chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Rash, Vertigo, Vomiting
Clinical narrative: Rash from elbow to armpit all the way to the back; Vertigo; Nausea/vomiting; Tired/ could not make 2 steps; Nausea, vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash from elbow to armpit all the way to the back) and VERTIGO (Vertigo) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and METFORMIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash from elbow to armpit all the way to the back) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting). At the time of the report, RASH (Rash from elbow to armpit all the way to the back), VERTIGO (Vertigo), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patent stated that 6 to 10 days after the administration of the second vaccine the patient started to develop a rash from his elbow to his armpit, then the next day the rash was all the way to his back. Patient also experienced nausea, vomiting and vertigo. The patient went to the emergency room on 21-APR-2021 and was prescribed prednisone, ibuprofen, loratadine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Feeling abnormal, Hypertension, Pyrexia
Clinical narrative: Was delirious for 2 days; Wasn't feeling good; Had high blood pressure; Had chills; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Was delirious for 2 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo and Dizziness.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DELIRIUM (Was delirious for 2 days) (seriousness criterion medically significant), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever). On 04-Apr-2021, DELIRIUM (Was delirious for 2 days), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Patient reported that all the possible adverse events subsided by 04-Apr-2021. Patient stated that she took combination medication of nexium, antihistamine, and unspecified third product which alleviated the adverse events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Limb discomfort, Muscular weakness, Nausea
Clinical narrative: Peripheral neuropathy got worsened; Dizziness; Weakness in her legs; Could not walk; Could not feel her legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included BP and Peripheral neuropathy.  On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) (seriousness criterion medically significant), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea) outcome was unknown.  The action taken with mRNA-1273 in response to the event was not applicable.  The patient using BP and peripheral neuropathy medication currently. The patient called physician and got medicines for nausea.  Company Comment: Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy got worsened; Dizziness; Weakness in her legs; Could not walk; Could not feel her legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included BP and Peripheral neuropathy.  On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) (seriousness criterion medically significant), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea) outcome was unknown.  The action taken with mRNA-1273 in response to the event was not applicable.  The patient using BP and peripheral neuropathy medication currently. The patient called physician and got medicines for nausea.  Company Comment: Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Pulmonary embolism
Clinical narrative: Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs; had trouble breathing; sharp pain on the right side of the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 007C21A) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included SIMVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs) (seriousness criteria hospitalization and medically significant), DYSPNOEA (had trouble breathing) (seriousness criterion hospitalization) and CHEST PAIN (sharp pain on the right side of the chest) (seriousness criterion hospitalization). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to CHEST PAIN, DYSPNOEA and PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\  multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram: multiple pulmonary emboli CT scan showed multiple Pulmonary emboli like a spray of blood clots.         Patient was taken to emergency room (ER) on 20-APR-2021. Patient was discharged next day given prescription of blood thinners and pain medications.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Helicobacter infection, Pain in extremity
Clinical narrative: Helicobacter pylori; arm pain; a little bit cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included AMLODIPINE for Hypertension.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273, the report did not provide any causality assessment.  The patient was prescribed to take lansoprazole 30 milligrams, amoxicillin 500 milligrams, and clarithromycin 500 milligrams for 14 days to treat Helicobacter pylori.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Off label use, Pneumonia
Clinical narrative: Double pneumonia; Heart attack; was hospitalized was not able to get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced OFF LABEL USE (was hospitalized was not able to get second dose). On an unknown date, the patient experienced PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient was hospitalized on 31-Mar-2021 due to PNEUMONIA. On 09-Apr-2021, OFF LABEL USE (was hospitalized was not able to get second dose) had resolved. At the time of the report, PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know if she should repeat first dose. It was reported that patient was on "a lot" of concomitant medications but did not specify. The patient was in the intensive care unit. No treatment medication was reported.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Erythema, Rash papular, Skin burning sensation
Clinical narrative: I  was alright during my 30 min wait after the shot but when I arrived home I noticed my right back  hand seemed a little red. After taking a nap  for 2 hours I went to the bathroom and noticed a raised rash on my left cheek and a raised rash on the same back hand as well as a rashed red rash on my right and left arm ( forearm and upper arm) a raised rash on my upper torso and neck. very small bumps and thick like eczema. a day later the skin began to peel a little. I immediately called the pharmacy and was told to take Benadryl. they also asked if I had shortness of breath which I didnt.  The rash doesnt itch its just swollen and to report it to VAERS as well as my MD. I texted the Medical center right afterwards but they were closed and I was told they would pass the information on to my Dr.  But I never got around to messaging VAERS till now.  I asked the pharmacy to renew my epipen and I told them I had Benadryl and famotidine at home and I would take it if necessary.  I only took 1 benadryl 25mg cap. the rash died down after 5 days. it burned to put lotion on my skin and the dead  skin flaked off . It's still a little thick like eczema
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymphadenopathy
Clinical narrative: Brain fog Swollen lymph nodes under arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Herpes zoster, Muscle spasms, Oral mucosal blistering
Clinical narrative: Second vaccine not in list, COVID Pfizer done on  2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain, Ultrasound scan
Clinical narrative: Second vaccine not in list, COVID Pfizer done on  2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chills, Groin pain, Testicular pain
Clinical narrative: I received the J&J vaccine after 1 PM, on Tuesday, May 4th. Around 9PM that night (last night) I started experiencing chills and a dull, aching pain focused in my testicles, groin and lower abdomen.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever almost 12 hours after injections. Highest was 99.8. Body aches & chills. Headache. Side Effects lasted until 4pm the following day.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, body ache, fatigue - started morning after injection - treating with Ibuprofen and rest
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Hair loss
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Groin pain, Injection site pain, Pain, Pelvic pain
Clinical narrative: PAIN/SORENESS IN LEFT ARM FOR 2-3 DAYS, PAIN STARTED IN PELVIC REGION 4 DAYS AFTER INJECTION AND THEN MOVED TO LOWER RIGHT SIDE OF ABDOMEN, GROIN AREA AND INTENSIFIED ON DAY 7-8. PAIN WORSE WHEN I LIFT MY RIGHT LEG. PAIN LEVEL HAS DECREASED BUT ON DAY 14, THE AREA IS STILL PAINFUL AND I'M CONSIDERING GOING TO SEEK TREATMENT FROM MY DOCTOR AT THIS POINT.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Patient requested help after complaining of vertigo after receiving her vaccine.  Patient was assessed by EMS and nursing and she stated she felt better and was okay to go home and rest.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyschezia, Dysmenorrhoea, Dysstasia, Dysuria
Clinical narrative: Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated.  Still cramping in lower abdomen today.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia oral, Injection site irritation, Injection site pruritus, Injection site urticaria
Clinical narrative: Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated.  Still cramping in lower abdomen today.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Menstruation irregular, Pain in extremity, Pharyngeal hypoaesthesia
Clinical narrative: Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated.  Still cramping in lower abdomen today.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Mobility decreased, Nausea, Neck pain
Clinical narrative: covid arm, headache, nausea, pain neck, very sore arm at injection site, difficulty to lift arm, fever
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: covid arm, headache, nausea, pain neck, very sore arm at injection site, difficulty to lift arm, fever
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Skin haemorrhage
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported experiencing rash and hives after recieving her first dose of the vaccine. After her second dose, she noticed her skin started to become bumpy and red around the injection site. Patient also reported bleeding under the skin. Patient was referred to primary care physician and dermatologist.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in right arm from shoulder to finger
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever and headache
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: Tired, achy, headache, fever, chills, nausea, muscle aches, dizziness, couldn't lift arm past 90 degrees.  All symptoms showed up about 4 hours after shot (12 pm) and did not subside until about 1 pm Tuesday May 4th.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Tired, achy, headache, fever, chills, nausea, muscle aches, dizziness, couldn't lift arm past 90 degrees.  All symptoms showed up about 4 hours after shot (12 pm) and did not subside until about 1 pm Tuesday May 4th.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears, persistent...
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Very strong reaction; This spontaneous report was received a currently 42-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (dose, route, lot number and expiration date were not reported).  On an unknown date, the patient experienced a very strong reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). The outcome of the event was not provided.  The reporter considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot # T039454, and expiration date since it makes match with the auto-populated expiration date 14-DEC-2021) (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 9 degrees Celsius for 10 hours and 56 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2104USA003768.
Sex: M
Vaccine: MMR
Symptoms: Mouth swelling, Swollen tongue, Urticaria
Clinical narrative: 15 to 20 minutes after administration of the vaccine, consumer's mouth and tongue began to swell; 15 to 20 minutes after administration of the vaccine, consumer's mouth and tongue began to swell; consumer broke out in hives; This spontaneous report was received from a patient's grandmother and refers to a male patient of unknown age. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On an unknown date (also reported as years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  On the same date, 15 to 20 minutes after administration of the vaccine, the patient's mouth and tongue began to swell and he broke out in hives. On an unknown date, he sought medical attention. The unspecified injection and unspecified medication were given to treat the reaction. The outcome of the events was not reported. The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Product storage error
Clinical narrative: no adverse event; temperature excursion with PROQUAD and VARIVAX; a patient was inadvertently administered both PROQUAD and VARIVAX on the same day; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml injection, lot # T010288, expiration date: 20-SEP-2021 (route of administration and anatomical location were not reported) for prophylaxis and with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml injection, lot # T015999, expiration date: 08-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis (Incorrect product storage and Accidental overdose).  Administered doses of vaccines underwent the temperature excursion of 6 to 14  degrees Fahrenheit (F) (10 F) for 45 minutes. Digital data logger was not involved. The vaccines underwent previous temperature excursion of 6 to 14 F (13 F) for 15 minutes. No other adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: No additional adverse experiences; administration of an expired dose of ROTATEQ; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 27-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, single dose, orally, lot # 1676327 was confirmed to be valid, expiration date 19-APR-2021 for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired dose of ROTATEQ administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 28-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose (exact dose was not reported), orally, lot # 1660946 was confirmed to be valid, expiration date 10-APR-2021 for prophylaxis. No additional adverse event was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes simplex
Clinical narrative: bell's palsy; herpes simplex; This spontaneous report was received from a consumer referring to herself, a 60-year-old female patient. The patient's medical history included peripheral swelling and swelling after received two unspecified tetanus vaccines. The patient's concurrent conditions and concomitant medications were not provided.  On 05-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route, vaccination schedule, anatomical site, lot# and expiration date were not provided).  On 07-JAN-2015, the patient experienced bell's palsy and was hospitalized on an unknown date due to this event; during hospitalization the patient was diagnosed with herpes simplex. The patient went out from hospital after one and a half days.  The outcome of bell's palsy and herpes simplex was not provided.  The causality assessment between the occurrence of the events and the suspect vaccine administration was not provided.  Upon internal review, the event of bell's palsy was considered to be medically significant.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details are available; a patient who started the GARDASIL 9 series 2 years ago and came to their office yesterday (4/28/2021) to receive their second dose; This spontaneous report was received from a medical assistant referring to a 24 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  In April 2019 (also reported as 2 years ago), the patient started with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis.  On 28-APR-2021 (also reported as yesterday), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Confirmed with the customer that no other AE occurred.; a dose of PROQU AD that was administered after experiencing a temperature excursion.; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-APR-2021,the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, lot # t028139, expiration date 15-FEB-2022 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) has been verified as recombinant human albumin (rHA). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-10.7) Celsius for 1 hour and 6 minutes. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion on GARDASIL 9; This spontaneous report was received from a nurse prescriber and refers to a 18-year-old male patient. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 26-APR-2021, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S031287, expiration date 08-APR-2022 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine was stored in the temperature of 0.18 degrees Celsius for 3 hours and in temperature of 8.69 degrees Celsius for 30 minutes. Data logger was involved. There were no previous excursions reported. 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: S031287; expirationdate: 08-APR-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
Sex: M
Vaccine: FLUN3
Symptoms: Illness
Clinical narrative: MY SON SICK AND IN THE HOSPITAL; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) (batch number unknown), via nasal route, on an unknown date.     On an unknown date, the patient experienced my son sick and in the hospital (preferred term: Illness).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered serious (hospitalised).     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Boostrix administered instead of Infanrix; 18 months old / Boostrix administered instead of Infanrix; This case was reported by a physician via sales rep and described the occurrence of accidental underdose in a 18-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The physician reported that 18 moths old patient received Boostrix instead of Infanrix, which led to accidental underdose and inappropriate age at vaccine administration. The patient did not experienced any adverse events. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Got the 2nd shingle shot yesterday / 4 years after the first one; Headaches; Fatigue; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose approximately 4 years ago from the day of reporting).   On 1st May 2021, the patient received the 2nd dose of Shingles vaccine. On 1st May 2021, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache, fatigue and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient itself. The age group was not reported but selected as adult as per the vaccine indication. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule and experienced headaches and fatigue. The patient's blood pressure was 160/90 mmHg and pulse rate were 104 beats/min. The patient asked if he or she was okay. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: I had the vacine but still got shingles/suspected vaccination failure; I had the vacine but still got shingles; They hurt; They / itch like--; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had the vaccine but still got shingles, they hurt and itch like. Reporter's physician said it would have been a lot worse if he or she had not gotten the vaccine. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; nowhave shingles; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had the shingles shot and now had shingles, very painful. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Got the vaccine. Hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received vaccine and it hurt like hell but not gotten shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: had the shingles shot 5 years ago! Then \got the shingles\ Suspected vaccination failure; shingles; shingles! Dr. Said was from stress; still have the terrible pain if I do to much; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stress and pain. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, stress and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had shingles shot 5 years before reporting. The patient experienced the shingles. The physician said was from stress. It would be 4 years in September, still had the terrible pain. Would not wish this on anyone. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had the shingles vaccine, then ended up with shingles in her eye\ Suspected vaccination failure; shingles in her eye; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine, then ended up with shingles in eye. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; shingles / They are so painful; itch something awful / have used everything on them and still itch; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles. The patient stated that, they were so painful and itch something awful. The patient had used everything on them, had taken the required medication but still itch and nothing had helped till the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; had a very mild case; just itchy; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had mild shingles which were itchy. The patient further commented on post as bummer'. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.