chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation, Pruritus, Respiratory rate, Syncope
Clinical narrative: syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscular on 19Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included manual vacuum aspiration (MVA), traumatic brain injury (TBI) from 2007 to an unknown date, vagovasal and hypotension post TBI, Celiac disease, allergy to milk products, diagnosed with COVID-19 from Aug2020 to an unknown date prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), and folic acid. The patient was previously vaccinated with the first dose of bnt162b2 (lot number: EL3246) at the age of 30-year-old, intramuscularly for COVID-19 immunisation on 19Jan2021 at 14:15 and experienced heart flutters and "fell faint" (fainted). The patient also previously took ibuprofen and experienced allergies. After approximately 5 minutes after the patient had the second dose of vaccine (19Feb2021 14:20), the patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138. Patient awakened and reported "feeling funny" on 19Feb2021, but was A &Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. At 14:20 the patient was given Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. At 15:00, EMS called for ER transport to due prolonged recovery. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Heart rate, Oxygen saturation, Pneumonia, Rhinitis allergic
Clinical narrative: severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin.  The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin.  The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: Maternal exposure during pregnancy; Preterm delivery at 24 2/7 weeks.; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is a baby report. Only this case is serious.  A 33-year-old female mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) on 28Jan2021 at single dose for Covid-19 immunization. The mother's medical history included obstructive sleep apnea, anxiety, and environmental allergies. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), calcium carbonate (TUMS), calcium chews, fluticasone propionate (FLONASE), and triamcinolone ointment. The mother had preterm delivery at 24 2/7 weeks on 20Feb2021 via emergency cesarean section. The last menstruation date was 09Sep2020. Gestational period was also reported as 22 weeks (pending clarification). The due date was reported as 10Jun2021. The fetus experienced maternal exposure during pregnancy via transplacental route on an unspecified date. The events resulted in emergency room/department or urgent care and hospitalization for 2 days. The mother had nasal swab COVID test on 20Feb2021 with negative result. The outcome of the events was recovered.  Information about lot/batch number has been requested.; Sender's Comments: Pending the clinical course of pregnancy and risk factors for premature delivery, the company considered there is not a reasonable possibility that the event premature baby was related to BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021199045 maternal case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Eating disorder, Oxygen saturation, Oxygen saturation decreased, Pneumonia
Clinical narrative: His oxygen dropped too low to 76; Pneumonia; something with toxins; he couldn't eat or swallow; he couldn't eat or swallow; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports.   This consumer (wife) reported for a 75-year-old male patient that received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 31Jan2021 (at the age of 75-years-old) for COVID-19 immunization. Medical history included dialysis for approximately 2.5 years, a lung problem, blood pressure. Concomitant medications included carvedilol and warfarin and other unspecified medications.  The patient experienced pneumonia and died on 11Feb2021 03:00 AM. An autopsy was not performed. The cause of death was reported to be  pneumonia. Clinical course was the follows the next day on 01Feb2021 at 9:30AM the patient was dressed and ready to go to dialysis. His oxygen dropped too low to 76. He wanted an ambulance called. He went into the hospital. The patient was confused, and he was not normally confused. In the hospital the physicians said he had pneumonia, but it wasn't that bad. The doctors were baffled. He also was in the hospital for something with toxins. He had a lung problem for a long time. If he didn't go to the bathroom the toxins were hitting the liver and then the toxins were going to the brain. When he was in the hospital he couldn't eat or swallow. The first day he did eat a bit, but he had dialysis in the hospital, and it knocks him out. They were giving him antibiotics IV. He couldn't swallow any of his pills. He was in there for 11 days and had not eaten. He couldn't swallow any pills. He started going to sleep and they started giving him Morphine drip at the end. They couldn't get any medicine in him because he couldn't swallow. The patient died of pneumonia, the outcome of the other adverse events was unknown.   Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247875 Same report, different patient/event; Reported Cause(s) of Death: Pneumonia
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Toxicity to various agents
Clinical narrative: His oxygen dropped too low to 76; Pneumonia; something with toxins; he couldn't eat or swallow; he couldn't eat or swallow; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the 1st of 2 reports.   This consumer (wife) reported for a 75-year-old male patient that received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 31Jan2021 (at the age of 75-years-old) for COVID-19 immunization. Medical history included dialysis for approximately 2.5 years, a lung problem, blood pressure. Concomitant medications included carvedilol and warfarin and other unspecified medications.  The patient experienced pneumonia and died on 11Feb2021 03:00 AM. An autopsy was not performed. The cause of death was reported to be  pneumonia. Clinical course was the follows the next day on 01Feb2021 at 9:30AM the patient was dressed and ready to go to dialysis. His oxygen dropped too low to 76. He wanted an ambulance called. He went into the hospital. The patient was confused, and he was not normally confused. In the hospital the physicians said he had pneumonia, but it wasn't that bad. The doctors were baffled. He also was in the hospital for something with toxins. He had a lung problem for a long time. If he didn't go to the bathroom the toxins were hitting the liver and then the toxins were going to the brain. When he was in the hospital he couldn't eat or swallow. The first day he did eat a bit, but he had dialysis in the hospital, and it knocks him out. They were giving him antibiotics IV. He couldn't swallow any of his pills. He was in there for 11 days and had not eaten. He couldn't swallow any pills. He started going to sleep and they started giving him Morphine drip at the end. They couldn't get any medicine in him because he couldn't swallow. The patient died of pneumonia, the outcome of the other adverse events was unknown.   Information on lot number/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247875 Same report, different patient/event; Reported Cause(s) of Death: Pneumonia
Sex: F
Vaccine: FLUR4
Symptoms: Condition aggravated, Electromyogram normal, Mobility decreased, Neck pain, Neuralgia
Clinical narrative: nerve pain from the neck; spine trouble; shoulder impingement; Her range of motion was limited as patient can move her arm but cannot move side to side; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via global medical information (GMI) (Reference number- 00489616) and transmitted to Sanofi on 23-Feb-2021.  This case involves female patient (age unspecified) who experienced nerve pain from the neck (neuralgia), spine trouble (spinal pain), shoulder impingement (rotator cuff syndrome) and her range of motion was limited as patient can move her arm but cannot move side to side (mobility decreased), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was reported that, patient had a preexisting neck condition (Neck discomfort/Musculoskeletal discomfort).  Past medical treatment, vaccination, family history and concomitant medication were not reported.  On 29-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number, expiry date not reported] via an unknown route at the shoulder (as per reporter: too high on her shoulder) for prophylactic vaccination.  On an unknown date, the patient had non-serious nerve pain from the neck (neuralgia), spine trouble (spinal pain), shoulder impingement (rotator cuff syndrome) and her range of motion was limited as patient can move her arm but cannot move side to side (mobility decreased), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient believes that, the vaccination was given too high to her shoulder and till the time of reporting she was suffering to it and this was related to the discomfort she is experiencing.  Also, patient reported that, physicians were misdiagnosing her situation.    Relevant laboratory test results included: Electromyogram - On an unknown date: EMG indicates that the patient's trouble was not coming from her spine.   Patient reported that, trouble coming from her shoulder and for EMG thought, maybe there was carpal tunnel, but she wore a hand thing for several weeks and that wasn't it.  She got a cortisone shot in her shoulder and that provided relieve for the past couple of days.   For mobility decrease patient reported that, it was from the flu shot and she had pre-existing conditions which was frustrating for her.   At the time of reporting, the patient was not recovered from the reported events.   At the time of reporting, the patient wanted to know data about the effects of FLUBLOK administration that was too high on the shoulder and if FLUBLOK contain latex or un-natural latex.   The information provided was not entirely clear to the consultant but is being documented to the best that can be determined.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Rotator cuff syndrome, Spinal pain
Clinical narrative: nerve pain from the neck; spine trouble; shoulder impingement; Her range of motion was limited as patient can move her arm but cannot move side to side; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via global medical information (GMI) (Reference number- 00489616) and transmitted to Sanofi on 23-Feb-2021.  This case involves female patient (age unspecified) who experienced nerve pain from the neck (neuralgia), spine trouble (spinal pain), shoulder impingement (rotator cuff syndrome) and her range of motion was limited as patient can move her arm but cannot move side to side (mobility decreased), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was reported that, patient had a preexisting neck condition (Neck discomfort/Musculoskeletal discomfort).  Past medical treatment, vaccination, family history and concomitant medication were not reported.  On 29-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number, expiry date not reported] via an unknown route at the shoulder (as per reporter: too high on her shoulder) for prophylactic vaccination.  On an unknown date, the patient had non-serious nerve pain from the neck (neuralgia), spine trouble (spinal pain), shoulder impingement (rotator cuff syndrome) and her range of motion was limited as patient can move her arm but cannot move side to side (mobility decreased), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient believes that, the vaccination was given too high to her shoulder and till the time of reporting she was suffering to it and this was related to the discomfort she is experiencing.  Also, patient reported that, physicians were misdiagnosing her situation.    Relevant laboratory test results included: Electromyogram - On an unknown date: EMG indicates that the patient's trouble was not coming from her spine.   Patient reported that, trouble coming from her shoulder and for EMG thought, maybe there was carpal tunnel, but she wore a hand thing for several weeks and that wasn't it.  She got a cortisone shot in her shoulder and that provided relieve for the past couple of days.   For mobility decrease patient reported that, it was from the flu shot and she had pre-existing conditions which was frustrating for her.   At the time of reporting, the patient was not recovered from the reported events.   At the time of reporting, the patient wanted to know data about the effects of FLUBLOK administration that was too high on the shoulder and if FLUBLOK contain latex or un-natural latex.   The information provided was not entirely clear to the consultant but is being documented to the best that can be determined.  There will be no information available on the batch number for this case.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headache; Mild tiredness; chills; low fever; This is a spontaneous report from a contactable Consumer. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (Lot Number: EW 5318) via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3248) on 13Jan2021 without expected adverse event (arm pain and tiredness). The patient had lymphadenopathy in the glands of the armpit were the first and second shot were given on 05Feb2021. Strong headache (not improving with Acetaminophen 500 mg on 04Feb2021, Mild tiredness, chills and low fever on 03Feb2021. The patient started Tylenol for the common symptoms expected after the shot that day (as recommended by the vaccination center). Tiredness started that day. The strong headache started late afternoon of 04Feb2021 (less than 24 hrs. from reporting). On 05Feb2021 around 8:00 the armpit swollen. There was not a sudden but a progression of symptoms. The patient didn't report the events aware that are common from vaccination, and reported (1 hour, 25 minutes) about the armpit swollen. The patient stated that the tiredness was indicated as a common effect so not report it Tylenol was recommended. The strong headache started late on 04Feb2021 and the armpit swollen the day after 05Feb2021 (Early in the morning). The patient took rest on the weekend and changed from Tylenol to Naproxen. Headache and swollen armpit (left side where the shot was given) disappeared. Feeling well since yesterday (currently without medication). The outcome of the event strong headache and Lymphadenopathy in the glands of the armpit were the first and second shot were given was recovered and outcome of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: HEP, HEPA, HEPA, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccines; No adverse event; This spontaneous report was received from a registered nurse, referring a patient of unknwon age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On an unknown date the patient was vaccinated with an was administered improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T007035 with expiration date on 15-APR-2021 and T007035, 01-MAY-2022 , hepatitis a vaccine, inactivated (VAQTA): T014590, expiration: 15-APR-2021, T014589, expiration: 25-OCT-2021, Hepatitis A Vaccine, Inactivated (VAQTA), Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB): T025374, expiration 25-JAN-2023, and a dose of  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported), However no adverse events were reported.   t was reported that the vaccines were exposed to temperature of 15.8 Centigrade range for a time frame of 22 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.  Lot Number T017285 is an invalid to number for Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: M
Vaccine: RV5
Symptoms: Dyschezia
Clinical narrative: experienced dyschezia; This spontaneous report was received from a physician via a company representative referring to a 4 months old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.     On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, lot# and expiration date were not reported) orally for prophylaxis.        Then on an unknown date, he was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 dosage form, strength, lot# and expiration date were not reported) orally for prophylaxis.         On an unknown date, the patient experienced dyschezia. The patient sought medical attention and contacted physician. Information about treatment given and lab diagnostics/studies performed were not reported. The patient recovered from dyscheziaon an unknown date. The patient did not get the third dose. Action taken with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not applicable.   The causality between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Reporter needed to knowalternate dosing schedule per call they have a patient who will be coming in after the patient got the first dose in January of 2020 (2 years ago).; No other information provided.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In 2020, the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    The reporter needed to know alternate dosing schedule because the patient will be coming in after the patient got the first dose 2 years ago. No other information provided.
Age: 11.0
Sex: U
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product preparation error, Product preparation issue, Wrong product administered
Clinical narrative: Customer reports patient experienced no systemic reactions. No additional adverse event reported; Customer reports PROQUAD was inadvertently mixed with MENACTRA as a diluent and administered to a patient.; Customer reports PROQUAD was inadvertently mixed with MENACTRA as a diluent and administered to a patient.; This spontaneous report has been received from a registered nurse concerning a 11-year-old patient. The patient's relevant medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 26-FEB-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA (recombinant human albumin)) (1 dose, lot # T027113, expiration date: 07-FEB-2022. Strength, dose, route of administration, anatomical location, and frequency, were not provided) for prophylaxis, which was inadvertently mixed with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (1 dose, lot # U6787AA, expiration date: 08-NOV-2021. Strength, dose, route of administration, anatomical location, indication and frequency, were not provided) as a diluent (wrong product administered) (product preparation error). During this visit, the patient was also given HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (1 dose, lot # T007035, expiration date 01-MAY-2022. Strength, dose, route of administration, anatomical location, and frequency, were not provided), which was administered appropriately for prophylaxis according to prescribing information (unspecified information).   According to the reporter, the patient did not experience any systemic reactions and no additional adverse event was reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Cardiac failure congestive, Herpes zoster, Ill-defined disorder
Clinical narrative: Congestive heart failure; Other related health complications; Bell's Palsy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to 76-year-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. In September 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (also reported as shingles vaccine) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided) at a pharmacy (he was 73-year-old when he received the vaccine). On an unknown date, as result of said administration, the patient suffered congestive heart failure, including any and all of its sequelae. Then, in or about January 2015, as a result of his receipt of zoster vaccine live (ZOSTAVAX), he suffered shingles. Then, in or about February 2015, as a result of his receipt of zoster vaccine live (ZOSTAVAX), he suffered Bell's Palsy, including any and all of its sequelae. On an unknown date, he also experienced other related health conditions (ill-defined disorder). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. In addition, the patient required and would continue to require healthcare and services. He had incurred and would continue to incur medical and related expenses. Besides, he had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient reported direct medical losses and costs included physician care, monitoring, and treatment. He had incurred and would continue to incur mental and physical pain and suffering. The outcome of cardiac failure congestive, facial paralysis, herpes zoster and ill-defined disorder was reported as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Cardiac failure congestive, facial paralysis, herpes zoster and ill-defined disorder were considered disabling events by the reporter.  Upon internal review, facial paralysis and cardiac failure congestive were considered medically significant events.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Product administered to patient of inappropriate age
Clinical narrative: The consumer received the ROTATEQ vaccine at 18-weeks-old.; Bloody stool; This spontaneous report was received from a consumer referring to an 18 week old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021, the patient was vaccinated  at 18 weeks old with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) for routine vaccination.  The reporter was concerned because the patient's age at vacciantion was outside of that 6 to 12 weeks window that was the correct vacciantion schedule. On an unknown date in February 2021, the patient was taken to the Emergency Room, for bloody stools (haematochezia)(patient was not admitted to the Hospital).   At the time of the report, the outcome of haematochezia was unknown. The reporter did not mention the causality assessment between the event and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) vacciantion.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they did not experience any side effects; PROQUAD that was administered to 17 year old. PROQUAD should not be administered to anyone over the the age 12; Route of Administration: IM; This spontaneous report was received from a nurse referring to a 17 years old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 02-MAR-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (0.5 ml, strength was not reported, lot # T025508 has been verified as valid, expiration date 23-JAN-2022) intramuscularly (IM) (incorrect route of product administration) for prophylaxis. According to reporter's information, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) should not be administered to anyone over age 12. The patient did not experience any side effects. The outcome of the events were unknown.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Heplisav-B Given After High Temperature Excursion; Initial Report Received on 23-Feb-2021  A nurse reported that a 76 year-old male (race and ethnicity not provided) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization past the 8 hours of exposure time allowance to room temperature.  No other medical history was reported.  No relevant concomitant medications were reported.    On 22-Feb-2021, the patient received a dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 43528-003-05 and serial number 451427834640) to the left deltoid at a doctor's office from a medical assistant. The doctor's office was closed the previous week due to a power outage. There was a note placed on the vaccine refrigerator of "do not use vaccine" because the vaccine temperature was out of range (16.3 C° or 61.3 F°) past the 8 hours of exposure allowance time to room temperature. However, the medical assistant did not see the refrigerator sign and gave the HEPLISAV-B vaccine to the patient.  The patient reported no adverse reactions or side effects.     No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Drooling, Pseudostroke
Clinical narrative: thought that it might be a stroke; Lip is dripping at the right side; A spontaneous report was received from a Healthcare professional which concerns 37-year-old male nurse patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a situation where his right lip is dripping and thought that it might be a stroke.  The patient's medical history was not provided. The concomitant medication included Tizanidine.  On 23-Dec-2021, approximately 27 days prior to the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18-Jan-2021, Patient experienced a situation where his right lip are is dripping and thought that it might be a stroke.  Treatment information was not provided.  Action taken with mrna-1273 in response to the events was unknown.  The outcome of the event(s) where his right lip is dripping and thought that it might be a stroke was unknown.; Reporter's Comments: Limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypersensitivity
Clinical narrative: Difficulty Breathing; Chest Tightness; allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events difficulty breathing and chest tightness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, immediately after the first dose, the patient experienced the events difficulty breathing and chest tightness.  Treatment details included, Benadryl - Given by the ER HCP to alleviate the allergic reaction to the Moderna COVID-19, Vaccine.  The events of difficulty breathing and chest tightness were considered to be serious with criteria of life threatening.  Action taken with mRNA-1273 in response to the events was unknown.   On 29 Jan 2021 the outcome of events difficulty breathing and chest tightness was resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; A Spontaneous report was received from a consumer concerning a 85-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed seizure.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, two hours prior to the onset of the event seizure, the patient received their second of two planned doses of mRNA-1273 (Lot 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Feb 2021, 2 hours post vaccination the patient developed medically significant event of seizure. Treatment for the event included lorazepam.    Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event seizure was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Gait inability, Hallucination, Mental impairment
Clinical narrative: gradual decline in her abilities both mental and physical; gradual decline in her abilities both mental and physical; tremors; could no longer walk; lost use of right arm; hallucinating; fallen and could not get up; A spontaneous report was received from a consumer concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm.   The patient's medical history was not provided by the reporter. Concomitant medicines were not reported.  On 19-Feb-2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 30M20A)  in the right arm for prophylaxis of COVID-19 infection.  On Saturday 20-Feb-21, it was reported that the patient had fallen and could not get up.  On Sunday 21-Feb-21, per report, the patient had a noted decline in her mental and physical abilities, was hallucinating, having tremors, difficulty walking and had lost the use of her right arm. The patient was transported to the hospital via ambulance and admitted. The computed tomography scan was negative.  Testing for urinary tract infection was negative as well.      The patient received both scheduled dose of mRNA-1273, therefore, action taken with the drug in response to the events was not applicable.   The outcomes of the events, a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm, were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Physical deconditioning, Tremor, Urinary tract infection
Clinical narrative: gradual decline in her abilities both mental and physical; gradual decline in her abilities both mental and physical; tremors; could no longer walk; lost use of right arm; hallucinating; fallen and could not get up; A spontaneous report was received from a consumer concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm.   The patient's medical history was not provided by the reporter. Concomitant medicines were not reported.  On 19-Feb-2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 30M20A)  in the right arm for prophylaxis of COVID-19 infection.  On Saturday 20-Feb-21, it was reported that the patient had fallen and could not get up.  On Sunday 21-Feb-21, per report, the patient had a noted decline in her mental and physical abilities, was hallucinating, having tremors, difficulty walking and had lost the use of her right arm. The patient was transported to the hospital via ambulance and admitted. The computed tomography scan was negative.  Testing for urinary tract infection was negative as well.      The patient received both scheduled dose of mRNA-1273, therefore, action taken with the drug in response to the events was not applicable.   The outcomes of the events, a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm, were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Herpes zoster, Loss of consciousness, Paralysis
Clinical narrative: Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt weak; A spontaneous report was received from a consumer concerning a female patient of 75 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced loss of consciousness, paralysis, weakness and shingles in the ear.  The patients medical history, as provided by the reporter, included myasthenia gravis. Concomitant medications reported included lidocaine patch and prednisone.  On 10 feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number:010M20A  ) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection.   On 11 feb 2021, one day after vaccination,patient experienced loss of consciousness,paralysis and weakness. The  event loss of consciousness and paralysis was also considered to be medically significant. On 16 feb 2021, patient experienced shingles in the ear. Treatment for the events included acyclovir and ice.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events loss of consciousness, paralysis, weakness and shingles in the ear were considered as unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Intraductal proliferative breast lesion, Lymphadenopathy
Clinical narrative: swollen lymph nodes; (DCIS)Ductal Carcinoma In Situations and Causes; A spontaneous report was received from an consumer concerning a female patient (unspecified age) who experienced Ductal Carcinoma In Situations and Causes and swollen lymph nodes.   The patient's medical history included hypertension and cholesterol since an unknown date.  Concomitant product use was not provided by the reporter.  On 23 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On date 26 Jan 2021 the patient was diagnosed with (DCIS) Ductal Carcinoma In Situations and Causes at stage o grade and on date 14 Feb 2021 Patient experienced swollen lymph nodes.  The event Ductal Carcinoma In Situations and Causes was considered medically significant.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The events, ductal carcinoma in situations and causes and swollen lymph nodes were unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting.   The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia