chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Lymphadenopathy, Mobility decreased, Nausea, Neck pain
Clinical narrative: About 20 minutes after shot left side of face started to tingle.  Moved up face and grew numb.  Felt like shot of novocaine from Dentist.  Felt very nauseous, thought I would throw up.  Hand started tingling, some numbness in arm, some pressure in chest, no pain.  Called Dr., went to walk-in clinic.  By that time, teeth were chattering, very fatigued and would have slept except for nausea.  They did EKG.  Doctor said all fine but probably related to shot. Went home.  Severe headache that night, could not lie down.   Arm sore, not painful.  Sore throat, swollen glands.  Week later, lower cheek still numb, headache better.  Jan 18 - Arm starts intense itch and breaking out in rash.  Spreading under arm.   Left eye very sore and bloodshot.  Face increasing numbness (left side).  Headache back.  Extreme fatigue, tinnitus.    Jan 19 - Arm worse, feels like shingles, fatigued laid down and could hardly move.  Husband woke me.  Could not form words because of numb lips.  Arm burning, extreme itch.  Throat sore.  Jan 21 - Face very numb, rash improving, eyes itching, throughout sore, swollen.  New rash at shot site.  Jan 23 - Lips tingling, numb face, headache, arm much more sore.  Very nauseous.  Jan 27 - Face numb, rash on face.  Jan 29 - Face numb, nauseous, sweating, arm breaking out itchy.  Jan 30 - Left eye very sore/bloodshot.  Burning and red welt at shot site.  Rash on left side of face and numb.  Feb 1 - Left eye very sore, neck sore. Feb 2-4 - Can't smile the same.  Left side weaker,  Tongue numb.  Feb 16 - Face now tingling, not as numb.  Rash on arm.  Nauseous.  Eye painful.  Feb. 24 - Woke in night - lips numb, Left eye numb into brow.   April 21 - Still having original symptoms.  Face numbness increase/decrease.  Heart fluttering, palpitations, chest discomfort that has become painful, have trouble getting enough breath.  Constant.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: About 20 minutes after shot left side of face started to tingle.  Moved up face and grew numb.  Felt like shot of novocaine from Dentist.  Felt very nauseous, thought I would throw up.  Hand started tingling, some numbness in arm, some pressure in chest, no pain.  Called Dr., went to walk-in clinic.  By that time, teeth were chattering, very fatigued and would have slept except for nausea.  They did EKG.  Doctor said all fine but probably related to shot. Went home.  Severe headache that night, could not lie down.   Arm sore, not painful.  Sore throat, swollen glands.  Week later, lower cheek still numb, headache better.  Jan 18 - Arm starts intense itch and breaking out in rash.  Spreading under arm.   Left eye very sore and bloodshot.  Face increasing numbness (left side).  Headache back.  Extreme fatigue, tinnitus.    Jan 19 - Arm worse, feels like shingles, fatigued laid down and could hardly move.  Husband woke me.  Could not form words because of numb lips.  Arm burning, extreme itch.  Throat sore.  Jan 21 - Face very numb, rash improving, eyes itching, throughout sore, swollen.  New rash at shot site.  Jan 23 - Lips tingling, numb face, headache, arm much more sore.  Very nauseous.  Jan 27 - Face numb, rash on face.  Jan 29 - Face numb, nauseous, sweating, arm breaking out itchy.  Jan 30 - Left eye very sore/bloodshot.  Burning and red welt at shot site.  Rash on left side of face and numb.  Feb 1 - Left eye very sore, neck sore. Feb 2-4 - Can't smile the same.  Left side weaker,  Tongue numb.  Feb 16 - Face now tingling, not as numb.  Rash on arm.  Nauseous.  Eye painful.  Feb. 24 - Woke in night - lips numb, Left eye numb into brow.   April 21 - Still having original symptoms.  Face numbness increase/decrease.  Heart fluttering, palpitations, chest discomfort that has become painful, have trouble getting enough breath.  Constant.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Rash, Sjogren's syndrome, Swelling
Clinical narrative: About 20 minutes after shot left side of face started to tingle.  Moved up face and grew numb.  Felt like shot of novocaine from Dentist.  Felt very nauseous, thought I would throw up.  Hand started tingling, some numbness in arm, some pressure in chest, no pain.  Called Dr., went to walk-in clinic.  By that time, teeth were chattering, very fatigued and would have slept except for nausea.  They did EKG.  Doctor said all fine but probably related to shot. Went home.  Severe headache that night, could not lie down.   Arm sore, not painful.  Sore throat, swollen glands.  Week later, lower cheek still numb, headache better.  Jan 18 - Arm starts intense itch and breaking out in rash.  Spreading under arm.   Left eye very sore and bloodshot.  Face increasing numbness (left side).  Headache back.  Extreme fatigue, tinnitus.    Jan 19 - Arm worse, feels like shingles, fatigued laid down and could hardly move.  Husband woke me.  Could not form words because of numb lips.  Arm burning, extreme itch.  Throat sore.  Jan 21 - Face very numb, rash improving, eyes itching, throughout sore, swollen.  New rash at shot site.  Jan 23 - Lips tingling, numb face, headache, arm much more sore.  Very nauseous.  Jan 27 - Face numb, rash on face.  Jan 29 - Face numb, nauseous, sweating, arm breaking out itchy.  Jan 30 - Left eye very sore/bloodshot.  Burning and red welt at shot site.  Rash on left side of face and numb.  Feb 1 - Left eye very sore, neck sore. Feb 2-4 - Can't smile the same.  Left side weaker,  Tongue numb.  Feb 16 - Face now tingling, not as numb.  Rash on arm.  Nauseous.  Eye painful.  Feb. 24 - Woke in night - lips numb, Left eye numb into brow.   April 21 - Still having original symptoms.  Face numbness increase/decrease.  Heart fluttering, palpitations, chest discomfort that has become painful, have trouble getting enough breath.  Constant.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About 20 minutes after shot left side of face started to tingle.  Moved up face and grew numb.  Felt like shot of novocaine from Dentist.  Felt very nauseous, thought I would throw up.  Hand started tingling, some numbness in arm, some pressure in chest, no pain.  Called Dr., went to walk-in clinic.  By that time, teeth were chattering, very fatigued and would have slept except for nausea.  They did EKG.  Doctor said all fine but probably related to shot. Went home.  Severe headache that night, could not lie down.   Arm sore, not painful.  Sore throat, swollen glands.  Week later, lower cheek still numb, headache better.  Jan 18 - Arm starts intense itch and breaking out in rash.  Spreading under arm.   Left eye very sore and bloodshot.  Face increasing numbness (left side).  Headache back.  Extreme fatigue, tinnitus.    Jan 19 - Arm worse, feels like shingles, fatigued laid down and could hardly move.  Husband woke me.  Could not form words because of numb lips.  Arm burning, extreme itch.  Throat sore.  Jan 21 - Face very numb, rash improving, eyes itching, throughout sore, swollen.  New rash at shot site.  Jan 23 - Lips tingling, numb face, headache, arm much more sore.  Very nauseous.  Jan 27 - Face numb, rash on face.  Jan 29 - Face numb, nauseous, sweating, arm breaking out itchy.  Jan 30 - Left eye very sore/bloodshot.  Burning and red welt at shot site.  Rash on left side of face and numb.  Feb 1 - Left eye very sore, neck sore. Feb 2-4 - Can't smile the same.  Left side weaker,  Tongue numb.  Feb 16 - Face now tingling, not as numb.  Rash on arm.  Nauseous.  Eye painful.  Feb. 24 - Woke in night - lips numb, Left eye numb into brow.   April 21 - Still having original symptoms.  Face numbness increase/decrease.  Heart fluttering, palpitations, chest discomfort that has become painful, have trouble getting enough breath.  Constant.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramping in my arm and my whole right side.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion missed, Exposure during pregnancy, Foetal death, Gene mutation identification test, Pathology test
Clinical narrative: Pregnancy ending in missed abortion at 16 weeks fetus death based on measurements at 13 weeks same week booster was administered. 12 week ultrasound WNL. Estimated due date 9/1/2022
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound antenatal screen normal, Uterine dilation and curettage
Clinical narrative: Pregnancy ending in missed abortion at 16 weeks fetus death based on measurements at 13 weeks same week booster was administered. 12 week ultrasound WNL. Estimated due date 9/1/2022
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Mom states pt. started  itching her left leg on 4/12/22. She said it was swollen about twice it normally is. No fever. She said her left leg is red and you can see where the vaccines were given. She hasn't complained of it at all. She is walking on her leg normally. Advised mom to give her Benadryl and see if that helps. Spoke to mom on 4/13/22 at 1015am. She states her leg "looks worse" and is really red. It is not purple looking. Pt. still has not complained of it hurting. Scheduled appt for patient to be seen today in office at 130om. Patient was seen in office 4/13/22 at 130pm. See providers recommendations below.
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: No symptoms. Given the 12 year Covid vaccine dose instead of the 5-11 year dose
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Rash
Clinical narrative: Associate became nauseated, lightheaded and developed a rash on her chest
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Condition aggravated, Gastrointestinal disorder, Haematochezia
Clinical narrative: Within 3 or 4 days of getting my second Pfizer shot, I began having digestive issues with bloody stool. Within about a week or two, I saw my PCP, who referred me to a gastroenterologist. The gastroenterologist performed a colonoscopy, and I was diagnosed with ulcerative colitis and prescribed prednisone, which I took for about 2 weeks. After that, I was prescribed Balsalazide. For a while, I took 9 pills a day. At the time of this writing, I take 6 a day.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Pain, Urticaria
Clinical narrative: I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).". The event "i had an allergic reaction (full body hives, lip was starting to swell before i made it to er)." required emergency room visit.  Additional information: I had received my first Covid-19 vaccination on 21Jan2022. I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER). I would like to do allergy testing to find out what exactly caused the allergic reaction. I am wondering if Pfizer is able to help pay for the testing as my health insurance does not cover it and the cost is too expensive and we cannot afford it. Please reach out to me and let me know if you have any options for me.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).". The event "i had an allergic reaction (full body hives, lip was starting to swell before i made it to er)." required emergency room visit.  Additional information: I had received my first Covid-19 vaccination on 21Jan2022. I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER). I would like to do allergy testing to find out what exactly caused the allergic reaction. I am wondering if Pfizer is able to help pay for the testing as my health insurance does not cover it and the cost is too expensive and we cannot afford it. Please reach out to me and let me know if you have any options for me.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER).". The event "i had an allergic reaction (full body hives, lip was starting to swell before i made it to er)." required emergency room visit.  Additional information: I had received my first Covid-19 vaccination on 21Jan2022. I had an allergic reaction (full body hives, lip was starting to swell before I made it to ER). I would like to do allergy testing to find out what exactly caused the allergic reaction. I am wondering if Pfizer is able to help pay for the testing as my health insurance does not cover it and the cost is too expensive and we cannot afford it. Please reach out to me and let me know if you have any options for me.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood disorder, Erythema, Inflammation
Clinical narrative: Patient complained of waking up 6 hours after receiving vaccine with profuse rash. On 2/23 she cut her hand which required stitches and an ER visit, they gave her clindamycin IV in ER and sent her home to pick up clindamycin to take at home. When she went to pick up prescription at the pharmacy she received her pfizer booster vaccine and went home and then took her clindamycin pills at home. The next morning 2/24 she developed a profuse rash and went to urgent care and was sent home on prednisone and given an epi-pen in case she needed it. She stated a few days later she felt like her throat was closing up and chest tightness so her husband gave her an injection of epi. On 2/27 she went to ER for rash that continued and at the time had stopped clindamycin. they sent her home on prednisone and felt that the rash was from a medication. Nothing was noted about a vaccine reaction. She went home and continued to have problems and ended up going to Inspira Hospital and was admitted from 3/1 to 3/6. The history section of the chart was not the same as ER history. Patient was discharged home on 3/6/22. She is still continuing to complain of leg pain, rash and pain.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Pain, Pain in extremity, Rash, Throat tightness
Clinical narrative: Patient complained of waking up 6 hours after receiving vaccine with profuse rash. On 2/23 she cut her hand which required stitches and an ER visit, they gave her clindamycin IV in ER and sent her home to pick up clindamycin to take at home. When she went to pick up prescription at the pharmacy she received her pfizer booster vaccine and went home and then took her clindamycin pills at home. The next morning 2/24 she developed a profuse rash and went to urgent care and was sent home on prednisone and given an epi-pen in case she needed it. She stated a few days later she felt like her throat was closing up and chest tightness so her husband gave her an injection of epi. On 2/27 she went to ER for rash that continued and at the time had stopped clindamycin. they sent her home on prednisone and felt that the rash was from a medication. Nothing was noted about a vaccine reaction. She went home and continued to have problems and ended up going to Inspira Hospital and was admitted from 3/1 to 3/6. The history section of the chart was not the same as ER history. Patient was discharged home on 3/6/22. She is still continuing to complain of leg pain, rash and pain.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Patient complained of waking up 6 hours after receiving vaccine with profuse rash. On 2/23 she cut her hand which required stitches and an ER visit, they gave her clindamycin IV in ER and sent her home to pick up clindamycin to take at home. When she went to pick up prescription at the pharmacy she received her pfizer booster vaccine and went home and then took her clindamycin pills at home. The next morning 2/24 she developed a profuse rash and went to urgent care and was sent home on prednisone and given an epi-pen in case she needed it. She stated a few days later she felt like her throat was closing up and chest tightness so her husband gave her an injection of epi. On 2/27 she went to ER for rash that continued and at the time had stopped clindamycin. they sent her home on prednisone and felt that the rash was from a medication. Nothing was noted about a vaccine reaction. She went home and continued to have problems and ended up going to Inspira Hospital and was admitted from 3/1 to 3/6. The history section of the chart was not the same as ER history. Patient was discharged home on 3/6/22. She is still continuing to complain of leg pain, rash and pain.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster shot, Manufacturer unknown), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered".  Additional Information:  Subject: Patient Assistance Customer Verbatim: Developed Tinnitus week after 2nd booster shot - has not gone away.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: Fever, chills, inability to feel fingers on both hands lasting 12 hours. Now, 50% of the time in the morning, I still cannot feel my 4th and 5th fingers on both hands.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neuralgia, Sciatica
Clinical narrative: Patient had left sided sciatica and severe nerve pain in his left hip after the shot.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Insomnia, Muscle spasms, Neuralgia, Sciatica
Clinical narrative: Patient had left sided sciatica and severe nerve pain in his left hip after the shot.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neuralgia, Sciatica
Clinical narrative: intense sciatic nerve pain and spasm that are persistent for 4 days and counting after the 4 Pfizer vaccine (my second booster). It is so intense that I went to the emergency room at 10 pm on April 21, 2022. The pain feels like an electrical shock that occurs every few seconds. On April 21, 2022 it happened all day. I cannot sleep at all during such intense pain. I have had this pain before, but an Advil usually helps, but this day nothing helped, not 200 mg of Advil,  no 50mg of Tramadol that I took at home. In the Emergency I was given a steroid shot, then oral methocarbamol 750 mg, Neither one helped, then I was given an injection of Valium. Then I was discharge and went home with the same intense pain that I came in with. I did not sleep the night of April 22, 2022.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Insomnia, Muscle spasms, Neuralgia, Sciatica
Clinical narrative: intense sciatic nerve pain and spasm that are persistent for 4 days and counting after the 4 Pfizer vaccine (my second booster). It is so intense that I went to the emergency room at 10 pm on April 21, 2022. The pain feels like an electrical shock that occurs every few seconds. On April 21, 2022 it happened all day. I cannot sleep at all during such intense pain. I have had this pain before, but an Advil usually helps, but this day nothing helped, not 200 mg of Advil,  no 50mg of Tramadol that I took at home. In the Emergency I was given a steroid shot, then oral methocarbamol 750 mg, Neither one helped, then I was given an injection of Valium. Then I was discharge and went home with the same intense pain that I came in with. I did not sleep the night of April 22, 2022.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: No adverse events.  Patient created an appointment to receive a 2nd booster. Upon reviewing his profile post vaccination,  noticed he was not qualified based on the current CDC second booster eligibilty guidelines. Per pt, thought overweight and high BMI was qualified as part of immunocompromised status.I added overweight and high BMI as part of the health conditions post vaccination. Monitored patient for 15 minutes and no reactions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in ears
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Anxiety, Decreased appetite, Food intolerance, Insomnia
Clinical narrative: Sense of smell has changed where I often smell things that are not there often its the smell of burnt toast or Marijuana. My sense of taste has also changed drastically to the point I don't eat I don't like food anymore.I have also developed a need to organize and clean and reorganize almost constantly and unorganized settings as well as places that aren't clean cause anxiety. My sleeping habits have changed drastically as well I become more alert at night and am only able to sleep around 4 to 5 hours a night. Throughout the time that I've gotten vaccinated I have lost over 150 pounds without trying and I continue to lose weight. I have not been to a doctor because I can't afford a Dr,it has been 10 months with no change for the better at first the weight loss was great it was needed but if I continue to lose weight at the same pace I will be underweight in a few weeks.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Taste disorder, Weight decreased
Clinical narrative: Sense of smell has changed where I often smell things that are not there often its the smell of burnt toast or Marijuana. My sense of taste has also changed drastically to the point I don't eat I don't like food anymore.I have also developed a need to organize and clean and reorganize almost constantly and unorganized settings as well as places that aren't clean cause anxiety. My sleeping habits have changed drastically as well I become more alert at night and am only able to sleep around 4 to 5 hours a night. Throughout the time that I've gotten vaccinated I have lost over 150 pounds without trying and I continue to lose weight. I have not been to a doctor because I can't afford a Dr,it has been 10 months with no change for the better at first the weight loss was great it was needed but if I continue to lose weight at the same pace I will be underweight in a few weeks.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue
Clinical narrative: tired feeling; 100°F temperature for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE ABNORMAL (100°F temperature for 24 hours) and FATIGUE (tired feeling) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced FATIGUE (tired feeling). On an unknown date, the patient experienced BODY TEMPERATURE ABNORMAL (100°F temperature for 24 hours). At the time of the report, BODY TEMPERATURE ABNORMAL (100°F temperature for 24 hours) and FATIGUE (tired feeling) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree Fahrenheit for 24 hours..         Patient didn't had allergies. Concomitant medication was not reported. Patient had not tested COVID-19 positive previously. Treatment medication was not reported.   This case was linked to MOD-2022-544448 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that after receiving Moderna primary series, the patient experienced regular symptoms, tiredness, fever, chills, those kind of things.  No treatment medications were provided.   This case was linked to MOD-2022-543630, MOD-2022-543627, MOD-2022-543615 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pyrexia, Throat irritation
Clinical narrative: Burning in throat; Fever; feeling exhausted; Had COVID; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID). At the time of the report, THROAT IRRITATION (Burning in throat), PYREXIA (Fever), FATIGUE (feeling exhausted) and COVID-19 (Had COVID) outcome was unknown.            No concomitant medications were reported. Treatment included Antiviral Pills for 5 days. Company comment: This spontaneous case concerns a 79-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 2 months after the booster dose of mRNA-1273 vaccine. She took antiviral oils as treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-543973.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, approximately 2 months after the booster dose of mRNA-1273 vaccine. She took antiviral oils as treatment. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; Seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications past drug reaction or allergies were not reported.  On 07-JAN-2022, the patient was vaccinated with one (1) improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T039467 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 20-MAY-2023) for prophylaxis (product storage error).   The vaccine previously underwent a temperature excursion of 33.4 degrees Fahrenheit (F) for 2595 hours. There was no previous temperature excursion. No further information provided.   No other adverse events were reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007825: US-009507513-2203USA007997: US-009507513-2203USA008097:
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; a dose of VARlV AX was administered intramuscularly to the patient; This spontaneous report has been received from a nurse referring to a 3-year-old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 24-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, intramuscularly (strength was not reported) (lot number U015677 has been verified to be a valid lot number, expiration date: 18-MAY-2023) for prophylaxis (Incorrect route of product administration). No additional adverse event reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The nurse reported the patient received improperly stored vaccines; No additional AEs; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # U026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The nurse reported the patient received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-MAR-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # U026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; Licensed practical nurse reporting expired dose of VAQTA administered to patient; This spontaneous report was received from a Licensed practical nurse refers to a patient of unknown age and gender.There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 08-APR-2022, the patient was vaccinated with 1 milliliter expired dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe, dose:1 milliliter,  frequency reported as once, lot # t040581, expiration date: 28-MAR-2022,  for prophylaxis (route and dose number were not reported) (expired product administered). No temperature excursion.  Read supported statement.  No additional adverse event information.  No PQC.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; No other issues or concerns noted; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date (reported as 20-MAY-2022), the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; Vaccine coordinator responsible for handling and storage of vaccines reporting expired dose of VAQTA administered to a patient.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 31-MAR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA), 0.5 milliliter once, lot number 2013204, expiration date 03-DEC-2021 for prophylaxis (route of administration not reported) (expired product administered). No adverse event was reported.  Lot number 2013204 is an invalid lot number for hepatitis a vaccine, inactivated(VAQTA). Lot number 2013204 does not match any Company product as confirmed by Lot Verification team .
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Customer reporting the administration of improperly stored PROQUAD.; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 11-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD)0.5 milliliters, lot number U039262, expiration date 09-JUN-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 45 degrees Fahrenheit for 3 hours and 45 minutes. No previous excursions were detected.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Caller reports expired dose of PROQUAD was administered. No temperature excursion on the vaccine. No additional AE reported, no PQC reported. Please note vaccine was administered to a set of twins with same initials, this AE is for twin #2; AE for tw; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 12-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T034825, expiration date 11-APR-2022 (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.  This is one of 2 cases notified by the same reporter. The other case refers to the patient's twin.; Sender's Comments:  US-009507513-2204USA004793:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Inbound call from HCP stating that a dose of GARDASIL 9 was inadvertently administered past it's expiration date. No additional AE details or PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-APR-2022, the patient had inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #S028738, expiration date: 03-APR-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) past the expiry date (Expired product administered). No additional adverse event (AE) reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # T034825, expiration date: 11-APR-2022) for prophylaxis (expired product administered).     No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The medical assistant is reporting that a patient received an improperly stored vaccine today; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not reported.  On 14-APR-2022, the patient was vaccinated with 1 dose of improperly stored vaccine (temperature: 66 Fahrenheit degrees, time frame: 15 hours and 10 minutes) (product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number: 1837116 was found to be valid, expiration date: 24-MAR-2023, route of administration defaulted to oral, for prophylaxis. No additional adverse events were reported. It was reported, that there were no previous temperature excursions. It was unknown if the temperature excursion occurred as a result of a reading from Data Logger. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA005479:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; ROTATEQ administered after a temperature excursion; This spontaneous report was received from office manager and referred to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not applicable.  On 14-APR-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742463, expiration date: 20-SEP-2022) orally for prophylaxis (strength, and dose were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 55 Fahrenheit (F) for a time frame of 1 hours. There were no previous temperature excursions.   No other adverse event (AE) occurred.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 mL, lot #T027935, expiration date: 18-AUG-2022, subcutaneously (SQ) for prophylaxis (strength was not provided), after temperature excursion (product storage error).  The administered dose of the vaccine experienced a temperature excursion in 47.8 degrees Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No additional adverse events (AEs).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; a patient received an expired PNEUMOVAX 23 on 4/17/2022; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot #T022294 was confirmed to be valid, expiration date 26-MAR-2022 (expired product administered) (dose, route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired vaccine was administered; This spontaneous report was received from Office Manager and refers to a 16-month-old child of unknown gender.The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided.  On 18-APR-2022, the patient was vaccinated with an expired dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #S030966, expiration date: 14-APR-2022 (expired product administered) (dose, route of administration and injection site were not provided) for prophylaxis.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were noticed after the administration of the expired vaccine; an expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age, gender and race.  The patient's concurrent conditions, medical history and, concomitant therapies were not reported.  On 18-APR-2022, the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter, once, with the lot #T034827 and an expiration date from 11-APR-2022, administered for prophylaxis (route of administration not provided). Moreover, the reporter stated that no adverse effects were noticed after the administration of the expired vaccine . No additional information was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.  ?; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 05-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported