chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster, Inappropriate schedule of product administration, Neuralgia, Oral herpes
Clinical narrative: Suspected vaccination failure/; shingles on her back, near the wing of her shoulder; fever blisters around her lips together with the shingles outbreak; nerve pain that begins in her tooth, and travels up to her ear and then scalp; dose 1 of Shingrix in August 2018 / dose 2 in April 2020; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1-2 shingles outbreaks per year).   In April 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever blister and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and fever blister were not recovered/not resolved and the outcome of the nerve pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, fever blister and nerve pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received both doses of Shingrix in an unknown deltoid. The patient received the 2nd dose of Shingrix later than recommended schedule, which led to lengthening of the vaccination schedule. Specific vaccination dates were unknown. The patient developed shingles on back, near the wing of shoulder. The patient also experienced fever blisters around her lips together with the shingles outbreak, nerve pain that began in tooth and traveled up to her ear and then scalp. It was stated that onset date was unknown but events after the 2nd dose. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Toothache, Vaccination failure, Varicella post vaccine
Clinical narrative: Suspected vaccination failure/; shingles on her back, near the wing of her shoulder; fever blisters around her lips together with the shingles outbreak; nerve pain that begins in her tooth, and travels up to her ear and then scalp; dose 1 of Shingrix in August 2018 / dose 2 in April 2020; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (1-2 shingles outbreaks per year).   In April 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever blister and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and fever blister were not recovered/not resolved and the outcome of the nerve pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, fever blister and nerve pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received both doses of Shingrix in an unknown deltoid. The patient received the 2nd dose of Shingrix later than recommended schedule, which led to lengthening of the vaccination schedule. Specific vaccination dates were unknown. The patient developed shingles on back, near the wing of shoulder. The patient also experienced fever blisters around her lips together with the shingles outbreak, nerve pain that began in tooth and traveled up to her ear and then scalp. It was stated that onset date was unknown but events after the 2nd dose. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3YN2L, expiry date 12th March 2021) for prophylaxis.   On 13th April 2021, the patient received Boostrix. On 13th April 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Boostrix which was expired, which led to expired vaccine used. The reporter consented to follow up. No date of birth of patient was available at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Two patients that received Shingrix first dose almost a year ago; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th January 2020, almost a year ago). Concurrent medical conditions included peanut allergy, penicillin allergy and allergic reaction to analgesics. Concomitant products included cholesterol.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up by email. This case has been linked with US2021AMR085160, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR085160:Same reporter. Pt 2.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was given on Jan2020 and second dose on Oct2020.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 1st January 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 1st October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient called for information regarding another dose or not of Shingrix for this situation. The patient disconnected before they could be transferred to GRC or more data could be collected. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Myalgia, Pain
Clinical narrative: SHORTNESS OF BREATH; QUADRICEP MUSCLE PAIN; EXTREME FATIGUE; WHOLE BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 128 pounds, and height was 64 inches. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included no known drug allergies. no drug abuse or illicit drug usage. no pertinent medical information advised by consumer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced whole body aches. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced quadricep muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body aches, chills, and extreme fatigue on 07-APR-2021, and had not recovered from quadricep muscle pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site pain, Injection site rash
Clinical narrative: CHILLS; NOT FEELING WELL; MUSCLE ACHES; HEADACHE; FEVER; PAIN AT INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy, and seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site rash. On 12-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 17:00, the subject experienced chills. On 12-APR-2021 17:00, the subject experienced not feeling well. On 12-APR-2021 17:00, the subject experienced muscle aches. On 12-APR-2021 17:00, the subject experienced headache. On 12-APR-2021 17:00, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site rash on 13-APR-2021, was recovering from pain at injection site, had not recovered from not feeling well, muscle aches, headache, and chills, and the outcome of fever was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: CHILLS; NOT FEELING WELL; MUSCLE ACHES; HEADACHE; FEVER; PAIN AT INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy, and seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site rash. On 12-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 17:00, the subject experienced chills. On 12-APR-2021 17:00, the subject experienced not feeling well. On 12-APR-2021 17:00, the subject experienced muscle aches. On 12-APR-2021 17:00, the subject experienced headache. On 12-APR-2021 17:00, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site rash on 13-APR-2021, was recovering from pain at injection site, had not recovered from not feeling well, muscle aches, headache, and chills, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Chills, Pain in extremity, Pyrexia
Clinical narrative: 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 rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced back pain. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone pain, back pain, leg pain, chills, and fever on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: BODY ACHES; VOMITING; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 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, route of admin not reported, batch number: 1808980, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced headaches. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, vomiting, headaches, and nausea on APR-2021. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate.  On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate.  On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: WARM TO THE TOUCH ON INJECTION SITE; PAIN ON INJECTION SITE; SWOLLEN INJECTION SITE; REDNESS ON INJECTION SITE; This spontaneous report received from a patient concerned a male 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced warm to the touch on injection site. On 12-APR-2021, the subject experienced pain on injection site. On 12-APR-2021, the subject experienced swollen injection site. On 12-APR-2021, the subject experienced redness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on injection site, warm to the touch on injection site, swollen injection site, and redness on injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: BAD BODY ACHE; THREW UP; CHILLS; EXHAUSTED/FATIGUE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a41a, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body ache. On 07-APR-2021, the subject experienced threw up. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced exhausted/fatigue. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad body ache, chills, fever, headache, nausea, exhausted/fatigue, and threw up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: BAD BODY ACHE; THREW UP; CHILLS; EXHAUSTED/FATIGUE; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a41a, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body ache. On 07-APR-2021, the subject experienced threw up. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced exhausted/fatigue. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad body ache, chills, fever, headache, nausea, exhausted/fatigue, and threw up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: DIZZY; NOT THERE MENTALLY OR CONFUSED; RACING HEART EVEN WHEN LAYING DOWN; FEELING FATIGUED; NAUSEATED; VERY INTENSE HEADACHE; This spontaneous report received from a patient concerned an adult female. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced not there mentally or confused. On 10-APR-2021, the subject experienced racing heart even when laying down. On 10-APR-2021, the subject experienced feeling fatigued. On 10-APR-2021, the subject experienced nauseated. On 10-APR-2021, the subject experienced very intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigued, nauseated, dizzy, not there mentally or confused, racing heart even when laying down, and very intense headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: DIZZY; NOT THERE MENTALLY OR CONFUSED; RACING HEART EVEN WHEN LAYING DOWN; FEELING FATIGUED; NAUSEATED; VERY INTENSE HEADACHE; This spontaneous report received from a patient concerned an adult female. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced dizzy. On 10-APR-2021, the subject experienced not there mentally or confused. On 10-APR-2021, the subject experienced racing heart even when laying down. On 10-APR-2021, the subject experienced feeling fatigued. On 10-APR-2021, the subject experienced nauseated. On 10-APR-2021, the subject experienced very intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigued, nauseated, dizzy, not there mentally or confused, racing heart even when laying down, and very intense headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: BLISTER RASH SITE; 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, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced blister rash site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blister rash site was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: LEFT SIDE NUMBNESS ON FACE, ARMS, AND LEGS; DIZZINESS; NUMBNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced left side numbness on face, arms, and legs. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced numbness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021, and had not recovered from left side numbness on face, arms, and legs, and numbness at injection site. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Disorientation, Dizziness, Fatigue
Clinical narrative: HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE  IN LOW BACK, HIPS,BONES CONNECTING SPINE; FEELING DISORIENTED; NIGHT SWEAT; DIZZINESS AND LIGHT HEADED; LOSS OF APPETITE; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:21 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. On APR-2021, the subject experienced unable to sleep. On 10-APR-2021, the subject experienced feeling disoriented. On 10-APR-2021, the subject experienced night sweat. On 10-APR-2021, the subject experienced bone ache in low back, hips, bones connecting spine. On 10-APR-2021, the subject experienced dizziness and light headed. On 10-APR-2021, the subject experienced loss of appetite. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 15:21, the subject experienced severe fatigue. On 10-APR-2021 16:21, the subject experienced severe body aches. On 10-APR-2021 17:21, the subject experienced headache elevated to migraine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, positive, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, feeling disoriented, night sweat, headache elevated to migraine, severe body aches, loss of appetite, headache, and fever, and bone ache in low back, hips, bones connecting spine on 12-APR-2021, and had not recovered from severe fatigue, dizziness and light headed, and nausea. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Migraine, Nausea, Night sweats
Clinical narrative: HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE  IN LOW BACK, HIPS,BONES CONNECTING SPINE; FEELING DISORIENTED; NIGHT SWEAT; DIZZINESS AND LIGHT HEADED; LOSS OF APPETITE; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:21 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. On APR-2021, the subject experienced unable to sleep. On 10-APR-2021, the subject experienced feeling disoriented. On 10-APR-2021, the subject experienced night sweat. On 10-APR-2021, the subject experienced bone ache in low back, hips, bones connecting spine. On 10-APR-2021, the subject experienced dizziness and light headed. On 10-APR-2021, the subject experienced loss of appetite. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 15:21, the subject experienced severe fatigue. On 10-APR-2021 16:21, the subject experienced severe body aches. On 10-APR-2021 17:21, the subject experienced headache elevated to migraine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, positive, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, feeling disoriented, night sweat, headache elevated to migraine, severe body aches, loss of appetite, headache, and fever, and bone ache in low back, hips, bones connecting spine on 12-APR-2021, and had not recovered from severe fatigue, dizziness and light headed, and nausea. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE  IN LOW BACK, HIPS,BONES CONNECTING SPINE; FEELING DISORIENTED; NIGHT SWEAT; DIZZINESS AND LIGHT HEADED; LOSS OF APPETITE; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:21 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. On APR-2021, the subject experienced unable to sleep. On 10-APR-2021, the subject experienced feeling disoriented. On 10-APR-2021, the subject experienced night sweat. On 10-APR-2021, the subject experienced bone ache in low back, hips, bones connecting spine. On 10-APR-2021, the subject experienced dizziness and light headed. On 10-APR-2021, the subject experienced loss of appetite. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 15:21, the subject experienced severe fatigue. On 10-APR-2021 16:21, the subject experienced severe body aches. On 10-APR-2021 17:21, the subject experienced headache elevated to migraine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, positive, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, feeling disoriented, night sweat, headache elevated to migraine, severe body aches, loss of appetite, headache, and fever, and bone ache in low back, hips, bones connecting spine on 12-APR-2021, and had not recovered from severe fatigue, dizziness and light headed, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Somnolence
Clinical narrative: DIZZINESS; HEADACHE (RIGHT ON TEMPLES); SLEEPINESS; FEELING LIKE FLU; NO ENERGY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On APR-2021, the subject experienced sleepiness. On APR-2021, the subject experienced feeling like flu. On APR-2021, the subject experienced no energy. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced headache (right on temples). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021, had not recovered from headache (right on temples), and the outcome of no energy, sleepiness and feeling like flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: BAD ACHES; SORE ARM STILL FROM NEEDLE; 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bad aches. On 09-APR-2021, the subject experienced sore arm still from needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad aches on 09-APR-2021, and had not recovered from sore arm still from needle. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report received from a patient concerned a 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced missed period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of missed period was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Infrequent bowel movements
Clinical narrative: STOMACH FEELS FULL; NO BOWEL MOVEMENT FOR 2 DAYS; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's past medical history included left rotator cuff tear, and hip replacement, and concurrent conditions included type 2 diabetes, no alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced no bowel movement for 2 days. On an unspecified date, the subject experienced stomach feels full. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no bowel movement for 2 days, and the outcome of stomach feels full was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Sneezing
Clinical narrative: EXTREME FATIGUE/EXTREMELY TIRED; SNEEZING; GENERALIZED PAIN; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced generalized pain. On 25-MAR-2021, the subject experienced flu like symptoms. On 26-MAR-2021, the subject experienced sneezing. On 31-MAR-2021 17:00, the subject experienced extreme fatigue/extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on 31-MAR-2021, had not recovered from extreme fatigue/extremely tired, and generalized pain, and the outcome of flu like symptoms was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills and fever
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Enuresis, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Pt urinated while unconscious-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Pt reported no feeling well. Denied trouble breathing/swallowing. Pt lost consciousness. We were able to prevent him from falling or any\r\ninjury. 911 was called. He was out about 15 seconds. Regained consciousness. Was startled and confused but was quickly became reoriented to where he was, that he had just recieved vaccine and passed out. Patient's BP and condition was monitored until paramedics arrived.  After coming around patient started to feel nauseous and felt like he would vomit.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Nausea, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Pt urinated while unconscious-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Pt reported no feeling well. Denied trouble breathing/swallowing. Pt lost consciousness. We were able to prevent him from falling or any\r\ninjury. 911 was called. He was out about 15 seconds. Regained consciousness. Was startled and confused but was quickly became reoriented to where he was, that he had just recieved vaccine and passed out. Patient's BP and condition was monitored until paramedics arrived.  After coming around patient started to feel nauseous and felt like he would vomit.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Pt urinated while unconscious-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Pt reported no feeling well. Denied trouble breathing/swallowing. Pt lost consciousness. We were able to prevent him from falling or any\r\ninjury. 911 was called. He was out about 15 seconds. Regained consciousness. Was startled and confused but was quickly became reoriented to where he was, that he had just recieved vaccine and passed out. Patient's BP and condition was monitored until paramedics arrived.  After coming around patient started to feel nauseous and felt like he would vomit.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pruritus, Urticaria
Clinical narrative: 10/10/21 , pregnant with second child and currently 200 lbs  I had a reaction of severe itching and hives
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Immediate post-injection reaction, Tachycardia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after patient received vaccine and went to a seat in the patient monitoring area she notified us that she felt that her throat did not feel right and felt like it was tighting. Therefore we guided her to lie down on the floor, elevated her feet, got her a bottle of water, put some ice packs behind her neck, and gave her 10 ml approximately of liquid benadryl.   Afterwards, she gave me permission to give her 2 Epipen injections and we called Ambulance.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Differential white blood cell count, Dizziness, Full blood count, Haemoglobin normal
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after patient received vaccine and went to a seat in the patient monitoring area she notified us that she felt that her throat did not feel right and felt like it was tighting. Therefore we guided her to lie down on the floor, elevated her feet, got her a bottle of water, put some ice packs behind her neck, and gave her 10 ml approximately of liquid benadryl.   Afterwards, she gave me permission to give her 2 Epipen injections and we called Ambulance.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Human chorionic gonadotropin, Laboratory test, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after patient received vaccine and went to a seat in the patient monitoring area she notified us that she felt that her throat did not feel right and felt like it was tighting. Therefore we guided her to lie down on the floor, elevated her feet, got her a bottle of water, put some ice packs behind her neck, and gave her 10 ml approximately of liquid benadryl.   Afterwards, she gave me permission to give her 2 Epipen injections and we called Ambulance.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: Immediately after patient received vaccine and went to a seat in the patient monitoring area she notified us that she felt that her throat did not feel right and felt like it was tighting. Therefore we guided her to lie down on the floor, elevated her feet, got her a bottle of water, put some ice packs behind her neck, and gave her 10 ml approximately of liquid benadryl.   Afterwards, she gave me permission to give her 2 Epipen injections and we called Ambulance.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Immediate post-injection reaction, Tachycardia, Throat tightness, Tremor
Clinical narrative: Almost immediately began to experience lightheadedness, racing heart, and throat tightening. Informed nurse. Was told to sit on ground and was given liquid Benedryl. Was told to lie down with legs propped up on chair while ice pack was put under my neck. Throat continued to tighten. Gave permission for epi pen, which was administered. Laid back down for a few minutes and tightening did not seem to worsen. After a few minutes I sat back up and was told to sip a few sips of water. After the third sip, my throat began to tighten, laid back down which did not help. Technicians called an ambulance and administered a second epi pen with my permission. EMTs arrived and took me to their rig. My vitals were fairly steady but my lips and tongue had started to tingle and my throat was still tight. EMTs took me to Emergency Room. Was given steroids, pepcid, and benedryl. While throat was still tighter than normal, my stats were good, so I was discharged between 5-6, with perscriptions for prednesone, benedryl, pepcid, and 2 epi pens.  At approximately midnight, began to feel throat tighten up again, took benedryl at 1:00, when condition did not improve, went back to ER approx, 2:20 am. Around 7-8 am was given steroids and benedryl, however my body began to react to the steroids with full body sensation of tingling/feeling as though it was going to sleep. Was given an ativan which calmed system down and allowed me to sleep. Eventually discharged around 11 am, told not to use steroids but to continue benedryl as needed.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Differential white blood cell count, Dizziness, Full blood count, Haemoglobin normal
Clinical narrative: Almost immediately began to experience lightheadedness, racing heart, and throat tightening. Informed nurse. Was told to sit on ground and was given liquid Benedryl. Was told to lie down with legs propped up on chair while ice pack was put under my neck. Throat continued to tighten. Gave permission for epi pen, which was administered. Laid back down for a few minutes and tightening did not seem to worsen. After a few minutes I sat back up and was told to sip a few sips of water. After the third sip, my throat began to tighten, laid back down which did not help. Technicians called an ambulance and administered a second epi pen with my permission. EMTs arrived and took me to their rig. My vitals were fairly steady but my lips and tongue had started to tingle and my throat was still tight. EMTs took me to Emergency Room. Was given steroids, pepcid, and benedryl. While throat was still tighter than normal, my stats were good, so I was discharged between 5-6, with perscriptions for prednesone, benedryl, pepcid, and 2 epi pens.  At approximately midnight, began to feel throat tighten up again, took benedryl at 1:00, when condition did not improve, went back to ER approx, 2:20 am. Around 7-8 am was given steroids and benedryl, however my body began to react to the steroids with full body sensation of tingling/feeling as though it was going to sleep. Was given an ativan which calmed system down and allowed me to sleep. Eventually discharged around 11 am, told not to use steroids but to continue benedryl as needed.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Human chorionic gonadotropin, Laboratory test, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Almost immediately began to experience lightheadedness, racing heart, and throat tightening. Informed nurse. Was told to sit on ground and was given liquid Benedryl. Was told to lie down with legs propped up on chair while ice pack was put under my neck. Throat continued to tighten. Gave permission for epi pen, which was administered. Laid back down for a few minutes and tightening did not seem to worsen. After a few minutes I sat back up and was told to sip a few sips of water. After the third sip, my throat began to tighten, laid back down which did not help. Technicians called an ambulance and administered a second epi pen with my permission. EMTs arrived and took me to their rig. My vitals were fairly steady but my lips and tongue had started to tingle and my throat was still tight. EMTs took me to Emergency Room. Was given steroids, pepcid, and benedryl. While throat was still tighter than normal, my stats were good, so I was discharged between 5-6, with perscriptions for prednesone, benedryl, pepcid, and 2 epi pens.  At approximately midnight, began to feel throat tighten up again, took benedryl at 1:00, when condition did not improve, went back to ER approx, 2:20 am. Around 7-8 am was given steroids and benedryl, however my body began to react to the steroids with full body sensation of tingling/feeling as though it was going to sleep. Was given an ativan which calmed system down and allowed me to sleep. Eventually discharged around 11 am, told not to use steroids but to continue benedryl as needed.