chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: she has been experiencing radiating pain in the arm where the GARDASIL 9 was administered on 11-JAN-2021.; This spontaneous report was received from a nurse midwife and refers to a 42-year-old female patient. The patient's pertinent medical history included "HPV 91618". No known drug allergies was reported.      On 11-JAN-2021, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1687292, which has been verified to be valid, the expiration date was reported and validated as 25-AUG-2022), administered intramuscularly, as prophylaxis (reported as for prevention of other types of HPV because the patient already has "HPV 91618") (dose and anatomical site of vaccination were not provided).    On 24-MAR-2021, the patient was supposed to received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), however the patient stated that she has been experiencing radiating pain in the arm where the vaccine was administered (vaccination site pain). According to the patient the pain started on 11-JAN-2021 and has not stopped hurting since then, but she was still able to move and use her arm. Additionally, it was reported that the patient was referred to primary care provider for possible treatment. The second dose administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was postponed.  The causal relationship etween the event of vaccination site pain and the suspect vaccine was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Blindness, Cardiac failure congestive, Cardiovascular symptom, Hypoacusis
Clinical narrative: loss of vision; congestive heart failure; cardiovascular event; hearing problems; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 16-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, route of administration and anatomical location were not reported) for the long-term prevention of shingles and zoster-related conditions.         Subsequently, on an unknown date, the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: cardiovascular event, congestive heart failure, loss of vision, hearing problems and balance issues. The outcome of the events was unknown. The reporter considered all events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the events of congestive heart failure and loss of vision were considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Ill-defined disorder, Post herpetic neuralgia
Clinical narrative: loss of vision; shingles; other zoster-related conditions; postherpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 09-OCT-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster).  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles, other zoster-related conditions (ill-defined disorder), post herpetic neuralgia and loss of vision. At the reporting time, the outcome of the events was unknown.  The reporter considered the events of Shingles, other zoster-related conditions (ill-defined disorder), post herpetic neuralgia and loss of vision to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of loss of vision was considered as medically significant.
Age: 11.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Product preparation issue, Wrong product administered
Clinical narrative: PROQUAD was accidentally mixed with Menactra and administered to a patient instead of Adacel; PROQUAD was accidentally mixed with Menactra and administered to a patient; This spontaneous report was received from a nurse regarding an 11 year old, male patient.  No information regarding concurrent conditions, medical history was provided. It was reported the patient received a concomitant vaccine for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis on an unknown date.  It was reported that on 26-FEB-2021, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live  (PROQUAD) was accidentally mixed with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and administered to the patient instead of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) on the right arm for prophylaxis(wrong product administered and product preparation error) (Lot, expiration date, vaccination scheme and route of administration was not reported.)   At the time of the this report, no adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Ear pain, Facial pain, Limb discomfort, Mobility decreased
Clinical narrative: could not use arm or hand without taking pill; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/pain; the pain has moved to the side of her face, around the ear area/ pain; This spontaneous report was received from a female patient of unknown age who was reporting on herself. Her pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 17-MAR-2021, reported as 13 days ago, the patient was vaccinated with zoster vaccine live ( ZOSTAVAX) at a dose of 0.65 ml as prevention of shingles (dose #, route of administration, anatomical location, lot # and expiration date were not provided).  Since the vaccination, she has been experiencing pain to the point of taking pain medication every day. The patient stated it was a moving pain which she described as feeling like she had been punched or hit. The pain feels stronger than a bruising pain. The first couple of days she could not use her arm or hand without taking pain medication. The patient had taken off work a few days and used a heating pad which worked as long as it was on, but she could not work with a heating pad. The patient stated the pain transferred from her arm and hand to her neck and shoulder. At the time of the report, reported as this morning, she reported that the pain has moved to the side of her face, around the ear area. The pain had gone away from arm on an unknown date in March 2021. She sought medical attention and called to doctor office, but did not get a response.  The outcome of the event of pain in arm was considered as resolved on an unknown date in March 2021 (reported as the pain gone away from arm). The outcome of the rest of the events was reported as not resolved.   The relatedness between zoster vaccine live ( ZOSTAVAX) and the events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: could not use arm or hand without taking pill; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/ pain; pain transferred from her arm and hand to her neck and shoulder/pain; the pain has moved to the side of her face, around the ear area/ pain; This spontaneous report was received from a female patient of unknown age who was reporting on herself. Her pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 17-MAR-2021, reported as 13 days ago, the patient was vaccinated with zoster vaccine live ( ZOSTAVAX) at a dose of 0.65 ml as prevention of shingles (dose #, route of administration, anatomical location, lot # and expiration date were not provided).  Since the vaccination, she has been experiencing pain to the point of taking pain medication every day. The patient stated it was a moving pain which she described as feeling like she had been punched or hit. The pain feels stronger than a bruising pain. The first couple of days she could not use her arm or hand without taking pain medication. The patient had taken off work a few days and used a heating pad which worked as long as it was on, but she could not work with a heating pad. The patient stated the pain transferred from her arm and hand to her neck and shoulder. At the time of the report, reported as this morning, she reported that the pain has moved to the side of her face, around the ear area. The pain had gone away from arm on an unknown date in March 2021. She sought medical attention and called to doctor office, but did not get a response.  The outcome of the event of pain in arm was considered as resolved on an unknown date in March 2021 (reported as the pain gone away from arm). The outcome of the rest of the events was reported as not resolved.   The relatedness between zoster vaccine live ( ZOSTAVAX) and the events was not provided.
Sex: U
Vaccine: HPV9
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: COVID; has now missed a dose of GARDASIL 9; This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient got COVID, then waited two weeks and on an unknown date (reported as "now"), has missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) . The outcome of the events was unknown. There was no causality assessment provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 27-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a heart attack. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of heart attack was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event of heart attack to be disability.  Upon internal review, the event of heart attack was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No PQC or additional AEs reported.; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 11-MAR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not provided; lot# was 1691300 and expiration date was 24-NOV-2021) which was involved in a temperature excursion, 2 milliliter orally for prophylaxis.  The administered dose was involved in a temperature excursion at 11.7 degree Celsius for 75 minutes. There was no previous temperature excursion. It was detected by a date logger. No additional adverse events (AEs) was reported.
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Respiratory arrest
Clinical narrative: stopped breathing; had a febrile seizure; This spontaneous report was received from a consumer referring to her daughter. The patient had no concomitant medications nor pertinent medical history. She had allergy to amoxicillin (also reported as "amoxyalclin").   On an unspecified date on 2005, the patient was vaccinated with  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (also reported as "was recommended by doctor")(formulation, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not reported; lot number and expiration date were not provided).   On an unspecified date on 2005 (reported as sometimes in 2005), experience a febrile seizure (febrile convulsion) and stopped breathing (respiratory arrest), events which required that the patient had to be taken by ambulance to the Emergency room (ER). She received treatment for the events (unspecified). On an unknown date, she recovered from the events.   The causal relationship between respiratory arrest, febrile convulsion and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) is unknown.  Upon internal review, respiratory arrest was considered as medically significant event.
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: body aches; This spontaneous report has been received from a physician referring to a male patient. The patient's age was reported as 60 (units unknown). The patient's concurrent conditions included diabetes, hypertension and hypercholesterolemia. No known drug allergies. The information of concomitant medication was unknown.    On 10-DEC-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, route was reported as injected, once, strength, lot number and expiration date were unknown) for vaccination.         On an unknown date in 2013, following the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced body aches. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. The outcome of body aches was reported as recovered. The causality between this event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of VAQTA administered to patient; This spontaneous report was received from an office manager and refers to a 12-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.   On 05-APR-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated(VAQTA), 0.5 ml, intramuscularly ( lot # S030587 with expiration date: 06-JAN-2021) for prophylaxis.(expired vaccine administered). The vaccine had no temperature excursions prior to administration. The vaccine was not available for retrieval.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001082: US-009507513-2104USA001254:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Musculoskeletal stiffness, Myalgia
Clinical narrative: These may be symptoms of the vaccine- and I'm not sure this is necessarily considered an AE (I am filling this form myself)- but I believed it to be relevant data: -Severe Nausea -Fever of 101 F -Severe chills/shivering -Extreme Fatigue: muscle stiffness/soreness left me bed ridden for 16-24 hours and time off work -High resting heart rate (normally 45-55- RHR of 68 on night after vaccine) -Soreness in arm
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: These may be symptoms of the vaccine- and I'm not sure this is necessarily considered an AE (I am filling this form myself)- but I believed it to be relevant data: -Severe Nausea -Fever of 101 F -Severe chills/shivering -Extreme Fatigue: muscle stiffness/soreness left me bed ridden for 16-24 hours and time off work -High resting heart rate (normally 45-55- RHR of 68 on night after vaccine) -Soreness in arm
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: fever (98-99),chills, body ache, headache, fatigue: last 24 hours. followed by coughing last 48 hours, followed by stomach ache and diarrhea: 1 hour. Feel normal after 4 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever (98-99),chills, body ache, headache, fatigue: last 24 hours. followed by coughing last 48 hours, followed by stomach ache and diarrhea: 1 hour. Feel normal after 4 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: Pain and soreness where the shot was administered that lasted for 2 days. The third day arm was much better with mild pain and soreness. Fourth day, no pain unless you push on site. Also experienced achy legs the day after getting the vaccine for a day.  3 days after getting the vaccine, I started to get mild headache mid-day. Took some Tylenol and headache eventually went away. The next day, headache came back in the evening and not going away this time with Tylenol or with a nap.  Will keep taking Tylenol and with time headache will go away.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Swelling, redness and extreme pain at injection site, itching at injection site, headaches,  hot/cold flashes, bruising at injection site, tired.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and extreme pain at injection site, itching at injection site, headaches,  hot/cold flashes, bruising at injection site, tired.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 102.7 degree fever, muscle pain, very slight nausea and chills from fever
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Muscle fatigue
Clinical narrative: Severe Swollen lymph nodes. Hard to swallow food. Back fatigue
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Moderna arm rash - a red area  (horizontal oval shape 4-5in diameter) on the location of the vaccine injection.  It feels warmer than the rest of the arm. It hurts a little when touched. Started noticing it 2 days after the injection. No other symptoms or side effects. It has been only a few hours since I noticed it.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Disturbance in attention, Fatigue
Clinical narrative: Tired, lack of focus, stomach upset
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site pain, Nausea, Swelling face
Clinical narrative: Soreness at injection site, fatigue, swelling of face, nausea, vomiting, diarrhea
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Soreness at injection site, fatigue, swelling of face, nausea, vomiting, diarrhea
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001253: US-009507513-2104USA001082:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia, Skin warm
Clinical narrative: Started with fever of 101. Then whole body felt hot to the touch. Body aches that made it difficult to move. Extremely painful headache. Gland under clavicle on left arm swollen along with glands in neck and head. No response to anything for pain except Tylenol, but it didn't help the aches. Took Benadryl and symptoms cleared up completely.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Gait inability, Heart rate increased
Clinical narrative: onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Muscle spasms, Nausea, Pyrexia, Spinal pain
Clinical narrative: onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Headache, Heart rate increased
Clinical narrative: Strong fatigue and accelerated heartbeat the evening of the shot. The following day, my pulse was racing at 153 BPM shine in the shower. After resting, laying down, the lowest it would go is 11 -107 BPM. We decided to go to the emergency office. I got an EKG, and by that time everything had slowed down and looked fine. A headache persisted. I've never had a resting pulse that high before. It was weird.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours.  Then it went away with mild fatigue for a couple days.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours.  Then it went away with mild fatigue for a couple days.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 102°F, pretty intense body aches starting at 3 AM after vaccine. Took Advil, went back to bed around 4:30AM. Woke up at 8:30AM feeling mostly okay. On and off body aches rest of the day.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: I got a rash like symptom, it looked like mosquito bites ALL OVER  my legs and arms. It itches A LOt and ends up red when I scratch. It ended up actually worsening so I went to urgent care and was told that my immune system was just reacting to vaccine. I was prescribed a stronger benadryl .
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: About 20 minutes after vaccination, started to feel tingly sensation in mouth, tongue.  About 1 hour after vaccination my lips felt numb.  No blue lips, no rash/hive, no swelling of tongue, lips or face, no difficulty breathing or swallowing.  Just numbness in lips and tingling feeling on tongue, all over mouth.   The numbness felt like novacaine shot you would get if you were getting dental work done.  Numbness in lips lasted about 3 hours but gradually reduced to just tingling feeling after.  The tingling feeling in my mouth gradually got better every hour after that.  It still lasted all night.  It did not completely go away until the next morning.  After the morning, numbness and tingling sensation went away.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Muscle spasms, Neck pain, Pain
Clinical narrative: Muscle pain and muscle spasms starting in neck and on entire back all the way down to lower back lasted 7 days with consistent improvement with each passing day; treated with Tylenol. Splotchy red rash on arms and part of legs, accompanied by pins and needles feeling in majority of body. Treated as an allergic reaction since symptoms were same as those from allergic reaction to Zofran. Treated with hydroxyzine and Benadryl; resolved in 24 hours. Chills causing entire body to shake lasted approximately 1 1/2 hours and resolved suddenly on its own. Feeling feverish and verified by checking temperature for 3 days after vaccination, starting day after vaccination; took Tylenol. Pain at injection site was almost same as for any other vaccination, just a bit more.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: Muscle pain and muscle spasms starting in neck and on entire back all the way down to lower back lasted 7 days with consistent improvement with each passing day; treated with Tylenol. Splotchy red rash on arms and part of legs, accompanied by pins and needles feeling in majority of body. Treated as an allergic reaction since symptoms were same as those from allergic reaction to Zofran. Treated with hydroxyzine and Benadryl; resolved in 24 hours. Chills causing entire body to shake lasted approximately 1 1/2 hours and resolved suddenly on its own. Feeling feverish and verified by checking temperature for 3 days after vaccination, starting day after vaccination; took Tylenol. Pain at injection site was almost same as for any other vaccination, just a bit more.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Muscle pain and muscle spasms starting in neck and on entire back all the way down to lower back lasted 7 days with consistent improvement with each passing day; treated with Tylenol. Splotchy red rash on arms and part of legs, accompanied by pins and needles feeling in majority of body. Treated as an allergic reaction since symptoms were same as those from allergic reaction to Zofran. Treated with hydroxyzine and Benadryl; resolved in 24 hours. Chills causing entire body to shake lasted approximately 1 1/2 hours and resolved suddenly on its own. Feeling feverish and verified by checking temperature for 3 days after vaccination, starting day after vaccination; took Tylenol. Pain at injection site was almost same as for any other vaccination, just a bit more.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIB had a temperature excursion and was administered; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 19-FEB-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T020614 with an expiration date on 12-MAR-2023) (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis which had a temperature excursión of 34.5 degrees Fahrenheit (°F) for 29 minutes (product storage error).      There were previous temperature excursions of 34.2 °F and 35.4°F for 15 minutes which was recorded by a data logger.  No product quality complaint (PQC) reported.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIV underwent a temperature excursion and was administered to patient; This spontaneous report was received from a nurse referring to a 3-month-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 09-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T020614 with an expiration date on 12-MAR-2023) (strength, dose, anatomical location, and route of administration were not reported) for prophylaxis.  The vaccine was stored in a temperature of 34.5 degrees Fahrenheit (°F) for 29 minutes as recorded by a data logger. There were previous temperature excursions of 34.2 °F and 35.4°F for 15 minutes.  No product quality complaint (PQC) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: No adverse event; Patient received a dose of VARIVAX and wanted a shingles vaccine; This spontaneous report was received from a registered pharmacist referring to a 67 year old patient of unspecified gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 05-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported), but the patient wanted a shingles vaccine.  The reporter stated that they were overwhelmed with Covid vaccines that she did not catch the error before.  No additional adverse events or product quality complaints were reported.
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient reported no additional AE; a 54-year-old male patient was administered Gardasil 9; This spontaneous report was received from a pharmacist concerning a 54-year-old male patient.   The patiente's concurrent conditions, medical history, and concomtiant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration not reported) (lot # S033308, expiration date not reported, but upon internal validation stablished as 08-APR-2022) for prophylaxis (product administered to patient of inappropriate age) (onset date / date first identifiesd reported as 08-MAR-2021). The patient did not report additional adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (excessively dry mouth) in 79-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunization. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route) had second Covid vaccine. On 12-Mar-2021, the patient experienced DRY MOUTH (excessively dry mouth). The action taken with Eliquis(Oral) was unknown. At the time of the report, DRY MOUTH outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, COVID-19, Erythema, Headache, Injection site erythema
Clinical narrative: Her right arm / was red; Her right arm / was warm to the touch; Her right arm / was / swollen/swelling; Her right arm / was / a little bit itchy; Exposed to Covid-19  / test results / positive for Covid-19; Redness at the injection site; Swelling / at the injection site; Joint pain /  mild Covid-19 symptoms including joint pain; Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 3rd December 2020, refer linked case US2021072885).   On 19th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th March 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 20th March 2021, the patient experienced joint pain, general body pain and headache. On 24th March 2021, the patient experienced covid-19. On 30th March 2021, the patient experienced erythema of extremities, skin warm, swelling arm and pruritus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were recovered/resolved and the outcome of the covid-19 was unknown and the outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not recovered/not resolved.   The reporter considered the injection site erythema, injection site swelling, joint pain, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the covid-19, erythema of extremities, skin warm, swelling arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced injection site erythema, injection site swelling, joint pain, general body pain,headache, erythema of extremities, skin warm, swelling arm and pruritus. The outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were resolved. The outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not resolved. On 24th March 2021, the patient found out that she had been exposed to Covid 19 by a coworker.  On 26th March 2021, patient's test results showed that she was positive for Covid 19. The reporter consented to follow-up. This case had been linked with US2021072885, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072885:Same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pruritus, SARS-CoV-2 test positive
Clinical narrative: Her right arm / was red; Her right arm / was warm to the touch; Her right arm / was / swollen/swelling; Her right arm / was / a little bit itchy; Exposed to Covid-19  / test results / positive for Covid-19; Redness at the injection site; Swelling / at the injection site; Joint pain /  mild Covid-19 symptoms including joint pain; Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 3rd December 2020, refer linked case US2021072885).   On 19th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th March 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 20th March 2021, the patient experienced joint pain, general body pain and headache. On 24th March 2021, the patient experienced covid-19. On 30th March 2021, the patient experienced erythema of extremities, skin warm, swelling arm and pruritus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were recovered/resolved and the outcome of the covid-19 was unknown and the outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not recovered/not resolved.   The reporter considered the injection site erythema, injection site swelling, joint pain, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the covid-19, erythema of extremities, skin warm, swelling arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced injection site erythema, injection site swelling, joint pain, general body pain,headache, erythema of extremities, skin warm, swelling arm and pruritus. The outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were resolved. The outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not resolved. On 24th March 2021, the patient found out that she had been exposed to Covid 19 by a coworker.  On 26th March 2021, patient's test results showed that she was positive for Covid 19. The reporter consented to follow-up. This case had been linked with US2021072885, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072885:Same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Vaccine positive rechallenge
Clinical narrative: Her right arm / was red; Her right arm / was warm to the touch; Her right arm / was / swollen/swelling; Her right arm / was / a little bit itchy; Exposed to Covid-19  / test results / positive for Covid-19; Redness at the injection site; Swelling / at the injection site; Joint pain /  mild Covid-19 symptoms including joint pain; Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 3rd December 2020, refer linked case US2021072885).   On 19th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th March 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 20th March 2021, the patient experienced joint pain, general body pain and headache. On 24th March 2021, the patient experienced covid-19. On 30th March 2021, the patient experienced erythema of extremities, skin warm, swelling arm and pruritus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were recovered/resolved and the outcome of the covid-19 was unknown and the outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not recovered/not resolved.   The reporter considered the injection site erythema, injection site swelling, joint pain, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the covid-19, erythema of extremities, skin warm, swelling arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced injection site erythema, injection site swelling, joint pain, general body pain,headache, erythema of extremities, skin warm, swelling arm and pruritus. The outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were resolved. The outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not resolved. On 24th March 2021, the patient found out that she had been exposed to Covid 19 by a coworker.  On 26th March 2021, patient's test results showed that she was positive for Covid 19. The reporter consented to follow-up. This case had been linked with US2021072885, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072885:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: very bad local reaction to the first dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a 65-year-old 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 local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported.  The patient received 1st dose of shingrix and experienced local bad reaction and afraid of getting 2nd dose. The reporter inquired about the efficacy of 1 dose of shingrix. The reporter just wanted to know the percentage effectiveness of one dose. The information regarding consent to follow was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: a rash around my main torso on my back and underarms/ itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash 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 selected as adult as per the vaccine indication. The patient stated that, since getting the Shingrix vaccine, he or she had been breaking out in a rash around his or her main torso, on back and underarms. The patient also mentioned that, the rash seemed to clear up some and then break out again. There were no blisters, just fine but very itchy rash. The patient was asking if this was normal. No further information was provided.  Note- as per the nature of event (rash), TTO is kept unknown even if reported as since getting shingrix vaccine. Also no dates were provided.