Medical history included ongoing three stents in her artery, heart issue where they took test to see if she had a heart issue, and everything came back negative, high blood pressure, high cholesterol, overweight, penicillin allergy, IV iodine allergy, allergy to pollens, inhalants, dust and animals. There were no concomitant medications. The patient previously took phenytoin (DILANTIN), bacitracin;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and cefalexin (KEFLEX); all of which patient experienced allergies/ drug hypersensitivity. On 01Feb2021 09:45, immediately after receiving the vaccine, her tongue swelled up, she had difficulty swallowing, and she has a pain in her chest that went through to her back. The patient was sent and admitted to the ER and got an IV shot injection of diphenhydramine (BENADRYL) that got tongue back down. She didn't need an Epi pen, it wasn't that bad. They took the test to see if she had a heart issue, and everything came back negative. The patient was advised by the head of ER that she shouldn't get the second shot because of the reaction. It could be more severe with the second dose he said. The outcome of the events was recovered on 01Feb2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: My tongue felt like it was scolded and the back of it felt like it was swollen; This is a spontaneous report from a contactable consumer reported for herself. The 63-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: El9262) , via an unspecified route of administration on 30Jan2021 10:00AM on left arm at single dose for covid-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease (Acid reflux (GERD)), dry eye syndrome, fibromyalgia, osteoarthritis, pre-diabetic, allergies to medications, food, or other products and all from an unknown date and unknown if ongoing. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) supplements, melatonin and allergy medicine. The patient experienced "my tongue felt like it was scolded and the back of it felt like it was swollen" (medically significant) on 30Jan2021 10:30AM with outcome of recovered with sequelae (Recovered with lasting effects). Therapeutic measures were taken as a result of the event included "IV Anti-histamine and prednisone I believe". She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that "Just after the shot I was fine while talking to my husband while waiting I had a fast onset strange feeling in my tongue and back of the throat. My tongue felt like it was scolded and the back of it felt like it was swollen." Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic response; This is a spontaneous report from a contactable consumer (the patient). A 72-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) via an unspecified route of administration on 18Feb2021 08:45 a.m. at the age of 72 years old, at single dose in left arm for COVID-19 immunisation. No other vaccine was received in four weeks. No COVID prior vaccination, no COVID tested post vaccination. Medical history included Parkinson's. Concomitant medication included atorvastatin, carbidopa, flecainide, escitalopram oxalate (LEXAPRO), and metoprolol succinate (TOPROL), all taken for unspecified indication from an unspecified date. The patient previously took codeine and experienced "allergies: Codeine", dextropropoxyphene hydrochloride (DARVON) and experienced "allergies: darvon". The patient experienced anaphylactic response (onset date reported as "13Feb2021", pending clarification) which resulted in emergency room/department or urgent care. No treatment was received for the event. The outcome of the event was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash morbilliform, Vaccination site pain
Clinical narrative: mildly pruritic erythematous macular morbilliform eruption on the lower back; mild subjective fevers; headache; injection site soreness in the deltoid region; This is a literature report.  Herein, the authors report the development of a morbilliform rash on the trunk of a patient two days following vaccination, a hitherto unreported event. A 30-year-old male healthcare worker with no past medical history presented for vaccination with the SARS-CoV2, the Pfizer-BioNTech COVID-19 vaccine. The day after vaccination the patient experienced mild subjective fevers, headache, and injection site soreness in the deltoid region without overlying skin changes. Forty-eight hours after administration of the vaccine, the patient developed a mildly pruritic erythematous macular morbilliform eruption on the lower back (Figure 1). Over the course of the following 24 hours, the patient's rash resolved without intervention. Twenty-one days following the initial vaccine, the patient received the second dose of the PfizerBioNTech COVID-19 vaccine, after which he experienced chills, fatigue and myalgias. Forty-eight hours after administration of the second dose, the patient developed a recurrent morbilliform eruption most prominent on the bilateral flanks and flesh colored papules on the right flank with significantly increased pruritus and body surface area involvement. Notably, areas which were previously spared by the first rash including the flanks, proximal extremities and upper back were involved (Figure 2). Of note, regions affected in the first rash (lower back) were similarly affected in the recurrent rash. This rash similarly resolved over the following 24 hours without treatment. Herein, the authors report a case of morbilliform rash secondary to the Pfizer-BioNTech COVID-19 vaccine, like that seen in COVID-19 infection. Figure 1. A) Morbilliform, erythematous macular patches on the lower back of the patient. B) Closer view of morbilliform eruption, revealing erythematous macules with confluence and intervening areas of unaffected skin. Figure 2. Recurrent morbilliform eruption on the right flank with flesh-colored papules on the posterior right flank. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event  rash morbilliform cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021226966 Same author, patient, drug/ different event.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via Social media.  This case is linked to case 2020SA292550 (same reporter)  This case involves a patient (demographics unknown) who was sick (illness), when received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number: not reported; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Every time when the patient received the vaccine the patient got sick. The patient had not received the flu shot since they retired (date unspecified) and did not get sick even once.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia
Clinical narrative: down for a week so weak; Initial information received on 15-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced down for a week so weak (asthenia), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was down for a week so weak (asthenia) with in an hour following the administration of INFLUENZA VACCINE (whenever the patient got one ).  It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not provided.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for asthenia.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Impaired work ability
Clinical narrative: sick; Initial information was received on 15-OCT-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via media.  This case involves a patient (age and gender unspecified) who was sick (Illness), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (Illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient reported that, a year ago, It was mandatory to take it where consumer worked, had to be out sick for a week every year.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments:  SanofiPVPortal20210218000264: SanofiPVPortal20210218000293: SanofiPVPortal20210218000303: SanofiPVPortal20210218000328: SanofiPVPortal20210218000339: SanofiPVPortal20210218000353: SanofiPVPortal20210218000372: SanofiPVPortal20210218000382: SanofiPVPortal20210218000399: SanofiPVPortal20210218000423: SanofiPVPortal20210218000436:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: Flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via media.  This case was linked to case 2020SA292550 (same reporter).  This case involves a 40-year-old patient (gender not specified) who had flu (influenza), after the patient received INFLUENZA VACCINE.  The past vaccinations included Influenza vaccine and the patient had flu last two times after getting the shot.  It was unknown if the patient had any concomitant disease, or risk factor.  Medical treatment, concomitant medication, and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported; expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   It was reported, the patient had flu three times.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm lil sore; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer via media .  This case involves patient of unknown demography who experienced arm lil sore (pain in extremity), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arm lil sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event pain in extremity.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Vaccination complication
Clinical narrative: horrible reaction to the flu shot; sick; Initial information received on 21-Feb-2021 regarding an unsolicited valid serious case from a media via consumer or non-health care professional.  This case involves adult patient (age and gender unspecified) who experienced horrible reaction to the flu shot (vaccination complication) and sick (illness), while patient received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot and expiry date: not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious horrible reaction to the flu shot (vaccination complication) unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was reported that, patient ended up in the hospital with a horrible reaction to the flu shot not taking that one.  On an unknown date, the patient developed a non-serious sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for events.  Information on the batch number was requested.; Sender's Comments: This case involves adult patient (age and gender unspecified) who presented with vaccination complication and illness after vaccination with INFLUENZA VACCINE. The time to onset is unknown.There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered expired ACTHIB to a patient because the diluent was still in date but the powered portion was expired; with no reported AE; Initial information was received on 23-Feb-2021 regarding an unsolicited valid non-serious case from a other healthcare professional in the United States.  This case involves child patient (age and gender unknown) who inadvertently administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lyophilized powder: lot number: UJ184AA, expiration date: 15-Feb-2021) via an unknown route at an unknown administration site on 23-Feb-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was reported that this occurred because diluent was still in date but the powered portion was expired [diluent: lot number: U6723AA, expiration date: 17-Sep-2021]. The agent asked caller if she can answer additional questions for a safety report. Caller stated that she cannot but if safety wants to send her the questions via email she can follow up that way.  It was an actual medication error due to expired vaccine used (latency: 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 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin swelling, Swelling
Clinical narrative: Itchy and puffy spots of swelling in various spots on whole body, lasted from 24-48 hours after vaccination before subsiding.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Urticaria
Clinical narrative: Hives, principally on face and upper torso. Muscle soreness in neck.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood uric acid, Cellulitis, Culture, Erythema
Clinical narrative: Arm pain and gout.  On Feb 4 it started as a small red bump on toe with pain. then Toe swelled very quickly, redness spread through toe. Labs and uric Acid levels were normal so suspected cellulitis. received antibiotics.  Toe continued to swell/increased pain. On Feb 5 -  referred to podiatrist who drained the toe and had fluid samples tested.  Gout was diagnosed when it was positive for sodium urate crystals.  This incident resolved without medications over 10-14 days. After the 2nd Covid vaccination there was severe pain in same toe but no swelling. pain lasted only 2-4 days.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain in extremity, Skin swelling, Smear test, Synovial fluid crystal present
Clinical narrative: Arm pain and gout.  On Feb 4 it started as a small red bump on toe with pain. then Toe swelled very quickly, redness spread through toe. Labs and uric Acid levels were normal so suspected cellulitis. received antibiotics.  Toe continued to swell/increased pain. On Feb 5 -  referred to podiatrist who drained the toe and had fluid samples tested.  Gout was diagnosed when it was positive for sodium urate crystals.  This incident resolved without medications over 10-14 days. After the 2nd Covid vaccination there was severe pain in same toe but no swelling. pain lasted only 2-4 days.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Arm pain and gout.  On Feb 4 it started as a small red bump on toe with pain. then Toe swelled very quickly, redness spread through toe. Labs and uric Acid levels were normal so suspected cellulitis. received antibiotics.  Toe continued to swell/increased pain. On Feb 5 -  referred to podiatrist who drained the toe and had fluid samples tested.  Gout was diagnosed when it was positive for sodium urate crystals.  This incident resolved without medications over 10-14 days. After the 2nd Covid vaccination there was severe pain in same toe but no swelling. pain lasted only 2-4 days.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 10 days after the first dose of the vaccine I developed hives and a rash over my entire back arms and legs and ears. I also had sever itching.   I began a twice daily dose of Zyrtec and a regular dose of Benadryl. I continued the Treatment for 3 days.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Red rash appeared on arm near injection site approximately 2"x 4". Disappeared in approximately 60 hours. Not raised, not itchy. Area was slightly sore as rash was disappearing.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: After 20 hours of receiving vaccine, I had chills,  fever,  sweats, dizziness, & nausea feeling.    Returned to bed;  slept 4 hours; & then ate & began to feel better.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Confusional state, Influenza like illness, Malaise, Muscular weakness
Clinical narrative: By 9:00pm I was feeling a  little sick, like the flu. By morning I had a temp of 100.1 and felt very sick but did not get out of bed.  At 1;00PM  I woke up and stood up out of bed and collapses onto the floor.  I was unable to get up.  I found my phone which had fallen onto the floor.  I was shaking so bad I kept dropping it.  I looked and my phone and was  unable to figure out how to make a call.  The screen did not make sense.  Eventually I was able to call my daughter who decided to call 911.  The paramedics came, picked me up  off of the floor and helped me walk to the living room.  My legs kept giving out like I was going to fall again.  They were asking questions but I was unable  to answer coherently. I was so confused.  My brain was not working.  They took me to the hospital where I was admitted and many tests were done.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Tremor, X-ray
Clinical narrative: By 9:00pm I was feeling a  little sick, like the flu. By morning I had a temp of 100.1 and felt very sick but did not get out of bed.  At 1;00PM  I woke up and stood up out of bed and collapses onto the floor.  I was unable to get up.  I found my phone which had fallen onto the floor.  I was shaking so bad I kept dropping it.  I looked and my phone and was  unable to figure out how to make a call.  The screen did not make sense.  Eventually I was able to call my daughter who decided to call 911.  The paramedics came, picked me up  off of the floor and helped me walk to the living room.  My legs kept giving out like I was going to fall again.  They were asking questions but I was unable  to answer coherently. I was so confused.  My brain was not working.  They took me to the hospital where I was admitted and many tests were done.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Vaccination complication
Clinical narrative: "Covid Arm" Large rash on left arm around and below injection site with moderate pain.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia oral
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary, Chest discomfort, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Erythema, Incomplete course of vaccination, Joint swelling, Laboratory test
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, Peripheral swelling, Pharyngeal swelling, Rash pruritic, Skin burning sensation
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood thyroid stimulating hormone decreased, Bronchial hyperreactivity, Chest pain, Computerised tomogram thorax
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea, Echocardiogram normal, Electrocardiogram
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling jittery, Fibrin D dimer increased, Hypoaesthesia oral, Muscle spasms, Neck pain
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, Pruritus, Scan normal
Clinical narrative: Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Injection site pain, Joint stiffness
Clinical narrative: all over body pain and joint stiffness,  severe pain at injection site, debilitating fatigue, headache, drowsiness altered breathing and abdominal pain.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiration abnormal, Somnolence
Clinical narrative: all over body pain and joint stiffness,  severe pain at injection site, debilitating fatigue, headache, drowsiness altered breathing and abdominal pain.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, X-ray normal
Clinical narrative: Extreme pain , weakness in right arm . Can?t lift arm . For two weeks already
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Skin swelling
Clinical narrative: Very itchy rash on my right side back rib cage midway up; two circles 1/2 inch in diameter and rash right side lower rib cage 3 inch in diameter and puffy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, warm to touch and tchy close to the injection site from the shoulder close to the elbow.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Rash, dizziness, fever, muscle aches, joint pain, headache, injection site pain, fatigue, and sniffles. Dizziness gone on day 2. Rash gone after 10 days.  Fever gone after2 days.  Muscle aches, joint pain, headache, fatigue, and sniffles gone on day 3.  Injection site pain gone after10 days.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Rash, dizziness, fever, muscle aches, joint pain, headache, injection site pain, fatigue, and sniffles. Dizziness gone on day 2. Rash gone after 10 days.  Fever gone after2 days.  Muscle aches, joint pain, headache, fatigue, and sniffles gone on day 3.  Injection site pain gone after10 days.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Severe Headache, body aches. Treated with Tylenol, rest
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, chills, really bad headache. Took  200 mg of Acetaminophen at 9:AM  (after 8 hours), and slept all day. Felt fine  when I woke up. around dinner time.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Chills, muscle aches, bone pain, body aches, injection site Pain lasting 36 hours. Scale of 1 to 10, pain was 7.   Itchy bump at injection site 13 days post injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Chills, muscle aches, bone pain, body aches, injection site Pain lasting 36 hours. Scale of 1 to 10, pain was 7.   Itchy bump at injection site 13 days post injection.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Pain
Clinical narrative: Temp of 100 degrees, muscle aches, chills lasted about 24 hours. Following day three episodes of diarrhea
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in abdominal rash
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36 hours (about), aches and pain lasted about 48 hours. Tylenol for fever.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Apnoea, Bradycardia, Exposure during pregnancy, Headache, Oropharyngeal pain
Clinical narrative: 34 week twin gestation at time of vaccination. Healthy pregnancy. No comorbidity.  Developed headache and sore throat on Jan 19 . Headache continued and developed Pre-Eclampia (diagnosed Jan 24th-25th). Emergent C-section for Pre-Eclampsia on Jan 26th. Infants spent 3 days in NICU for tachypnea/bradycardia/apnea spells and mother (the vaccinated patient) went to ICU at 12 hours postpartum for syncope episode. The twin infants birth weights were 5 lb 8 oz and 5 lb 13 oz and were discharged on DOL 3 to 5. Mother discharged home at day 3 to 4 post birth.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Packed red blood cell transfusion, Pre-eclampsia, Red blood cell count decreased, Syncope, Tachypnoea
Clinical narrative: 34 week twin gestation at time of vaccination. Healthy pregnancy. No comorbidity.  Developed headache and sore throat on Jan 19 . Headache continued and developed Pre-Eclampia (diagnosed Jan 24th-25th). Emergent C-section for Pre-Eclampsia on Jan 26th. Infants spent 3 days in NICU for tachypnea/bradycardia/apnea spells and mother (the vaccinated patient) went to ICU at 12 hours postpartum for syncope episode. The twin infants birth weights were 5 lb 8 oz and 5 lb 13 oz and were discharged on DOL 3 to 5. Mother discharged home at day 3 to 4 post birth.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Had outbreak of hives. Managed at home with steroid cream. Self-resolved after 48 hours.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Redness and swelling around the injection site (it?s hard around the site and itchy). There is no rash anywhere else but I also felt very tired and had a headache the day of and then for most of the following day. I will continue to monitor the symptoms - so far it?s only been 2 days.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Redness and swelling around the injection site (it?s hard around the site and itchy). There is no rash anywhere else but I also felt very tired and had a headache the day of and then for most of the following day. I will continue to monitor the symptoms - so far it?s only been 2 days.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Severe body aches/chills and 101 fever for about 8 hours had to be in bed couldn?t function This occurred with the 2 nd shot also
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: My legs throb down the back side of each leg. They ache and hurt walking and sitting. The only relief I get is where they are elevated and I put heat on them.  Ive never had problems with my legs.  It started two days after the first shot, ive received my second shot and they are just as bad. I will see my Dr on the 9th of this month ( march).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Full blood count, Headache
Clinical narrative: After receiving first mRNA Covid vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Pregnancy test, Troponin I
Clinical narrative: After receiving first mRNA Covid vaccine, patient experienced flushing, headache, chest tightness, shortness of breath, and nausea. Patient was initially monitored in an observation area, given crackers and juice. After 35 minutes she was transferred to the ED. IV line was placed, labs drawn, and given acetaminophen and ketorolac, fluids and ondansetron. Patient was later discharged after remaining stable.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A week later had redness around injection site, warm to touch, sore, and tender to touch. A little bit of swelling.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: I received my #2 vaccine at 6:55 PM on March 02, 2021.  I got up at about 2 AM March 03, with my left arm hurting rather badly.  I also got severe chills.  I went back to bed and about 30 minutes later, both the arm pain and chills were gone.  Neither has returned and I feel fine now.  It is now 09:50 PM March 03, 2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Chills, Cough, Dyspnoea
Clinical narrative: Headache Fever/Chills  Ringing in ears Loss of balance Visual distortion  Nausea/gas Sharp stomach pain comes and goes Injection site soreness  Gout flare up Cough/congestion  Shortness of breath requiring oxygen  Symptoms didn?t improve much for about 7 days
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Gout, Headache, Injection site pain, Nausea
Clinical narrative: Headache Fever/Chills  Ringing in ears Loss of balance Visual distortion  Nausea/gas Sharp stomach pain comes and goes Injection site soreness  Gout flare up Cough/congestion  Shortness of breath requiring oxygen  Symptoms didn?t improve much for about 7 days
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Tinnitus, Visual impairment
Clinical narrative: Headache Fever/Chills  Ringing in ears Loss of balance Visual distortion  Nausea/gas Sharp stomach pain comes and goes Injection site soreness  Gout flare up Cough/congestion  Shortness of breath requiring oxygen  Symptoms didn?t improve much for about 7 days