chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Shoulder pain; Sore under left arm (armpit); Neck are throbbing pain that moves around; This is a spontaneous report from two contactable consumers (the patient's husband and the patient herself). The consumers reported similar events for two patients. This is the second of two reports. This report is for the wife.  A 67-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via intramuscular route of administration in the left arm on 09Feb2021 at 10:15 (Batch/Lot Number: EL9263, at the age of 67-years-old at vaccination) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. Historical vaccine information included the patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an intramuscular route of administration in the left arm on 18Jan2021 at 10:30 (Batch/Lot Number: EL1283, at the age of 67-years-old at vaccination) as a single dose for COVID-19 immunisation. On 09Feb2021, the patient received the second dose of the BNT162B2 vaccine. The husband reported that 1 month later in Mar2021, his wife developed a horrible shoulder pain and "hers left the right side". In Mar2021, the shoulder started hurting and she was sore under left arm (armpit), and in the neck was a throbbing pain that moves around. On 28Jul2021, the patient reported that the shoulder pain was getting worse 3-4 weeks after vaccination. It was also reported that the right shoulder was better but left arm up through the neck had throbbing pain that moves around. She was sore under the left arm (armpit) but that was better. She was going for EMG (Electromyogram) in "Jul2022". Seriousness criteria was reported as persistent and significant disability and incapacity. The adverse events required a visit to the physician office.  The patient underwent lab tests and procedures which included blood test was okay in 2021, c-reactive protein was okay in Jun2021, red blood cell sedimentation rate was okay in Jun2021. The outcome of events shoulder pain and sore under left arm (armpit) was recovering. The outcome of event neck throbbing pain that moves around was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021676900 same reporters, drug, and event in different patients
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Maternal exposure during breast feeding, Pyrexia, Rash, Roseola
Clinical narrative: I am breastfeeding my 7 month old son and within hours after my second dose, he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time. He hadn't even had a fever like this; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time; This is a spontaneous report from a contactable consumer (patient's mother). A 07-months-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via trans mammary dose 2, single on left arm on 07Jun2021 for Covid-19 immunization. The patient's medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, single for Covid-19 immunization. The concomitant medications were not reported. Patient did not have any covid prior to vaccination. Patient did not have covid test after vaccination. Consumer reported that "I am breastfeeding my 7 months old son and within hours after my second dose, he developed symptoms of Roseola (Rash, fever, dismissed appetite) for his first time. He hadn't even had a fever like this ever before. I am a stay-at-home mom and he is my only child, so we are pretty isolated from other children. It was strange timing with my shot. My husband is a firefighter/EMT and after reading about Roseola we decided to watch the fever before seeking medical consultation, both because of the time & cost. We were able to break the fever within 24 hours with acetaminophen, the appetite has improved somewhat, and we are waiting on the rash to clear up. Before the shot I was prepared for it to affect me, but I did not expect this for my baby. It was very alarming. The outcome of the events was resolving.  information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684117 same reporter/vaccine different patient/AE
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Myalgia, Oropharyngeal pain
Clinical narrative: Moderate muscle and joint pain; Moderate muscle and joint pain; Fever; Chills; Minor sore throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 07May2021 09:45 (at the age of 52-year-old) as dose 2, single for covid-19 immunisation. Medical history included drug hypersensitivity (penicillin allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 as dose 1, single for covid-19 immunisation. On 10Jun2021, the patient experienced moderate muscle and joint pain, fever, chills, minor sore throat, cough. Reported as onset of symptoms was over a month from date of last vaccine. No known contact with infected persons, working from home, minimal social contact. It was unknown if patient received treatment as a result of events. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderate muscle and joint pain; Moderate muscle and joint pain; Fever; Chills; Minor sore throat; Cough; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 07May2021 09:45 (at the age of 52-year-old) as dose 2, single for covid-19 immunisation. Medical history included drug hypersensitivity (penicillin allergy) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 as dose 1, single for covid-19 immunisation. On 10Jun2021, the patient experienced moderate muscle and joint pain, fever, chills, minor sore throat, cough. Reported as onset of symptoms was over a month from date of last vaccine. No known contact with infected persons, working from home, minimal social contact. It was unknown if patient received treatment as a result of events. The outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test, Swollen tongue, Throat tightness, Tongue coated
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 65-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via an unspecified route in the left arm on 15Feb2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient did not have COVID-19 prior to vaccination. The patient had not received any other vaccines within 4 weeks of the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262) on 23Jan2021 at 19:30 (at the age of 65-years-old) in the left arm as a single dose for COVID-19 immunization. On 15Feb2021 at 21:00, patient experienced diarrhea for 7 days, white coated tongue followed by tongue swelling (3 instances) occurring about every 2 weeks for 6 weeks following vaccine, throat tightness, heart - PVC's. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included fexofenadine hcl (ALLEGRA) four times a day; epinephrine (EPI-PEN). The outcome of the events was unknown. The patient was COVID tested post vaccination via nasal swab on 14Apr2021 with result: negative. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This 65-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via an unspecified route in the left arm on 15Feb2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient did not have COVID-19 prior to vaccination. The patient had not received any other vaccines within 4 weeks of the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262) on 23Jan2021 at 19:30 (at the age of 65-years-old) in the left arm as a single dose for COVID-19 immunization. On 15Feb2021 at 21:00, patient experienced diarrhea for 7 days, white coated tongue followed by tongue swelling (3 instances) occurring about every 2 weeks for 6 weeks following vaccine, throat tightness, heart - PVC's. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included fexofenadine hcl (ALLEGRA) four times a day; epinephrine (EPI-PEN). The outcome of the events was unknown. The patient was COVID tested post vaccination via nasal swab on 14Apr2021 with result: negative. Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: headache; joint pain; fatigue; This is a spontaneous report from a contactable other hcp (Nurse).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWO153) dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 10:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing , emphysema from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing. Concomitant medications included hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported and flax seed. The patient previously took chantix and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity. There were no other vaccines within four weeks of vaccine administration. It was reported that, there was no covid prior to vaccination. Tested post vaccination on 07May201 via nasal swab test, which resulted negative. It was reported that, on 14Apr2021 at 10:00, the patient has experienced headache, joint pain (arthralgia) and fatigue. No treatment was received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07May2021. The outcome for the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Is pregnant: Yes; constant ringing in the ears; dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional reported information for both mother and fetus/baby. This is a maternal report. An 87-year-old pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration, administered in arm left on 12Mar2021 13:00 (at the age of 87-year-old) as single dose for COVID-19 immunisation. Medical history included carcinoma (CA) and allergies to Sulfa; both from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin (GABAPENTIN); alectinib hydrochloride (ALECENSA); bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC [BIFIDOBACTERIUM INFANTIS; LACTOBACILLUS ACIDOPHILUS]); biotin (MANUFACTURER UNKNOWN); aspirin [acetylsalicylic acid] (MANUFACTURER UNKNOWN); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Covid prior vaccination and covid tested post vaccination was reported as no. The patient experienced constant ringing in the ears, dizziness on 13Mar2021 06:00. The mother reported she became pregnant while taking bnt162b2. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included hydration. The outcome of the events was reported as resolved with sequel.  Information about lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hot flush, Throat tightness, Urticaria
Clinical narrative: some difficulty breathing/Shortness of breath; Severe hives all over body; throat tightening; hot flash, feeling hot; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) dose 1 intramuscular, administered in the left arm on 23May2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Jun2021, the patient experienced some difficulty breathing/shortness of breath (disability, life threatening). On 12Jun2021, the patient experienced hot flash/feeling hot (disability, medically significant). On 12Jun2021 at 02:00, the patient experienced throat tightening (non-serious), and severe hives all over body (disability, medically significant). Severe hives all over body started on 12Jun2021, on the 20th day since the vaccination date. It lasted 4 days after taking hydroxyzine, famotidine, and prednisone. Then throat tightening started happening afterwards with some difficulty breathing. Took some OTC antihistamines (Benadryl, Allerclear) to ease the symptom. The patient recovered from the events, hot flash/feeling hot, some difficulty breathing/shortness of breath, and severe hives all over body. The patient was recovering from the events, throat tightening.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in his leg; This is a spontaneous report from a contactable consumer or other non hcp. An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced numbness in his leg on an unspecified date. Device date was reported as 25Jun2021. The patient did not receive any treatment for adverse event. The outcome of event was recovered.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Tachycardia
Clinical narrative: Tachycardia; I am trying to up breath but I can't do more; Tachycardia; I am trying to up breath but I can't do more; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0177, Expiration date: Unknown), via an unspecified route of administration on 23Jun2021 as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jun2021, after vaccination, the patient felt tachycardia, because before 50 minutes patient was driving to home and felt little bit tachycardia or something like that and then chills; but the first day was normal. Patient still feeling the tachycardia and when patient trying to up breath, patient can't do more. Patient don't know if it's normal or a different reaction. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Heart rate, Heart rate increased
Clinical narrative: He had a quick pulse rate, symptoms like heart is beating fast even when he is resting; He is feeling a little bit agitated; This is a spontaneous report from a Pfizer Sponsored Program Regulatory Authority. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Jun2021 as Dose 1,Single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced quick pulse rate, symptoms like heart is beating fast even when he is resting on an unspecified date in Jun2021 and he is feeling a little bit agitated. The patient underwent lab tests and procedures which included heart rate: quick in Jun2021. He had a quick pulse rate, symptoms like heart is beating fast even when he is resting. The outcome for the events was Unknown.  Information about lot/batch number has been requested. Additional information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Hypoaesthesia, Hypoaesthesia oral, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: numbness in arm 45 mins after shot; numbness in arm and shoulder 45 mins after shot/It radiated down arm, then to my lips, tongue and then to my right hip; It radiated down arm, then to my lips, tongue and then to my right hip.; Pain in arm 5 mins after shot; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular, administered in arm right on 25Jun2021 at 09:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included fibromyalgia from 09Sep2006 and ongoing, hypoglycemia, COVID-19 (if Covid prior vaccination: Yes) and known allergies: Latex, bananas, kiwi, avocado, steroids, all from an unknown date. Concomitant medications included ibuprofen (MOTRIN) taken for an unspecified indication, start and stop dates were not reported. The patient experienced pain in arm 5 mins after shot on 25Jun2021 at 09:05; numbness in arm 45 mins after shot, numbness in arm and shoulder 45 mins after shot/it radiated down arm, then to my lips, tongue and then to my right hip on 25Jun2021 at 09:45. The clinical course was as follows: 1st vaccine administered at 0900. Arm started going numb at 0945. It moved to right side of face and then right hip and went to ER once it moved to face. It took about 3 days for numbness to completely wear off. Events required visit to the Emergency room. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included cardiac stress test: ok on 24Jun2021. There was no treatment received for the events. The outcome of the events was recovered on 27Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: IPV
Symptoms: Anaphylactic reaction, Anaphylactic shock
Clinical narrative: anaphylactic reactions; Initial information received on 02-Aug-2021 regarding an unsolicited valid serious case received from other health professional.  This case was linked with SAD20210802001552 (Suspects PENTACEL, QUADRACEL, MENACTRA, DAPTACEL, ACTHIB, and ADACEL).  This case involves a patient of unknown age who had anaphylactic reactions (anaphylactic shock), while patient received IPV (VERO) [IPOL].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (lot number: T1D482M and expiration date: 25-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious, anaphylactic reactions (anaphylactic shock), (unknown latency) following the administration of IPV (VERO).  Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event.  No laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown.; Sender's Comments: This case concerns a patient of unknown age who had anaphylactic shock following vaccination with IPOL. The time to onset is unknown. However, patient's medical condition at the time of vaccination and other lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired dose of Adacel vaccine/ No AE; Initial information received on 28-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via physician (Medical assistant/ practice supervisor) via phone via Agency number: 00700841.  This case involves a 27 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   List concomitant: No other vaccines.  On 28-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot number: C5577A, expiry date: 20-Feb-2021, Frequency: once, Strength: standard via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: unknown).  It was reported Medical assistant/ practice supervisor called informing that employee gave tetanus vaccine that expired in February 2021. I am wondering if it is ok to administer another. Reporter relationship: HCP Product used: Used and Still using product: No.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received Quadracel vaccine via subcutaneously instead of intramuscularl/no AE; Initial information was received on 29-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical information under reference number - 00702552).  This case involves child patient of unknown age and gender patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] via subcutaneously instead of intramuscularly (Incorrect route of product administration).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 26-Jul-2021, the patient received first dose (once) 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date 26-Aug-2022) via subcutaneous route at the left deltoid for prophylactic vaccination.  It was reported that, "Do they need to receive a second dose for immunity?"  It was case of an actual medication error due to inappropriate route of vaccination (latency was on same day)  At the time of report, no adverse event was reported.  There were no laboratory data/results available.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: The patient received an injection of ACTHIB using a diluent of 0.9% nebulized saline, no AE; A 63 year old patient was vaccinated with ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00704024) and transmitted to Sanofi on 30-Jul-2021.  This case involves a 63-year-old male patient who was vaccinated HIB (PRP/T) VACCINE [ACT-HIB] using a diluent of 0.9% nebulized saline (Product administered to patient of inappropriate age and Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and MENINGOCOCCAL VACCINE for prophylactic vaccination and RABIES VACCINE (RABIES) used for an unknown indication.  On 29-Jul-2021, the patient received a 0.5 ml booster dose of suspect HIB (PRP/T) VACCINE (lot number not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong diluent used and inappropriate age at vaccine administration (latency same day).  It was reported that "Pharmacist stated that a patient received an injection of ACTHIB on 29JUL2021 using a diluent of 0.9% nebulized saline and asked about adverse event data regarding the use of alternative diluents. Pharmacist states that the product was sent from a satellite office without the diluent and that a new nurse used the 0.9% nebulized saline as an alternative"  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site induration, Injection site mass, Myalgia
Clinical narrative: Severe pain at time of shot. Hard lump developed immediately at injection site and remains still. Muscle pain all over body and headache, nausea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Severe pain at time of shot. Hard lump developed immediately at injection site and remains still. Muscle pain all over body and headache, nausea.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on arms, torso, legs, feet, hands
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Muscle contracture, Poor peripheral circulation
Clinical narrative: Extreme cold, chills, teeth chatter, contraction in upper chest area( more than a shiver), feeling of blood leaving hands and feet, mild headache  Started 12:30 am aug 1 Added wool afghan, small airline style microfiber blanket, large king size dpuble layer microfiber blanket, polyester filled quilt Ended 4:30 AM. TOTAL 4 hours
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test normal, Colonoscopy normal, Full blood count normal, Irritable bowel syndrome
Clinical narrative: Severe bowel distress. All symptoms of irritable bowel syndrome with no associated physical conditions. Colonoscopy performed. No adverse conditions. Extensive blood workup showed no underlying causes.  Palliative care only, OTC Imodium to control symptoms.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Thrombosis
Clinical narrative: Shortly after receiving 2nd vaccine, developed 2nd superficial blood clot in right leg. Also developed blood clot after receiving 1st vaccine but not sure if the vaccine had anything to do with it or not. Just seems awfully coincidental. Hasn?t had any clots since 2008 until this year.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Differential white blood cell count, Dizziness, Electrocardiogram, Fall
Clinical narrative: Pt received her second Moderna vaccine on 08/06/21 around 1000. Pt states that she woke up around 0330 on 08/07/21 feeling very warm and light-headed. She then took her dog outside and upon re-entering the home, fell against the wall, and called for help (to her husband). Per her husband, he found her slumping against the wall for support, shortly before experiencing a syncopal episode with what he describes as convulsive movements. He estimates she was unresponsive for approx. 1 minute.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Full blood count, Metabolic function test, Prothrombin time, Seizure
Clinical narrative: Pt received her second Moderna vaccine on 08/06/21 around 1000. Pt states that she woke up around 0330 on 08/07/21 feeling very warm and light-headed. She then took her dog outside and upon re-entering the home, fell against the wall, and called for help (to her husband). Per her husband, he found her slumping against the wall for support, shortly before experiencing a syncopal episode with what he describes as convulsive movements. He estimates she was unresponsive for approx. 1 minute.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Troponin, Unresponsive to stimuli
Clinical narrative: Pt received her second Moderna vaccine on 08/06/21 around 1000. Pt states that she woke up around 0330 on 08/07/21 feeling very warm and light-headed. She then took her dog outside and upon re-entering the home, fell against the wall, and called for help (to her husband). Per her husband, he found her slumping against the wall for support, shortly before experiencing a syncopal episode with what he describes as convulsive movements. He estimates she was unresponsive for approx. 1 minute.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Nausea, Rash
Clinical narrative: Weakness, headache & nausea & after my 2nd shot my effects were 90% milder but have a light-medium non itchy rash on upper torso unrelated to any other health issues atm feels like blah. 1st shot I was sick 2 weeks afterwards.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia oral
Clinical narrative: Tongue tingling, tightness in right calf,
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pulsatile Tinnitus in my left ear.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears are ringing all of the sudden.  Never experienced this before now.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Oropharyngeal pain, Urine analysis
Clinical narrative: I spotted for my period more than 1 week early.  I bled for 12 days.   I normally have a 5-6 day period.  After the second shot I bled for 14 days.  Then I got bacterial vaginosis in June and given 10 days of Flagyl.  Not only are my periods more than double, I also spot between periods.  In July I got a sore throat.  I was diagnosed with strep throat for the first time in my entire life.  I was given 10 days of penicillin.  I'm spotting again right now.  I'm hoping to see my obgyn on Monday.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood test normal, Chest X-ray normal, Condition aggravated, Electrocardiogram normal
Clinical narrative: Very high blood pressure followed by somewhat lower within same day, continuously going up & down, Dr has doubled the dose on Losarten 2 times. Started with 25 mg now, 100 mg, added Bystolic on 7/28/21, 2 Dr visits so far, another scheduled for 8/31/21 after heart echo test on 8/26/21
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Very high blood pressure followed by somewhat lower within same day, continuously going up & down, Dr has doubled the dose on Losarten 2 times. Started with 25 mg now, 100 mg, added Bystolic on 7/28/21, 2 Dr visits so far, another scheduled for 8/31/21 after heart echo test on 8/26/21
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diarrhoea, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Patient started feeling bad the day following the injection.  Tired, diarrhea, nausea. Death - Died on 4/12/21 at approximately 5:00 AM
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Malaise
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: patient's son was with patient in waiting area. patient's son alerted pharmacist that patient was not feeling well. observed patient having difficulty breathing. son requested 911 be called. 911 called for patient.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: nausea and vommiting
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Seizure
Clinical narrative: Systemic: Seizure-Medium, Additional Details: Per patient and wife he does not have a history of seizures. Pt suffered an episode of seizures soon after vaccine was administered. Paramedics were called and pt was monitored. Seizures less for less than 1 or 2 min. Paramedics and pharmacist recommended pt if considering second covid dose it must be administered at a hospital or at his doctor's office due to adverse reaction.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Sensation of foreign body, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Upon completion of vaccination-patient was with parents & brother-was asked twice to wait for 15 min for observation-but mother would only wait outside-returned approx 10-15 min after with daughter saying she felt a lump in throat-had patient sit in room, asked about other symptoms (none at that time)-offered to call 911-mother decided to take her across street to urgent care. Called mom later to check on patient and told she was given Epipen at urgent care and went to hospital from urgent care
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Today around 6am I started having sudden onset of chest pain and SOB, never experienced chest pain before.  Pain is sharp and tight. Just want to get this documented in case it is related to the Covid vaccination I received 10-11 days ago. No cardiac history.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Vomiting-Severe
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Vomiting-Severe
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Sluggishness
Clinical narrative: Fatigue, Chills, Headache, Upset stomach, sluggish  2nd dose given earlier that day
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia, Injection site pruritus, Mouth swelling, Paraesthesia
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Swollen tongue
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: MILD ADVERSE REACTION: (HIVES) FACE, NECK, CHEST  AND BACK; LASTED ABOUT 3 HOURS THEN SUBSIDED.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After second vaccine I slowly began to notice a ringing in my ears (tinnitus) that at first came and went and was low. But it progressively got louder and instead of coming and going it stayed so now it is persistent high pitched humming in the ears. I never had this issue before.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Migraine, body aches, fever, sore throat
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fall, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Around 5 minutes after administration, patient fell from a sitting position to the floor. I ran to his aide were I turned patient on his side and he was able to come to. Upon question with him and his father it is believed that through anxiety patient fainted and fell to the floor. We then called 911 and EMTs came to check patient to clear him to go home with his father. This was also upon his father's request.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Around 5 minutes after administration, patient fell from a sitting position to the floor. I ran to his aide were I turned patient on his side and he was able to come to. Upon question with him and his father it is believed that through anxiety patient fainted and fell to the floor. We then called 911 and EMTs came to check patient to clear him to go home with his father. This was also upon his father's request.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pain, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: shooting pain up her neck-Severe, Systemic: Unable to Sleep-Medium
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fine motor skill dysfunction, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: on about 6/15  my thumbs were numb,by the next couple of days my fingers on both hands were tingling feeling cold. I began to have great difficulty walking , standing,and,dexterity. This continues today 8/7 with no improvement.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: on about 6/15  my thumbs were numb,by the next couple of days my fingers on both hands were tingling feeling cold. I began to have great difficulty walking , standing,and,dexterity. This continues today 8/7 with no improvement.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Flushing, Head injury, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: pt was nervous before administration, cited fear of needles. rph tried to relax pt with breathing exercises, pt seemed okay, shot was administered and he stated he felt good. rph let pt sit in consultation room a moment before instructing pt to have a seat in the waiting area, rph was consulting at drive thru when tech called over stating pt fell out of chair and hit his head, pt was on the floor w/abrasion over left eye. rph instructed tech to call EMS, rescue arrived and pt declined ambulance
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: pt was nervous before administration, cited fear of needles. rph tried to relax pt with breathing exercises, pt seemed okay, shot was administered and he stated he felt good. rph let pt sit in consultation room a moment before instructing pt to have a seat in the waiting area, rph was consulting at drive thru when tech called over stating pt fell out of chair and hit his head, pt was on the floor w/abrasion over left eye. rph instructed tech to call EMS, rescue arrived and pt declined ambulance
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: n/a
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Booster Given Too Early-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Eye movement disorder, Incoherent
Clinical narrative: Systemic: Seizure-Severe, Systemic: Weakness-Severe, Additional Details: Janssen vaccine given at 05:44pm. patient reported that she felt faint about 1 minute later. provider went over to patient to attempt to help her to exam table. patient's head went back, eye rolled back, arms and legs became rigid. provider placed her hand behind patient's head to avoid injury and yelled for nurse. What looked to be a seizure lasted approximately 20 seconds. Nurse entered room. Patient became alert but was confused and incoherent. 5:52EMS called.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Posture abnormal, Seizure
Clinical narrative: Systemic: Seizure-Severe, Systemic: Weakness-Severe, Additional Details: Janssen vaccine given at 05:44pm. patient reported that she felt faint about 1 minute later. provider went over to patient to attempt to help her to exam table. patient's head went back, eye rolled back, arms and legs became rigid. provider placed her hand behind patient's head to avoid injury and yelled for nurse. What looked to be a seizure lasted approximately 20 seconds. Nurse entered room. Patient became alert but was confused and incoherent. 5:52EMS called.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Systemic: Diarrhea-Mild, Systemic: Vomiting-Medium
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: 5 minutes after pt received Moderna Dose 1 pt fainted
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Hyperhidrosis, Syncope, Tachycardia
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: fainted in the morning following vaccination
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: fainted in the morning following vaccination
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Discomfort, Facial pain, Feeling abnormal
Clinical narrative: I got vaccinated on the 08/05/2021 @about 10am and immediately I felt my arm feeling numb and heavy. My heart started racing as the evening progressed, I took a Tylenol and went to bed around 12 midnight . I woke up around 4:30am and could not return to sleep because my heart felt like it was beating 170mph I felt nervous and weak internally and in my left arm so I began praying for my new symptoms to go away. (Praying brings me comfort)  I finally returned to sleep at 6am woke up at 7:45am everything was fine until about 11am my face suddenly felt numb and heavy.  And by 3pm my eyes were swollen shut and I couldn?t see to drive. I called my friend and asked her to meet me because I wasn?t feel good, I wasn?t feeling like myself and when she arrived she was astonished at the condition of my face it was swollen hurting, burning and covered with bumps and I have photos to prove it. I?m just praying that my face returns to normal  Yesterday I too two Tylenol?s , two Zyrtec and two Benadryl?s nothing to my complete avail? woke up this morning face still deformed and eyes still swollen but I can see today.