chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: Swelling of whole thigh (where vaccine was given) & tender. Child limping secondary to pain. This child otherwise as per Mom never complains. BENADRYL & then oral antihistamine QD helped.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site; no fever.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient was administered the AFLURIA vaccine on her left upper am. Her arm has been sore for at least a month at her site of injection and felt painful when lifting her arm. Her doctor advised her to take MOTRIN & warm compress. She only took one tablet only, but her pain continue.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site reaction, Rash erythematous, Rash papular
Clinical narrative: Erythematous papule rash both thighs developed 24 h after getting vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Urticaria
Clinical narrative: Severe urticaria - local and generalized. TX: PO BENADRYL, Prednisone.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Redness and swelling at site of injection, also shingles at site of injection.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, RECOMBIVAX HB was exposed to -2, f for one month; this includes more than two cycles into and back out of the temperature range of below 0, f. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccine (Lot#, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of several reports that received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 69 year old female patient. Approximately on 01-MAR-2013 (about 1 week ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose unspecified), subcutaneously in the pharmacy. No concomitant medications were reported. Approximately on an unknown date in March 2013, the patient experienced redness and swelling at the injection site. There were no lesions. The patient sought medical attention (called pharmacy). No treatment was given. No lab tests were performed. The patient was recovering from redness and swelling at the injection site. The relatedness for redness and swelling at the injection site was unknown for ZOSTAVAX. Additional information was not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified nurse practitioner concerning a patient of unknown age and gender. On 08-MAR-2013, the patient who was intended to received ZOSTAVAX, was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously due to human error (this is not a product quality complaint). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old female patient. On 29-JAN-2013 the patient was vaccinated with ZOSTAVAX lot# H018798. Route of administration was not provided. She used no concomitant medication and has no drug reactions/allergies. In 2013 (also reported as 03-FEB-2013 but it is not clear which event started) the patient experienced rash at the site of insertion, and about 3 days later feeling a tingling sensation on her mid forehead. She had a light rash on her forehead. The outcome of rash at the site of insertion, light rash on her forehead and feeling a tingling sensation on her mid forehead is unknown. No causality was provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an medical assistant refers to a female patient of unknown age. On 04-MAR-2013 the patient was vaccinated with (Merck) VARIVAX (strength, dose, frequency not provided) injection, in error, instead of (Merck) ZOSTAVAX. No adverse event reported. No product confusion discovered, just medication error. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, PNEUMOVAX 23 was exposed to -2 F for one month; this includes more than two cycles into and back out of the temperature range of below 0 F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse referred to a unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigerator malfunction, VAQTA was exposed to -2 F for one month; this includes more than two cycles into and back out of the temperature range of below 0 F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licenseed practical nurse referred to unspecified numbers of patients (age and gender were unknown). This nurse noted that due to a refrigeration malfunction, GARDASIL was exposed to -2F for one month; this includes more than two cycles into and back out of the temperature range of below 0F. This nurse noted that on unspecified dates an unspecified number of "patients might have been administered these vaccines (Lot #, dose/frequency, route and duration were unspecified)". No adverse effect reported. At the time of reporting, the outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.
Age: 0.98
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse refers to a 11 month old female patient. The patient received her first dose of VAQTA on 07-DEC-2010 and a second dose of VAQTA on 14-JUN-2011. No adverse symptoms reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Anti-transglutaminase antibody negative, Antibody test negative, Biopsy intestine, Blood immunoglobulin A decreased, Blood immunoglobulin G normal
Clinical narrative: It was reported in a Letter to the Editor, a 31 year old female patient with systemic lupus erythematosus, common variable immune deficiency and sinopulmonary infection. The patient's medical  history included decreased igg and decreased igm. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). Past drug therapy included: hydroxychloroquinem prednisone (manufacturer unknown), mycophenolate mofetil, pulse-dose methylprednisolone and cyclophosphamide for systemic lupus erythematous. In April 2009, based on a history of recurrent sinopulmonary infection and decreased serum IgG and IgM levels, she was diagnosed with CIVD and began receiving monthly IVIG. In February 2010, she developed debilitating watery diarrhea causing dehydration. She had no evidence of parasitic or bacterial infections, did not respond to a strict gluten-free diet, and her antitissue transglutaminase IgA titer was negative. In September 2010, biopsies of the duodenum showed patchy mild villous blunting and increased numbers of intraepithelial lymphocytes (35 lymphocytes/100 enterocytes) with no viral cytopathic effect. In November 2010, her diagnosis of CVID was confirmed with undetectable titers to tetanus toxoid and pneumococcal vaccines. On the same date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Blood immunoglobulin M decreased, Clostridium test negative, Dehydration, Diarrhoea, Immunodeficiency common variable
Clinical narrative: It was reported in a Letter to the Editor, a 31 year old female patient with systemic lupus erythematosus, common variable immune deficiency and sinopulmonary infection. The patient's medical  history included decreased igg and decreased igm. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). Past drug therapy included: hydroxychloroquinem prednisone (manufacturer unknown), mycophenolate mofetil, pulse-dose methylprednisolone and cyclophosphamide for systemic lupus erythematous. In April 2009, based on a history of recurrent sinopulmonary infection and decreased serum IgG and IgM levels, she was diagnosed with CIVD and began receiving monthly IVIG. In February 2010, she developed debilitating watery diarrhea causing dehydration. She had no evidence of parasitic or bacterial infections, did not respond to a strict gluten-free diet, and her antitissue transglutaminase IgA titer was negative. In September 2010, biopsies of the duodenum showed patchy mild villous blunting and increased numbers of intraepithelial lymphocytes (35 lymphocytes/100 enterocytes) with no viral cytopathic effect. In November 2010, her diagnosis of CVID was confirmed with undetectable titers to tetanus toxoid and pneumococcal vaccines. On the same date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Immunoglobulin therapy
Clinical narrative: It was reported in a Letter to the Editor, a 31 year old female patient with systemic lupus erythematosus, common variable immune deficiency and sinopulmonary infection. The patient's medical  history included decreased igg and decreased igm. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). Past drug therapy included: hydroxychloroquinem prednisone (manufacturer unknown), mycophenolate mofetil, pulse-dose methylprednisolone and cyclophosphamide for systemic lupus erythematous. In April 2009, based on a history of recurrent sinopulmonary infection and decreased serum IgG and IgM levels, she was diagnosed with CIVD and began receiving monthly IVIG. In February 2010, she developed debilitating watery diarrhea causing dehydration. She had no evidence of parasitic or bacterial infections, did not respond to a strict gluten-free diet, and her antitissue transglutaminase IgA titer was negative. In September 2010, biopsies of the duodenum showed patchy mild villous blunting and increased numbers of intraepithelial lymphocytes (35 lymphocytes/100 enterocytes) with no viral cytopathic effect. In November 2010, her diagnosis of CVID was confirmed with undetectable titers to tetanus toxoid and pneumococcal vaccines. On the same date, the patient experienced antibody test negative. The outcome of antibody test negative was unknown. The reporter considered antibody test negative to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous). Route, dose and lot number were not reported. In 2013 (reported as a couple of weeks ago on 21-FEB-2013), one day after vaccination the patient experienced the injection site was red, the injection site was itchy and the injection site was painful. The events lasted for one week. The outcome of the injection site was red, the injection site was itchy and the injection site was painful was reported as recovered/resolved. The injection site was red, the injection site was itchy and the injection site was painful was unknown related to ZOSTAVAX. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, VARCEL
Symptoms: Arthralgia, Asthenia, Dizziness, Lethargy, Pain
Clinical narrative: Stabbing pain in tonsils for first 72 hours. C/o being lethargic, weak, dizzy, vertigo & joint pain. 3 days after vaccines given had localized bump & wheal show up on left deltoid/subcutaneous tissue. Itchiness, went to urgent care & given topical hydrocortisone on 2/15/13 - did not help. Saw private physician today (2-22-13), given prescription for prednisone & told to come to health department to report symptoms. Has 2 1/2 inch red wheal with 1 inch bump on left arm, 2 1/2 to 3 inches below deltoid toward subcutaneous tissue. TWINRIX & Varicella given on left. Discussed common side effects of vaccines given: TWINRIX (Hep A/Hep B) Lethargy, weakness. MMR (joint aches). Varicella (chicken pox like rash after 2-3 weeks) no vesicles noted. Flu (tenderness at injection site).
Age: 39.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, VARCEL
Symptoms: Pruritus, Rash, Tonsillar disorder, Urticaria, Vertigo
Clinical narrative: Stabbing pain in tonsils for first 72 hours. C/o being lethargic, weak, dizzy, vertigo & joint pain. 3 days after vaccines given had localized bump & wheal show up on left deltoid/subcutaneous tissue. Itchiness, went to urgent care & given topical hydrocortisone on 2/15/13 - did not help. Saw private physician today (2-22-13), given prescription for prednisone & told to come to health department to report symptoms. Has 2 1/2 inch red wheal with 1 inch bump on left arm, 2 1/2 to 3 inches below deltoid toward subcutaneous tissue. TWINRIX & Varicella given on left. Discussed common side effects of vaccines given: TWINRIX (Hep A/Hep B) Lethargy, weakness. MMR (joint aches). Varicella (chicken pox like rash after 2-3 weeks) no vesicles noted. Flu (tenderness at injection site).
Age: 26.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Muscle twitching, Pain, Pyrexia
Clinical narrative: A call was received 2-26-13 from patient's wife stating he had been having a high fever ranging from 100-102 degrees. She asked if this was normal, after the immunizations, and if not what they should do. She said she had given him OTC medications to reduce the fever, but they weren't working. I told her that a high fever is not a normal reaction and she should take him to his primary provider, or to the ER if the fever did not go down. Patient's wife is a prenatal client with the Health Office, who had a return appointment 2-27-13. She stated during her visit that she took her husband to the ER 2-26-13 because he couldn't get in to see his provider at the Health Center and his face started twitching. She said in the E.R. he was given medication to reduce the fever and also given antibiotics and released the same day. The patient came into the clinic 2-27-13, during his wife's visit. He said the Tdap, which was given on the left arm had not bothered him, and was told by the E.R. staff that it was most likely the pneumonia shot that caused the reaction. Redness and swelling noted to right upper arm. Patient stated it hurt to lift that arm. No other complaints related to the immunizations were given by patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling at injection site. Patient given antibiotic by MD.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: M
Vaccine: MNQ, RAB
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Erythema of upper arm with itching and tenderness, starting approximately 6pm on vaccination day. Pt took 1 dose of diphenhydramine. Resolved in 2 days.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Injection site pain, Malaise
Clinical narrative: Initial report was received 28 February 2013 from a consumer which involved a case of misuse (incorrect route of vaccine administration). A 63-year-old female patient who had a past history of pneumonia but was not ill at the time of vaccination, had received an injection of FLUZONE HIGH-DOSE (lot number not reported) on 17 October 2012 and an unspecified amount of time later that day, she developed fever of 100-101, dizziness, loss of appetite and she wanted to sleep a lot. She also developed injection site redness and swelling that day. The subject had been taking estrogen as hormone replacement therapy and B12 injections concomitantly. According to the patient, she was administered FLUZONE HIGH-DOSE in the lower part of the left arm "2 knuckles" above the elbow. She did not remember having the site cleaned and remembered seeing something orange in the pharmacist's hands when he was administering the product to her. She was evaluated numerous times by her physician and all blood tests, x-rays and ID testing for TB and Hepatitis were negative. The patient declined to be evaluated by an infectious disease specialist per the recommendation of her physician. The patient further stated that her husbands neurologist stated that her body was rejecting an antigen in the vaccine. Outcome was not recovered (also reported as unknown). Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Decreased appetite, Dizziness, Hepatitis viral test negative, Incorrect route of drug administration
Clinical narrative: Initial report was received 28 February 2013 from a consumer which involved a case of misuse (incorrect route of vaccine administration). A 63-year-old female patient who had a past history of pneumonia but was not ill at the time of vaccination, had received an injection of FLUZONE HIGH-DOSE (lot number not reported) on 17 October 2012 and an unspecified amount of time later that day, she developed fever of 100-101, dizziness, loss of appetite and she wanted to sleep a lot. She also developed injection site redness and swelling that day. The subject had been taking estrogen as hormone replacement therapy and B12 injections concomitantly. According to the patient, she was administered FLUZONE HIGH-DOSE in the lower part of the left arm "2 knuckles" above the elbow. She did not remember having the site cleaned and remembered seeing something orange in the pharmacist's hands when he was administering the product to her. She was evaluated numerous times by her physician and all blood tests, x-rays and ID testing for TB and Hepatitis were negative. The patient declined to be evaluated by an infectious disease specialist per the recommendation of her physician. The patient further stated that her husbands neurologist stated that her body was rejecting an antigen in the vaccine. Outcome was not recovered (also reported as unknown). Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling, Laboratory test normal, Mycobacterium tuberculosis complex test negative, Pyrexia
Clinical narrative: Initial report was received 28 February 2013 from a consumer which involved a case of misuse (incorrect route of vaccine administration). A 63-year-old female patient who had a past history of pneumonia but was not ill at the time of vaccination, had received an injection of FLUZONE HIGH-DOSE (lot number not reported) on 17 October 2012 and an unspecified amount of time later that day, she developed fever of 100-101, dizziness, loss of appetite and she wanted to sleep a lot. She also developed injection site redness and swelling that day. The subject had been taking estrogen as hormone replacement therapy and B12 injections concomitantly. According to the patient, she was administered FLUZONE HIGH-DOSE in the lower part of the left arm "2 knuckles" above the elbow. She did not remember having the site cleaned and remembered seeing something orange in the pharmacist's hands when he was administering the product to her. She was evaluated numerous times by her physician and all blood tests, x-rays and ID testing for TB and Hepatitis were negative. The patient declined to be evaluated by an infectious disease specialist per the recommendation of her physician. The patient further stated that her husbands neurologist stated that her body was rejecting an antigen in the vaccine. Outcome was not recovered (also reported as unknown). Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Somnolence, X-ray normal
Clinical narrative: Initial report was received 28 February 2013 from a consumer which involved a case of misuse (incorrect route of vaccine administration). A 63-year-old female patient who had a past history of pneumonia but was not ill at the time of vaccination, had received an injection of FLUZONE HIGH-DOSE (lot number not reported) on 17 October 2012 and an unspecified amount of time later that day, she developed fever of 100-101, dizziness, loss of appetite and she wanted to sleep a lot. She also developed injection site redness and swelling that day. The subject had been taking estrogen as hormone replacement therapy and B12 injections concomitantly. According to the patient, she was administered FLUZONE HIGH-DOSE in the lower part of the left arm "2 knuckles" above the elbow. She did not remember having the site cleaned and remembered seeing something orange in the pharmacist's hands when he was administering the product to her. She was evaluated numerous times by her physician and all blood tests, x-rays and ID testing for TB and Hepatitis were negative. The patient declined to be evaluated by an infectious disease specialist per the recommendation of her physician. The patient further stated that her husbands neurologist stated that her body was rejecting an antigen in the vaccine. Outcome was not recovered (also reported as unknown). Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient complaint of soreness on left upper arm/left shoulder. This pain lingered longer than 5 days with gradual increase of pain. She had pain with any slight movement of left arm & even during sleep. C/o started after injection (1/16/13) & continued on as of 02/13/13. Dr. expected symptoms will improve w/o surgical management.
Age: 31.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site joint pain, Injection site pain, Pain
Clinical narrative: Patient complaint of soreness on left upper arm/left shoulder. This pain lingered longer than 5 days with gradual increase of pain. She had pain with any slight movement of left arm & even during sleep. C/o started after injection (1/16/13) & continued on as of 02/13/13. Dr. expected symptoms will improve w/o surgical management.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Dizziness, Fatigue, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: After that day I began to feel a bit tired; by the next week a strong headache and pain in the arm started. I felt that the arm was swollen and in pain. The skin color was yellow and I felt dizziness and worsening everyday more and more.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Yellow skin
Clinical narrative: After that day I began to feel a bit tired; by the next week a strong headache and pain in the arm started. I felt that the arm was swollen and in pain. The skin color was yellow and I felt dizziness and worsening everyday more and more.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: White blood cell count increased, Yellow skin
Clinical narrative: After that day I began to feel a bit tired; by the next week a strong headache and pain in the arm started. I felt that the arm was swollen and in pain. The skin color was yellow and I felt dizziness and worsening everyday more and more.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Dizziness, Full blood count abnormal, Headache, Injection site pain, Laboratory test
Clinical narrative: After that day I began to feel a bit tired; by the next week a strong headache and pain in the arm started. I felt that the arm was swollen and in pain. The skin color was yellow and I felt dizziness and worsening everyday more and more.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Muscular weakness, Rash vesicular, Sinusitis, Tremor, Yellow skin
Clinical narrative: After that day I began to feel a bit tired; by the next week a strong headache and pain in the arm started. I felt that the arm was swollen and in pain. The skin color was yellow and I felt dizziness and worsening everyday more and more.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Feeling hot, Infection, Myositis, Swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old female patient. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014561, expiration date was 21-MAR-2014, intramuscular). On 28-FEB-2013, the patient experienced deep tissue cellulitis after receiving PNEUMOVAX23. The outcome of event was reported as not recovered/not resolved. The relationship between PNEUMOVAX23 and event was unknown. The patient sought medical attention and unspecified antibiotic was given for treatment. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old female patient. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014561, expiration date was 21-MAR-2014, intramuscular). On 28-FEB-2013, the patient experienced deep tissue cellulitis after receiving PNEUMOVAX23. The outcome of event was reported as not recovered/not resolved. The relationship between PNEUMOVAX23 and event was unknown. The patient sought medical attention and unspecified antibiotic was given for treatment. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old female patient. On 27-FEB-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H014561, expiration date was 21-MAR-2014, intramuscular). On 28-FEB-2013, the patient experienced deep tissue cellulitis after receiving PNEUMOVAX23. The outcome of event was reported as not recovered/not resolved. The relationship between PNEUMOVAX23 and event was unknown. The patient sought medical attention and unspecified antibiotic was given for treatment. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Erythema, Full blood count, Pain, Rash
Clinical narrative: Swelling, red, hot rash. VERY painful, went to ER Sat afternoon as it was extensive. Given IV infusion therapy/prophylaxis/Dx, ordered blood culture, CBC, Rx Bactrim and Vicodin.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, red, hot rash. VERY painful, went to ER Sat afternoon as it was extensive. Given IV infusion therapy/prophylaxis/Dx, ordered blood culture, CBC, Rx Bactrim and Vicodin.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Cytogenetic analysis normal, Endocrine test normal, Infertility female, Injection site pain
Clinical narrative: Infertility and menopausal symptoms.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menopausal symptoms, Nuclear magnetic resonance imaging normal, Ultrasound scan normal
Clinical narrative: Infertility and menopausal symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Rash, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date the patient experienced flu symptoms, upper respiratory infection and rash. The outcome of flu symptoms, upper respiratory infection and rash was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender unspecified). On 12-JAN-2012, the patient was vaccinated with the first dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On 26-MAR-2012, the patient was vaccinated with the second dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On 29-MAY-2012, the patient was vaccinated with the third dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse event was reported. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Rash, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date the patient experienced flu symptoms, upper respiratory infection and rash. The outcome of flu symptoms, upper respiratory infection and rash was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to a approximately 17 year old male patient. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot # H016238, expiry date and dose were not reported) intramuscularly. On an unknown date, after administration of the vaccine the patient passed out for a few seconds, appeared to have had a seizure. The patient did not eat or drink till the morning of the shot. The patient sought medical attention (was at the office at the time of the adverse experience). The outcome of the event was unknown. Upon internal review, the event of Patient passed out for a few seconds, appears to have had a seizure was considered as medically significant event. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 84 year old female patient with penicillin allergy, sulfa allergy and diabetes. The patient's medical history included unspecified cancer and heart disease. On 04-FEB-2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # H012519, exp 09-OCT-2013) subcutaneously. Concomitant therapy was unknown. On approximately 08-FEB-2013, the patient broke out in a rash and a lot of pain. The patient developed shingles. The rash was on her right side. The patient visited her primary care physician on approximately 08-FEB-2013. At the time of the report, the patient was still experiencing quite a bit of pain however rash was mostly gone. No lab drawn. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report has been received from a 50 year old female patient via agency (manufacturer local reference # MK23575), for ZOSTAVAX, a Pregnancy Registry product, concerning herself. The consumer started ZOSTAVAX (lot # was not reported), unknown dose was administered once, on an unknown date in February 2013 for cold sores. Her relevant medical history included seizures, arthritis, allergies, and asthma. Her relevant concomitant medication included TOPAMAX. Her relevant drug history was unknown. Sometime in February 2013, she received a vaccination with ZOSTAVAX while 2 to 3 months pregnant. She had a miscarriage in March 2013. In addition, she had been exposed to 2 infants, while babysitting. Her relevant laboratory data was unknown. As of 07-MAR-2013, it was unknown if she would continue to take ZOSTAVAX. The outcome of her exposure to 2 infants was unknown. The outcome of miscarriage was unknown and the relatedness of miscarriage was unknown for ZOSTAVAX. Upon internal review, miscarriage was considered as medically significant events. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Diplopia, Lumbar puncture, Multiple sclerosis, Neurological examination, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt received rabies vaccine s/p animal bite-dog. Dog is still alive and well. Pt developed double vision and was dx'd with MS 8 days after last dose of rabies vaccine.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Pyrexia, Skin warm
Clinical narrative: Seen by Dr. on 3/6/13. 6x8 mm indurated warm to touch area. Mlid low grade fever. Not tx with anything. Advised to observe the area and call back if sx worsen.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Arthralgia, Local swelling, Pyrexia, Skin irritation, Syncope
Clinical narrative: Localized swelling, irritation. Syncopal episode, joint pain, fever. Developed 1-2 days after immunization. Improved within 3 days and symptomatic treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient has no pertinent medical history. The patient has egg allergy. On 04-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number reported as H021712, expiry date 06-MAR-2014 and route was not reported). On an unknown date, the patient developed injection site reaction following vaccination of ZOSTAVAX. The time frame development of the injection site reaction following vaccination of ZOSTAVAX was unspecified. The patient described the injection site reaction as a raised, red, warm, itchy area at the injection site of ZOSTAVAX vaccination. Laboratory diagnostics was not performed. The outcome of the events were reported as not recovered. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Raised bump day of vaccine, itchy, red still has raised bump itchy, red as of 3/5/13.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of children of unknown age and gender. On an unknown date, reported as many years ago, the children were vaccinated with VARIVAX (Merck) (dose, route and lot number unknown). No other suspect therapies or concomitant medications were reported. The pharmacist reported that many years ago when her children were in daycare, there were an the unspecified number of children at the daycare who developed chickenpox even though they were vaccinated with VARIVAX (Merck). The pharmacist's children were not involved with any other the cases. These were cases involving other children who attended the same daycare. All cases were mild. No treatment information was reported. It was unknown whether VARIVAX (Merck) was continued. The reporters relatedness of unspecified number of children developed chickenpox to VARIVAX (Merck) is unknown. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: On 2/19/13 vaccine TENIVAC adm. Pt said arm sore for 2 or 3 days. On 2/26/13 arm started itching a lot. Red and swollen at site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abnormal behaviour, Streptococcal infection
Clinical narrative: Mother states that student was 'just lying around' after school. She took student to the ER that night and states he was diagnosed with strep.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Rec'd vaccines 2/27/13 -> MMRV & Hep A. Developed hives on 2/20/13.
Age: 25.0
Sex: F
Vaccine: IPV, MNQ, TYP
Symptoms: Headache
Clinical narrative: Headache, no other symptoms woke with headache done by noon drank fluids, recovered.
Age: 65.0
Sex: M
Vaccine: IPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt said (R) arm swollen, hot from injection site to elbow, and pain. Low grade fever.
Age: 1.37
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Blister, Pyrexia
Clinical narrative: Child received immunizations on 2/07/13 at clinic. Father then took child to another clinic on 02/18/13 and child got vaccines again. Father stated "Did not show vax" that child had had vaccine - child had break out blisters head to toe and fever.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abscess limb, Oedema peripheral, Ultrasound scan abnormal
Clinical narrative: Child received Hib & PREVNAR at 15 mnth visit on 2/22/2012. Had small rings, then on 3/28/12, seen for (L) thigh swelling. Sono done on 3/28 c/w with abscess, sent to ER -> surgery evaluation.
Age: 0.52
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Unconsolable crying for 1 week.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Lethargy, Pyrexia, Vomiting projectile
Clinical narrative: Lethargy and projectile vomiting for 24 hours. Also low grade fever. No treatment (I was not notified by foster parent).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: Severe redness & bump. Onset of light case of shingles on chest.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMR, VARCEL
Symptoms: Erythema, Petechiae, Rash
Clinical narrative: Facial rash - erythema (B) cheeks & periorbital petechiae. Gave TYLENOL & BENADRYL. Monitored x 20 minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site nodule, Injection site swelling, Respiratory syncytial virus infection
Clinical narrative: Mom says day after Flu shot child's arm had red spot & swollen size of 1/2 dollar, it spread & doubled in size & knotted lip. She took child to Dr, he told her she had an allergic reaction & had parent give BENADRYL. Symptoms went away in a few days. Mom says H1N1 vaccine 1-4-10 child was admitted with RSV hosp 3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Respiratory syncytial virus test
Clinical narrative: Mom says day after Flu shot child's arm had red spot & swollen size of 1/2 dollar, it spread & doubled in size & knotted lip. She took child to Dr, he told her she had an allergic reaction & had parent give BENADRYL. Symptoms went away in a few days. Mom says H1N1 vaccine 1-4-10 child was admitted with RSV hosp 3 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: First swollen knot, red, painful, itchy injection site.   On 03/06/2013 noticed a rash higher on my shoulder.  By next day rash look like shingles.  There is no information to tell me if this IS shingles and what steps I should take to protect myself and others.   Merck should cover the rash reaction in their information. Is this rash shingles?   I still have the shingles rash, my doctor has prescribed a steroid and Valacyclovir but will the Valacyclovir negate the vaccine for which I have paid over $200?
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: First swollen knot, red, painful, itchy injection site.   On 03/06/2013 noticed a rash higher on my shoulder.  By next day rash look like shingles.  There is no information to tell me if this IS shingles and what steps I should take to protect myself and others.   Merck should cover the rash reaction in their information. Is this rash shingles?   I still have the shingles rash, my doctor has prescribed a steroid and Valacyclovir but will the Valacyclovir negate the vaccine for which I have paid over $200?
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given 5 shots that were not needed due to duplicate immunization records.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Abasia, Crying, Discomfort, Injection site erythema, Injection site induration
Clinical narrative: LT LEG INJECTION SITE FOR KINRIX (DTAP AND IPV) HAS A SOFTBALL SIZE LUMP THAT IS HARD, RED, PAINFUL AND PATIENT WILL NOT WALK OR USE THAT LEG. SHE IS VERY UNCOMFORTABLE AND CRYING.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: LT LEG INJECTION SITE FOR KINRIX (DTAP AND IPV) HAS A SOFTBALL SIZE LUMP THAT IS HARD, RED, PAINFUL AND PATIENT WILL NOT WALK OR USE THAT LEG. SHE IS VERY UNCOMFORTABLE AND CRYING.
Age: 65.0
Sex: F
Vaccine: PPV, TTOX, VARZOS
Symptoms: Chills, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: Fever, chills, severe pain at injection site, headache, general malaise.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site mass, Lymph node pain
Clinical narrative: Rec'd shingles vacination.  Developed a red and inflammed tennis ball size lump at the injection site (right arm).  Lymphnodes under the same arm swollen and painful.  Two red patches of skin on the side of the right breast.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Rec'd shingles vacination.  Developed a red and inflammed tennis ball size lump at the injection site (right arm).  Lymphnodes under the same arm swollen and painful.  Two red patches of skin on the side of the right breast.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Itchy hive like rash on right arm.  The rash extended up into the neck area and then down the arm towards the wrist and finger tips. It looked worse on the inside of lower arm.  This rash started the day after vaccination.  Minimal amount of soreness at the injection site.  Was taken to the doctors office on 3/7/13 and was advised to take Benadryl po and use a cream that they had at home to treat eczema to apply to area. Physician advised them that this looked like an allergic response to vaccine that was given 2 days prior.  Spoke with dad and daughter on 3/11/13 and patient feels rash has improved, dad is unsure if it is looking improved.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Skin exfoliation, Skin hyperpigmentation
Clinical narrative: Pt started with fever & blistery rash over trunk & extremities on 2/14/13. Most of the rash noted over the hyperpigmented aspects of child's body due to his diagnosis of Incontinentia Pigmenti (IP). The rash is now just present as flaky skin at medial aspect of lower legs, both axilla & (R) forearm. Some of the darker pigmented skin from IP got darker after reaction. Fever resolved after 4 days.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 07-FEB-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). The pharmacist report that the patient who received ZOSTAVAX had a prescription, dated on 04-MAR-2013 for prednisone (manufacturer unknown) The pharmacist had no information on why the patient needed the prednisone (manufacturer unknown). The prescription was for a three day course of prednisone (60 mg a day for 3 days). The outcome of the adverse event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: After vaccination was given, noticed red large rash, slightly raised to arms and upper torso. No cough or SOB or trouble breathing noted. No itching observed.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Administered 0.5mL GARDASIL (3rd dose) to patient. Approx. 30 sec after administering, patient became pale, fainted, and had body jerking in upper body for approx 10-15 sec. No hx of seizures. T 97.6. Vitas post incident - 88/52 BP, 50 P; 5 mins - 92/58 BP, 54 P; 20 mins - 90/60 BP, 58 P
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Oedema peripheral, Pain
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a male patient in his late 30's or early 40's. The patient's medical history included cerebral palsy. On an unknown date, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot#, route, dose not reported). No concomitant medications were reported. On an unknown date, the patient developed a serious local reaction, his arm was severely swollen and he complained of pain. No hospitalization, no death was reported. Patient sought medical attention (unspecified). The outcome of arm severely swollen and complained of pain was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patient were vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one the three reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patients were vaccinated with a dose of VARIVAX (Merck), (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one the three reports received from the same reporter. Additional information is not expected.