chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Depressed level of consciousness, Diarrhoea, Fatigue
Clinical narrative: 1st Dose Oct 9 at 10 AM, arm itched right after getting it By pm Had - headache, body ache + chills - But wasn't Real Bad - and a sore arm for next 2 days. had some fatigue with the above But was able to function. On 1-07-2020 had 2nd dose - arm started to itch Right after the shot about 5 pm after - By 8 pm my arm was very sore as the night went on I started to get a headache and my Arm was so sore I could hardly move it without it hurting. Wednesday - I also had Body Aches and chills - the next morning after a rough night of all the things listed - I then felt Nauseous, with a headache, chills, Fatigue, sore arm, body Aches, fever I also had a bout of diarrhea - I was so sick I could not move and just suffered and layed on the couch Because I didn't have strength to go up stairs to my Bed Because I had come down in the AM thinking if I ate something I would feel Better But that was not the answer - I only got worse and could not make it Back upstairs at one point I almost passed out! and stayed on the couch form 8 AM until 8 pm in and out of sleep and with all of the symptoms listed - Headache, fever, sore Arm, nauseous, (not able or wanted to eat or drink anything all day + Night, Body Aches, chills my husband wanted to take me to the Dr. or ER But I didn't feel strong enough to get up and go - Everything hurt + I was SO weak!! Thursday - the next day (Thursday) I still had the same symptoms but not as pronounced - after a very Bad night Because I hurt so Bad I was able to sit up and By 2:00 pm able to drink a portion of Vitamin Water. Still very weak + arm sore, aches all over + feeling feverish as the day went on I felt stronger. A strange thing happened on Thursday night my left side of my face + my eye socket hurt + the  nerves in my face only on that side hurt It hurt when I touched it. Friday - I felt much Better able to each still low energy and finally looked at my arm I had a red look like a huge hive where the injection was given it was at least 4 inches wide and long I should have look at it sooner But that was minor compared to all the other symptoms I had - But I guess that is why my arm hurt so badly - If you need to call me feel free Willing to talk to anyone - hope you can read this
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: 1st Dose Oct 9 at 10 AM, arm itched right after getting it By pm Had - headache, body ache + chills - But wasn't Real Bad - and a sore arm for next 2 days. had some fatigue with the above But was able to function. On 1-07-2020 had 2nd dose - arm started to itch Right after the shot about 5 pm after - By 8 pm my arm was very sore as the night went on I started to get a headache and my Arm was so sore I could hardly move it without it hurting. Wednesday - I also had Body Aches and chills - the next morning after a rough night of all the things listed - I then felt Nauseous, with a headache, chills, Fatigue, sore arm, body Aches, fever I also had a bout of diarrhea - I was so sick I could not move and just suffered and layed on the couch Because I didn't have strength to go up stairs to my Bed Because I had come down in the AM thinking if I ate something I would feel Better But that was not the answer - I only got worse and could not make it Back upstairs at one point I almost passed out! and stayed on the couch form 8 AM until 8 pm in and out of sleep and with all of the symptoms listed - Headache, fever, sore Arm, nauseous, (not able or wanted to eat or drink anything all day + Night, Body Aches, chills my husband wanted to take me to the Dr. or ER But I didn't feel strong enough to get up and go - Everything hurt + I was SO weak!! Thursday - the next day (Thursday) I still had the same symptoms but not as pronounced - after a very Bad night Because I hurt so Bad I was able to sit up and By 2:00 pm able to drink a portion of Vitamin Water. Still very weak + arm sore, aches all over + feeling feverish as the day went on I felt stronger. A strange thing happened on Thursday night my left side of my face + my eye socket hurt + the  nerves in my face only on that side hurt It hurt when I touched it. Friday - I felt much Better able to each still low energy and finally looked at my arm I had a red look like a huge hive where the injection was given it was at least 4 inches wide and long I should have look at it sooner But that was minor compared to all the other symptoms I had - But I guess that is why my arm hurt so badly - If you need to call me feel free Willing to talk to anyone - hope you can read this
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 1st Dose Oct 9 at 10 AM, arm itched right after getting it By pm Had - headache, body ache + chills - But wasn't Real Bad - and a sore arm for next 2 days. had some fatigue with the above But was able to function. On 1-07-2020 had 2nd dose - arm started to itch Right after the shot about 5 pm after - By 8 pm my arm was very sore as the night went on I started to get a headache and my Arm was so sore I could hardly move it without it hurting. Wednesday - I also had Body Aches and chills - the next morning after a rough night of all the things listed - I then felt Nauseous, with a headache, chills, Fatigue, sore arm, body Aches, fever I also had a bout of diarrhea - I was so sick I could not move and just suffered and layed on the couch Because I didn't have strength to go up stairs to my Bed Because I had come down in the AM thinking if I ate something I would feel Better But that was not the answer - I only got worse and could not make it Back upstairs at one point I almost passed out! and stayed on the couch form 8 AM until 8 pm in and out of sleep and with all of the symptoms listed - Headache, fever, sore Arm, nauseous, (not able or wanted to eat or drink anything all day + Night, Body Aches, chills my husband wanted to take me to the Dr. or ER But I didn't feel strong enough to get up and go - Everything hurt + I was SO weak!! Thursday - the next day (Thursday) I still had the same symptoms but not as pronounced - after a very Bad night Because I hurt so Bad I was able to sit up and By 2:00 pm able to drink a portion of Vitamin Water. Still very weak + arm sore, aches all over + feeling feverish as the day went on I felt stronger. A strange thing happened on Thursday night my left side of my face + my eye socket hurt + the  nerves in my face only on that side hurt It hurt when I touched it. Friday - I felt much Better able to each still low energy and finally looked at my arm I had a red look like a huge hive where the injection was given it was at least 4 inches wide and long I should have look at it sooner But that was minor compared to all the other symptoms I had - But I guess that is why my arm hurt so badly - If you need to call me feel free Willing to talk to anyone - hope you can read this
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on entire body, itching
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Anti-thyroid antibody positive, Antinuclear antibody positive, Autoimmune thyroiditis, Raynaud's phenomenon, Total complement activity increased
Clinical narrative: Raynauds phenomena 1/1/2019 onset Dx 1/21/2019 Hashimoto Thyroiditis Dx 1/31/2019
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Says that 3 days after receiving the flu shot, her right upper extremity became so sore she could barely move it. Said it gradually improved but still had some soreness when seen in office 1/24/2020.
Age: 1.5
Sex: F
Vaccine: FLU4, HIBV, MMR, PNC13
Symptoms: Extra dose administered
Clinical narrative: PT is a foster child, with unknown immunization status. It was thought she was unimmunized. We checked the database and she was not in it. Vaccines were given: MMR due to recent outbreaks, flu due to local flu activity and Prevnar, #13. Later it was reported that pt was fully immunized. The system showed a different birthdate and when the MA started to enter the vaccines into the computer, a full report printed showing the that patient was up to date on vaccines. Most recent were done about 3 months ago.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Fatigue, Headache
Clinical narrative: First 36 hours: Soreness at injection site, severe headache, head pain (jaw), tiredness, chills/shivering, muscle aches, slightly elevated temperature. Took ibuprofen and aspirin as needed.   About 72 hours after: Developed redness and sharp pain on left arm near but not at the injection site. Painful to the touch and when moving and bending arm. Hasn't gotten bad enough to take medication yet, and still experiencing this as I submit this report (8:30pm on 1/27/20).   NOTE: This was the 2nd of 2 shots for Shingrix, and with the first one I only experienced soreness at the injection side for about 3 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain, Pain in extremity, Pain in jaw
Clinical narrative: First 36 hours: Soreness at injection site, severe headache, head pain (jaw), tiredness, chills/shivering, muscle aches, slightly elevated temperature. Took ibuprofen and aspirin as needed.   About 72 hours after: Developed redness and sharp pain on left arm near but not at the injection site. Painful to the touch and when moving and bending arm. Hasn't gotten bad enough to take medication yet, and still experiencing this as I submit this report (8:30pm on 1/27/20).   NOTE: This was the 2nd of 2 shots for Shingrix, and with the first one I only experienced soreness at the injection side for about 3 days.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Blood pressure increased, Chest pain, Gait disturbance, Gait inability
Clinical narrative: I went to reception desk pt was standing at desk told me she was having a reaction to shots went to pt & started to walk with her back to the room. After walking 15-20 ft pt unable to walk anymore c/o back & leg pain. Put pt in chair - & notified Dr. who came to assess pt. Pt was sitting in a chair back in the clinic. Pt c/o pain across her chest and shoulders that then moved into her back, felt like spasm and moved down into legs making it difficult for her to walk. She was fully coherent the whole time. Normal RR and HR, elevated BP, see - clinical notes in chart. No leg swelling, no trouble breathing. Wheeled pt back to clinic room on chair. Pt able to walk to get onto exam talde. Had her lay back to relax. Watched pt for 10-15 more minutes, symptoms fully resolved pt able to walk and felt ready to go home. More was embarassed or frustrated that it happened. Felt much better and planned to go to the lab after clinic visit (was able to go).
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Muscle spasms, Pain in extremity
Clinical narrative: I went to reception desk pt was standing at desk told me she was having a reaction to shots went to pt & started to walk with her back to the room. After walking 15-20 ft pt unable to walk anymore c/o back & leg pain. Put pt in chair - & notified Dr. who came to assess pt. Pt was sitting in a chair back in the clinic. Pt c/o pain across her chest and shoulders that then moved into her back, felt like spasm and moved down into legs making it difficult for her to walk. She was fully coherent the whole time. Normal RR and HR, elevated BP, see - clinical notes in chart. No leg swelling, no trouble breathing. Wheeled pt back to clinic room on chair. Pt able to walk to get onto exam talde. Had her lay back to relax. Watched pt for 10-15 more minutes, symptoms fully resolved pt able to walk and felt ready to go home. More was embarassed or frustrated that it happened. Felt much better and planned to go to the lab after clinic visit (was able to go).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Transient ischaemic attack
Clinical narrative: Patients wife returned to store and said husband had passed on 12/20/19 and believes it was from receiving the shingrix shot. She reported he had mini strokes the day after receiving the shot
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: Allergic reaction, rashes and hives on the face and body
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Allergic reaction, rashes and hives on the face and body
Age: 18.0
Sex: F
Vaccine: ANTH, FLU4, JEV1, SMALL
Symptoms: Abortion spontaneous, Chlamydia test positive, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: THIS IS A FOLLOW-UP TO A PREVIOUSLY SUBMITTED VAERS REPORT 851507-1.  12 Dec 19: Complete spontaneous abortion. 09 Dec 19: Positive Chlamadyia
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Blood iron normal, Blood lactate dehydrogenase normal, Blood phosphorus normal
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Full blood count normal, Glycosylated haemoglobin normal, Inflammation, Insomnia
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test normal, Lipids normal, Metabolic function test normal, Musculoskeletal stiffness, Red blood cell sedimentation rate normal
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor negative, Serum ferritin normal
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aldolase, Antinuclear antibody, Arthralgia, Bacterial test, Blood creatine phosphokinase
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood uric acid, Borrelia test, C-reactive protein, Full blood count, Glycosylated haemoglobin
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lipids, Liver function test, Metabolic function test, Parasite blood test, Red blood cell sedimentation rate
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rheumatoid factor, Serum ferritin, Vitamin D
Clinical narrative: Patient developed bilateral shoulder joint pain 2 days after receiving vaccine. The joint pain then spread to other areas of her body.
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Analgesic drug level, Audiogram abnormal, Blood test normal, Borrelia test, C-reactive protein
Clinical narrative: Received vaccines Prevnar 13 (Pfizer lot AA7116) and Fluzone HD (Sanofi lot UJ241AD) right after my annual physical exam with my GP on 9/20/19. The next morning, I couldn't hear anything in my right ear with almost no change since. I've had auditory exams to confirm the problem and a CAT scan and MRI with contrast came back normal showing no underlying problem. I was told the prognosis for a return to normal is not good.
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Computerised tomogram head, Computerised tomogram normal, Deafness neurosensory, Deafness unilateral, Differential white blood cell count
Clinical narrative: Received vaccines Prevnar 13 (Pfizer lot AA7116) and Fluzone HD (Sanofi lot UJ241AD) right after my annual physical exam with my GP on 9/20/19. The next morning, I couldn't hear anything in my right ear with almost no change since. I've had auditory exams to confirm the problem and a CAT scan and MRI with contrast came back normal showing no underlying problem. I was told the prognosis for a return to normal is not good.
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Full blood count, International normalised ratio, Magnetic resonance imaging normal, Metabolic function test, Prothrombin time
Clinical narrative: Received vaccines Prevnar 13 (Pfizer lot AA7116) and Fluzone HD (Sanofi lot UJ241AD) right after my annual physical exam with my GP on 9/20/19. The next morning, I couldn't hear anything in my right ear with almost no change since. I've had auditory exams to confirm the problem and a CAT scan and MRI with contrast came back normal showing no underlying problem. I was told the prognosis for a return to normal is not good.
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Red blood cell sedimentation rate, Scan with contrast normal, Treponema test
Clinical narrative: Received vaccines Prevnar 13 (Pfizer lot AA7116) and Fluzone HD (Sanofi lot UJ241AD) right after my annual physical exam with my GP on 9/20/19. The next morning, I couldn't hear anything in my right ear with almost no change since. I've had auditory exams to confirm the problem and a CAT scan and MRI with contrast came back normal showing no underlying problem. I was told the prognosis for a return to normal is not good.
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Audiogram abnormal, Computerised tomogram normal, Deafness unilateral, Magnetic resonance imaging normal, Scan with contrast normal
Clinical narrative: Received vaccines Prevnar 13 (Pfizer lot AA7116) and Fluzone HD (Sanofi lot UJ241AD) right after my annual physical exam with my GP on 9/20/19. The next morning, I couldn't hear anything in my right ear with almost no change since. I've had auditory exams to confirm the problem and a CAT scan and MRI with contrast came back normal showing no underlying problem. I was told the prognosis for a return to normal is not good.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Severe pain at injection site
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Binocular eye movement disorder, Blister, Cellulitis
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Confusional state, Crying, Disturbance in attention, Ear pain, Eye movement disorder
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain, Haematocrit increased, Injection site pruritus, Magnetic resonance imaging brain abnormal, Platelet count increased
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Poor quality sleep, Rhinalgia, Screaming, Sensory disturbance, Sensory processing disorder
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Speech disorder, Staring, Urinary incontinence, VIth nerve paralysis, Vaccination site discolouration
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth, White blood cell count increased
Clinical narrative: 3/11/19 vaccine site hot, swollen, painful and discolored not sleeping well a lot of crying and screaming 3/12/19 return to the clinic circle discoloration instructed to apply compress and give ibuprofen, behavior changes by afternoon, still screaming, not using words, staring at walls, hitting,  confused, potty accidents. 3/13 discoloration at injection site darkened and doubled in size complaining od itching, cannot hot anything in his hand take to urgent care treated for cellulitis with an antibiotic, by night swelling is going down. 3/15 left eye turns in and gets stucks inward for a few hours behavior is still concerning. Trouble in school with focusing and displaying sensory struggles, complains of left eye pain and nose in the left ear, 6th nerve palsy suspected from ophthalmologist, a blister on eardrum noted by ENT 10/30
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009326: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009324: US-009507513-2001USA009323: US-009507513-2001USA009327:
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Menstruation delayed, Mumps antibody test, Pregnancy test urine positive
Clinical narrative: she was late for her menstrual period; The office did a urine pregnancy test on fue patient, which was positive; titers negative for mumps; This spontaneous report was received from a nurse prescriber concerning a 39-year-old female patient.  The patient concurrent conditions included multiple sclerosis and diabetes mellitus. The patient's drug reactions included hydromorphone hydrochloride (DILAUDID) (got urticaria and palpitations), latex (got urticaria), kiwis (got urticaria), ondansetron hydrochloride (ZOFRAN) (got urticaria). Concomitant therapies included empagliflozin (JARDIANCE), metformin hydrochloride (GLUCOPHAGE), clonazepam (KLONOPIN), amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL TABLETS), gabapentin, tramadol hydrochloride (ULTRAM), atorvastatin calcium (LIPITOR), and natalizumab (TYSABRI).   On an unknown date during the patient's childhood, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (lot # and expiration date were not reported) 1 dose, subcutaneously, for prophylaxis.   On an unspecified date, the patient became pregnant with a date of last menstrual period (LMP) of December 2019.   On 08-JAN-2020, she had titers drawn for the measles, mumps, and rubella diseases, which were negative for mumps (results came back on 13-AN-020) (mumps antibody test negative). Therefore, the patient was administered a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) booster, lot # S013719 and expiration date 05-MAY-2021, 1 dose, subcutaneously on 17-JAN-2020 (Gestation period at exposure: 1 trimester). Immediately after the patient was administered the vaccine, she stated that "she was late for her menstrual period" (menstruation delayed). Hence the office did an urine pregnancy test on then patient, which was positive. The patient also had blood drawn for a beta human chorionic gonadotropin (hCG) test (the result was not reported). The patient was referred to her obstetrician/gynecologist (OB/GYN) for follow-up. Te outcome of the events mumps antibody test negative and menstruation delayed was reported as not recovered.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA007135:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional adverse effect reported; a 1 year-old male was inadvertently administered a dose of properly stored PROQUAD instead of M-M-R II; This spontaneous report was received from a Licensed Practical Nurse referring to a 1 year-old  male patient. The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported.   On 20-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S019583, expiry date: 25-JUN-2021, strength, dosage information, route of administration and anatomical locations were unknown) and also was inadvertently administered a dose of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), Albumin status rHA (recombinant human albumin), (lot # S017255, expiry date: 01-DEC-2020, strength, dosage information, route of administration and anatomical locations were unknown) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (wrong product administered). Both varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effect reported. No additional information was reported.
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Rash, Rhinorrhoea, Rubella, Vaccination failure
Clinical narrative: Vaccination failure/ rubella patient; Rubella patient/mild infection/viral symptoms as well as rashing, fatigue and a runny nose; This spontaneous report has been received via IQVIA from an unspecified reporter referring to a female patient of unknown age during social media monitoring. Information about medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was fully vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced rubella and vaccine failure. The patient experienced mind infection. She experienced viral symptoms as well as rashing, fatigue and a runny nose. The outcome of the events was unknown. Causality assessment was not provided.
Sex: F
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Vaccination failure/ rubella patient; Rubella patient/mild infection/viral symptoms as well as rashing, fatigue and a runny nose; This spontaneous report has been received via IQVIA from an unspecified reporter referring to a female patient of unknown age during social media monitoring. Information about medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was fully vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced rubella and vaccine failure. The patient experienced mind infection. She experienced viral symptoms as well as rashing, fatigue and a runny nose. The outcome of the events was unknown. Causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms being reported; Inadvertently received an expired dose; Information has been received from a certified medical assistant concerning to a 4 week old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 23-JAN-2020, the patient was vaccinated with an expire dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (Lot No. N009802, exp. date 20-DEC-2019) first dose immunization series. No symptoms were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse symptoms reported; improperly stored PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from an office manager, concerning a patient of unknown age and gender. Information on concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On 23-JAN-2020, the patient was vaccinated with an improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAS23) one 0.5 mL injection, (dose number, route of administration and location of administration were not reported) (lot # S005856, expiration date: 03-DEC-2020), administered for prophylaxis.   The vaccine was exposed to a temperature of 47.8 degrees Fahrenheit for a time frame of 48 hours. There were no previous temperature excursions. A data logger was not involved. No additional adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was inadvertently administered a dose of VARIVAX that had been impropertly stored; No additional adverse effect reported; patient was inadvertently administered a dose of VARIVAX that had been impropertly stored; This spontaneous report was received from a Registered Nurse (RN) referring to a 12 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 20-JAN-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S015464, expiring on 20-MAY-2021, for prophylaxis (dose, route of administration, and injection site were not reported).   The administered dose of the vaccine experienced a temperature excursion of -13 degrees Celsius for 5 minutes, and 4.69 degrees Celsius for 1  hour and 45 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009326: US-009507513-2001USA009327: US-009507513-2001USA009325: US-009507513-2001USA009328: US-009507513-2001USA009324:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA006234: US-009507513-2001USA009323: US-009507513-2001USA009326: US-009507513-2001USA009327:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009326: US-009507513-2001USA006234: US-009507513-2001USA009328: US-009507513-2001USA009323: US-009507513-2001USA009327: US-009507513-2001USA009324:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.   On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009323: US-009507513-2001USA009327: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009324:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an unknown number of doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA006234: US-009507513-2001USA009328: US-009507513-2001USA009325: US-009507513-2001USA009323: US-009507513-2001USA009324: US-009507513-2001USA009326:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009323: US-009507513-2001USA006234: US-009507513-2001USA009326: US-009507513-2001USA009325: US-009507513-2001USA009327: US-009507513-2001USA009324:
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: Abdominal/stomach pains; Diarrhea; Spontaneous report received on 09DEC2019.  A nurse reported that a 13-year-old female consumer had abdominal/ stomach pains (PT: Abdominal pain) and diarrhea (PT: Diarrhoea) following immunization with Vivotif. On an unknown date, she had abdominal/ stomach pains and diarrhea that started in the middle of the night after her third dose of Vivotif. Action taken with Vivotif of reported event was vaccine discontinued. She was recovered from the reported events within 12 hours after onset of symptoms   Medical history included celiac disease and prolonged viral syndrome (2016).   Allergies included penicillin allergy (where she would experience rash), egg allergy (where she would experience nausea and vomiting, but she was able to receive the flu vaccine) and allergy to all type of nuts where she would experience anaphylaxis so she had an Epipen (epinephrine). She also had viral induced asthma.  Past medications included Qvar (beclomethasone; prescribed to take as needed) and albuterol (prescribed to take as needed) which she took once for viral induced asthma.  Additionally, the nurse reported that few medications included Wal-Zyr (5 mL per day for allergies), tums, Vitamin D, and multi-vite, were listed on the consumer's list, but she did not know if the consumer was taking these while taking Vivotif.  The reporter considered the events of abdominal/stomach pains and diarrhea were not related to Vivotif.  Company Comment: A consumer had abdominal pain and diarrhea after taking third dose of vivotif and the events resolved within 12 hours without any treatment. The consumer did not take the fourth dose of Vivotif due to the events. Considering the case information and potential of Vivotif to cause abdominal pain and diarrhea, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer had abdominal pain and diarrhea after taking third dose of vivotif and the events resolved within 12 hours without any treatment. The consumer did not take the fourth dose of Vivotif due to the events. Considering the case information and potential of Vivotif to cause abdominal pain and diarrhea, the causality of both the events is assessed as possible with Vivotif.