chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV, UNK, UNK
Symptoms: Blister, Cellulitis, Crying, Erythema, Pain in extremity
Clinical narrative: Complained of pain in left  arm right after which would be common I thought: gave MOTRIN around  one and nine pm. Woke up from sleep five thirty am with pain. Crying. By nine thirty am had fever of one hundred one point three, big red area that was hot touch.., gave MOTRIN started to form blister..went to urgent care Dx with cellulitis.. took to pediatrician was told that she has chicken pox.. needle didn't go under skin enough. On generic BACTRIM and cream for 10 days.. blister area must stay covered.. pt is contagious now.
Age: 4.0
Sex: F
Vaccine: MMRV, UNK, UNK
Symptoms: Pyrexia, Skin warm, Varicella post vaccine
Clinical narrative: Complained of pain in left  arm right after which would be common I thought: gave MOTRIN around  one and nine pm. Woke up from sleep five thirty am with pain. Crying. By nine thirty am had fever of one hundred one point three, big red area that was hot touch.., gave MOTRIN started to form blister..went to urgent care Dx with cellulitis.. took to pediatrician was told that she has chicken pox.. needle didn't go under skin enough. On generic BACTRIM and cream for 10 days.. blister area must stay covered.. pt is contagious now.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Duplicate Flu Vaccine given during pregnancy; EDD 05/06/2018; Vaccines were given on 11/08/2017 &  01/25/2018; Called Patient and she stated she had no adverse reactions to the vaccines.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood alkaline phosphatase increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of alkaline phosphatase increased in a 70-year-old male patient who received SHINGRIX. The patient's past medical history included multiple myeloma. Concurrent medical conditions included neoplasm and blood pressure. Concomitant products included Aspirin, ELIQUIS, POMALYST and ZOMETA. On 6th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th April 2018, 29 days after receiving SHINGRIX, the patient experienced alkaline phosphatase increased. On an unknown date, the outcome of the alkaline phosphatase increased was unknown. It was unknown if the reporter considered the alkaline phosphatase increased to be related to SHINGRIX. Additional details were provided as follows: On 6th March 2018 10:00, the patient received SHINGRIX. The patient stated that he had a blood test done on 7th March 2018, which showed normal alkaline phosphatase levels of 47 micro per liter. The next report was performed on 4th April 2018 and the blood test results showed elevated alkaline phosphate levels of 493 micro per liter. The patient stated that he was feeling okay at the time of reporting. The patient gave permission to contact his health care provider.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Erythema, Headache, Injection site hypersensitivity, Nausea
Clinical narrative: Delayed regional allergic reaction to entire (L) upper arm. Severe pain, itching, redness and swelling. Headache, nausea and fever. Mental confusion.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Delayed regional allergic reaction to entire (L) upper arm. Severe pain, itching, redness and swelling. Headache, nausea and fever. Mental confusion.
Age: 10.0
Sex: M
Vaccine: HEPAB
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylaxis in a 10-year-old male patient who received TWINRIX. Co-suspect products included ADVAIR inhalation powder for an unknown indication. On 1st March 2018, the patient received TWINRIX. On 28th February 2018, the patient started ADVAIR at an unknown dose and frequency. On 3rd March 2018, 2 days after receiving TWINRIX and 3 days after starting ADVAIR, the patient experienced anaphylaxis (serious criteria GSK medically significant and life threatening). TWINRIX was continued with no change. ADVAIR was discontinued on 1st March 2018 (Dechallenge was negative). Rechallenge with ADVAIR was positive. On 4th March 2018, the outcome of the anaphylaxis was recovered/resolved. The reporter considered the anaphylaxis to be related to TWINRIX. It was unknown if the reporter considered the anaphylaxis to be related to ADVAIR.
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: On 4/23/2018 at approximately 1:45 pm. Pt reported to the office manager that after injections which were given on 4/20/18, he experienced severe R and L arm pain that caused severe bilat arm weakness which lasted about 28 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX. Concomitant products included Aspirin (Baby), Vitamin C and BENADRYL. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were recovering/resolving. The reporter considered the injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional information was received as follows: Concomitant medication also included Vitamin D and Multivitamin. The patient reported that she received the SHINGRIX vaccine on the right arm last Monday and later that day she experienced redness at the injection site. The patient stated that the site was hot and there was itching at the site as well. The patient reported that the next day, the redness had grown to a 4 inch square. The patient stated that she used BENADRYL spray and that had helped. The patient stated that she was not sure if she would receive the 2nd dose. The patient had denied permission to contact their physician.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX. Concomitant products included Aspirin (Baby), Vitamin C and BENADRYL. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were recovering/resolving. The reporter considered the injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional information was received as follows: Concomitant medication also included Vitamin D and Multivitamin. The patient reported that she received the SHINGRIX vaccine on the right arm last Monday and later that day she experienced redness at the injection site. The patient stated that the site was hot and there was itching at the site as well. The patient reported that the next day, the redness had grown to a 4 inch square. The patient stated that she used BENADRYL spray and that had helped. The patient stated that she was not sure if she would receive the 2nd dose. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: Had varicella injection left arm on 4/19/18 and area turned red/hot with small pustules 4 days later.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a elderly female patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown. It was unknown if the reporter considered the general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 84 or 85 years. The patient received SHINGRIX vaccine three weeks before the date of reporting, in left arm and was feeling body aches and fatigue. The patient felt that the symptoms were getting worse. The patient has denied permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Induration, Injection site pain, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: The site stung upon needle injection going in and burning coming out. Immediate swelling of arm, stiffness followed by low grade fever within 4 hours. Swollen to size of orange and hard even after massage. Took TYLENOL - pain subsided 3rd day, still some swelling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The site stung upon needle injection going in and burning coming out. Immediate swelling of arm, stiffness followed by low grade fever within 4 hours. Swollen to size of orange and hard even after massage. Took TYLENOL - pain subsided 3rd day, still some swelling.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an administrator refers to 8-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date in 2012, the patient was vaccinated with first dose in the three dose of RECOMBIVAX HB (dose, units and frequency were unknown) (lot# and expiration date unknown) via intramuscular route. It was reported that on 11-APR-2018 the patient was in the physician's office to receive the second dose in the three-dose RECOMBIVAX HB vaccination series, but the vaccine was not available to administer to the patient, so the patient still has not received the second dose. No adverse effects reported. The outcome of the event the vaccine was not available to administer to the patient was unknown. The casual relationship between event the vaccine was not available to administer to the patient and RECOMBIVAX HB was not provided. There was no product quality compliant reported.
Sex: F
Vaccine: FLU4
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Computerised tomogram thorax abnormal, Culture negative, Dyspnoea
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 21 days after receiving Influenza vaccine Quadrivalent, the patient experienced anti-neutrophil cytoplasmic antibody positive vasculitis (serious criteria GSK medically significant), fatigue, dyspnea and lung consolidation. On an unknown date, the outcome of the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation were unknown. The reporter considered the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis in a 75-years old female patient who was vaccinated with unspecified flu vaccine (manufacturer unknown). The patient was a healthy female. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, 3 weeks after flu vaccination, the patient developed with sudden onset fatigue and extreme dyspnoea with minimal exertion. She had no joint pain or rashes. Complete blood count (CBC) and renal function were both un-remarkable. A computed tomography (CT or CAT) scan showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. CAT scan of the chest done 5 months prior to this presentation was essentially unremarkable. All respiratory cultures were negative. Vasculitis workup was positive for cytoplasmic-ANCA (c-ANCA). Treatment was unknown. The outcome of the event was unknown. The author considered the event of ANCA Vasculitis associated with unspecified influenza vaccine. The author stated, "The etiology of ANCA associated vasculitis (AAV) in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV." The author concluded, "Although causality is difficult to prove, there is a temporal associated between the flu vaccine, our patient's presentation and her subsequent diagnosis with c-ANCA. By reporting the 9th case of influenza vaccine associated ANCA-vasculitis we hope to add to data that may generate future hypotheses, and epidemiological studies to elucidate the underlying etiology."
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea exertional, Fatigue, Full blood count normal, Lung consolidation, Renal function test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 21 days after receiving Influenza vaccine Quadrivalent, the patient experienced anti-neutrophil cytoplasmic antibody positive vasculitis (serious criteria GSK medically significant), fatigue, dyspnea and lung consolidation. On an unknown date, the outcome of the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation were unknown. The reporter considered the anti-neutrophil cytoplasmic antibody positive vasculitis, fatigue, dyspnea and lung consolidation to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis in a 75-years old female patient who was vaccinated with unspecified flu vaccine (manufacturer unknown). The patient was a healthy female. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified flu vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, 3 weeks after flu vaccination, the patient developed with sudden onset fatigue and extreme dyspnoea with minimal exertion. She had no joint pain or rashes. Complete blood count (CBC) and renal function were both un-remarkable. A computed tomography (CT or CAT) scan showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. CAT scan of the chest done 5 months prior to this presentation was essentially unremarkable. All respiratory cultures were negative. Vasculitis workup was positive for cytoplasmic-ANCA (c-ANCA). Treatment was unknown. The outcome of the event was unknown. The author considered the event of ANCA Vasculitis associated with unspecified influenza vaccine. The author stated, "The etiology of ANCA associated vasculitis (AAV) in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV." The author concluded, "Although causality is difficult to prove, there is a temporal associated between the flu vaccine, our patient's presentation and her subsequent diagnosis with c-ANCA. By reporting the 9th case of influenza vaccine associated ANCA-vasculitis we hope to add to data that may generate future hypotheses, and epidemiological studies to elucidate the underlying etiology."
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX. Concurrent medical conditions included penicillin allergy (since 1961). Concomitant products included Levothyroxine, NASACORT, SINGULAIR and ASMANEX. On 11th April 2018 16:33, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain, contusion and pruritus. On 17th April 2018, the patient experienced erythematous rash. On an unknown date, the outcome of the pain and contusion were recovering/resolving and the outcome of the pruritus was not recovered/not resolved and the outcome of the erythematous rash was unchanged. The reporter considered the pain, contusion and pruritus to be probably related to SHINGRIX. The reporter considered the erythematous rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient developed soreness, itching and a little bruise initially. In the morning of reporting day, 6 days after receiving SHINGRIX, the patient experienced itching and a red rash of the size of half a clementine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: On 4/24/2018, Patient had pain, swelling and redness on right upper arm where TDAP and MENACTRA were given. He complained of "not feeling well" and had a fever of 101.0 and a headache. He was seen again in office and prescribed Azithromycin 200mg/5ml oral suspension Sig - Take 12.5 ml everyday by oral route for 5 days. Patient's mother did not give the medication. She told the provider she gave the patient BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: On 4/24/2018, Patient had pain, swelling and redness on right upper arm where TDAP and MENACTRA were given. He complained of "not feeling well" and had a fever of 101.0 and a headache. He was seen again in office and prescribed Azithromycin 200mg/5ml oral suspension Sig - Take 12.5 ml everyday by oral route for 5 days. Patient's mother did not give the medication. She told the provider she gave the patient BENADRYL.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left arm red, swollen, hot to touch and tender. Patient was seen after hours 48 hours after vaccines, started SEPTRA. On 4/16/18 was seen by Primary Care Provider. SEPTRA was discontinued and Prednisone 20 mg for 5 days was given.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiomyopathy, Dyspnoea, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 20-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient was diagnosed with shingles and developed difficulties with breathing, including shortness of breath.  Thereafter, the patient presented to a hospital cardiology clinic and was diagnosed as suffering from nonischemic cardiomyopathy.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The event of Nonischemic cardiomyopathy was determined to be medically significant. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Injection site pain, Nausea
Clinical narrative: Very sore arm at injection site. Chills and low grade fever started evening of day of shot. By night time the day of vaccine, had extreme stomach pain and nausea. Waves of nausea and some stomach pain day following. Arm still sore. Two days after vaccine, arm still sore and stomach still uncomfortable. Still have periods of nausea.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Very sore arm at injection site. Chills and low grade fever started evening of day of shot. By night time the day of vaccine, had extreme stomach pain and nausea. Waves of nausea and some stomach pain day following. Arm still sore. Two days after vaccine, arm still sore and stomach still uncomfortable. Still have periods of nausea.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient stated he had arm and back pain following the SHINGRIX shot. He stated the pain began the night of the vaccine or shortly after and continued for approximately one to two weeks. The pain is now resolved and patient does not have any ongoing issues.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Rash, Rash erythematous
Clinical narrative: Headache, severe aches, severe pain at injection site, red rash on upper arm not at injection site (still have) not painful or itchy.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Two days after vaccine was administered, patient developed a warm, red, firm lump (1inchx3inch) about 1 inch below injection site. Patient describes this as painful like a bruise. Does not report any fainting, fever, chills, or anything else besides redness/pain/swelling.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Two days after vaccine was administered, patient developed a warm, red, firm lump (1inchx3inch) about 1 inch below injection site. Patient describes this as painful like a bruise. Does not report any fainting, fever, chills, or anything else besides redness/pain/swelling.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Rash macular
Clinical narrative: Two days after vaccine was administered, patient developed a warm, red, firm lump (1inchx3inch) about 1 inch below injection site. Patient describes this as painful like a bruise. Does not report any fainting, fever, chills, or anything else besides redness/pain/swelling.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle tightness, Myalgia, Tic
Clinical narrative: Awoke 3:30 am with marked muscle aching in arms and upper torso, this cleared some what with ASA in a half hour. Shortly thereafter at about 4:30 am I started having severe episodic tightening of the facial and neck muscles and throat too. Each episode would last about 10 seconds and occur several times per minute. They were not stoppable. No problem breathing or swallowing. Extremities were not involved unless I stretched my arms out then my hands would episodically flap up and down like a tic.  The whole deal looked almost like Tourette's I got up after 20 min. and it all went away. No recurrence and only minor muscle soreness in arms and shoulders. I am a retired Neurologist.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Mother reported this incident to me when she saw me at a basketball game on 4/28/18. She did not come into the clinic, and I never saw the patient during the time of the reaction. Mother reports: Patient woke up on 04/20/18 with a "low grade" fever that became 104 by the afternoon. She kept the temp through Sunday afternoon. She also kept a severe headache, dizziness, and neck stiffness during this time. Monday morning, she had only a low grade fever again (no number provided). By Monday 4/23/18 symptoms were gone and Patient was feeling fine. Mother reports today 4/30/18 via follow up phone call that Patient has had no further problem.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient explained that she had arm soreness and swelling within the first 24 hours of vaccination, by day 12 (Thursday 4/26/2018) her elbow was red and hurting and her hand was red, on day 14 (Saturday 4/28/2018) she went to urgent care where they diagnosed her with cellulitis and sent her to hospital, where patient was admitted for one overnight. Patient was discharged on Sunday 4/29/2018 and received generic AUGMENTIN 875 mg po BID for 7 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid got very swollen, sore and hot. Patient got BENADRYL and cold compresses. Patient  improved, no more swelling or redness after taking BENADRYL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: A 4-inch in diameter spot swelled up on my arm, turned bright red, was hot and itched and it lasted 9 days. Although the symptoms decreased over that time, the reaction far exceeded the 2-3 day period that is in all the literature on this drug.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest pain, Flushing, Oral discomfort, Throat irritation
Clinical narrative: Patient experienced burning sensation on the left side of her upper torso, throat and chest as well in her mouth which she described as a "taste" that burned.. (vaccine was injected into the left deltoid).  She also experienced extreme flushing of the face and chest. These symptoms lasted for approximately ten minutes and then subsided.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The vaccinations were administered on April 26, 2018. The patient's mother stated she noticed that the patient's right upper arm was turning red on April 28, 2018. The patient stated the area to his upper arm was itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Patient reports receiving the injection at her local pharmacy. The next morning she was out working in her garden and began to feel very tired so she went inside. She states about 6 pm she went to bed and slept through the night. She has experienced tenderness, redness at the injection site, chills, fatigue, body aches (severe back pain) lack of appetite and headache. She states the symptoms resolved on Friday. Yesterday she went hiking and wore a long sleeve shirt, had itching and noted the area looked like a bug bite but was not bit by anything. She states now she has a raised area on the back of her neck.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pruritus, Swelling
Clinical narrative: Patient reports receiving the injection at her local pharmacy. The next morning she was out working in her garden and began to feel very tired so she went inside. She states about 6 pm she went to bed and slept through the night. She has experienced tenderness, redness at the injection site, chills, fatigue, body aches (severe back pain) lack of appetite and headache. She states the symptoms resolved on Friday. Yesterday she went hiking and wore a long sleeve shirt, had itching and noted the area looked like a bug bite but was not bit by anything. She states now she has a raised area on the back of her neck.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: Patient is Pregnant; EDD of 05/29/2018 is presently 35 weeks and 6 days; Flu vaccine given on 01/25/2018 & again on 02/22/2018; Called and spoke to Patient who states she has had no adverse reactions to the vaccines.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Unusual soreness, nausea, chills, fever. Lasted 30 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Nausea
Clinical narrative: Patient described Nausea, Dizziness, couldn't raise left arm, and Headache.
Age: 43.0
Sex: F
Vaccine: JEV1
Symptoms: Back pain, Myalgia
Clinical narrative: Patient c/o R sided myalgia in arms and leg and lower back pain. This started 4 days after receiving the JE vaccine. She actually received the vaccine in the L deltoid, which is opposite of where she is having pain. She cannot recall any other reason why she would be having discomfort. She has no fever or other symptoms. She still has full function of her extremities and denies numbness/tingling however she does have signifcant pain. She tried taking Ibuprofen which did not help.
Age: 1.42
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAP, MMR, PNC13, VARCEL
Symptoms: Contusion
Clinical narrative: Child was taken to their family doctor 4 weeks after the shot was given for bruising all over body for 2 weeks.  Family doctor sent child to ER on Saturday April 28th.  Per nurse at Family doctor.
Age: 1.42
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAP, MMR, PNC13, VARCEL
Symptoms: Contusion, Full blood count, Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Child was taken to their family doctor 4 weeks after the shot was given for bruising all over body for 2 weeks.  Family doctor sent child to ER on Saturday April 28th.  Per nurse at Family doctor.
Age: 1.42
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAP, MMR, PNC13, VARCEL
Symptoms: Contusion
Clinical narrative: Bruising and petechiae noted 2 wks post vaccine administration. Seen at ER on 4/28/18 and diagnosed with ITP (Idiopathic thrombocytopenic purpura), consulted by pediatric hematologist - Dr, due to MMR.
Age: 1.42
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAP, MMR, PNC13, VARCEL
Symptoms: Contusion, Full blood count, Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Bruising and petechiae noted 2 wks post vaccine administration. Seen at ER on 4/28/18 and diagnosed with ITP (Idiopathic thrombocytopenic purpura), consulted by pediatric hematologist - Dr, due to MMR.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Pox-like reaction over torso and extremities. Presented as patches of intact blisters. Pt endorsed itch but no pain. Ongoing symptoms for 3-4 days at time of report. No respiratory reaction or other allergic reactions.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Pruritus, Pyrexia
Clinical narrative: Developed a brief 100 degree fever, felt tired & weak, headache the day after the injection. Now developed a some on/off itching on the left side area underneath my left arm pit to my waist.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RV1
Symptoms: Crying, Diarrhoea, Pyrexia, Screaming
Clinical narrative: Fever of 103 for 8 hours. Uncontrollable crying/screaming for over ten minutes. Diarrhea for 2 weeks.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pallor
Clinical narrative: Patient stopped by to the clinic after 1 hr from the initial vaccination stating that she was not feeling well. Patient looked pale and bilateral fingers were feeling not well. Patient was awake, alert oriented and denied difficulty in breathing or sensation of tongue swelling or chest tightness or sensation of throat closing. BP were 120/70, HR62-65, SatO2 100 %. Patient sat down in the clinic chair after few min, she started feeling much calmer and reported she feels better.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Myalgia, Rash generalised, Tremor
Clinical narrative: Pt's email: "About 4 hours after the injections I developed a rash all over my body (purple splotches about the size of freckles, not raised or itchy), my muscles tightened up a lot and got achy (especially muscles I'd worked out in the past day), and I started shaking uncontrollably (I couldn't insert the power plug into my phone to recharge it). I called the advice nurse since I was home alone and was concerned that the symptoms could advance quickly and no one would know I was in trouble. Since I didn't have trouble swallowing, breathing or have a significant temperature the advice nurse didn't recommend I head in to Emergency and had a doctor call me a couple of hours later. The symptoms subsided over the next hour. The doctor recommended that I take 1000 mg of TYLENOL, which I did, and all was fine thereafter". Pt has had Influenza vaccinations in past.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Pyrexia
Clinical narrative: Pt reported that the day after SHINGRIX vaccine he had severe itching from head to toe but worst on the scalp. He states this along with a low grade fever of 100 lasted for approx 3 days. Reporting the itching as an adverse event as this is not listed in the product information of a reported SE.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Blood culture, Blood potassium decreased, Chills, Injection site erythema, Injection site pain
Clinical narrative: The day following injection patient developed fever, chills, body aches, nausea, vomiting. Three days after the injection she noticed swelling, redness, warmth, pain of L upper arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: The day following injection patient developed fever, chills, body aches, nausea, vomiting. Three days after the injection she noticed swelling, redness, warmth, pain of L upper arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: The day following injection patient developed fever, chills, body aches, nausea, vomiting. Three days after the injection she noticed swelling, redness, warmth, pain of L upper arm.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Localized reaction, 3 red round spots of the left arm near the injection site.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Pruritus generalised
Clinical narrative: Rash, hives, red swollen, feverish, itching all over. Redness and pain where the shot was given, fatigue.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Swelling, Urticaria
Clinical narrative: Rash, hives, red swollen, feverish, itching all over. Redness and pain where the shot was given, fatigue.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dry mouth, Dyspnoea
Clinical narrative: THE PATIENT REPORTED INCREASED BLOOD PRESSURE, DRY MOUTH, AND DIFFICULTY BREATHING.
Age: 18.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash
Clinical narrative: Rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Dizziness, Myalgia, Nausea
Clinical narrative: Sore arm initially. After 12-15 hours, developed dizziness, nausea, muscle aches, drop in blood pressure to 57/43 (BP returned to normal within an hour with hydration and putting feet up). Muscle aches and chills followed, peaking at 20-hour point. Relieved by ibuprofen and a nap. Recovered and nearly back to normal 24 hours after injection. Minor arm soreness on day 2 but not bothersome; able to perform normal activities.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm initially. After 12-15 hours, developed dizziness, nausea, muscle aches, drop in blood pressure to 57/43 (BP returned to normal within an hour with hydration and putting feet up). Muscle aches and chills followed, peaking at 20-hour point. Relieved by ibuprofen and a nap. Recovered and nearly back to normal 24 hours after injection. Minor arm soreness on day 2 but not bothersome; able to perform normal activities.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Eye swelling, Peripheral swelling
Clinical narrative: Patient experienced swelling of the arm after the immunization (when she got home). Patient said the swelling was the size of a golf ball. Patient also said that she had stomach pain and diarrhea. On 4/28/18 she experienced swelling of both eyes. She said she was doing fine after the eye surgery she had a month prior but now both eyes are swollen. She does not know if this is related to the surgery or to the immunization. Patient is going to see her doctor today.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Bilirubin urine, Blood glucose normal, Blood urine present, Body temperature increased, Chills
Clinical narrative: 4/27- 22 Hours after immunization, had 99.0F temp- progressed though out the day to 101.0 F with chills. 4/28 - Woke in am with raised, red itchy rash on chest and neck. Seen at Clinic on Call 4/28 - 7:00PM. As of 4/30- AM- Temp 99.0 F, scattered  raised, red, itchy rash on back and abdomen continue. Pt. has returned to work.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Nitrite urine absent, Protein urine absent, Rash pruritic, Specific gravity urine normal
Clinical narrative: 4/27- 22 Hours after immunization, had 99.0F temp- progressed though out the day to 101.0 F with chills. 4/28 - Woke in am with raised, red itchy rash on chest and neck. Seen at Clinic on Call 4/28 - 7:00PM. As of 4/30- AM- Temp 99.0 F, scattered  raised, red, itchy rash on back and abdomen continue. Pt. has returned to work.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis, Urine ketone body absent, Urobilinogen urine decreased, White blood cells urine negative, pH urine normal
Clinical narrative: 4/27- 22 Hours after immunization, had 99.0F temp- progressed though out the day to 101.0 F with chills. 4/28 - Woke in am with raised, red itchy rash on chest and neck. Seen at Clinic on Call 4/28 - 7:00PM. As of 4/30- AM- Temp 99.0 F, scattered  raised, red, itchy rash on back and abdomen continue. Pt. has returned to work.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Facial pain, Headache, Myalgia, Nausea
Clinical narrative: Headache, pain in neck and face, general muscle ache, nausea, chill.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Headache, pain in neck and face, general muscle ache, nausea, chill.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm
Clinical narrative: Arm was red and warm to touch. Later it turned itchy. With my advice pt finally went to the doctor after over 2 week was doctor said it was cellulitis. Doctor prescribed KEFLEX 500 mg twice a day for 7 days.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site pain, Muscle tightness, Musculoskeletal stiffness, Pain
Clinical narrative: Patient developed muscle tightness, pain, and stiffness in entire body starting 4 days after and lasting 4 days with only ongoing symptoms being pain at Hep B site.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right upper extremity swelling and redness, warm to the touch.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Seizure
Clinical narrative: New onset of seizure.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Malaise
Clinical narrative: Within a few hours I did not feel well and started to shiver. I had to go to bed early and the next day I was feeling so fatigued that I could not get out of bed. I stayed in bed all day. I had to cancel a flight for the next day because I didnt know how long I would feel sick. I shivered all day.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Urinary incontinence
Clinical narrative: Patient got a SHINGRIX vaccination and she developed dizziness, sweating and weakness and lost bladder control.  She did not lose consciousness but I called 911 because she wasn't feeling any better. After paramedics examination it WAS found out that her vitals are ok but she felt dizzy while standing up so they took her to the ER.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Redness at injection site 3 inches in diameter. Arms soreness.
Age: 76.0
Sex: F
Vaccine: HEPA, PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: SHARP, THROBBING PAIN FROM MIDDLE OF NECK DOWN TO LEFT SHOULDER. STILL UNABLE TO USE LEFT ARM 3 DAYS LATER. HAS DR APPOINTMENT SCHEDULED FOR 5/8/2018.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Painful arm, very sore muscle pain in arm with injection, swollen, pinkish and red. Tired and fatigued. Pulsating Headache that extended in to right shoulder, ringing ear. One instance of diarrhea. Diarrhea Self resolved He was told to apply ice to swollen, red arm. Recommened to take TYLENOL or Ibuprofen. When he called back his headache was improving and was starting to feel better. He was also told to check with his primary care prescriber in 1-2 days if symptoms still persisted.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Tinnitus
Clinical narrative: Painful arm, very sore muscle pain in arm with injection, swollen, pinkish and red. Tired and fatigued. Pulsating Headache that extended in to right shoulder, ringing ear. One instance of diarrhea. Diarrhea Self resolved He was told to apply ice to swollen, red arm. Recommened to take TYLENOL or Ibuprofen. When he called back his headache was improving and was starting to feel better. He was also told to check with his primary care prescriber in 1-2 days if symptoms still persisted.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Nausea, Tremor
Clinical narrative: Shaking chills (this is not a shiver which is significantly underplayed in package insert), this was over 4 hours of rigors associated weakness and nausea for 12 hours after that (which are reported adverse effects). This in a person who has absolutely never had any reaction to a vaccine other than a little soreness at the site administered. This is an entirely different vaccine reaction and I wonder how safe it is now for my patients.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fall, Joint injury, Pain, Sciatica
Clinical narrative: Intense painful low back, radiating down into sciatica pattern on right leg. Unrelenting pain. Treatment: Naproxen, chiropractic, heat, ice, massage, Epsom salts bath in which I slipped and fell, injuring my right knee. I then went to Urgent Care for my knee.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Intense painful low back, radiating down into sciatica pattern on right leg. Unrelenting pain. Treatment: Naproxen, chiropractic, heat, ice, massage, Epsom salts bath in which I slipped and fell, injuring my right knee. I then went to Urgent Care for my knee.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itchy, hot, painful area of injection site (possibly infected).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came back into pharmacy 2 days after injection with a large (maybe 4 to 5 inch diameter) red spot around the site of injection. She stated it was painful and was slightly warm to the touch. Patient was instructed to take BENADRYL and to go to doctor/ER is symptoms worsened or signs and symptoms of anaphylactic reaction.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient develops rash on his face and, the top of his head and his shoulder.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: PATIENT DROPPED BY THE PHARMACY FRIDAY AFTERNOON 4/27/18 TO SHOW PHARMACIST ON DUTY HER LEFT ARM. SHE HAD GOTTEN A SHINGRIX VACCINE ON 4/26/18. SHE STILL HAD THE BAND-AID ON. THE SITE SHE SHOWED WAS CONNECTING FROM THE INJECTION SITE AND WAS MEASURED WITH A MEASURING TAPE. IT WAS APPROX. 1 3/4 " X 3" OF REDNESS. ON 4/27/18 IT DID NOT FEEL HOT TO THE TOUCH. THE PATIENT SAID SHE HAD NOT RUN A FEVER AND THAT THE SITE WAS NOT ACTUALLY BOTHERING HER, BUT THAT IT LOOKED STRANGE. THE PHARMACIST ON DUTY ADVISED HER TO USE AN ICE PACK ON IT AND TO TAKE SOME BENADRYL. SHE WAS ALSO ADVISED TO WASH HER HANDS, THEN REMOVE THE BAND-AID AND WIPE THE INJECTION SITE WITH AN ALCOHOL PAD. SHE STATED SHE DID NOT TAKE BENADRYL FOR IT CAUSED HER TO HAVE RESTLESS LEGS. SHE DID HAVE SOME LORATADINE IN THE HOME AND SAID SHE WOULD TAKE IT INSTEAD. SHE WAS ADVISED THAT IF SHE STARTED HAVING A FEVER, NAUSEA OR NOT FEELING WELL OR IF THE SITE APPEARANCE GOT WORSE THAT SHE SHOULD GO BE SEEN BY A NP OR MD. SHE WAS CALLED BY THE RPH ON 4/27/18 PM TO CHECK TO SEE HOW SHE WAS DOING. SHE STATED THAT SHE FELT OK AND HAD BEEN USING THE ICE AND HAD TAKEN THE LORATADINE. SHE MENTIONED THAT HER HOUSEKEEPER HAD DRAWN ON HER ARM TO MARK THE BORDER OF THE SITE SO SHE COULD TELL IF IT HAD GROWN BIGGER IN THE FUTURE. SHE WAS CALLED AGAIN ON 4/28/18. SHE SAID THAT SHE FELT OK, STILL NO FEVER, BUT THAT THE SITE HAD GROWN BEYOND THE PEN MARKS. SHE WAS ADVISED TO GO TO THE CLINIC TO BE SEEN. SHE WENT THERE AND THEN LEFT TO GO TO CONVENIENT CARE (FOR THEY WOULD FILE HER INSURANCE). SHE WAS DIAGNOSED WITH CELLULITIS. SHE CAME TO OUR PHARMACY TO PICK UP AN ANTIBIOTIC RX AND SHOWED THE ON-DUTY RPH THE SITE. IT HAD GROWN TO A SIZE OF APPROX. 3 1/4" X 5 1/2". IT WAS RED AND FELT HOT TO THE TOUCH. SHE WAS ASKED WHEN SHE FIRST NOTICED THE REDNESS. SHE COULD NOT REMEMBER.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Broke out in hives 2 days after being vaccinated. Was given BENADRYL which didn't work then was given Prednisone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Lethargy, Peripheral swelling
Clinical narrative: Rigors, fever, swelling arm, redness, lethargic, headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rigors, fever, swelling arm, redness, lethargic, headache.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, X-ray limb normal
Clinical narrative: Left arm pain, limitation in left arm use due to deltoid pain over the next month.