chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Immediate headache Soreness in arm Nausea within 1 hour Fever lasting 48 hours, spiking to 103f & breaking 10/9/21 Violent Vomiting- 12 hours after receiving jab Persistent Headache- migraine status to 72 hours Chills, aches, night sweats to 72 hours post jab  Nausea past 72 hours post jab  Unsteady when standing -- 24 to 60 hours Dizzy, blurred vision-- immediately to 60 hours post jab Extreme soreness at injection site-- lasted beyond a week post jab
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Throat irritation, Vaccine positive rechallenge
Clinical narrative: A day after the first shot, I had a burning in the back of my throat for several hours. A day after the second shot, the same thing happened. I now have a burning sensation in my throat about once a week or once every other week that lasts between 6 hours and 2 to 3 days. It's not painful per se. It doesn't impede eating or drinking. It's just mildly uncomfortable. I don't have any other symptoms that go along with it.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Neuralgia, Pyrexia, Skin sensitisation
Clinical narrative: Fever , Swollen Lymph Nodes , Lymphadenopathy, muscle aches, nerve pain, skin sensitivity,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Contrast media allergy, Drug hypersensitivity, Food allergy
Clinical narrative: Patient had anaphylactic reaction. Within 12 hours patient had hives on legs, arms, chest, throat had been closing. Patient had already felt she may genetically at risk for an adverse outcome. She premedicated with Nurtec and Benadryl. She took more Benadryl with the onset of the reaction.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 antibody test positive, Throat tightness, Urticaria
Clinical narrative: Patient had anaphylactic reaction. Within 12 hours patient had hives on legs, arms, chest, throat had been closing. Patient had already felt she may genetically at risk for an adverse outcome. She premedicated with Nurtec and Benadryl. She took more Benadryl with the onset of the reaction.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Catheterisation cardiac normal, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Potential heart attack, troponin level .75 and admitted to hospital for severe chest pain. Heart cath showed no damage however multiple blood tests showed heart attack happened.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Troponin increased
Clinical narrative: Potential heart attack, troponin level .75 and admitted to hospital for severe chest pain. Heart cath showed no damage however multiple blood tests showed heart attack happened.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Dizziness, Nausea
Clinical narrative: I contracted COVID-19 and began feelings symptoms on September 2nd, 2021. I was officially tested through state-offered testing on September 3rd and received a positive result on September 5th. I quarantined for 2 weeks while I felt symptoms. The symptoms I experienced were extreme dizziness with occasional nausea, sinus pain and congestion, body aches, and a sore throat. I also lost my taste and smell during this period. I was able to eventually turn to work and I feel better now. All of my symptoms have gone away and I've recovered my taste and smell.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test positive, Sinus congestion, Sinus pain
Clinical narrative: I contracted COVID-19 and began feelings symptoms on September 2nd, 2021. I was officially tested through state-offered testing on September 3rd and received a positive result on September 5th. I quarantined for 2 weeks while I felt symptoms. The symptoms I experienced were extreme dizziness with occasional nausea, sinus pain and congestion, body aches, and a sore throat. I also lost my taste and smell during this period. I was able to eventually turn to work and I feel better now. All of my symptoms have gone away and I've recovered my taste and smell.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Illness, Immediate post-injection reaction
Clinical narrative: Should pain immediately after injection.   Pain worse one day after vacination.  Very sick for three days after vacination (fever, extreme muscle pain, weakness, chills)  Shoulder pain did not show any signs of improvement for 2 months.  Diagnosed with Covid in August 2021, 2 months after vacination.   Slowly getting more range of motion in arm but still painful to lift left arm above shoulder height.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Joint range of motion decreased, Myalgia, Pyrexia, Vaccine breakthrough infection
Clinical narrative: Should pain immediately after injection.   Pain worse one day after vacination.  Very sick for three days after vacination (fever, extreme muscle pain, weakness, chills)  Shoulder pain did not show any signs of improvement for 2 months.  Diagnosed with Covid in August 2021, 2 months after vacination.   Slowly getting more range of motion in arm but still painful to lift left arm above shoulder height.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: Anaphylaxis  reaction including - pressure in my chest, shortness of breath, throat closing and heart beat very fast, palpitations, high blood pressure.  I went to Emergency, I was kept for a few hours on observation.  I also went to a doctor and he prescribed blood pressure medicine, but I did not have high blood pressure before I took the vaccine.  Continue having shortness of breath and palpitations for 4 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Palpitations, Throat tightness
Clinical narrative: Anaphylaxis  reaction including - pressure in my chest, shortness of breath, throat closing and heart beat very fast, palpitations, high blood pressure.  I went to Emergency, I was kept for a few hours on observation.  I also went to a doctor and he prescribed blood pressure medicine, but I did not have high blood pressure before I took the vaccine.  Continue having shortness of breath and palpitations for 4 days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Migraine, Palpitations
Clinical narrative: Severe diarrhea (more than 10 episodes per day), racing heart, dizziness, migraine
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Vaccine not given at this site, so unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Vaginal bleeding post menopause.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast pain, Contusion, Dizziness, Fatigue
Clinical narrative: -early mensuration after just having normal period  -pain, light headed and almost passed out, heavy blood -BLOOD CLOTS the size of tomatoes and some smaller -breast pain in left breast & very sensitive bruising  -never before been irregular, has blood clots nor heavy bleeding in 22 years of having a period until the shot  -Swollen painful bruise/swell at injections site,  -headache, - exhaustion
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heavy menstrual bleeding, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: -early mensuration after just having normal period  -pain, light headed and almost passed out, heavy blood -BLOOD CLOTS the size of tomatoes and some smaller -breast pain in left breast & very sensitive bruising  -never before been irregular, has blood clots nor heavy bleeding in 22 years of having a period until the shot  -Swollen painful bruise/swell at injections site,  -headache, - exhaustion
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Polymenorrhoea, Presyncope
Clinical narrative: -early mensuration after just having normal period  -pain, light headed and almost passed out, heavy blood -BLOOD CLOTS the size of tomatoes and some smaller -breast pain in left breast & very sensitive bruising  -never before been irregular, has blood clots nor heavy bleeding in 22 years of having a period until the shot  -Swollen painful bruise/swell at injections site,  -headache, - exhaustion
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Feeling abnormal, Malaise, Nausea
Clinical narrative: S/S started the following day for both shots. N/V, headache, total body ache, weakness, malaise, fever, no taste.  Feeling like I got hit by a train and ran over by a dump truck. Having the actual covid virus never felt as bad as the getting the vaccine. One size does not fit all.  This thing is dangerous and should be illegal.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: S/S started the following day for both shots. N/V, headache, total body ache, weakness, malaise, fever, no taste.  Feeling like I got hit by a train and ran over by a dump truck. Having the actual covid virus never felt as bad as the getting the vaccine. One size does not fit all.  This thing is dangerous and should be illegal.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Arm pain, large pink area on arm near injection site that is itchy and feels hot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy generalized for two months and counting
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient fully vaccinated and died due to Covid related causes
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Gait inability, Nausea
Clinical narrative: Dizzy falling stumbling as to crawl across floor to let dogs out so I didn?t fall. Some nausea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Blood test, Computerised tomogram
Clinical narrative: Started with stiff neck and headache at around 1pm on 8/19/21 aprix 4 to 5 hours after vaccination.  Headache becomes sever by 5pm. Fatigue, weak and fever that night. Woke from a nap due to checking on blood. Headache so sever and bloody nose and mouth. This about 12 hours after vaccination. I was so weak I couldn't get of the floor to get myself something to drink.  I missed work and had to call for help. I had to have someone monitor me to assure I could breath due to the swelling in my neck.  Swollen lymph knots in neck, armpit, abdomen and groin. Right arm sever weaknesses, swelling. Sweating from armpit that is sever just weeping almost. Gi upset on and off with no appetite. I was not able to return to work until day 5. I still have the one sided headaches with brain fog, body aches with weakness and right arm is still swelling with the armpit sweating several.  I have also had a trip to the ER due to abdomen pain and weakness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: Started with stiff neck and headache at around 1pm on 8/19/21 aprix 4 to 5 hours after vaccination.  Headache becomes sever by 5pm. Fatigue, weak and fever that night. Woke from a nap due to checking on blood. Headache so sever and bloody nose and mouth. This about 12 hours after vaccination. I was so weak I couldn't get of the floor to get myself something to drink.  I missed work and had to call for help. I had to have someone monitor me to assure I could breath due to the swelling in my neck.  Swollen lymph knots in neck, armpit, abdomen and groin. Right arm sever weaknesses, swelling. Sweating from armpit that is sever just weeping almost. Gi upset on and off with no appetite. I was not able to return to work until day 5. I still have the one sided headaches with brain fog, body aches with weakness and right arm is still swelling with the armpit sweating several.  I have also had a trip to the ER due to abdomen pain and weakness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Hyperhidrosis, Impaired work ability, Lymphadenopathy
Clinical narrative: Started with stiff neck and headache at around 1pm on 8/19/21 aprix 4 to 5 hours after vaccination.  Headache becomes sever by 5pm. Fatigue, weak and fever that night. Woke from a nap due to checking on blood. Headache so sever and bloody nose and mouth. This about 12 hours after vaccination. I was so weak I couldn't get of the floor to get myself something to drink.  I missed work and had to call for help. I had to have someone monitor me to assure I could breath due to the swelling in my neck.  Swollen lymph knots in neck, armpit, abdomen and groin. Right arm sever weaknesses, swelling. Sweating from armpit that is sever just weeping almost. Gi upset on and off with no appetite. I was not able to return to work until day 5. I still have the one sided headaches with brain fog, body aches with weakness and right arm is still swelling with the armpit sweating several.  I have also had a trip to the ER due to abdomen pain and weakness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Mouth haemorrhage, Muscular weakness, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Started with stiff neck and headache at around 1pm on 8/19/21 aprix 4 to 5 hours after vaccination.  Headache becomes sever by 5pm. Fatigue, weak and fever that night. Woke from a nap due to checking on blood. Headache so sever and bloody nose and mouth. This about 12 hours after vaccination. I was so weak I couldn't get of the floor to get myself something to drink.  I missed work and had to call for help. I had to have someone monitor me to assure I could breath due to the swelling in my neck.  Swollen lymph knots in neck, armpit, abdomen and groin. Right arm sever weaknesses, swelling. Sweating from armpit that is sever just weeping almost. Gi upset on and off with no appetite. I was not able to return to work until day 5. I still have the one sided headaches with brain fog, body aches with weakness and right arm is still swelling with the armpit sweating several.  I have also had a trip to the ER due to abdomen pain and weakness.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Urine analysis, X-ray
Clinical narrative: Started with stiff neck and headache at around 1pm on 8/19/21 aprix 4 to 5 hours after vaccination.  Headache becomes sever by 5pm. Fatigue, weak and fever that night. Woke from a nap due to checking on blood. Headache so sever and bloody nose and mouth. This about 12 hours after vaccination. I was so weak I couldn't get of the floor to get myself something to drink.  I missed work and had to call for help. I had to have someone monitor me to assure I could breath due to the swelling in my neck.  Swollen lymph knots in neck, armpit, abdomen and groin. Right arm sever weaknesses, swelling. Sweating from armpit that is sever just weeping almost. Gi upset on and off with no appetite. I was not able to return to work until day 5. I still have the one sided headaches with brain fog, body aches with weakness and right arm is still swelling with the armpit sweating several.  I have also had a trip to the ER due to abdomen pain and weakness.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in jaw
Clinical narrative: Headaches and Pulsating on both sides of neck near jugular ~ for approximately 72 hours after vaccine.  Intermitten neck and jaw pain on left side up to today ~ October 15
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Tender lymphadenopathy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site pain, Joint range of motion decreased, Metabolic function test, Pain
Clinical narrative: 2nd shot given high in the shoulder (higher than any vaccine I've received. A couple weeks following the shot I awoke at night with extreme pain at what seemed the shot site after which I gradually lost the ability to move my arm/shoulder without extreme pin and couldn't move it - diagnosed in April 2021 with adhesive capsulitis initially - pain radiates to hand and arm. In August 2021, right shoulder began to experience symptoms. I saw a doctor 10/07/2021, he recommended I have a referral to a rheumatologist because he believes the radiating pain might be systemic. Oct 14, 2021 I saw an article about Parsonage Turner syndrome and the Moderna vaccine. I have 11/15/2021 appointment with a rheumatologist.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Sleep disorder, Ultrasound Doppler
Clinical narrative: 2nd shot given high in the shoulder (higher than any vaccine I've received. A couple weeks following the shot I awoke at night with extreme pain at what seemed the shot site after which I gradually lost the ability to move my arm/shoulder without extreme pin and couldn't move it - diagnosed in April 2021 with adhesive capsulitis initially - pain radiates to hand and arm. In August 2021, right shoulder began to experience symptoms. I saw a doctor 10/07/2021, he recommended I have a referral to a rheumatologist because he believes the radiating pain might be systemic. Oct 14, 2021 I saw an article about Parsonage Turner syndrome and the Moderna vaccine. I have 11/15/2021 appointment with a rheumatologist.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: The morning after my first vaccination, I experienced extreme fatigue. I felt as if I did not sleep at all. I had a very painful injection site. I then proceeded to get full body chills and aches for the next 3 days. I had to take Tylenol around-the-clock to manage the symptoms. I felt like I had influenza. My second injection was similar simtoms as the first, but only for 1 day following the injection. Additionally, by the next night 9/9/2021, I had a temperature of 102.3ºF.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischemic Stroke
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm (site of injection) pain when in movement.; This is a spontaneous report from a non-contactable physician, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 at 13:00 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia, history of cancer and inverse psoriasis (on topicals). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included enalapril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Feb2021 at 18:00, the patient experienced left arm (site of injection) pain when in movement. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm (site of injection) pain when in movement was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Left arm pain at site of injection; Pain was majorly at movement; This is a spontaneous report from a non-contactable physician. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, dyslipidemia, cancer and inverse psoriasis on topical treatment. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included enalapril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN), both taken for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021, on the day of injection around 18:00 to 19:00, the patient had left arm pain at site of injection and had lasted less than 24 hours and experienced pain majorly at movement. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm pain at site of injection and pain majorly at movement were resolved on an unknown date on Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Trigger finger
Clinical narrative: Right hand and right knee swelled less than 24 hours after vaccine.  Right ring finger had slight ?trigger finger?  issue when there has been no previous issues like this.  Swelling of both the right hand and right knee last about 3 days, and then went away.  Had no further problems with it until approximately 09/15/21 when hand swelled and had trigger finger issues with ring finger.  Will be having surgery got this in Oct. 2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Goitre, Magnetic resonance imaging, Thyroidectomy, Ultrasound thyroid abnormal
Clinical narrative: Enlargement of goiter noted starting one week after 1st dose and continued for the next two months. Thyroidectomy was done 10/4/21.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Two male patients received VARIVAX intramuscularly instead of subcutaneously; No additional AE were reported; This spontaneous report was received from a pharmacist, and refers to a male patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneously for prophylaxis (dose, lot number and expiration date were not reported). No adverse events were reported.  This is one of two cases received from the same source.   ; Sender's Comments:  US-009507513-2110USA003312:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered 02SEP2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional referring to a 4-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and established as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 02-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported) as prophylaxis (product storage error).
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No additional adverse events have occurred; patient was administered GARDASIL 9 intramuscularly in right glute; This spontaneous report was received from a nurse and refers to a 29-year-old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 09-SEP-2021, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the right glute (product administered at inappropriate site), 0.5ml milliliter,  lot # T030746,  expiration date 16-MAR-2023 for prophylaxis. No additional adverse event and no product quality compliant were reported.
Sex: F
Vaccine: MMR, MMRV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Experienced swelling throughout her entire body "from head to toe" / Allergic reaction; Experienced swelling throughout her entire body "from head to toe" / Allergic reaction; This spontaneous report has been received from the mother of the female patient of unknown age. The patient did not have concurrent conditions, pertinent medical history, drug reactions or allergies and was not taking concomitant therapies.    On an unspecifed date in 2005, the patient received one dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injectionn in the arm (dose, route of administration, lot # and expiration date were not provided) as routine vaccination. Other suspect therapy included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, lot # and expiration date were not provided) as routine vaccination. The reporter could not recall if the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).   On an unspecified date in 2005, after the vaccination, the patient experienced swelling throughout her entire body form "head to toe" (Swelling). The patient sought medical attention and treatment was given. The reporter stated that the patient did not received the second dose of the vaccine due to the allergic reaction (Hypersensitivity) she experienced with the first dose. On an unspecified date in 2005 (reported as "approximately one week after the vaccination") the patient recovered from the events.   The reporter did not assess the relationship between the events and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).
Sex: U
Vaccine: HIBV, UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a dose of PEDVAXHIB was reconstituted with 0.7ml of Merck Sterile Diluent and administered to a patient; No additional AE reported; 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 an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot number T037650, expiration date 21-JUL-2023 (dose and route of administration were not reported) for prophylaxis that was reconstituted with 0.7 milliliters of sterile diluent(MERCK STERILE DILUENT) (lot number and expiration date not reported) (product preparation issue). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers.  This is an amended report. This case is a non-valid report but it was distributed in error. Case being re-sent to notify all recipients.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion for VARlVAX have been administered to patients; This spontaneous report was received from a nurse referring to a 2-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 07-SEP-2021 and 09-SEP-2021, the products including varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced an excursion of 4 degree Celsius (C) from -10 C to 8 C for 20 minutes during each transport. On 13-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, route, frequency were not provided; Lot# U015682 has been verified to be a valid lot number, expiration date reported as 18-MAY-2023) for prophylaxis. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005648: US-009507513-2109USA005618: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005662: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005881: US-009507513-2109USA005902: US-009507513-2109USA005648:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; a temperature excursion for VARlVAX, vaccine  have been administered; This spontaneous report has been received from a registered nurse (also reported as medical assistant) referring to a 4 years old patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On 14-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose: 1(unit not provided), lot#: U010400 with expire date 01-APR-2023; strength and route were not reported) for prophylaxis (product storage error). The vaccine experienced an excursion of -10 degree Celsius to 8 degree Celsius (4C) for 20 minutes on 07-SEP-2021 during transport and -10 degree Celsius to 8 degree Celsius (4C) for 20 minutes on 09-SEP-2021 during transport. Previous temperature excursion was -10 degree Celsius to 8 degree Celsius for 7 hours and 30 minutes. No adverse events reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2109USA005628:
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Oral mucosal blistering
Clinical narrative: blisters inside of his mouth and on the palate of his mouth; This spontaneous report was received from a male physician in his 30s reporting on himself. The patient's medical history included blisters in his mouth. In approximately July 2021, "about two months ago", the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not reported). Concomitant therapies included covid-19 vaccine and another routine vaccine.  On an unspecified date in approximately July 2021, the patient experienced small blisters inside of his mouth and on the palate of his mouth. The patient stated the blisters lasted for about 1 month after vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). He also stated that he had an endoscopy around the same time he received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). At the time of the report, the patient had recovered.  The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 22-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (2 milliliter, lot # 1742080 with expire date 14-JUL-2022) orally for prophylaxis (product storage error). The vaccine experienced temperature excursion of 0.9C for 47 hours and 52 minutes. There was no previous temperature excursion. No additional adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional Aes; vaccine administered after temperature excursion/Temperature 48.9F; This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-SEP-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated( VAQTA) injection in prefilled syringe, lot # T035720, expiration date: 15-APR-2022 (also reported as 4815/2022) (exact dose, injection site and route of administration were not provided) for prophylaxis.  On an unknown date, the administered dose experienced a temperature excursion of 48.9 degrees Fahrenheit for 30 minutes. No previous temperature excursion had occurred. No additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a physician and refers to a 4-year-old patient. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.  Concomitant vaccinations included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) which did not experienced a temperature excursion.  On 27-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # U007471 and expiration date 08-MAR-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of 28.56 degree fahrenheit (°F) for 44 hours and 5 minutes on an unspecified date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: Caller reporting AE for improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 16-SEP-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1707457 and expiration date 23-FEB-2022; and with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)  (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # T026961 and expiration date 02-APR-2023 both administered as prophylaxis.  The improperly stored doses of the suspect vaccines experienced a temperature excursion of 48.7 degree fahrenheit (°F) for 10 minutes on 10-SEP-2021; no previous temperature excursions were reported.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No additional adverse effect; an expired dose of RECOMBIV AX HB that was given to a five year old child.; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-SEP-2021, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), lot number reported as 77BS9, expiry date reported as 22-SEP-2021, 0.5 milliliter (injection site and route of administration were not provided) for prophylaxis (Expired vaccine used). No additional adverse effect was reported.  Lot number 77BS9 is an invalid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB). Lot number 77BS9 does not match any Company product as confirmed by Lot Verification Team.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: GARDASIL 9 but is unable to confirm or deny if Patient completed series; no additional adverse events reported; This spontaneous report has been received from a physician assistant, referring to a male patient who was 17 years old at the time of the report. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On an unspecified date, the patient was vaccinated with either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (route of administration, anatomical site of vaccination and vaccine scheme were not reported; dose, lot number and expiration date were unknown by the reporter) as prophylaxis.   The physician assistant reported that the patient's mother stated that she was unable to confirm or deny if the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). In addition, it was reported that it was unknown if the patient completed the vaccine series (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: PROQUAD that underwent a temperature excursion was admnistered; No additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, or concomitant medication were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number U015481 with expiration date 13-NOV-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, which underwent a temperature excursion, at 14 to 46°F (33F) for 8 hours 0 minutes and 0 seconds (Product storage error). There was no previous temperature excursion. No additional adverse effect reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA002855:
Sex: U
Vaccine: MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: No additional AE reported; improperly stored vaccines administered after a temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not provided.  On 29-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD), 0.5 milliliters (mL) (dose number, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T035389 has been verified to be valid, expiration date reported and established as 14-APR-2022) as prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of minus 14 degrees Celsius (-14C) to minus 10 degrees Celsius (-10C) (-13.7C) during a time frame of 30 minutes; minus 10 degrees Celsius (-10C) to 8 degrees Celsius (-2.8C) during a time frame of 30 minutes; minus 10 degrees Celsius (-10) to 8 degrees Celsius (7.9C), during a time frame of 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events provided; administration of expired MMR and sterile diluent; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 01-OCT-2021, the patient was vaccinated with expired doses of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 ml (reported as .5 ml) lot # R036582, expiration date 17-DEC-2020 (route of administration was not provided) and sterile diluent lot # S008565, expiration date 09-AUG-2021 (dose and route of administration were not provided). No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE reported; improperly stored vaccines administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 29-SEP-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), 0.5 milliliter (lot number T035389, expiration date 14-APR-2022) (strength, frequency and route of administration were not provided) for prophylaxis. No adverse event was reported. According to the reporter, the temperature excursions were -14 to -10 (-13.7) degrees Celsius for a time frame of 30 minutes; -10 to 8 (-2.8) degrees Celsius for a time frame of 30 minutes and -10 to 8 (7.9) degrees Celsius for a time frame of 30 minutes, all temperature excursions on 20-SEP-2021, without any previous temperature excursion
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: that her husband is allergic to an ingredient in Pneumonia vaccine called pneumovax, her husband had an allergic reaction many years ago due to the vaccine; This spontaneous report was received from a patient's wife and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, reported as many years ago, the patient had an allergic reaction due to the vaccine. He was allergic to an ingredient in Pneumonia vaccine called Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The outcome of allergy to vaccine was unknown.  The reporter considered the event of allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Hypothyroidism, Lymph node palpable, Lymphadenitis, Lymphadenopathy
Clinical narrative: Subclinical hypothyroidism; and they are inflamed and you are able to see them.; they said her antibodies were low and she had to get re-dosed; chain of lymph nodes in her neck; This spontaneous report was received from a 47 year old white female patient reporting on herself. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.  On unspecified date in 2014 (also reported as: "around 2014"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On unspecified date in 2014 (also reported as: "around 2014"), the patient experienced subclinical hypothyroidism, chain of lymph nodes in her neck and they are inflamed and "you are able to see them". In addition, her antibodies were low and she had to get re-dosed.  The outcome of hypothyroidism, antibody test abnormal, lymph node palpable and lymphadenopathy was not provided.  Causality assessment between hypothyroidism, antibody test abnormal, lymph node palpable and lymphadenopathy and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.  Upon internal review, hypothyroidism was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Neuropathy peripheral, Pain of skin
Clinical narrative: neuropathy; dermatomal pain; suffered multiple outbreaks of herpes zoster; suffered multiple outbreaks of herpes zoster; myalgias; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 04-OCT-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unknown date, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, dermatomal pain, neuropathy and myalgias. As a result of these symptoms, the patient was seen and treated by a medical provider and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of neuropathy peripheral, shingles, herpes zoster reactivation, pain and myalgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event Neuropathy peripheral was considered to be medically significant.