chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: DTP
Symptoms: Pyrexia
Clinical narrative: Patient received Tetanus/Diphtheria 0.5 ml IM was given 8/14 in Left Deltoid; Manufacturer: Sanofi Pasteur, Lot Number: U6021AA Exp: 27JUL20). Patient sent message on site to physician describing symptoms as follows "I basically had flu-like symptoms, to include chills (severe, couldn't sleep), fever (didn't check it often, but it was 101 at one point), very low energy, body was aching all over, no appetite (not even thirsty), and I felt "high". As expected, arm was a little sore too. Symptoms started 11 hours after I got the shot (about 10:30pm). I couldn't work or barely do anything. Today, I still have chills on and off and I have a slight headache." ADR entered.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Syncope, Vaccination complication
Clinical narrative: Patient turned pale, fainted, no fever or other symptoms, felt better after a little time, went get IV fluids. Patient fine. First time reaction to vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 27-NOV-2015, the female patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered shingles and Bell's palsy. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the ZOSTAVAX, the patients have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Bell's palsy and shingles were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Atypical pneumonia, Burning sensation, Choking, Cough
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on 19Dec2018 at single dose for immunisation. Relevant medical history included allergy to iodine and sulfa. Concomitant medications were not reported. The patient reported that on an unspecified date her arm blew up from her shoulder to her elbow and she had burning. By the 3rd day, she had a sore throat and felt like her airway was closing and she was choking. She was coughing and choking so much tears were coming out of her eyes. She saw three doctors and was given cough syrup and one recommended she get an EPIPEN because of her allergic reaction to the vaccine. She has an allergy to iodine and sulfa but never had a reaction to a vaccine. It's been about a month and she still feels her immune system was and is wiped out. She went outside and felt her nose tingling and like she has walking pneumonia. She feels weak and just can't get better.  She is trying to figure out what caused this. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Lacrimation increased, Oropharyngeal pain, Paraesthesia, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on 19Dec2018 at single dose for immunisation. Relevant medical history included allergy to iodine and sulfa. Concomitant medications were not reported. The patient reported that on an unspecified date her arm blew up from her shoulder to her elbow and she had burning. By the 3rd day, she had a sore throat and felt like her airway was closing and she was choking. She was coughing and choking so much tears were coming out of her eyes. She saw three doctors and was given cough syrup and one recommended she get an EPIPEN because of her allergic reaction to the vaccine. She has an allergy to iodine and sulfa but never had a reaction to a vaccine. It's been about a month and she still feels her immune system was and is wiped out. She went outside and felt her nose tingling and like she has walking pneumonia. She feels weak and just can't get better.  She is trying to figure out what caused this. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on 19Dec2018 at single dose for immunisation. Relevant medical history included allergy to iodine and sulfa. Concomitant medications were not reported. The patient reported that on an unspecified date her arm blew up from her shoulder to her elbow and she had burning. By the 3rd day, she had a sore throat and felt like her airway was closing and she was choking. She was coughing and choking so much tears were coming out of her eyes. She saw three doctors and was given cough syrup and one recommended she get an EPIPEN because of her allergic reaction to the vaccine. She has an allergy to iodine and sulfa but never had a reaction to a vaccine. It's been about a month and she still feels her immune system was and is wiped out. She went outside and felt her nose tingling and like she has walking pneumonia. She feels weak and just can't get better.  She is trying to figure out what caused this. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Inflammation
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inflammation and went to the emergency room (ER) and took prednisone on an unspecified date. The patient recovered from the event on an unknown date. Information on batch number has been requested. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of patient demographics, medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of PREVENAR 13 and location of the inflammation. A possible causal association between administration of PREVNAR 13 and the onset of the event might not be fully excluded, assuming a plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Shaking, pain in right arm, feverish, mild headache, general malaise (flu-like symptoms).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Shaking, pain in right arm, feverish, mild headache, general malaise (flu-like symptoms).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Scab
Clinical narrative: Five to ten flat, round, red, crusty patches on back of neck, both shoulders and arms, but more on left side. Most are the size of a fingertip but some are thumbprint size. They slightly itch when showering, otherwise no itching. They appear to be slowly resolving on their own, but more have developed since first noticing the effect.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Deafness, Dizziness, Hypersensitivity, Loss of consciousness, Tinnitus
Clinical narrative: Patient was at home and reported that she felt lightheaded approximately 3 - 5 mins, then felt like she passed out for a second, couldn't hear for approximately 2 mins, sisters saw her hands shaking - unk duration and thought she was having a seizure and 911 was called, and then she had ringing in her ears for approximately 3-5 minutes. Evaluated by Fire Department on 01/20/19 and stated, she was advised to follow up with her doctor and stated, they were agreeing that she had an allergic reaction per patient but wasn't transported. States, vitals were taken, no other treatment. Sx all resolved.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Patient was at home and reported that she felt lightheaded approximately 3 - 5 mins, then felt like she passed out for a second, couldn't hear for approximately 2 mins, sisters saw her hands shaking - unk duration and thought she was having a seizure and 911 was called, and then she had ringing in her ears for approximately 3-5 minutes. Evaluated by Fire Department on 01/20/19 and stated, she was advised to follow up with her doctor and stated, they were agreeing that she had an allergic reaction per patient but wasn't transported. States, vitals were taken, no other treatment. Sx all resolved.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per ER evaluation dated 8/18/04: S: Anthrax vaccine dose 6 yesterday..."this one has swollen worse than any others with rash that has continued to spread". Patient complaining of right shoulder pain and redness after receipt of 6th anthrax vaccine yesterday. No SOB, no N/V/D, no chest pain. O: Afebrile. Right deltoid with mild erythema (approx size of fist), mild edema, no vesicles, mild warmth. A/P: Vaccine side effect. Tx with hot compress, Ibuprofen 800 mg 3x/day, and follow up as needed. Jan 2019 note: Patient has had ongoing chronic health concerns which he relates to receipt of anthrax vaccine.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Per ER evaluation dated 8/18/04: S: Anthrax vaccine dose 6 yesterday..."this one has swollen worse than any others with rash that has continued to spread". Patient complaining of right shoulder pain and redness after receipt of 6th anthrax vaccine yesterday. No SOB, no N/V/D, no chest pain. O: Afebrile. Right deltoid with mild erythema (approx size of fist), mild edema, no vesicles, mild warmth. A/P: Vaccine side effect. Tx with hot compress, Ibuprofen 800 mg 3x/day, and follow up as needed. Jan 2019 note: Patient has had ongoing chronic health concerns which he relates to receipt of anthrax vaccine.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling and bruising and pain at injection site immediately at time (1/20). Muscle pain: various areas (at site, back of thigh and calf (1/20, 1/21, 1-22). Headache and stiff neck (1/20, 1/21). Localized rash/ hives below neck, upper chest, upper back 1/22, 1/23, 1/24.....).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Rash, Urticaria
Clinical narrative: Swelling and bruising and pain at injection site immediately at time (1/20). Muscle pain: various areas (at site, back of thigh and calf (1/20, 1/21, 1-22). Headache and stiff neck (1/20, 1/21). Localized rash/ hives below neck, upper chest, upper back 1/22, 1/23, 1/24.....).
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: ADULT DOSE OF HEPATITIS A WAS INADVERTENTLY ADMINISTERED TO AN 18 YEAR OLD CLIENT, INSTEAD OF THE PEDIATRIC DOSE LICENSED FOR THAT AGE.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Seizure occurred 1/21/19. Lasted about 2 minutes. She was unresponsive and was rushed via ambulance to Hospital.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: Oral herpes 1inside mouth began 1/7/2019 lasted about 10 days, herpes in ear, eustachian tube, throat began 1/15/2019. Both on left side lasting 10+ days.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Bedridden, Erythema, Fatigue, Influenza virus test negative
Clinical narrative: On the day after the vaccine, he reported right arm redness and subjective fever. The following day, started fevers (up to 102.5 F) and severe fatigue, became functionally bedbound (though denied focal weakness) due to fatigue; fever responded mildly to antipyretics (TYLENOL, ibuprofen). Called our office; given that he had 3 sick contacts with influenza, suspected possible URI, recommended supportive care and to call us if symptoms evolved. The following day, presented to an urgent care facility for further evaluation; tested negative for the flu, was prescribed course of OMNICEF. The redness in his right arm had spread, he was denying any upper respiratory symptoms/cough at this point. Continued with supportive care and agreed with course of antibiotics for 5 days to see if he'd improve. By the following Monday, his fevers had improved and he had not developed any sore throat, rhinorrhea, cough, shortness of breath; however, his right arm had continued to become more red, and he was still reporting malaise. On exam, showed erythema over the vaccination site. His fevers had resolved by day 5 off of antipyretics. Suspected that he had a systemic inflammatory response after vaccination.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Malaise, Pyrexia, Systemic inflammatory response syndrome, Vaccination site erythema
Clinical narrative: On the day after the vaccine, he reported right arm redness and subjective fever. The following day, started fevers (up to 102.5 F) and severe fatigue, became functionally bedbound (though denied focal weakness) due to fatigue; fever responded mildly to antipyretics (TYLENOL, ibuprofen). Called our office; given that he had 3 sick contacts with influenza, suspected possible URI, recommended supportive care and to call us if symptoms evolved. The following day, presented to an urgent care facility for further evaluation; tested negative for the flu, was prescribed course of OMNICEF. The redness in his right arm had spread, he was denying any upper respiratory symptoms/cough at this point. Continued with supportive care and agreed with course of antibiotics for 5 days to see if he'd improve. By the following Monday, his fevers had improved and he had not developed any sore throat, rhinorrhea, cough, shortness of breath; however, his right arm had continued to become more red, and he was still reporting malaise. On exam, showed erythema over the vaccination site. His fevers had resolved by day 5 off of antipyretics. Suspected that he had a systemic inflammatory response after vaccination.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: On the day after the vaccine, he reported right arm redness and subjective fever. The following day, started fevers (up to 102.5 F) and severe fatigue, became functionally bedbound (though denied focal weakness) due to fatigue; fever responded mildly to antipyretics (TYLENOL, ibuprofen). Called our office; given that he had 3 sick contacts with influenza, suspected possible URI, recommended supportive care and to call us if symptoms evolved. The following day, presented to an urgent care facility for further evaluation; tested negative for the flu, was prescribed course of OMNICEF. The redness in his right arm had spread, he was denying any upper respiratory symptoms/cough at this point. Continued with supportive care and agreed with course of antibiotics for 5 days to see if he'd improve. By the following Monday, his fevers had improved and he had not developed any sore throat, rhinorrhea, cough, shortness of breath; however, his right arm had continued to become more red, and he was still reporting malaise. On exam, showed erythema over the vaccination site. His fevers had resolved by day 5 off of antipyretics. Suspected that he had a systemic inflammatory response after vaccination.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Diarrhoea, Head banging, Influenza like illness
Clinical narrative: Joint pain, nausea, back pain, diarrhea, headache- flu like symptoms.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Joint pain, nausea, back pain, diarrhea, headache- flu like symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Patient woke up next morning with sore arm, itching, redness, bump at the site of injection and pain. Patient saw her PCP and it was determined that she had reaction to immunization. This was reported by the patient to pharmacist on duty. PCP advised her she would recover with time.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Mobility decreased, Nerve block, Pain, Pain in extremity
Clinical narrative: One week of moderate soreness, as warned. Then, about three weeks later, return of upper arm soreness, together wtih migrating (temporary and changing from day to day) impaired muscular movements. As full range of motion returned in each instance after 1-2 days, conclude temporary nerve inflammation/block (perhaps due to intense immune reaction to target in vivo viral proteins still being expressed on nerve cell surfaces?).
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Bacterial test negative
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin decreased, Blood calcium abnormal, Blood chloride normal
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Blood creatine phosphokinase normal, Blood creatinine decreased, Blood fibrinogen increased, Blood glucose increased, Blood potassium increased
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Blood sodium decreased, Blood urea normal, Blood urine absent, C-reactive protein increased, Carbon dioxide normal
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Coagulation test, Differential white blood cell count, Fibrin D dimer normal, Full blood count, Glomerular filtration rate
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Glucose urine absent, Haematocrit increased, Haemoglobin normal, Haemolysis, Henoch-Schonlein purpura
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Injection site pain, Injection site reaction, International normalised ratio normal, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Mean cell volume decreased, Metabolic function test, Nitrite urine absent, Pain in extremity, Pain management
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Palpable purpura, Peripheral swelling, Platelet count increased, Polyarthritis, Protein total normal
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Protein urine present, Prothrombin time shortened, Purpura, Red blood cell count increased, Red blood cell sedimentation rate increased
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Red blood cells urine negative, Specific gravity urine increased, Urine analysis abnormal, Urine bilirubin decreased, Urine ketone body absent
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Urine leukocyte esterase, Urobilinogen urine decreased, Weight bearing difficulty, White blood cell count normal, White blood cells urine negative
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: pH urine normal
Clinical narrative: 1st day after vaccines, increased R leg pain and L upper extremity pain and swelling. Purpura on thighs and trunk. Unable to bear weight on R leg. Admitted and treated for IV fluids and pain management. Improved overnight. Labs unremarkable and was discharged the next day. 4 days after vaccination child returned with polymigratory arthritis, palpable purpura, and 1+ protein in urine. Suspect Henoch Schonlein purpura. Currently still admitted for pain management.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness (vertigo) after receiving the vaccines.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: Strong, flu-like symptoms starting 4 hours after administration (arthralgias, myalgias, fatigue, weakness, headache), persisting for 24 hours then easing off to mild flu-like symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Strong, flu-like symptoms starting 4 hours after administration (arthralgias, myalgias, fatigue, weakness, headache), persisting for 24 hours then easing off to mild flu-like symptoms.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling about golf ball size to the injection site, headache, fatigue last 12-24hrs, recommended TYLENOL or MOTRIN as directed on box, BENADRYL also as directed on box.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Local reaction at site of IM injection within about 8 hours - redness, swelling, pain (lasted about 2 weeks). At about 24 hours post vaccine: fever of 100.9 degrees F, chills, flu-like symptoms.  Stayed home all day. Fever down by next day but muscle aches & fatigue continue for about 2 weeks total with some activity limitations. Only home treatment with TYLENOL- did not see my doctor. NOTE: I had a similar reaction to the first SHINGRIX Vaccine given on 6/12/2018 (TP5E5) except that problems only lasted about a week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local reaction, Myalgia, Pyrexia
Clinical narrative: Local reaction at site of IM injection within about 8 hours - redness, swelling, pain (lasted about 2 weeks). At about 24 hours post vaccine: fever of 100.9 degrees F, chills, flu-like symptoms.  Stayed home all day. Fever down by next day but muscle aches & fatigue continue for about 2 weeks total with some activity limitations. Only home treatment with TYLENOL- did not see my doctor. NOTE: I had a similar reaction to the first SHINGRIX Vaccine given on 6/12/2018 (TP5E5) except that problems only lasted about a week.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain/soreness lasted longer than usual week, has persisted through today's date from the Dec. 12 2018 shot. Is getting it looked at by orthopedist in coming week.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt received flu shot at her work were I did a clinic in sept 2018. Pt called me on 01/23/19 states her arm has been hurting her since I gave her the flu vaccine also states saw her md and received a cortisone shot and has been going to therapy. She still states her arm is still hurting.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Nausea
Clinical narrative: Client states that she went to bed at 10pm and felt fine. Awoke at 11pm very cold and shivering. States that she did not take her temperature. States she took a muscle relaxer and fell back asleep. This morning she felt fatigue, nauseated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling, Urticaria
Clinical narrative: Severe pain in arm for one week, swelling with large red welts (I hope to send you the photo), continuing pain deep in my arm almost one month later.
Age: 39.0
Sex: M
Vaccine: TYP, YF
Symptoms: Chills, Decreased appetite, Dehydration, Nausea, Pyrexia
Clinical narrative: Client called and reported Jan 10th he began experiencing high fevers, chills and decreased appetite lasting until January 14, 2019. All symptoms subsided until January 18, 2019 where high fevers, decreased appetite and nausea started. He was seen in the ER on January 21 and Dx was "dehydration" and given fluids and then returned to the ER on January 22, 2019 with the same symptoms and given fluids again and discharged. Symptoms are ongoing as of today.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt received vaccine at health clinic on 1/10/19, pt started to feel pain and unable to move his left arm. Finally pt thought something is wrong and came to our office on 1/22/2019. Dr ordered VOLTAREN gel, ADVIL, TYLENOL and Physical Therapy. No outcome as this just was started yesterday.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concurrent conditions was not reported. On 24-OCT-2018, the patient was vaccinated with PROQUAD lot# R012272 with expiration date 28-OCT-2019, via subcutaneous (dose detail was not reported) for prophylaxis. The vaccine experienced improperly stored and was stored at 28 Fahrenheit degrees for less than 1 hour. There was no previous temperature excursion. The temperature excursion was detected by a data logger. The concomitant therapy sterile diluent (lot#M015992 with expiration date 26-NOV-2018) was not reported to be improperly stored by the reporter. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1901USA001175: US-009507513-1901USA001565:
Age: 63.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: That same day the patient also received GlaxoSmithKline's SHINGRIX vaccine (Lot # 3Z4KL) in her left deltoid and the original order of PPD (Lot # C5471AA, manufacturer unknown) in her left forearm.  On March 23, 2018, 2 days post-Td administration, the patient was seen at the same facility for interpretation of the TB-PPD skin test and it was confirmed that she did not experience any adverse reactions after Td administration. The reporter indicated that the drug administration error occurred due to a misunderstanding between the nurse and the pharmacist. The nurse requested "PPD, TB" but the pharmacist misunderstood and thought "Td" was ordered. The nurse then did not confirm that the vial provided by the pharmacist was PPD and subsequently administered Td to the patient.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered instead of PPD as a PPD skin test. MassBiologics sent a letter containing information regarding this event to the manufacturer of SHINGRIX, GlaxoSmithKline, on May 31, 2018.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Tachycardia
Clinical narrative: Pt reported swelling of the arm from the injection site to his lower arm near his inner elbow. Pt also experienced tachycardia later that evening.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Redness and swelling of arm. Fever [over 101]; body aches, shivering.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site infection, Injection site reaction, Injection site swelling, Skin infection
Clinical narrative: Patient developed severe swelling and a skin infection on the arm at the injection site. She was prescribed a seven day course of Cephalexin.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness and swelling of arm [redness lasted 5 days]. Fever, chills, aches. Fever not as high as dose #1 because I took Tylenol immediately after the shot].
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Pt had vasovagal reaction to vaccine for less than 20 seconds. Had pt lay down on exam table, was given a cool pack for the back of neck and given water. Pt was asked to wait an additional 15 minutes to assure no other reaction took place. Pt was instructed to notify if any light headedness or dizziness occured again. After 15 minutes pt stated he felt fine and left.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Patient came to pharmacy to discuss adverse events that had occurred a month prior. He actually said he had the same reaction to both SHINGRIX vaccines. Everything he mentioned was on the VIS from which he was counseled. He did not have any serious events but did experience soreness at injection site as well as fever, shivering, and fatigue for over a week. He described the way he felt as flu-like symptoms. He has had no problems since.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Injection site pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: About 10 hrs after the injection, not only was the muscle aching at the site of the injection but it travelled down the arm to the forearm. About 12 hrs after the injection, patient became nauseous with cold sweats. That lasted about 30 min. Primary care physician was contacted and was advised to go to urgent care if symptoms persisted. 24 hrs later, the arm pain was subsiding with the pain only at the injection site. After 48 hrs arm seems to be getting back to normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Body temperature increased, Erythema, Headache
Clinical narrative: Rec'd Sat. 3:10 PM, woke up next day w/temp of 101.3, red itchy painful red welt oval about 5 in long and 3 in wide, painfully joints, achy muscles, bad muscle spasms in lower back mostly on the right side, headache, no appetite, slept most of the day for 3 days, extremely weak and couldn't function. I missed 1 day of work, it was a weekend and we were off on Monday, I missed Tuesday. I started feeling better with some strength, I ate, showered, had a headache and the red welt on my arm still exists, is itchy, less painful. So everything lasted about 3 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Loss of personal independence in daily activities, Muscle spasms, Myalgia, Pruritus
Clinical narrative: Rec'd Sat. 3:10 PM, woke up next day w/temp of 101.3, red itchy painful red welt oval about 5 in long and 3 in wide, painfully joints, achy muscles, bad muscle spasms in lower back mostly on the right side, headache, no appetite, slept most of the day for 3 days, extremely weak and couldn't function. I missed 1 day of work, it was a weekend and we were off on Monday, I missed Tuesday. I started feeling better with some strength, I ate, showered, had a headache and the red welt on my arm still exists, is itchy, less painful. So everything lasted about 3 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Rec'd Sat. 3:10 PM, woke up next day w/temp of 101.3, red itchy painful red welt oval about 5 in long and 3 in wide, painfully joints, achy muscles, bad muscle spasms in lower back mostly on the right side, headache, no appetite, slept most of the day for 3 days, extremely weak and couldn't function. I missed 1 day of work, it was a weekend and we were off on Monday, I missed Tuesday. I started feeling better with some strength, I ate, showered, had a headache and the red welt on my arm still exists, is itchy, less painful. So everything lasted about 3 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red, and painful about 3" dia at shot site.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Loss of consciousness, Pain, Pyrexia
Clinical narrative: Severe fever, loss of consciousness and body pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site pain, Loss of consciousness, Pyrexia
Clinical narrative: Severe fever, loss of consciousness and body pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient claims he got Guillain Barre Syndrome as a result from the vaccine.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Influenza virus test negative, Pyrexia, Seizure, Seizure like phenomena, Vomiting
Clinical narrative: Patient was seen in office for 6 month vaccines at 09:45am on 01/22/19. Patient tolerated well and left office. Per Urgent care documentation: Patient presented to Urgent Care with complaints of seizure like activity and fever starting around 3:00pm. Patient was monitored at urgent care and had a witnessed seizure and one episode of vomiting. After consultation among physicians patient was transferred to emergency department in the same facility and then transferred to a high level of care facility.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Muscular weakness, Pain, Pain in extremity
Clinical narrative: This initial non-serious spontaneous case, was received from other health professional (pharmacist) on 18-Nov-2017, concerns a 44-year-old female patient. The patient's medical history was not reported, concomitant medications included ibuprofen for pain. The patient's historical vaccine included flu vaccine on an unspecified date. On 26-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195248 and expiry date: Jun-2018). On 26-Oct-2017, the patient had soreness. On 28-Oct-2017, 3 days after vaccination, the patient had pain and muscle weakness in the arm, which lasted for about 3 weeks. On the day of vaccination, the patient did not have localized pain while administering injection but later had less pain than usual when receiving injection, no localized rash. She was on ibuprofen at the time of vaccination and was continuing with it, but she couldn't sleep at night due to pain. It was reported, that she had pain in her whole arm. It was hard for her to discern exactly the pain. On 18-Nov-2017, pharmacist stated that she had no sign of injection site reaction, no redness or swelling at the injection site on that day, no redness or swelling down the arm, no rash noted when visually observed by pharmacist. The outcome of the events was not recovered. Non-significant case correction received with IRD 18-Nov-2017 and CRD 04-Dec-2017: IRD and CRD was corrected for the initial version. Non-significant case correction received with IRD 18-Nov-2017: 'Expiry date of the product changed from 'Jun-2018 to 30-Jun-2018'. The "description to be coded" term was changed from insomnia to Sleep difficult.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Migraine, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: The spontaneous case, initially received from pharmacist on 15-Nov-2017, concerning 61-year-old, adult, female patient. On 29-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195240A and expiry date: 30-Jun-2018). On the same day of vaccination, soon after receiving the vaccination, the patient experienced severe pain in shoulder and could not move her arm. She also complained that she could not lift anything. Furthermore, she experienced pain in the arm, could not sleep and the pain radiated up to neck and down the arm causing migraine. No treatment medications were given to the patient. The outcome of the events shoulder pain and mobility decreased, was not reported. The patient was not recovered from the events activities of daily living impaired, pain in arm, sleep difficult, radiating pain, migraine was not recovered. The reporter assessed the case as non-serious. Non-significant follow up received on 07-Dec-2017: It was reported that, no treatment medications were given to the patient. The narrative was amended accordingly. Significant follow up received on 09-Jan-2018: Suspect vaccine was changed from FLUCELVAX TIV to FLUCELVAX QIV, indication of the suspect vaccine was changed from annual influenza vaccine to influenza prophylaxis, batch number and expiry date were added in the product tab. Events (arm pain, cannot sleep, pain radiates up neck and down arm and migraines) were added. Verbatim 'not being able to lift anything' was added to the LLT 'activities of daily living impaired' and treatment received was changed from unknown to 'no' for the event 'loss of personal independence in daily activities' in events tab. Narrative amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: The spontaneous case, initially received from pharmacist on 15-Nov-2017, concerning 61-year-old, adult, female patient. On 29-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195240A and expiry date: 30-Jun-2018). On the same day of vaccination, soon after receiving the vaccination, the patient experienced severe pain in shoulder and could not move her arm. She also complained that she could not lift anything. Furthermore, she experienced pain in the arm, could not sleep and the pain radiated up to neck and down the arm causing migraine. No treatment medications were given to the patient. The outcome of the events shoulder pain and mobility decreased, was not reported. The patient was not recovered from the events activities of daily living impaired, pain in arm, sleep difficult, radiating pain, migraine was not recovered. The reporter assessed the case as non-serious. Non-significant follow up received on 07-Dec-2017: It was reported that, no treatment medications were given to the patient. The narrative was amended accordingly. Significant follow up received on 09-Jan-2018: Suspect vaccine was changed from FLUCELVAX TIV to FLUCELVAX QIV, indication of the suspect vaccine was changed from annual influenza vaccine to influenza prophylaxis, batch number and expiry date were added in the product tab. Events (arm pain, cannot sleep, pain radiates up neck and down arm and migraines) were added. Verbatim 'not being able to lift anything' was added to the LLT 'activities of daily living impaired' and treatment received was changed from unknown to 'no' for the event 'loss of personal independence in daily activities' in events tab. Narrative amended accordingly.
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This initial spontaneous case, was received from a nurse on 07-Dec-2017, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported), which underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November through first December (unspecified year) with the lowest 27.5 degrees F. The reporter assessed the events as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from a nurse on 07-Dec-2017, concerning a 60-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.