chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Photophobia, SARS-CoV-2 test negative
Clinical narrative: Migraine began day of injection which downgraded to headache in days following.  Other symptoms beginning day after injection on April 9... muscle pain, joint pain, eye pain, sensitivity to light, fatigue, nausea.  All these symptoms have continued as of today April 18.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Sore throat/swollen glands started a week after receiving the COVID-19 vaccine. Swollen glands have been persistent for the past 3 days and have not improved at all.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Deafness, Ear discomfort, Ear pain
Clinical narrative: The day following my injection I experienced escalated Tinnitus.  Different tones and pitches.  Occasional ear pain.  Feeling of fullness in the ears that was not present before vaccine. Neck and shoulder pains.  1 week away from second dose and I am still experiencing escalated tinnitus.   Slightly improved from initial response but escalated from level before injection.  I feel I have had some hearing loss.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Tinnitus
Clinical narrative: The day following my injection I experienced escalated Tinnitus.  Different tones and pitches.  Occasional ear pain.  Feeling of fullness in the ears that was not present before vaccine. Neck and shoulder pains.  1 week away from second dose and I am still experiencing escalated tinnitus.   Slightly improved from initial response but escalated from level before injection.  I feel I have had some hearing loss.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Laboratory test, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Swollen throat, tongue and difficulty swallowing. Tingling lips and inside mouth.  Today's Visit Reason for Visit Allergic Reaction Diagnosis Acute allergic reaction, initial encounter Lab Tests in Progress Blue Top Tube-Hold Blood Lavender Top Tube-Hold Blood Red Top Tube-Hold Blood Done Today Discharge Home Insert PIV Medications Given diphenhydrAMINE (BENADRYL) Last given 4/18/2021 1:30 AM famotidine (PEPCID) Last given 4/18/2021 1:30 AM lactated ringers (LR) Stopped 4/18/2021 3:06 AM methylPREDNISolone sodium succinate (Solu-MEDROL) Last given
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes, Pyrexia
Clinical narrative: fever and altered mental status
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Loss of appetite -3 days, Fever 1 day, Headaches still having, Fatigue still having Going to Dr. on April 21, 2021
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tender feeling in armpit (potential swollen lymph node) 1 week after vaccine. Vaccine received  late afternoon Friday April 9. Only symptom immediately with in the 1-2 days after receiving vaccine was extra tiredness. Armpit tenderness was only noticed in the early AM of Saturday April 17 (1-2AM) before sleeping.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: About a week after the first dose I experienced muscle pain in my neck then it moved to my shoulder blade. It's been over a month and I'm still feeling pain in my shoulder blade near my spine.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pyrexia, Skin induration
Clinical narrative: 1: "covid arm", very painful was on fire, below the injection and round to the front of the arm.  Started on the night after the injection and pain lasted for two days.  Still itching on the fourth day. 2: High fever, woke up on Friday morning at 6 am with a 100.4 fever.  It started to rise, and went up to 102.9.  I took some Tylenol and the fever went down back down to around 100, but then went up again after it wore off.  This continued until 12 pm on 18 April, when the fever finally broke.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Confusional state, Dizziness, Fatigue
Clinical narrative: Terrible body pain, high temperature, chills, headache, confussion, dizziness, fatigue for almost a week.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Terrible body pain, high temperature, chills, headache, confussion, dizziness, fatigue for almost a week.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: tinnitus - constant high pitched whistling sound in my ears, intensity varies, wakes me up at night
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Malaise, Nausea, Pain
Clinical narrative: I started hurting with just my arm really bad, than, later like at  5pm I started feeling more sick like a headache than at 7:30pm I started with chills hot, like a fever and body ache and really bad all night like when I was sick from Covid-19. I had Covid in January 13th 2021,  and came negative in January 31st 2021. I still feel very sick I have been with a headache all day and right now I feel nauseas, and today is 4-18-2021 and its 11:42 pm I also have a big headache.  I started taking Tylenol 500mg and I'm still taking Tylenol 500mg and Advil 200mg
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I started hurting with just my arm really bad, than, later like at  5pm I started feeling more sick like a headache than at 7:30pm I started with chills hot, like a fever and body ache and really bad all night like when I was sick from Covid-19. I had Covid in January 13th 2021,  and came negative in January 31st 2021. I still feel very sick I have been with a headache all day and right now I feel nauseas, and today is 4-18-2021 and its 11:42 pm I also have a big headache.  I started taking Tylenol 500mg and I'm still taking Tylenol 500mg and Advil 200mg
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: About 12 hours after receiving the vaccine, I experienced a fever, chills, muscle aches, headache, fatigue, and some dizziness. My arm was extremely sore. It lasted for about 36 hours and then most symptoms were gone. My neck muscles were sore for about a week after.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: About 12 hours after receiving the vaccine, I experienced a fever, chills, muscle aches, headache, fatigue, and some dizziness. My arm was extremely sore. It lasted for about 36 hours and then most symptoms were gone. My neck muscles were sore for about a week after.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client received her second dose of Moderna on Day 17 (7 days earlier than Day 24). This was brought to our attention when doing chart audits on 4/16/2021. I immediately called the client and left a voicemail. She called back and we discussed the matter, she said she felt drowsy after her second dose. I told her that if it continued or became worse to call her primary card provider. I said I would fill out an incident report and VAERs about the incident.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills and body soreness
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Bitemporal headache unrelieved by ibuprofen and fever up to 101F lasting less than 24 hours.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Mild but very high pitched tinnitus in the right ear - new symptom.  Lasted for 36 hours so far (on and off but mostly on).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lacrimation increased, Lip swelling, Pruritus, Rhinorrhoea
Clinical narrative: itchy skin, runny eyes & nose / sneezing / shortness of breath / swollen lips - symptoms resolved after 5 hours
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: itchy skin, runny eyes & nose / sneezing / shortness of breath / swollen lips - symptoms resolved after 5 hours
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Tinnitus
Clinical narrative: Tinnitus started on 4/8, had a deep tissue massage that eve, noticed ringing that night... cold sore on my lip started around 4/12
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pt reported sudden onset 10/10 left elbow pain (no other symptoms) one day after 1st dose. pt reported current left elbow pain 5/10. Elbow was free from redness and hives. patient reported pain in right elbow that started after she turned 42 and history of left and right arm weakness after she turned 38. Pt reported family history of osteoperosis. Situation elevated to medical consult team. Pt then advised to follow up with doctor for her left arm, receive her 2nd dose of pfizer in the right arm, and wait in observation for 30 minutes. patient left facility after 30 minutes with 0/10 pain, steady gait and unlabored respirations.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling cold, Heart rate irregular, Palpitations
Clinical narrative: Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given orange juice.  Pt vitals assessed: BP  130 mmHg, HR 122 beats/min, SpO2 100%. Patient's extremities were cold upon palpation.  patient appeared dazed but was AxO x 4 and able to follow commands. Pt reported similar episode due to irregular heartbeat. Pt reported no pain, throat irritation, chest tightness, and itchiness.  Patient offered EMS--pt declined. Patient reassessed in 5 minutes at approx. 1334. Patient reported throat tightness and chest tightness. patient started trembling throughout the body. Pt revealed history of prior hospitalization due to left-sided paralysis. BP 140/80 mmH, HR  fluctuating 85-100 beats/minute, and RR 17 breaths/minute. EMS activated. Paramedics arrive at 1411 and assume care. Pt transported to hospital for further care.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: Pt reported dizziness and irregular heartbeat. at 1339.Patient put in anti-gravity chair and given orange juice.  Pt vitals assessed: BP  130 mmHg, HR 122 beats/min, SpO2 100%. Patient's extremities were cold upon palpation.  patient appeared dazed but was AxO x 4 and able to follow commands. Pt reported similar episode due to irregular heartbeat. Pt reported no pain, throat irritation, chest tightness, and itchiness.  Patient offered EMS--pt declined. Patient reassessed in 5 minutes at approx. 1334. Patient reported throat tightness and chest tightness. patient started trembling throughout the body. Pt revealed history of prior hospitalization due to left-sided paralysis. BP 140/80 mmH, HR  fluctuating 85-100 beats/minute, and RR 17 breaths/minute. EMS activated. Paramedics arrive at 1411 and assume care. Pt transported to hospital for further care.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Malaise, Rash
Clinical narrative: Sick day after shot, Rash in arm 3 days after shot, shingles 1 week after shot (
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Violent throwing up of stomach acid for several hours after being nauseated for several hours
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain of skin
Clinical narrative: skin pain, shivers, feeling sick for about 6 hours
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Fatigue, Nausea, Pain
Clinical narrative: Extreme arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme arm soreness, unable to lift or touch arm without severe pain. Dizzy spells accompanied with ?brain zaps?. Nausea. Fatigue.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Cardiac failure chronic, Hypoacusis, Lip swelling, Peripheral swelling
Clinical narrative: upper arm swelling ("several timed bigger"); lips and tongue swelling; lips and tongue swelling; a hot burning rash from head to toe; a hot burning rash from head to toe; recent diagnosis of chronic heart failure; very hard of hearing; This spontaneous report as received from currently a 83 years old female patient, reporting on herself.  The patient reported that while working in a hospital in 1982, she was exposed to unknown "medicinal chemicals" that broke down the immune system and caused a "multitude off problems from the point on". The patient experienced chemical and environmental sensitivities, allergies to seasonal pollen, and various unknown autoimmune problems as a result of the exposure. She also had "numerous side effects to a lot of medications and allergic reactions to medications". The only treatment provided at that time, was being sent to another region for twenty years to get away from any pollution in order to try to get her immune system to heal itself, "and it get stronger but has not healed completely". When she was asked to about the concomitant therapies, she reported "a multitude of medications for various ailments" that she could not remember.  In an unspecified date in March 2006, in the afternoon, when she was approximately 68 years old, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) 0.5 milligram (lot number reported as 121OR, but upon internal verification determined as 1210R which has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), with expiration date reported as March 2007, but upon internal validation established as 30-MAR-2007) for prophylaxis (route of administration and anatomical location were not reported).  She reported that she had a severe reaction to the vaccine. She waked up at 4 am with upper arm swelling ("several timed bigger"), a hot burning rash from head to toe, lips and tongue swelling. Therefore, on an unspecified date in 2006, she was hospitalized and was treated with an unknown medication by an allergist for an unknown amount of time. Additionally, she reported that was very hard to hear, and that she was recently diagnosed with chronic hear failure. The outcome of the events was not reported.  The causal assessment between the events hypoacusis and cardiac failure chronic with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided.  Upon internal review, the event cardiac failure chronic was determined to be medically significant.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Skin warm, Swollen tongue
Clinical narrative: upper arm swelling ("several timed bigger"); lips and tongue swelling; lips and tongue swelling; a hot burning rash from head to toe; a hot burning rash from head to toe; recent diagnosis of chronic heart failure; very hard of hearing; This spontaneous report as received from currently a 83 years old female patient, reporting on herself.  The patient reported that while working in a hospital in 1982, she was exposed to unknown "medicinal chemicals" that broke down the immune system and caused a "multitude off problems from the point on". The patient experienced chemical and environmental sensitivities, allergies to seasonal pollen, and various unknown autoimmune problems as a result of the exposure. She also had "numerous side effects to a lot of medications and allergic reactions to medications". The only treatment provided at that time, was being sent to another region for twenty years to get away from any pollution in order to try to get her immune system to heal itself, "and it get stronger but has not healed completely". When she was asked to about the concomitant therapies, she reported "a multitude of medications for various ailments" that she could not remember.  In an unspecified date in March 2006, in the afternoon, when she was approximately 68 years old, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) 0.5 milligram (lot number reported as 121OR, but upon internal verification determined as 1210R which has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), with expiration date reported as March 2007, but upon internal validation established as 30-MAR-2007) for prophylaxis (route of administration and anatomical location were not reported).  She reported that she had a severe reaction to the vaccine. She waked up at 4 am with upper arm swelling ("several timed bigger"), a hot burning rash from head to toe, lips and tongue swelling. Therefore, on an unspecified date in 2006, she was hospitalized and was treated with an unknown medication by an allergist for an unknown amount of time. Additionally, she reported that was very hard to hear, and that she was recently diagnosed with chronic hear failure. The outcome of the events was not reported.  The causal assessment between the events hypoacusis and cardiac failure chronic with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided.  Upon internal review, the event cardiac failure chronic was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's or PQC's noted; Caller reported a temperature excursion/ which was administered to multiple patients; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 30-MAR-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dosage form orally, lot # 1688825 and expiration date 24-NOV-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 47.7 degree fahrenheit (°F) for 8 minutes, 54 °F for 28 minutes and 47.8 °F for 12 minutes. Previous temperature excursions were reported with the following details: 61.9 °F for 9 hours and 21 minutes and 56.3 °F for 4 hours and 27 minutes.  The call was made due to a digital data logger. No adverse symptoms were reported. This is one of several cases from the same reporter; Sender's Comments:  US-009507513-2104USA003253: US-009507513-2104USA003130: US-009507513-2104USA003255:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse event.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse event.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 24-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/ frequency: 1,  lot # T010310, expiration date 24-MAR-2022, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.   This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse event.   This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 01-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/ frequency: 1,  lot # T010310, expiration date 24-MAR-2022, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.   This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 03-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 10-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved.   This is one of multiples cases received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 17-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Throat irritation
Clinical narrative: ITCHY THROAT; SORE THROAT; CONGESTION; This spontaneous report received from a patient concerned a female of unspecified age (ethnic origin unknown).  The patient's height, and weight were not reported.  The patient's concurrent conditions included allergies (further details not provided). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number unspecified) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced itchy throat, sore throat, and congestion (event captured as nasal congestion). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy throat, sore throat and congestion was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE WORSENED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient was previously treated with paracetamol for headache.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache worsened was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dysgeusia, Fatigue, Feeling hot, Headache
Clinical narrative: SHAKING; SINUS PAIN; BACK PAIN; BURNING SKIN ON AND OFF; PAIN IN PELVIS AREA; VOMITING; NAUSEA; SORENESS AT THE INJECTION SITE; MUSCLE ACHE; HEADACHE; FATIGUE; METALLIC TASTE; WARMTH IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 23:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced metallic taste. On 06-MAR-2021, the subject experienced warmth in body. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced sinus pain. On 07-MAR-2021, the subject experienced back pain. On 07-MAR-2021, the subject experienced burning skin on and off. On 07-MAR-2021, the subject experienced pain in pelvis area. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced soreness at the injection site. On 07-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 06-MAR-2021, was recovering from back pain, and warmth in body, had not recovered from fatigue, shaking, nausea, headache, sinus pain, soreness at the injection site, burning skin on and off, pain in pelvis area, and vomiting, and the outcome of muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pelvic pain, Sinus pain
Clinical narrative: SHAKING; SINUS PAIN; BACK PAIN; BURNING SKIN ON AND OFF; PAIN IN PELVIS AREA; VOMITING; NAUSEA; SORENESS AT THE INJECTION SITE; MUSCLE ACHE; HEADACHE; FATIGUE; METALLIC TASTE; WARMTH IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 23:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced metallic taste. On 06-MAR-2021, the subject experienced warmth in body. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced sinus pain. On 07-MAR-2021, the subject experienced back pain. On 07-MAR-2021, the subject experienced burning skin on and off. On 07-MAR-2021, the subject experienced pain in pelvis area. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced soreness at the injection site. On 07-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 06-MAR-2021, was recovering from back pain, and warmth in body, had not recovered from fatigue, shaking, nausea, headache, sinus pain, soreness at the injection site, burning skin on and off, pain in pelvis area, and vomiting, and the outcome of muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin burning sensation, Tremor, Vomiting
Clinical narrative: SHAKING; SINUS PAIN; BACK PAIN; BURNING SKIN ON AND OFF; PAIN IN PELVIS AREA; VOMITING; NAUSEA; SORENESS AT THE INJECTION SITE; MUSCLE ACHE; HEADACHE; FATIGUE; METALLIC TASTE; WARMTH IN BODY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 23:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced metallic taste. On 06-MAR-2021, the subject experienced warmth in body. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced sinus pain. On 07-MAR-2021, the subject experienced back pain. On 07-MAR-2021, the subject experienced burning skin on and off. On 07-MAR-2021, the subject experienced pain in pelvis area. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced soreness at the injection site. On 07-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 06-MAR-2021, was recovering from back pain, and warmth in body, had not recovered from fatigue, shaking, nausea, headache, sinus pain, soreness at the injection site, burning skin on and off, pain in pelvis area, and vomiting, and the outcome of muscle ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; FEVER; This spontaneous report was received from a consumer, and concerned a female patient of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. We are unable to perform follow-up to request the batch numbers. On 05-MAR-2021, the patient experienced body aches, headache, and fever.  The husband called to report his wife had fever, body aches, and a headache after administration with the Janssen Covid-19 vaccine. Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-MAR-2021, and had not recovered from body aches, and headache. The reporter considered the causality between the events (body aches, headache, and fever) and Covid-19 vaccine ad26.cov2.s as related. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Sleep disorder
Clinical narrative: SEVERE HEADACHE; BODY ACHES; ROUGH NIGHT SLEEP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced severe headache. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced rough night sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of body aches and rough night sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: HEADACHE; INJECTION SITE PAIN; CHILLS; TEMPERATURE CHANGE +2 DEGREES HIGHER; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced temperature change +2 degrees higher. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain, chills, muscle pain, temperature change +2 degrees higher and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Insomnia
Clinical narrative: SLIGHT HEADACHE; TUMMY FEELS FUNNY WITH MOVEMENT; FEELING VERY TIRED; UNABLE TO SLEEP; This spontaneous report received from a patient. The patient's past medical history included ovarian cancer, blood infection, and headache, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced slight headache, tummy feels funny with movement, feeling very tired and unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight headache, tummy feels funny with movement, feeling very tired, and unable to sleep. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFIT FROM THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and concurrent conditions included bursitis, heart problems, copd, arthritis, herniated disc, and pain in shoulder. The patient experienced drug allergy when treated with celecoxib, and dextromethorphan hydrobromide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 10:20 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced unexpected benefit from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit from the vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Muscle twitching, Pain, Pyrexia
Clinical narrative: MIGRAINE; FEVER; SHAKING UNCONTROLLABLY; BODY TWITCHING; BODY ACHING; This spontaneous report received from a parent concerned a White, Not Hispanic/Latino female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 05:00 for prophylactic vaccination. batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the patient experienced migraine, fever, shaking uncontrollably, body twitching, and body aching. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, fever, shaking uncontrollably, body twitching and body aching was not reported. This report was non-serious.