chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Pruritus, Rash, Urticaria
Clinical narrative: My mouth and tongue started itching; Skin broke out in a rash and became super itchy; Skin broke out in a rash and became super itchy; Have hives; This is a spontaneous report from a   consumer reporting for herself.  A 29-years-old female patient  received the first dose of bnt162b2 (BNT162B2; Lot # em9809) vaccine , via an unspecified route of administration in the left arm on 24Feb2021 14:30 at single dose  for covid-19 immunisation .  Medical history included asthma , attention deficit hyperactivity disorder , polycystic ovaries , sleep apnoea syndrome,  arthralgia , the patient was allergic to Albuterol, Penicillin, Cephalosporin, Iodine, Bees, all types of fish, all types of shellfish, peanuts, all types of tree nuts.  Concomitant medication included cefixime (FLEXERIL), acetylcarnitine hydrochloride (NEUROTIN ), naproxen (MOTRIN).  The patient experienced my mouth and tongue started itching  on 24Feb2021 14:30 with outcome of not recovered , skin broke out in a rash and became super itchy  on 24Feb2021 14:30 with outcome of not recovered , have hives on 24Feb2021 14:30 with outcome of not recovered.  The reported events were considered Life Threatening. The patient received Benadryl, and got epi on hand as treatment.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a contactable consumer reported for a patient (Husband) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date which required hospitalization until now. The outcome of event was not recovered.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Lip swelling
Clinical narrative: Little lip swollen that looks like a classic symptom of little angioedema on her left side; Little lip swollen that looks like a classic symptom of little angioedema on her left side; This is a spontaneous report from contactable consumer. This consumer reported for a female patient (mother in law) of an unspecified age that received first dose of bnt162b2 (BNT162B2, lot number: EN6201) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced little lip swollen that looks like a classic symptom of little angioedema on her left side on an unspecified date with outcome of unknown. Reporter stated, "It is for my mother in law. Looks like she has a little angioedema on her lip. She did have the second shot today, Pfizer, 2nd shot (Unspecified Medication). It is not severe but she does have a little lip swollen that looks like a classic symptom of little angioedema on her left side. She had the shot on her right side. I just was not sure, I mean should she take Benadryl."  Information on Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Dizziness, Headache, Heart rate
Clinical narrative: sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization.  Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00.  The patient outcome of the events was recovering.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Palpitations, Product use issue
Clinical narrative: sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization.  Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00.  The patient outcome of the events was recovering.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization.  Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00.  The patient outcome of the events was recovering.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Dtap/ipv portion was administered without reconstituting with the HIB portion/no AE; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (unknown demography) who had received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which DTAP/IPV portion was administered without reconstituting with the HIB portion (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case from a consumer via Regulatory authority (under reference number: 00482313).  This case involves female patient of unknown age who experienced allergic reaction (hypersensitivity), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   In 2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  In 2010, the patient developed a non-serious allergic reaction (hypersensitivity), (approximately in the same year, exact latency unknown) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event hypersensitivity.  Also reported that: Reporter wanted to know what were the components of that vaccine. Consumer was referred to her administering physician. Consumer stated she will check the website and she will call back tomorrow to speak to a supervisor. AE (adverse event) information not obtained due to long hold with consumer, and her main concern was just knowing the product composition of that FLUZONE HIGH-DOSE in 2010. Consumer was referred to the website and to her health care provider. She stated that she will call back tomorrow to speak to a supervisor.   There will be no information on the batch number for this case.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient who received an expired dose of Tenivac, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information  (Reference number- 00482322) and transmitted to Sanofi on 18-Feb-2021.  This case involves a 38 years male patient who received an expired 0.5 ml dose of DIPHTHERIA AND TETANUS TOXOIDS [Tenivac] (batch number C5578AA and expiration date:28-Jan-2021) via intramuscular route in the left deltoid for prophylactic vaccination (Expired product administered) on 29-Jan-2021.  The patient's medical history, past medical treatment(s), vaccination(s), family history, risk factor were not provided.  No concomitant medication were given to the patient.  It was an actual medication error due to expired vaccine used (same day latency).  Also reported that : MA (medical assistant) wants to know if the patient needs to be revaccinated  The patient did not experience any side effects.   No treatment provided.  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: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chalazion, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: headache.  right arm hard red swollen from shoulder to elbow painful fatigue neuralgia pains right eyelid swollen with chalazia
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Neuralgia, Swelling of eyelid
Clinical narrative: headache.  right arm hard red swollen from shoulder to elbow painful fatigue neuralgia pains right eyelid swollen with chalazia
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Injection site bruising, Injection site erythema
Clinical narrative: headache.  right arm hard red swollen from shoulder to elbow painful fatigue neuralgia pains right eyelid swollen with chalazia
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain, Pruritus
Clinical narrative: headache.  right arm hard red swollen from shoulder to elbow painful fatigue neuralgia pains right eyelid swollen with chalazia
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: headache.  right arm hard red swollen from shoulder to elbow painful fatigue neuralgia pains right eyelid swollen with chalazia
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body Ache
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Chills
Clinical narrative: chills and 100.0 temp
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Chest X-ray normal, Electrocardiogram, Laboratory test, Lung infiltration
Clinical narrative: Developed acute respiratory distress with bilateral pulmonary infiltrates.  Suspicious for pulmonary edema.  CXR clear 2/6/21.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Developed acute respiratory distress with bilateral pulmonary infiltrates.  Suspicious for pulmonary edema.  CXR clear 2/6/21.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Got vaccine on Friday evening. On Saturday developed low grade fever; fatigue; sore arm for several days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity, Pruritus, Rash erythematous, Rash papular
Clinical narrative: I developed what is being called "Covid Vaccine Arm" a little more than a week after receiving the first dose of the Moderna vaccine in my right arm.  The "rash" spread over my arm from the injection site almost to my elbow.  It was somewhat red, raised, and hot and extremely itchy. It gradually faded and resolved after a week.  I received my 2nd dose of the Moderna vaccine on February 26, 2021. This time--on the advice of my doctor--I got the injection in my left arm.  I started developing a rash again, but this time the day after (2/27/21).  While it does not itch as much as what I experienced previously, my arm has been far more sore and the area of redness (which is raised) is larger than the first time.  I am primarily reporting the first incident, but want to include that it happened again, but more quickly.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination complication
Clinical narrative: I developed what is being called "Covid Vaccine Arm" a little more than a week after receiving the first dose of the Moderna vaccine in my right arm.  The "rash" spread over my arm from the injection site almost to my elbow.  It was somewhat red, raised, and hot and extremely itchy. It gradually faded and resolved after a week.  I received my 2nd dose of the Moderna vaccine on February 26, 2021. This time--on the advice of my doctor--I got the injection in my left arm.  I started developing a rash again, but this time the day after (2/27/21).  While it does not itch as much as what I experienced previously, my arm has been far more sore and the area of redness (which is raised) is larger than the first time.  I am primarily reporting the first incident, but want to include that it happened again, but more quickly.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Systemic: RHABDOMYLOSIS-Medium, Additional Details: AFTER RECEIVING THE VACCINE PATIENT HAD MUSCLE WEAKNESS AND FELL DOWN. PATIENT WAS TAKEN TO DOCTOR AND DIAGNOSED WITH RHABDOMYLOSIS
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Eye swelling, Mouth swelling, Oropharyngeal discomfort, Paraesthesia
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: Muscle pain 102 Fever Sleepiness
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased, Speech disorder, Staring, Unresponsive to stimuli
Clinical narrative: Systemic: Weakness-Severe, Additional Details: patient was unresponsive and staring blankly later that evening after receiving the first dose of vaccine, she was not able to verbalize symptoms, however, she experienced weakness in legs requiring assistance to walk per her caregiver
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash on neck, chest, abdomen, and back. Hot, but not very itchy. Present between 24 - 60 hours after vaccine, treated with Benadryl. Also, very intense pain in left arm, treated with ibuprofen. This began several hours after the vaccine and lasted about 48 hours.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site is still swollen and painful 2 days after injection.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gastrointestinal pain, Muscle spasms, Nausea, Sleep disorder
Clinical narrative: I woke up at 11:30 pm with severe intestinal cramping.  I have IBS so I used what normally worked - heat and a dicyclomine capsule.  It got worse and worse to the point my whole body was shaking.  I felt nauseous and thought I might throw up from the pain (I didn't).  At 1:00 am I took a 5mg Oxycodone pill.  I got a little relieft at about 1:45 am.  The spasms started coming in waves.  At 3:15 am I took another dicyclomine and again used the heating pad.  At about 4:30 am, I was able to fall asleep.  This is absolutely the worst spasming I have ever had.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I woke up at 11:30 pm with severe intestinal cramping.  I have IBS so I used what normally worked - heat and a dicyclomine capsule.  It got worse and worse to the point my whole body was shaking.  I felt nauseous and thought I might throw up from the pain (I didn't).  At 1:00 am I took a 5mg Oxycodone pill.  I got a little relieft at about 1:45 am.  The spasms started coming in waves.  At 3:15 am I took another dicyclomine and again used the heating pad.  At about 4:30 am, I was able to fall asleep.  This is absolutely the worst spasming I have ever had.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: First:  Vaccine was not given at Center.  It was a drive-up at  Drive Thru.    Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021:  fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite.  Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations
Clinical narrative: First:  Vaccine was not given at Center.  It was a drive-up at  Drive Thru.    Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021:  fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite.  Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Limb discomfort, Peripheral swelling, Swelling
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: reported \"heaviness\" in arm and shoulder, swelling of arm and neck area-Mild, Additional Details: no numbness, tingling, or decreased circulation. 25mg diphenhydramine given\r\nsymptoms occured 2+ hours after immunization administered, patient observed for 1 hour post reporting, no increase or worsening of condition
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, General physical health deterioration, Malaise
Clinical narrative: Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Illness
Clinical narrative: Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: receipient of the vaccine , Patient, reported being ill the the following day after receiving the Pfizer N tech Vaccine. Patient's health deteriorated significantly afterwards and the overseeing Nurse at the facility predicted death in the near term. Patient died Feb. 14,2021. Two weeks and two days after receiving the COVID vaccine.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, General physical health deterioration, Malaise
Clinical narrative: receipient of the vaccine , Patient, reported being ill the the following day after receiving the Pfizer N tech Vaccine. Patient's health deteriorated significantly afterwards and the overseeing Nurse at the facility predicted death in the near term. Patient died Feb. 14,2021. Two weeks and two days after receiving the COVID vaccine.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Illness
Clinical narrative: receipient of the vaccine , Patient, reported being ill the the following day after receiving the Pfizer N tech Vaccine. Patient's health deteriorated significantly afterwards and the overseeing Nurse at the facility predicted death in the near term. Patient died Feb. 14,2021. Two weeks and two days after receiving the COVID vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC reported; Expired vaccine used; This spontaneous report was received from a medical director referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 04-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin (rHA)) (M-M-R II) (lot # R030806, expiration date was 24-OCT-2020, strength, frequency and route were not reported) for prophylaxis (expired vaccine used). No additional adverse event was reported.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: no adverse reaction; vaccination date: 27-SEP-2002 and 18-MAR-2003; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet referring to a 56 years old female patient. On 27-SEP-2002, the patient was vaccinated with hepatitis b vaccine (manufacture unknown) (strength, dose, route, lot #, expiration date not reported) for prophylaxis by a physician. On 18-MAR-2003, the patient received another dose of hepatitis b vaccine (manufacture unknown) (strength, dose, route, lot #, expiration date not reported) (inappropriate schedule of product administration). There were no adverse reactions or side effects experienced.   This is one split report from a case in litigation (MARRS# 1907USA003404).; Sender's Comments:  US-009507513-1907USA003404:
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: no additional adverse event; he believes the child only got half dose; This spontaneous report has been received from a physician via company representative concerning a child patient of unknown gender. The patient's relevant medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2021, a nurse vaccinated the child with Measles (+) Mumps (+) Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (MMR-II) (strength, dose, dose number, route of administration, anatomical location not provided) (lot number reported as T006165 and expiration date as 19-FEB-2022) for prophylaxis; however, she did not hold the child very well. Thus, the investigator believed the child only got half dose. There was no additional adverse event.
Sex: M
Vaccine: HPV9
Symptoms: Product dose omission issue, Product storage error
Clinical narrative: Consumer stated he is unsure if it is still viable and if he can administer it since it was left in his car.; Consumer stated he has the vaccine, GARDASIL 9 and is unable to administer it. Consumer stated he was given the vaccine, not administered, from the pharmacy.; Consumer stated he has the vaccine, GARDASIL 9 and is unable to administer it / he was given the vaccine, not administered, from the pharmacy. Consumer stated he is unsure if it is still viable and if he can administer it since it was left in his car; This spontaneous report was received from a male consumer of unknown age who was reporting on himself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication and previous drug reactions or allergies was not provided.  On unknown date in February 2021, the consumer was given from the pharmacy a not administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, dose, and vaccination scheme frequency were not reported, lot number and expiration date were unknown) and he still had it but was unable to administer it. Additionally, the consumer stated he was unsure if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was still viable and if he could administer it since it was left in his car (product storage error, product dose omission issue and circumstance or information capable of leading to medication error).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other AE reported; patient received PROQUAD off schedule/ she received PROQUAD at 12 months of age and 25 months of age.; This spontaneous report was received from a physician referring to a 25 months old (currently 4-year-old) female patient. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.  In 2018 (reported as at 12 months of age) and in 2020 (reported as in 25 months of age), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route, lot# and expiration date were not provided) respectively for prophylaxis (inappropriate schedule of product administration). No other adverse event (AE) was reported. It was unknown if treatment was given. It was unknown if lab diagnostics and studies were performed. It was unknown if medical attention was sought.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; Spontaneous report received on 06MAR2020.   A pharmacist reported that a consumer "missed the second dose" (PT: Product dose omission) while being on Vivotif for immunisation. It was reported that the consumer missed the second dose of Vivotif on 05MAR2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif (missed dose). Vivotif should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif (missed dose). Vivotif should be taken every other day, and the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Ate breakfast at the same time as taking her first dose of Vivotif; Spontaneous report received on 09MAR2020.  A female consumer reported that she "ate breakfast at the same time as taking her first dose of Vivotif" (PT: Product administration error). She was receiving Vivotif for immunisation. She stated that she ate breakfast and had her first dose of Vivotif at the same time. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer ate breakfast at the same time as taking her first dose of Vivotif (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer ate breakfast at the same time as taking her first dose of Vivotif (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Product storage error
Clinical narrative: Took one unrefrigerated dose of Vivotif; Spontaneous report received on 09MAR2020.  A male consumer reported that he "took one unrefrigerated dose of Vivotif" (PT: Product storage error) for immunisation. On an unknown date, the consumer took one unrefrigerated Vivotif (lot number unavailable) capsule that was unrefrigerated since it was dispensed. He was prescribed a new regimen of Vivotif but would not be able to complete that according to the recommended schedule because he will be travelling on 16MAR2020. It was reported that he had not administered any doses from the new regimen. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took one unrefrigerated dose of Vivotif (Product storage error). The consumer did not refrigerate the Vivotif since it was dispensed, and the consumer has been prescribed with a new regimen. However, the consumer did not start the new regimen as he would not be able to complete the Vivotif course before his travel date. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took one unrefrigerated dose of Vivotif (Product storage error). The consumer did not refrigerate the Vivotif since it was dispensed, and the consumer has been prescribed with a new regimen. However, the consumer did not start the new regimen as he would not be able to complete the Vivotif course before his travel date. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Drug interaction, Medication error
Clinical narrative: Started antibiotics the day after finishing the Vivotif course; Spontaneous report received on 10MAR2020.  A nurse reported that a consumer "started antibiotics the day after finishing the Vivotif course" (PT: Labelled drug-drug interaction medication error). The consumer was receiving Vivotif for immunisation. The consumer had completed a course of Vivotif on Thursday. On the following day, the consumer initiated a five day course of unidentified antibiotics for a dental procedure that was also conducted on Thursday. No complications were reported. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer started antibiotics the day after finishing the Vivotif course (Labelled drug-drug interaction medication error). This consumer had a dental procedure on the day he took the last dose of Vivotif and the next day, the consumer started unknown antibiotic course without any complications. Antibiotics should not be started for at least three days of completing the Vivotif course. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer started antibiotics the day after finishing the Vivotif course (Labelled drug-drug interaction medication error). This consumer had a dental procedure on the day he took the last dose of Vivotif and the next day, the consumer started unknown antibiotic course without any complications. Antibiotics should not be started for at least three days of completing the Vivotif course. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Drank coffee 2-3 minutes after taking first dose of Vivotif; Spontaneous report received on 11MAR2020.  A male consumer reported that he "drank coffee 2-3 minutes after he took his first dose of Vivotif" (PT: Product administration error). The consumer was receiving Vivotif for immunisation. On 09MAR2020, the consumer took his first dose of Vivotif and after 2-3 minutes drank coffee. In the morning of 11MAR2020, he took his second dose of Vivotif with lukewarm water and had no coffee. Additionally, he reported that he took both doses an hour before eating food. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer drank coffee 2-3 minutes after he took his first dose of Vivotif ( Product administration error). Vivotif should be taken with cold or lukewarm water only. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer drank coffee 2-3 minutes after he took his first dose of Vivotif ( Product administration error). Vivotif should be taken with cold or lukewarm water only. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed the fourth dose of Vivotif; Spontaneous report received on 11MAR2020.  A medical assistant reported that a consumer (unknown age and gender) "missed the fourth dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. On an unknown date, the consumer started taking the Vivotif. It was reported that the consumer had received 3 doses of Vivotif (dates not provided). On an unknown date, the consumer missed the fourth dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed taking the fourth dose of Vivotif (missed dose). Vivotif must be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed taking the fourth dose of Vivotif (missed dose). Vivotif must be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took 3 doses of Vivotif in 3 consecutive days; Spontaneous report received on 11MAR2020.  A pharmacist reported that a consumer "took 3 doses of Vivotif in 3 consecutive days" (PT: Inappropriate schedule of product administration) for immunisation. The consumer took the first, second and third dose of Vivotif on 07MAR2020, 08MAR2020 and 09MAR2020 respectively. The consumer had not taken the fourth dose yet. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first three doses of Vivotif in three consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first three doses of Vivotif in three consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Did not take third dose of Vivotif for 4 days after taking the second dose; Spontaneous case was received on 30MAR2020.  A physician reported that male consumer who "did not take third dose of Vivotif for 4 days after taking the second dose" (PT: Product dose omission). He was receiving Vivotif for immunization. The consumer took the first and the second dose of Vivotif according to schedule but, did not take the third dose for 4 days after taking the second dose. The reporter did not know the exact dates of the doses but guessed he took the first two doses on 24MAR2020 and 26MAR2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome was unknown.  Company Comment: A consumer missed taking third dose of vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed taking third dose of vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Burning sensation/nerve burning in fingers on right hand; Dull achy pain in right arm that comes and goes; Spontaneous report received on 13MAY2020.  A female patient reported that she experienced burning sensation/nerve burning in fingers on right hand (PT: Burning sensation) and dull achy pain in right arm that comes and goes (PT: Pain in extremity) following immunization with BioThrax (anthrax vaccine adsorbed). It was reported that she received BioThrax (lot number: 300032; expiry 10AUG2020) third shot and experienced burning sensation and nerve burning in fingers and dull achy pain in right arm that comes and goes. Additionally, it was reported that she thought the vaccine might have been expired as she heard that all the people who were supposed to get the shot, they did not receive it because they were told that it was expired. She was the first to get the shot and now she was wondering if she received an expired shot. The outcome was unknown, at the time of report.    Company Comment: A consumer received third shot of BioThrax on an unknown date and then had burning sensation in fingers of her right hand (burning sensation) along with painful right arm (Pain in extremity). Further information of the events is limited. Burning sensation and pain in extremity are expected after BioThrax vaccination, and assuming the injection was in the right arm, the causality of both the events is assessed as possible. The case will be followed-up for the expiration date of BioThrax Lot number which was administered to the patient.; Sender's Comments: A consumer received third shot of BioThrax on an unknown date and then had burning sensation in fingers of her right hand (burning sensation) along with painful right arm (Pain in extremity). Further information of the events is limited. Burning sensation and pain in extremity are expected after BioThrax vaccination, and assuming the injection was in the right arm, the causality of both the events is assessed as possible. The case will be followed-up for the expiration date of BioThrax Lot number which was administered to the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I got the first shot and felt I'll the next day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got the first shot and felt ill the next day.  The patient had recently got the second dose and was questioning if the side effects were better or worse with 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002780:Same reporter,same suspect,same patient,different dose(second dose) , invalid case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Active shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had active shingles after first vaccination of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had 2 friends who got shingles after the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The reporter stated that the patient got shingles after the 1st shot of Shingrix. The information regarding consent to follow up was not reported. No other information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041568:Same reporter, different patient (Friend 2/2)
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site; Swelling at the injection site; Stayed in bed for 24 hours; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 23rd October 2020, refer linked case US2021AMR002675) and PNEUMONIA VACCINE (patient received on 23rd October 2020, refer linked case US2021AMR002675).   On 4th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were not recovered/not resolved and the outcome of the weakness generalized was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, weakness generalized, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient had received second dose of Shingrix at the MD office. The batch number and expiry date of Shingrix was unknown. After the second Shingrix shot, the patient had to stay in bed for 24 hours and then felt better.  The patient experienced all the side effects listed on the website such as pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever and upset stomach. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR002675:Same suspect, same reporter, same patient, different dose (1st dose)