chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Dyspnoea, Fatigue
Clinical narrative: Injection site pain; Tiredness/I am so tired; Headache/my head feels like it is gonna pump off; Muscle pain; Chills; I break out with cold sweat; Joint pain; I can hardly breathe; I still feel terrible; Cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176), via an unspecified route of administration two days before the reporting day (11May2021), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In May2021, the patient experienced injection site pain, tiredness, muscle pain, chills, cold, break out with cold sweat, joint pain, headache and her head were feeling like it was going to pump off. The patient also reported that she was so tired and could hardly breathe. The patient was still feeling terrible and mentioned that she had everything and just wanted to know how long this would last. The patient had been taking Tylenol for headache and stated it was not doing anything. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nasopharyngitis, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness/I am so tired; Headache/my head feels like it is gonna pump off; Muscle pain; Chills; I break out with cold sweat; Joint pain; I can hardly breathe; I still feel terrible; Cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176), via an unspecified route of administration two days before the reporting day (11May2021), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In May2021, the patient experienced injection site pain, tiredness, muscle pain, chills, cold, break out with cold sweat, joint pain, headache and her head were feeling like it was going to pump off. The patient also reported that she was so tired and could hardly breathe. The patient was still feeling terrible and mentioned that she had everything and just wanted to know how long this would last. The patient had been taking Tylenol for headache and stated it was not doing anything. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 antibody test
Clinical narrative: chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 05May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8729 and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and experienced very tip of tongue was tingly and a little bit dizzy. The patient experienced side effects with chills and fatigue in May2021. The patient had a COVID test on 10May2021 and it was negative. The outcome of these events was recovered on 11May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Colonoscopy, Polyp
Clinical narrative: Polyps; This is a solicited report based on the information received by Pfizer . (Mfr control no. # 21k-163-3844210-00). A non-contactable consumer (patient) reported a 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20Feb2021 at the age of 82-years-old (lot number ddm88) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 2 week) 40mg/0.4ml (40 milligram, solution for injection in pre-filled pen) for crohn's disease. Medical history included abstain from alcohol, prostate cancer (family history father), non-tobacco user, allergies of pollen during springtime manifested by recurrent sinus infection, runny nose. Concomitant medications included carvedilol taken for pacemaker syndrome; memantine taken for pacemaker syndrome. The historical vaccine included 1st dose BNT162B2 (lot number ddm88) on 25Jan2021 at the age of 82-years-old for covid-19 immunization via intramuscular. On 22Mar2021, the patient experienced polyps. In Mar2021, the polyps resolved. Covid-19 vaccine was also considered suspect. On 22Mar2021, he colonoscopy was done colonoscopy where one polyp was found and removed. He had rough time. After a week, in Mar2021 biopsy results came out, polyp removed came back benign.  On an unknown date, an unspecified blood works was no significant findings.  The action taken in response to the event for adalimumab was unknown.  The event outcome was recovered on an specified date in Mar2021.  The reporter's causality for the event of polyps with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  Abbvie's opinion is that there is no reasonable possibility that the event of polyps to humira 40mg/0.4ml(adalimumab).  The reporter's causality for the event of polyps with covid-19 vaccine was not related.; Sender's Comments: Based on the information currently available,Vaccine BNT162B2  or comirnarity is unrelated to the event polyp.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: passed away from COVID (positive test on 24Apr2021); passed away from COVID (positive test on 24Apr2021); This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported as EPT534) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19 immunisation. Patient with no comorbidities passed away from COVID (positive test on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient's family members provided vaccination card and she would like to verify if the lot numbers are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient developed fatal Covid a month after being fully vaccinated. Additionally, she would like to verify if it is possible to know where the vaccines were shipped or any other distribution or facility information she could get from these lots. Stated that the vaccination card has something written on a box from the right hand side. Reporter seriousness for Tested Positive for Covid was Hospitalization, Death. Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy details not available. Events outcome was fatal. The patient died on 09May2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events cannot be excluded in a context of LOE.  The impact of this report on the benefit/risk profile of the Pfizer drug 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. ; Reported Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-1 test
Clinical narrative: Pulmonary embolism; This is a spontaneous report received from a Pfizer sponsored program, received by a contactable consumer (patient's relative).  A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, in Feb2021 at single dose for COVID-19 immunization, administered at facility. Relevant medical history included COVID positive from an unknown date and resolved in Jan2021 (COVID test negative one moth before receiving vaccine). No relevant concomitant medications were provided. Patient's relative stated that she died 10 days after receiving the COVID vaccine. The cause of death was not known but caller stated it could be due to pulmonary embolism. The facility did not wait for 3 months before giving the vaccine. Caller stated it should be prominent that patient should wait for 3 months after being tested positive for COVID and receiving the vaccine. It was unknown if an autopsy was performed.  Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: pulmonary embolism
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, SARS-CoV-2 test
Clinical narrative: first shot began electric shocks in lower back; This is a spontaneous report from a contactable consumer (patient). The 67-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included concussion 8 years ago. The patient's concomitant medications were not reported.  The patient experienced first shot began electric shocks in lower back on an unknown date. The patient underwent lab tests and procedures which included Nasal Swab on 10May2021 and result was negative. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass
Clinical narrative: Lump in right side of neck (possibly a lymph node); Lump in right side of neck (possibly a lymph node); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female (no pregnant) received the second dose of BNT162B2 via an unspecified rout of  administration on the left arm on 30Apr2021 at 10:00 (Lot Number: EW0179) as single dose for COVID-19 immunization. Medical history included migraines with auras, vertigo, arthritis in knee and eczema. The patient had not been tested for COVID-19 since the vaccination and was not diagnosed with COVID-19 prior to vaccination. The patient do not received any other vaccines 4 weeks prior to the COVID vaccine. The patient's known allergies was none. Concomitant medication included ibuprofen and erenumab aooe (AIMOVIG). The patient previously took the first dose of BNT162B2 on Apr2021 at 10:00 AM (Lot Number: EW0150) on left arm for COVID-19 immunization. On 14May2021 at 16:00, the patient experienced lump in right side of neck, possibly a lymph node. This was opposite the arm the injections were given. It was not noticed until 14May. It was visible when looking at the patient's neck. Treatment was not taken. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Colitis ulcerative, Colonoscopy, Drug ineffective, Fatigue
Clinical narrative: Covid-19; Covid-19; Colonoscopy: active colitis; Fatigue; This is a solicited report based on the information from a non-contactable consumer (patient) received by Pfizer.  Solicited report from the USA by a consumer of an adult 59-year-old female patient with events of non-serious COVID-19 and FATIGUED with HUMIRA (ADALIMUMAB). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), intramuscularly on an unspecified date at single dose for COVID-19 immunisation/COVID-19 Vaccination; adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneously from an unspecified date to an unspecified date at unknown dose, single for Moderate to Severe Ulcerative Colitis. There was no reported medical history. Concomitant drugs not reported. On unknown dates, the patient experienced COVID-19 and FATIGUED. On an unknown date, COVID-19 resolved. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab test and procedure, which included Colonoscopy: active colitis on an unspecified date. The action taken in response to the events for adalimumab was permanently withdrawn on an unspecified date. The outcome of the events COVID-19 was recovered on an unspecified date, outcome of the other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information currently available the causal association of the reported events lack of efficacy, covid-19, ulcerative colitis and fatigue with the usage of the vaccine BNT162B2 cannot be meaningfully assessed. Also take into consideration the contributory role of the usage of the drug adalimumab. The case will be reassessed once the information regarding date of vaccination, onset of the events, patient's medical history and concomitant medications is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever; He is not feeling well.; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the first dose of the vaccine, on an unspecified dose, the patient experienced fever and a lot of symptoms. The patient also mentioned that he was not feeling well. The patient would like to know whether he can still be infected with the virus even after getting the first dose. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got covid after first dose; Got covid after first dose; This is a spontaneous report received from a consumer based on information received by Pfizer.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunisation. The patient also received pancreatin (CREON), oral from an unspecified date at unspecified dose for exocrine pancreatic insufficiency (EPI) not associated with cystic fibrosis.  Medical history and concomitant medications were not reported.  It was reported that on an unknown date the patient got COVID after first dose of bnt162b2 vaccine. The outcome of the event was unknown.  The action taken for pancreatin was unknown. Causality assessment as per reporter was not reported.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: just admitted to the hospital with chest pain; This is a spontaneous report from a contactable consumer (patient's relative).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/Lot number and expiration was not reported via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got received the Pfizer COVID vaccine second dose recently and he was just admitted to the hospital with chest pain on an unspecified date in May2021. They did a heart catheterization and found that they didn't feel that the patient had any blockage, and they were keeping him in hospital for monitoring and that for the reporter had information of the heart, but didn't have much details. The patient just had been kept in hospital for administration through the weekend. Currently, the patient was still in hospital. The outcome of the event chest pain was unknown.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood test, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: just admitted to the hospital with chest pain; This is a spontaneous report from a contactable consumer (patient's relative).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/Lot number and expiration was not reported via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got received the Pfizer COVID vaccine second dose recently and he was just admitted to the hospital with chest pain on an unspecified date in May2021. They did a heart catheterization and found that they didn't feel that the patient had any blockage, and they were keeping him in hospital for monitoring and that for the reporter had information of the heart, but didn't have much details. The patient just had been kept in hospital for administration through the weekend. Currently, the patient was still in hospital. The outcome of the event chest pain was unknown.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Echocardiogram, Ejection fraction normal, Electrocardiogram abnormal, Laboratory test
Clinical narrative: just admitted to the hospital with chest pain; This is a spontaneous report from a contactable consumer (patient's relative).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/Lot number and expiration was not reported via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got received the Pfizer COVID vaccine second dose recently and he was just admitted to the hospital with chest pain on an unspecified date in May2021. They did a heart catheterization and found that they didn't feel that the patient had any blockage, and they were keeping him in hospital for monitoring and that for the reporter had information of the heart, but didn't have much details. The patient just had been kept in hospital for administration through the weekend. Currently, the patient was still in hospital. The outcome of the event chest pain was unknown.  Information related to batch/Lot no. was requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: just admitted to the hospital with chest pain; This is a spontaneous report from a contactable consumer (patient's relative).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/Lot number and expiration was not reported via an unspecified route of administration on an unspecified date as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got received the Pfizer COVID vaccine second dose recently and he was just admitted to the hospital with chest pain on an unspecified date in May2021. They did a heart catheterization and found that they didn't feel that the patient had any blockage, and they were keeping him in hospital for monitoring and that for the reporter had information of the heart, but didn't have much details. The patient just had been kept in hospital for administration through the weekend. Currently, the patient was still in hospital. The outcome of the event chest pain was unknown.  Information related to batch/Lot no. was requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: Fever; Coughing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated, "I got my COVID shot and I got fever for four days." "I've got fever for four days and coughing, yes. I am not saying it, I am feeling it." The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Peripheral coldness, Syncope, Weight
Clinical narrative: I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right arm on 04May2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021, 1 day after the administration of vaccine the patient experienced I passed out or fainted and Hand and feet were extremely cold. Clinical course reported as I passed out or fainted and my hand and feet were extremely cold before fainting. Patient stated, that he had been trying to report an adverse reaction to the Pfizer COVID 19 Vaccine, the second shot through the 'portfolio' on the website and he tried 3 times and for whatever reasons it just won't transmit the information. So he was wondering, it is possible to report that with a live agent today. The outcome was not recovered for Hand and feet were extremely cold and unknown for rest of the events.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: contracted COVID-19, 8-9 days after vaccination; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medication were not reported. The patient experienced contracted covid-19, 8-9 days after vaccination (sars-cov-2 test positive) (non-serious) on an unspecified date Mar2021 with outcome of unknown. The patient underwent treatment with Ly-CoV555 injection which he also referred to as Bamlanivimab injection. He explained he was medically recommended to wait 90 days between this antibody therapy and the second dose of the vaccine. He asked if the second dose could be delayed. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm right on 20Apr2021 at age of 53 years old as a single dose for COVID-19 immunisation.  Medical history included anxiety, known allergies: fruits with a seed in the center i.e. peaches, cherries, apricots etc (fruit allergy). Concomitant medication included sertraline. The patient experienced allergic reaction including face swelling, cheeks were red and hot and hives on my neck., all on 20Apr2021 12:30.  No treatment received for the events. The outcome of the events was recovered in 2021. The report was reported as non-serious by reporter. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: General physical health deterioration, Systemic lupus erythematosus
Clinical narrative: the patient began to deteriorate (unspecified) shortly after, and the deterioration was eventually diagnosed as Lupus; Initial information was received on 07-May-2021 regarding an unsolicited valid serious case received from a consumer (patient's mother).  This case involves a 15 year-old male patient who began to deteriorate (unspecified) and the deterioration was eventually diagnosed as lupus (systemic lupus erythematosus), after receiving MENINGOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date in 2011, the patient received [once] dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient began to deteriorate (unspecified) which was eventually diagnosed as lupus (systemic lupus erythematosus) (unknown latency-reported as shortly after) following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant.  Caller stated that patient had life time AE [adverse event] from vaccination. It was a vaccine injury program and she was not aware of the program and she missed the benefits due to statute of limitations. Caller wanted to know if Sanofi offered in compensation. She stated it was a federal program. She asked for information regarding program Sanofi may have for injury. Caller seeking compensation after her son was diagnosed with Lupus after getting a MCV4 vaccine. The caller has been instructed to send a letter but the caller needs to verify the manufacturer of the vaccine in question due to all she had MCV4 vaccine. During the call the caller verbalized that she cannot use legal action due not having time.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, patient had not recovered from the event.  It was reported that the providers did not believe the MCV4 vaccine was the cause of the Lupus; that about 10-years later she found out that vaccines had a link to causing Lupus. That this year she went to a conference that said a vaccine could be a cause Lupus and she did not know the manufacturer of the MCV4 vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a 15 year-old male patient who experienced systemic lupus erythematosus after vaccination with MENINGOCOCCAL VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of IPOL/ NO AE; Initial information received on 29-Apr-2021 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 5 years old female patient who received first dose on 22-Feb-2016, second dose on 21-Apr-2016, and third dose on 21-Sep-2016 (not expired) of IPV (VERO) [IPOL]  then expired 0.5 mL booster dose of IPOL (strength: standard, frequency: once, lot number: R1B252M and expiry date: 13-Mar-2021 via subcutaneous route) (expired product administered) on 29-Apr-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Reporter want to know do they need to re-dose. Pharmacist asking about revaccination. Pharmacist asking if they should wait a week or longer before revaccinating. Pharmacist states that he will speak with the physician. Pharmacist states that the physician may want to wait four weeks before revaccinating.  At the time of reporting, 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of Menactra with no reported adverse event; Initial information was received on 06-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00590371).  It was reported that on 05-May-2021, a 16-year-old female patient received 0.5 ml of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (batch number: U6486AD) which was expired on 10-Jan-2021 via intramuscular route at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial nerve disorder, Laboratory test
Clinical narrative: Bell's palsy affecting left facial nerve
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Facial discomfort, Fatigue, Headache, Impaired work ability
Clinical narrative: Moderna COVID-19 Vaccine EUA - Migraine    Day 2 - I had terrible fatigue and migraine. I work from home so I couldn?t focus. Found it difficult to concentrate with the migraine. I clicked out work and went to sleep.   Day 3 - I had mild headache but not even to not be able to concentrate. At around 8-9pm the migraines started again. I went to bed at around 12am. Woke up at around 3am. The migraines are now as bad as they were on day 2. Feeling the migraine from the right side of my face
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Moderna COVID-19 Vaccine EUA - Migraine    Day 2 - I had terrible fatigue and migraine. I work from home so I couldn?t focus. Found it difficult to concentrate with the migraine. I clicked out work and went to sleep.   Day 3 - I had mild headache but not even to not be able to concentrate. At around 8-9pm the migraines started again. I went to bed at around 12am. Woke up at around 3am. The migraines are now as bad as they were on day 2. Feeling the migraine from the right side of my face
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Illness, Pneumonia
Clinical narrative: High Fever, 106+, convulsions, trouble breathing, pnemonia,   Ive never been so ill in my life.  I nearly died.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: High Fever, 106+, convulsions, trouble breathing, pnemonia,   Ive never been so ill in my life.  I nearly died.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Electrocardiogram, Full blood count normal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 13 May - Pt called back saying that last night she developed R side facial numbness including right half of tongue with blurred vision, denied facial droop, muscle weakness. Pt took a benadryl last night fell asleep and in the morning sxs resolved. However, pt states she is starting to feel sxs return, lip is turning red, feeling numbness/tingling on face. Denies light sensitivity and pupil is reacting appropriately to light per pt. Patient described distribution of trigeminal nerve all branches and ophthalmic nerve. 20 May - all symptoms resolved expect right eye visual disturbance described as "haziness". Exam including CN2-12, lymph and visual acuity all normal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Metabolic function test, Optic nerve disorder, Paraesthesia, Trigeminal nerve disorder
Clinical narrative: 13 May - Pt called back saying that last night she developed R side facial numbness including right half of tongue with blurred vision, denied facial droop, muscle weakness. Pt took a benadryl last night fell asleep and in the morning sxs resolved. However, pt states she is starting to feel sxs return, lip is turning red, feeling numbness/tingling on face. Denies light sensitivity and pupil is reacting appropriately to light per pt. Patient described distribution of trigeminal nerve all branches and ophthalmic nerve. 20 May - all symptoms resolved expect right eye visual disturbance described as "haziness". Exam including CN2-12, lymph and visual acuity all normal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 13 May - Pt called back saying that last night she developed R side facial numbness including right half of tongue with blurred vision, denied facial droop, muscle weakness. Pt took a benadryl last night fell asleep and in the morning sxs resolved. However, pt states she is starting to feel sxs return, lip is turning red, feeling numbness/tingling on face. Denies light sensitivity and pupil is reacting appropriately to light per pt. Patient described distribution of trigeminal nerve all branches and ophthalmic nerve. 20 May - all symptoms resolved expect right eye visual disturbance described as "haziness". Exam including CN2-12, lymph and visual acuity all normal.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injection site swelling
Clinical narrative: Sharp pain in left armpit. Occurred about a day or so after the vaccination. Has not worsened or gotten better.  Stiff swelling near vaccination site. Much more stiff than first dose but is going down a couple days after vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: enlarged axillary lymph node on L side - vaccination given on L deltoid.  soft, palpable tender to touch, no nodules palpated.  Decreasing in size slowly
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Severe weakness, severe fatigue, muscle pain, joint pain, chills, nausea, vomiting
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe weakness, severe fatigue, muscle pain, joint pain, chills, nausea, vomiting
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Movement disorder
Clinical narrative: Severe weakness, severe fatigue, muscle pain, joint pain, chills, nausea, vomiting
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Modern a 2nd dose. Extremely high fever. Headache, body aches, chills, nausea
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Pruritus, Swelling
Clinical narrative: "Covid arm" Moderate left arm swelling, itching, warmth, and numbness that appeared approximately 1 week after vaccination.  Symptoms resolved on its own over the course of 6 days after initial onset.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia
Clinical narrative: Unbearably metallic taste in the mouth interfering with taste/smell for ~1 week; better by day 8 but still not completely gone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: Horrible joint pains in all joints  all night. Nausea.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Seizure
Clinical narrative: Client experienced a seizure reaction shortly after vaccine injection (2 mins.) for few seconds (5).  Mother verbalized she always has that reaction after she shot.  VS BP 95/66, P 90, O2Sat 100%. VS 114/73, P 90, O2Sat 100%. After 30 mins. of observation resident stated, "I am feeling great."  Mom declined the need to go to the hospital.  In stable condition, resident was send home.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Herpes zoster, Pain, Rash
Clinical narrative: rash after receiving VARlVAX / she first developed chest pain / was diagnosed with Shingles in ER / continued pain and worsening rash; Route of Administration: intramuscular; This spontaneous report was received from a 53 years old female, not pregnant patient, who was referring to herself. The patient did not take any concomitant medications and had no known drug reactions/allergies. No information regarding the patient's pertinent medical history was provided.     On 09-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), intramuscularly for indication of vaccination (dose, lot# and expiration date were not reported). On 20-APR-2021, she developed rash and chest pain and was seen at urgent care. On 23-APR-2021, the patient went to Emergency Room (ER) and was diagnosed with shingles. She has been back on urgent care on 02-MAY-2021 for continued pain and worsening rash. The patient received treatment: acyclovir. The adverse events were not a cancer events and no overdose occurred. The outcome of the event was reported as not recovered/not resolved.  The causality assessment between the event and the suspect therapy was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002932: US-009507513-2105USA002936: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002866:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 11-MAY-2021, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) after expiration (0.5 ml, rHA, lot # S014431, expiration date 09-MAY-2021; anatomical location, strength and route were not reported) for prophylaxis (expired vaccine used). No additional adverse events was reported.