chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pneumonia, Positron emission tomogram, Respiratory failure
Clinical narrative: The day my husband received the SHINGRIX vaccine he became ill. After 2 Dr. visits, he was sent to the ER and was admitted, there for 19 days. His symptoms kept changing and worsening. First, apparent pneumonia, then to critical care unit for respiratory failure.Then severe "migratory pain" starting in chest and ending in excruciating right flank pain. Drs ran LOTS of tests...Xrays,CT's, MRI, even a PET scan. His C-Reactive Protein was 299 (normal is less than 2). Found nothing to explain this "inflammatory cascade" and finally said it was probably a severe reaction to the SHINGRIX (I have more info, here and other #'s but Continuation Page won't work.).
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication, X-ray
Clinical narrative: The day my husband received the SHINGRIX vaccine he became ill. After 2 Dr. visits, he was sent to the ER and was admitted, there for 19 days. His symptoms kept changing and worsening. First, apparent pneumonia, then to critical care unit for respiratory failure.Then severe "migratory pain" starting in chest and ending in excruciating right flank pain. Drs ran LOTS of tests...Xrays,CT's, MRI, even a PET scan. His C-Reactive Protein was 299 (normal is less than 2). Found nothing to explain this "inflammatory cascade" and finally said it was probably a severe reaction to the SHINGRIX (I have more info, here and other #'s but Continuation Page won't work.).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Flushing, Nausea
Clinical narrative: PATIENT BEGAN TO FEEL FLUSHED IN CHEST AREA AND FACE AND BECAME NAUSEOUS. HE ALSO FELT COLD.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Fall, Gait disturbance
Clinical narrative: Pt notified me for the first time on the morning of 2/18/19, roughly 2 weeks after the shot had been administered. She reported balance disturbances (resulting in several falls) and struggling to "walk straight." She takes several medications that can induce this type of reaction (ie, oxycodone, gabapentin, and VALIUM). I explained to her that it is not a known reaction to the vaccine, but that she should reach out to her doctor due to the fall incidents and potential severity. I also informed her that I would be reporting the reaction via VAERS.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient broke out in blisters near her lips or nose after receiving the second dose. Recommended patient to see primary physician.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Received vaccines at 10:30 am 12/10/18. By 1:30 pm, my right arm was extremely painful.  Excruciating pain in arm and shoulder all night. Returned to doctors office 12/11/18 and saw nurse practitioner who was no help whatsoever. Said to take anti-inflammatories  twice a day. Rt. arm and shoulder continued to be extremely painful for the next 5 weeks.....limited use of Rt. arm; unable to lift arm overhead..  Arm, shoulder (including injection site) continue to be painful. This is not getting better.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Rash erythematous, Skin warm, Swelling
Clinical narrative: Tiredness, swelling, red rash expanding in size and hot to the touch, arm soreness.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Cough, Mucosal discolouration, Pneumonia, Pyrexia
Clinical narrative: Severe cough, congestion, exuding green mucus for over 3 weeks, still cough, mucus/dry cough. High fever 3 days about 10 days after injection. Pearl drops, antibiotics, cough syrup, cough drops, not help. Also used local honey/lemon. Some help. Also given BREO by pulmonary doctor (helping).
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Severe cough, congestion, exuding green mucus for over 3 weeks, still cough, mucus/dry cough. High fever 3 days about 10 days after injection. Pearl drops, antibiotics, cough syrup, cough drops, not help. Also used local honey/lemon. Some help. Also given BREO by pulmonary doctor (helping).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Immediately after vaccine developed left office and within 24 hours - headache, dizziness, vomiting, abdominal pain, chills, sweating, sore arm, numbness in hands, raw throat, runny nose, swelling at inj. site. No redness at site, no fever.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site swelling, Pain in extremity, Rhinorrhoea
Clinical narrative: Immediately after vaccine developed left office and within 24 hours - headache, dizziness, vomiting, abdominal pain, chills, sweating, sore arm, numbness in hands, raw throat, runny nose, swelling at inj. site. No redness at site, no fever.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative, Throat irritation, Vomiting
Clinical narrative: Immediately after vaccine developed left office and within 24 hours - headache, dizziness, vomiting, abdominal pain, chills, sweating, sore arm, numbness in hands, raw throat, runny nose, swelling at inj. site. No redness at site, no fever.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Two days after receiving GARDASIL, patient went to urgent care for bilateral rash on hands and feet that developed the same day vaccine was given. BENADRYL was recommended for pruritus and redness of hands and feet. Per the urgent care report, these symptoms began on 12-28-18.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Tenderness
Clinical narrative: Red lump right upper extremity that was tender.
Age: 30.0
Sex: M
Vaccine: FLU4, HEPAB
Symptoms: False positive investigation result, Hepatitis B DNA assay, Hepatitis B antigen positive, Polymerase chain reaction
Clinical narrative: Hep B AG screening test showed positive. 1-17-19 (It was done 2 days after TWINRIX #1 vaccine shot). (False positive). 2-15-19 Hep B Ag Screening-Neg test negative.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Back pain, Blood glucose normal, Blood iron increased, Blood thyroid stimulating hormone
Clinical narrative: Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urea decreased, C-reactive protein increased, Condition aggravated, Croup infectious, Fatigue
Clinical narrative: Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Glycosylated haemoglobin normal, Haematocrit decreased, Haemoglobin decreased, Injection site erythema
Clinical narrative: Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Metabolic function test normal, Nasal dryness, Night sweats, Platelet count normal
Clinical narrative: Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Thyroxine free normal, Weight decreased, White blood cell count normal
Clinical narrative: Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt. called in with a complaint of a rash on her neck that started on 1 side of her neck and then switched sides. It did not start until well over a week after vaccination and patient says she never had a local reaction.
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Antibody test, Blood test, Coeliac disease, Diabetes mellitus, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a currently 27 year old male patient referring to himself. He had no pertinent medical history, no drug reactions/allergies, and was not taking any concomitant medications. In 2006 (at approximately 15 years old), the patient was administered M-M-R II 0.5 ml (route and lot # not provided). This was given concomitantly with an unspecified diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (reported as DTaP) (manufacturer not specified), an unspecified hepatitis A vaccine (manufacturer not specified) and "maybe one more."  The patient did not say whether he received any more 0.5 ml doses of M-M-R II after this one. The patient felt sick when he left the office after getting the vaccines and just got sicker over the next 12 hours. He also developed shingles the day after the vaccines were given.  Since that time, the patient developed celiac disease (onset not specified) and diabetes in 2008 (reported as at age 17).  He was not diagnosed with diabetes until 2012 (reported as when he was 21 years old).  On an unspecified date after the vaccinations, the patient was hospitalized "for a few months" where he was diagnosed with schizophrenia. Treatment was given for the events described as "diabetes medications." The patient had unspecified blood work and antibodies checked (results not provided).  He sought medical attention by doctor's visit and hospitalization. On unspecified dates after receiving the vaccines, the patient started to believe that the Federal Bureau of Investigations (FBI) came to his home and was following him around and that they burst the pipes in his parents' home.  He also came to believe that vaccines are poison and that pharmaceutical companies want to use them to kills people as a means for population control. The patient said he posted information on what he experienced on the internet but believes it was taken down by the government. He also stated that the aluminum and mercury in the vaccines were responsible for his condition. The events were not resolved at the time of the report. The patient felt the events were related to M-M-R II, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and the unspecified hepatitis A vaccine.  The patient stated he contacted about 100 lawyers to pursue legal action against the Company for the adverse events but they would not take this case because it was beyond the three year statute of limitations for vaccine related lawsuits. Upon internal review, schizophrenia, diabetes, and celiac disease were considered to be medically significant events. Additional information has been requested.
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Malaise, Schizophrenia
Clinical narrative: This initial spontaneous report was received from a currently 27 year old male patient referring to himself. He had no pertinent medical history, no drug reactions/allergies, and was not taking any concomitant medications. In 2006 (at approximately 15 years old), the patient was administered M-M-R II 0.5 ml (route and lot # not provided). This was given concomitantly with an unspecified diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (reported as DTaP) (manufacturer not specified), an unspecified hepatitis A vaccine (manufacturer not specified) and "maybe one more."  The patient did not say whether he received any more 0.5 ml doses of M-M-R II after this one. The patient felt sick when he left the office after getting the vaccines and just got sicker over the next 12 hours. He also developed shingles the day after the vaccines were given.  Since that time, the patient developed celiac disease (onset not specified) and diabetes in 2008 (reported as at age 17).  He was not diagnosed with diabetes until 2012 (reported as when he was 21 years old).  On an unspecified date after the vaccinations, the patient was hospitalized "for a few months" where he was diagnosed with schizophrenia. Treatment was given for the events described as "diabetes medications." The patient had unspecified blood work and antibodies checked (results not provided).  He sought medical attention by doctor's visit and hospitalization. On unspecified dates after receiving the vaccines, the patient started to believe that the Federal Bureau of Investigations (FBI) came to his home and was following him around and that they burst the pipes in his parents' home.  He also came to believe that vaccines are poison and that pharmaceutical companies want to use them to kills people as a means for population control. The patient said he posted information on what he experienced on the internet but believes it was taken down by the government. He also stated that the aluminum and mercury in the vaccines were responsible for his condition. The events were not resolved at the time of the report. The patient felt the events were related to M-M-R II, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and the unspecified hepatitis A vaccine.  The patient stated he contacted about 100 lawyers to pursue legal action against the Company for the adverse events but they would not take this case because it was beyond the three year statute of limitations for vaccine related lawsuits. Upon internal review, schizophrenia, diabetes, and celiac disease were considered to be medically significant events. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Administration site pain
Clinical narrative: This spontaneous report was received from a physician via Pfizer concerning a 77-year-old male patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in the morning (reported as "AM"), the patient was vaccinated with PNEUMOVAX 23 lot # N010105 (expiry date unspecified), 0.5 milliliter once intramuscularly in the left arm for prophylaxis. On 10-OCT-2017 at 05:00, the patient experienced pain/soreness at site of administration (vaccination site pain). The patient did not required any treatment. On an unknown date, the patient recovered from the event. The reporter considered the event to be not related to PNEUMOVAX 23 (reported as "adverse event thought due to site of administration and not thought due to specific vaccine). Sender's Comments: US-PFIZER INC-2018070876:WWID #
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: "Flu like symptoms and body aches for 3 days."
Age: 17.0
Sex: F
Vaccine: DT, HEPA, MNQ
Symptoms: Asthenia, Blood test, Cardiac monitoring, Disorientation, Feeling hot
Clinical narrative: Within 10 minutes after receiving the immunizations. Patience seized and then became unresponsive turning ashen white, not breathing. The actual time should be in the 911 report. Got her back and she seemed extremely disoriented. Said she was extremely hot and I opened all the windows in the van. Appeared very weak.
Age: 17.0
Sex: F
Vaccine: DT, HEPA, MNQ
Symptoms: Pallor, Respiratory arrest, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Within 10 minutes after receiving the immunizations. Patience seized and then became unresponsive turning ashen white, not breathing. The actual time should be in the 911 report. Got her back and she seemed extremely disoriented. Said she was extremely hot and I opened all the windows in the van. Appeared very weak.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 41-year-old female patient who experienced shoulder pain and limited range of motion, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 19-oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via intramuscular route in unknown administration site. On an unknown date, the patient developed a non-serious shoulder pain and limited range of motion following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data). Final diagnosis was shoulder pain and limited range of motion. It was not reported if the patient received a corrective treatment. The patient outcome is reported as not recovered for shoulder pain and unknown for rest of the events. Follow-up report was received from a nurse on 02-Nov-2018. The patient's age was reported. The patient's vaccination details were reported. An event was added based upon the follow up information. The event outcome was updated. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22-year-old female patient. The patient's concurrent conditions included hypothyroidism and depression. The patient's medical history included sulfonamide allergy. Concomitant therapies included SYNTHROID, unspecified medication for indication reported as birth control, vitamin D, TRINTELLIX. On 24-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously (lot# R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prophylaxis. On 25-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date, she sought medical attention via visit in physician's office. On unspecified dates, the patient was treated with an unspecified anti-histamine and an unspecified anti-inflammatory medications. No laboratory diagnostics or studies were performed. The outcome of the events was reported as recovered on 31-JAN-2019. The relatedness between the events and the suspect vaccine was not provided. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA006029: US-009507513-1902USA006028.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22-year-old female patient. The patient's concurrent conditions included hypothyroidism and depression. The patient's medical history included sulfonamide allergy. Concomitant therapies included SYNTHROID, unspecified medication for indication reported as birth control, vitamin D, TRINTELLIX. On 24-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously (lot# R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prophylaxis. On 25-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date, she sought medical attention via visit in physician's office. On unspecified dates, the patient was treated with an unspecified anti-histamine and an unspecified anti-inflammatory medications. No laboratory diagnostics or studies were performed. The outcome of the events was reported as recovered on 31-JAN-2019. The relatedness between the events and the suspect vaccine was not provided. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA006029: US-009507513-1902USA006028.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Mobility decreased, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms and product availability issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product availability issue was unknown.  It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms that left him down for a day and a half. Now there was a shortage and he want this shot and it was not available which you supposed to get it within 6 months of each other.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms and product availability issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product availability issue was unknown.  It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms that left him down for a day and a half. Now there was a shortage and he want this shot and it was not available which you supposed to get it within 6 months of each other.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness, Vomiting
Clinical narrative: 2 hours after shot when I took one bite of food, I felt my throat constrict. I stopped eating and tried to relax the sensation. Then I suddenly developed hiccups, followed by more tightness in my throat and esophogus, discomfort, pain in those areas, feeling like I couldnt' breathe well, then felt nauseous, ran to bathroom, still not breathing well, threw up only white mucus. Not the contents in my stomach. Sensation got worse for a bit, almost called 911 and then it started to subside. I was able to eat normally a few hours later. Feel fine today except for sore arm.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Hiccups, Nausea, Oesophageal discomfort, Oesophageal pain
Clinical narrative: 2 hours after shot when I took one bite of food, I felt my throat constrict. I stopped eating and tried to relax the sensation. Then I suddenly developed hiccups, followed by more tightness in my throat and esophogus, discomfort, pain in those areas, feeling like I couldnt' breathe well, then felt nauseous, ran to bathroom, still not breathing well, threw up only white mucus. Not the contents in my stomach. Sensation got worse for a bit, almost called 911 and then it started to subside. I was able to eat normally a few hours later. Feel fine today except for sore arm.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain, Pain in extremity, Throat tightness, Vomiting
Clinical narrative: 2 hours after shot when I took one bite of food, I felt my throat constrict. I stopped eating and tried to relax the sensation. Then I suddenly developed hiccups, followed by more tightness in my throat and esophogus, discomfort, pain in those areas, feeling like I couldnt' breathe well, then felt nauseous, ran to bathroom, still not breathing well, threw up only white mucus. Not the contents in my stomach. Sensation got worse for a bit, almost called 911 and then it started to subside. I was able to eat normally a few hours later. Feel fine today except for sore arm.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Flu symptoms.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Given wrong dose, patient should have received TDAP.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever, flu like symptoms.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician regarding to a 74-year-old female patient. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date in 2003, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2003, the patient experienced rash. The outcome of rash was unknown. The causality of event was not reported.; Sender's Comments: US-PFIZER INC-2018004088:
Age: 40.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 40 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 07-JAN-2019, the patient was vaccinated with the first dose of GARDASIL 9 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). On 07-FEB-2019, the patient received the second dose of GARDASIL 9. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R017642, expiration date 20-JUN-2020 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 6°F to 14°F (7.3 F) during 1 hour and 30 minutes. There was a previous temperature excursion of 6°F to 14°F (10.4 F) for 4 hours. It was reported that digital data logger was involved. The vaccine was reconstituted with properly stored sterile diluent lot # M044950, expiration date 30-MAY-2019. No adverse effect was reported.
Age: 0.58
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 month old male patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 06-FEB-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB injection 5/0.5 mcrg/ml (frequency, route of administration was not reported; lot # R012001, expiration date 06-NOV-2020) for prophylaxis. The temperature of excursion with RECOMBIVAX HB was above 9 Celsius degrees for 1 hour and 36 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA007125: US-009507513-1902USA007126.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 month old female patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 06-FEB-2019, the patient was vaccinated with improperly stored dose of M-M-R II (frequency, route of administration was not reported; lot # N026273, expiration date 21-SEP-2019) and dose of VARIVAX (frequency, route of administration was not reported; lot # N035937, expiration date 19-DEC-2019 for prophylaxis. Concomitant therapies included sterile diluent which was stored appropriately. The temperature of excursion with M-M-R II was above 9 Celsius degrees for 1 hour and 36 minutes and with VARIVAX was -14 to -10 Celsius degrees for 1 hour and 8 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA006504: US-009507513-1902USA007126.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female patient. Information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 11-FEB-2019, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB injection 5/0.5 mcrg/ml (frequency, route of administration was not reported; lot # R012001, expiration date 06-NOV-2020) for prophylaxis. The temperature of excursion with RECOMBIVAX HB was above 9 Celsius degrees for 1 hour and 36 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1902USA007125: US-009507513-1902USA006504.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Bronchitis, Dysstasia, Loss of personal independence in daily activities, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bedridden in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the bedridden was recovering/resolving and the outcome of the bronchitis and cold were recovered/resolved and the outcome of the sickness, difficulty in standing and activities of daily living impaired were unknown.  It was unknown if the reporter considered the bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Almost six months before the date of reporting the patient received 1st dose of SHINGRIX. The patient got sick that she had been dreaded for the second dose of SHINGRIX. The patient was completely bedridden for a week, and only a little better the second week. The patient could hardly stand up long enough to prepare something to eat, or even take a shower. Last month from the date of reporting, the patient got over a bad cold and bronchitis. The patient was retired and mentioned that did not miss two weeks of work. The patient did not want to receive second dose of SHINGRIX because of the horrendous side effects experienced early. The patient asked what would happen if second dose was missed.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bedridden in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired. On an unknown date, the outcome of the bedridden was recovering/resolving and the outcome of the bronchitis and cold were recovered/resolved and the outcome of the sickness, difficulty in standing and activities of daily living impaired were unknown.  It was unknown if the reporter considered the bedridden, bronchitis, cold, sickness, difficulty in standing and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Almost six months before the date of reporting the patient received 1st dose of SHINGRIX. The patient got sick that she had been dreaded for the second dose of SHINGRIX. The patient was completely bedridden for a week, and only a little better the second week. The patient could hardly stand up long enough to prepare something to eat, or even take a shower. Last month from the date of reporting, the patient got over a bad cold and bronchitis. The patient was retired and mentioned that did not miss two weeks of work. The patient did not want to receive second dose of SHINGRIX because of the horrendous side effects experienced early. The patient asked what would happen if second dose was missed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: Initial information received on 25-Jan-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves male patient (age not reported) who experienced heart attack, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On unknown date of September 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI812AA) Exp. Date, dose, route and administration site not reported. On unknown date, the patient developed heart attack (myocardial infarction), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized due to the event. Details of lab data not provided. Final diagnosis was heart attack. It was not reported if the patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns an elderly patient who presented with myocardial infarction after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination, concomitant medications and lab tests ruling out alternate etiologies were not reported. Based upon the reported information and considering the advanced age of the patient, the role of the vaccine is unlikely.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid serious case received from a physician via sales representative. This case involves an elderly male patient who developed guillain barre, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a serious guillain barre (guillain-barre syndrome) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was also reported that the patient was not a patient of the clinic. They did not know this patient, they did not know which flu vaccine he received. As the was elderly, so it was possible that it was the FLUZONE HIGH DOSE, but they did not know that for sure. No lab data was reported. Final diagnosis was guillain barre. It was not reported if the patient received a corrective treatment.  The patient outcome of guillain barre was not reported..; Sender's Comments: This case concerns an elderly male patient of unknown age who experienced Guillain-Barre syndrome after receiving INFLUENZA VACCINE produced by unknown manufacturer. Time to onset is unknown. However, there is no information regarding patient's medical condition at time of vaccination, medical history, concurrent condition and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Full blood count normal, Laboratory test normal, Loss of consciousness, Metabolic function test normal
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from an other health professional (medical assistant) via other company (Pfizer) under reference number: 2018203708. This case involves a female patient of unknown age who passed out after she received vaccines MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 04-May-2018, the patient received a dose of suspects MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA and TRUMENBA lot S56026 via unknown route (both vaccines in the left arm). On 04-May-2018, the patient passed out (loss of consciousness) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant (IME). The patient was taken via ambulance to the emergency room. Other relevant tests included: urinalysis, urinalysis for pregnancy, Basic metabolic panel (BMP) and Complete blood count (CBC), with results that showed "glucose of 124, platelets 101 and neutrophils 8.9". Final diagnosis was loss of consciousness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. (reported that patient was observed in the emergency room and was discharged). List of documents held by sender: none.; Sender's Comments: Sanofi Company Comment on 18-Feb-2019: A female patient of unknown age presented loss of consciousness same day after vaccination with MENACTRA and TRUMENBA. Time to onset is compatible with the role of vaccine. Basic metabolic panel (BMP) and Complete blood count (CBC) along with other laboratory testes were performed without any significant finding. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, lab test excluding other etiology would be needed to fully assess this case. Moreover, concomitant administration of two vaccines preceded the event. Based on available information the role of individual vaccine cannot be assessed.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neutrophil count increased, Platelet count decreased, Pregnancy test urine, Urine analysis
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from an other health professional (medical assistant) via other company (Pfizer) under reference number: 2018203708. This case involves a female patient of unknown age who passed out after she received vaccines MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 04-May-2018, the patient received a dose of suspects MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA and TRUMENBA lot S56026 via unknown route (both vaccines in the left arm). On 04-May-2018, the patient passed out (loss of consciousness) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant (IME). The patient was taken via ambulance to the emergency room. Other relevant tests included: urinalysis, urinalysis for pregnancy, Basic metabolic panel (BMP) and Complete blood count (CBC), with results that showed "glucose of 124, platelets 101 and neutrophils 8.9". Final diagnosis was loss of consciousness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. (reported that patient was observed in the emergency room and was discharged). List of documents held by sender: none.; Sender's Comments: Sanofi Company Comment on 18-Feb-2019: A female patient of unknown age presented loss of consciousness same day after vaccination with MENACTRA and TRUMENBA. Time to onset is compatible with the role of vaccine. Basic metabolic panel (BMP) and Complete blood count (CBC) along with other laboratory testes were performed without any significant finding. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, lab test excluding other etiology would be needed to fully assess this case. Moreover, concomitant administration of two vaccines preceded the event. Based on available information the role of individual vaccine cannot be assessed.