chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Local swelling, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of neck pain in a 50-year-old female  patient who received ENGERIX B. Concomitant products included DTPa (Reduced antigen), Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2014-2015 season), levothyroxine and ENGERIX B. On 12th January 2015, the patient received the 2nd dose of ENGERIX B (unknown). In January 2015, less than a month after receiving ENGERIX B and less than a day after receiving dTpa vaccine and Influenza vaccine unspecified 2014-2015 season, the patient experienced neck pain, pain in arm and local swelling. ENGERIX B was continued with no change. In January 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the neck pain and local swelling were not recovered/not resolved. It was unknown if the reporter considered the neck pain to be related to ENGERIX B. The reporter considered the pain in arm and local swelling to be related to ENGERIX B. See case US2015023566 for details regarding the events following previous vaccinations. Additional information was provided: She received her second shot of ENGERIX-B on January 12th and besides the normal soreness, the back of her neck again because sore. The patient again felt like all the medicine went straight to the back of her neck. The patient said it feels like a bone at the top of her spine and she cannot stop touching it. She also cannot sit good because of it. It will often get better when she goes to sleep but within hours of waking up it swells back up. She has not done anything to herself or gotten hurt so she is 100% that she is experiencing a rare side effect from ENGERIX-B.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported). No information regarding concomitant therapy was provided. The reporter stated that the patient fainted at an unspecified time after "jumping up from the table" after receiving their first dose of GARDASIL. The physician reported that the patient went to an unspecified emergency room at an unspecified time after fainting. The patient did not receive two more doses of GARDASIL on unspecified dates and did not develop any reactions to those two doses. The outcome of the event was unknown. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 26-MAR-2015 ("5 days ago") the patient was vaccinated with a dose of ZOSTAVAX at another pharmacy (lot#, expiration date, dose and route were not reported). On an unknown date of MAR-2015 the patient developed lesions around her eyes. Her unspecified physician diagnosed patient with shingles. Physician recommended VALTREX as treatment. The outcome of event was unknown. Additional information is not expected since the reporter did not want to be contacted.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site hypoaesthesia
Clinical narrative: Information has been received from a registered nurse via a company representative referring to a 16 year old female patient. Information regarding concurrent conditions and medical history was not provided. On 14-AUG-2014 and 24-NOV-2014 the patient was vaccinated with the first and second dose of GARDASIL respectively, intramuscularly (dose, lot # and application site were not reported). Concomitant therapy was not reported. On 31-MAR-2015, the patient was in physician's office to receive dose three, but she mentioned that since she received the second dose on 24-NOV-2014, when she laid dose, her arm got numb in the area in which she received the GARDASIL injections. No treatment was given for event. None of lab diagnostics studies was performed. The physician recommended that the patient receive the third dose at this time. The nurse reported that she thought the "numbness" at the GARDASIL injection site that the patient had experienced an unspecified amount of times since an unspecified date (patient reported "Since injection of second dose") might be due to the patient being a "weight lifter". The outcome of event was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a female patient of unknown age. On an unknown date in June 2007, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). One week later (in 2007), the patient experienced shingles on her forehead. The patient sought medical attention via the doctor's office visit. The outcome of shingles on her forehead was reported as recovered. Relatedness between the therapy and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of VAQTA (dose, route not reported, lot # K002744 with expiration date 19-SEP-2015, lot# J000985 with expiration date 20-AUG-2015, lot# H010106 with expiration date 21-FEB-2015, lot# J011629 with expiration date 20-SEP-2015) that were exposed to temperatures of 0 degree C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concomitant medications were not reported. On 31-MAR-2015 the patient was inadvertently vaccinated with ZOSTAVAX, that expired on 15-DEC-2014. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration were not provided). No information regarding concomitant medications were reported. The pharmacist reported that, on an unknown dates, after receiving ZOSTAVAX, the patients experienced similar reactions: a lump the size of a baseball under the injection site that was red, inflamed and itched. The outcome of the events was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician via company representative referring to a 71 year old female patient with osteopenia and drug reactions/allergies to general anesthesia. On 03-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # K015308, one single shot. On 23-MAR-2015, the patient developed shingles on her lower left back and abdomen after receiving ZOSTAVAX and she complained of burning and pain. The patient sought medical attention by spoken with the physician. The patient was treated with VALTREX, prednisone and NORCO (dosages, frequencies and manufacturers unknown). There was no lab diagnostics studies performed. The outcome of the event was reported as not resolved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Headache, Injection site reaction, Myalgia
Clinical narrative: 6 hours after shot, pt experienced chills, joint/muscle pain, fever, headache, rash appeared at site of injection four days after injection. Rash was red, bumpy, and itchy. No treatment was needed.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: 6 hours after shot, pt experienced chills, joint/muscle pain, fever, headache, rash appeared at site of injection four days after injection. Rash was red, bumpy, and itchy. No treatment was needed.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash, redness extending over left arm reaching 2 inches above elbow and upper shoulder.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: Significant inflammatory reaction (local inflammatory reaction) right deltoid.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patient received doses of ROTATEQ (lot#, dose, not reported, orally) stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a female patient of unknown age concerning herself. Information about patient's medical history was not provided. On 20-MAR-2015, the patient was vaccinated with a fourth dose of M-M-R II (therapy type, dose, frequency, route of administration and lot # were not reported), because her titer was seronegative after 3 previous doses of M-M-R II (date of laboratory test unspecified). No concomitant medication was reported. No treatment was given for adverse event. No additional laboratory tests were performed. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The outcome of the evert was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Incorrect Vaccine administered.  Patient here to have a pediatric dose of Hepatitis A Vaccine instead patient received a pediatric dose of Hepatitis B Vaccine.  Error was caught immediately after and the correct Vaccine HAV was also given. Patient had no Symptoms and Provider was notified.
Age: 57.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Headache, Muscle spasms, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, Charley-horse cramping, bodyaches, sniffles, headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red, raised, itchy, triangle-shape.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm swollen, red, itchy c/w allergic reaction to pertussis vaccine.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of redness, swelling and tenderness at injection site in Left arm. Patient was treated with Keflex 500 mg every 12 hours for 7 days. Apply ice to the site and take 600 mg of Ibuprofen for pain.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Patient developed shingles with neuropathic pain.  Continues with neuropathic pain in foot/ankle since then.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Radioallergosorbent test positive, Throat irritation, Urticaria
Clinical narrative: As recorded three weeks after the event by Allergist.  History reported by the patient. "63 year old we follow here for RAST test confirmed beef/pork/alpha gal allergy returns after a suspected reaction to a vaccine. He received the Shingles vaccine three weeks ago at pharmacy at about 12 noon.  Within 5 minutes, he reports developing ear, axillary and perineum itching, followed by generalized hives.  He drove home, then to the ER, and was given Benadryl in the ER.  No Epi. No trouble breathing.  Throat felt itchy.  NO N/V/D.   Hives all gone by 6 PM.  He reports this reaction was no where near as bad as some of his beef reactions." Zostavax; LOT#K008882; EXP. SEPTEMBER 20, 2015; RECIEVED VACCINE, JAN. 15,2015. The patient declined skin testing to vaccine components.  It is my judgement that this was an allergic reaction (anaphylaxis) to the Gelatin component, but I cannot rule out that is was a reaction to Bovine calf serum or another component.  The patient has been instructed to avoid vaccines containing Gelatin. Of note he has reacted to oral beef and pork, but has been tolerant of oral Gelatin.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia, Peripheral swelling
Clinical narrative: Swelling of upper and lower left arm, pain with consequential inability to sleep, and inability to raise arm. Ice and Tylenol. Later Naproxene.
Age: 49.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in arm symptoms similar to rotator cuff pain, for 6 months. Pain starting to ease after 6 months.
Age: 26.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Rash
Clinical narrative: Pt presented to Immunizations clinic on 03/31/15 with small bump like rash under both axillaries, and left groin area. Pt denied any other symptoms at this time. Consulted with Provider and placed the pt on quarters for 48. Pt returned to clinic on 04/2/15 with bigger bumps to aforementioned areas and had spread to both hands of the patient. Provider consulted with regional rep, who then passed in on to another Provider. Both providers agreed that no further action at this time is required. Pt is to keep area covered when in public areas. Pt being sent to a dermatologist for further eval of rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Local Redness and Swelling 70mm in Diameter. Mother denied trying any treatment and appointment made with PCM.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Discomfort, Erythema, Pruritus, Skin warm, Wrong technique in drug usage process
Clinical narrative: Localized redness, warm to touch, itching, discomfort. Proquad was reconstituted with the Kinrix.
Age: 1.59
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Gaze palsy, Seizure, Tremor
Clinical narrative: Very brief seizure - eyes turning white; legs shaking uncontrollably.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nausea
Clinical narrative: Approximately one hour after receiving the flu vaccine, client approached me reporting that he felt "queasy stomach and a mild headache. No other symptoms reported.  Advised to try to take antiacid and Tylenol which he states he has and then he wants to go home. I advised to call his personal physician for further advise, or care. Patient had hx of adverse reaction to flu vaccine?  close to 7 years ago and states that he had taken flu vaccines every year for the last 6 years with no problem. I called client after 3 hours and the following day (he went back to work) and said he was fine after he took several hours nap.  This is a second report filing to make sure the first one was  received.
Age: 20.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Lymphadenopathy, Myalgia, Nausea, Pain of skin, Pyrexia
Clinical narrative: Fever, skin hurt to touch, nausea, sore muscles, swollen lymph nodes.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 15-AUG-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose was unknown) intramuscularly which underwent an unsupported temperature excursion. No adverse effects reported. The lot number 5B23A is an invalid lot number for VAQTA. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of RECOMBIVAX HB (dose, route not reported, lot# J008227 with expiration date 07-FEB-2016, lot# J007946 with expiration date 24-MAR-2016, lot# H010050 with expiration date 31-OCT-2014, batch# J009049 with lot# 0589AE and expiration date 27-MAR-2015) that were exposed to temperatures of 0C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unspecified dates in March 2015 (reported as: since 02-MAR-2015), those patients were vaccinated with doses of VARIVAX (Merck) injection (lot # K010337 with expiry date: 22-JUL-2016 and lot # K011083 with expiry date: 08-AUG-2016; strength, dose and route of administration unspecified), which were exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse effects have been observed or reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Since December 2014 the patients were vaccinated with VARIVAX (Merck) (lot # J013907, expiration date 30-OCT-2015, dose, dose#, frequency and route not reported) which had been improperly stored. No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-MAR-2015, a nurse inadvertently vaccinated the patient with a dose of VARIVAX (Merck) (dose, route and lot number were not reported) instead of ZOSTAVAX. No adverse effects were reported. It was unspecified whether product confusion was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 24-SEP-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose was unknown) intramuscularly which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Since December 2014 the patients were vaccinated with M-M-R II (lot # J010993, expiration date 06-SEP-2015, dose, dose#, frequency and route not reported) which had been improperly stored. No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot# reported as K014833, expiration date 14-SEP-2016, dose, frequency and route of administration were not reported). No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information is not expected due to lack of physician's contact details.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 4 year old female child patient. On 31-MAR-2015 the patient was inadvertently vaccinated with PEDVAXHIB Lot J000564, expiration date 02-NOV-2015, 0.5 ml once, intramuscularly instead of ACTHIB (manufacturer unspecified). The patient was not treated for the event. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 17-NOV-2014 the patient was vaccinated with one dose of improperly stored VAQTA (lot number J015882, expiration date 22-OCT-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history was not provided. Since December 2014 the patients were vaccinated with PROQUAD (Merck) (lot # reported as K010796, expiration date 04-FEB-2016, dose, dose#, frequency and route not reported) which had been improperly stored (incorrect product stage). No information regarding concomitant therapy was provided. No adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 13-FEB-2015 the patient was vaccinated with one dose of VAQTA (lot number J015882, expiration date 22-OCT-2015, dose was unknown) for intramuscularly which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, Immediate post-injection reaction, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 71 year old male patient. Concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2015, the patient was vaccinated with expired dose of ZOSTAVAX, 19,400 plaque-forming units (PFU) vial, lot # J014812, expiry date 20-FEB-2015, (dose, frequency, route of administration and indication were not provided). On 26-MAR-2015, immediately following the injection, patient experienced itching at injection site. No treatment was given. Patient sought medical attention by informing pharmacist. On an unknown date in 2015, the outcome of itching at injection site was resolved. The outcome of expired product administered was unknown. Causality was not provided. No product quality complaint (PQC) was involved. No additional information was reported. This is one of the two reports that received from the same reporter (linked with MARRS# 1504USA000966). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient had a history of shingles. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, strength and lot # were not reported, subcutaneous). On 06-MAR-2015, the patient called to the pharmacy for medical attention and complained the injection site was sore and red, and raised about 3 cm in diameter. The patient stated that it "felt like a shingle". She also raised a rash about 3 cm in diameter which was stated "felt like a shingle" by the pharmacist. The outcomes of the events were reported as not recovered. Causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old female patient. The patient was allergic to macrolides, ketolides, salicylates. On 16-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot number: K020802, expiry date: 31-JAN-2016, 0.65 ml, once, subcutaneously. Concomitant therapies included losartan (manufacturer unknown), glipizide, amlodipine, lovastatin (manufacturer unknown) and metformin (manufacturer unknown). Subsequently, on an unspecified date in March 2015, the patient developed redness, swelling, and a "bump" (clarified as related to swelling and not any type of rash or lesion) at the injection site. The patient sought medical attention by called the pharmacist. No treatment was given for the event and none lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Pt received HPV, MENACTRA and TDAP on 4/1/15. Immediately after last vaccine was administered she stated not feeling well. She was lightheaded and felt nauseated. She never lost consciousness-was able to talk throughout. She layed down, then drank some juice and was feeling better. Phone call to her 2-3 hrs later-she said she felt fine.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Fatigue, Pyrexia, Rash maculo-papular, Rash vesicular, Rhinorrhoea
Clinical narrative: Pt woke up on 3/23/15 with fever of 102 degrees F and pimple-like rash on neck. Over the next several hours, pt developed red macular-papular rash on face, neck, abd, chest, back and groin. Pt has been more tired with rash. Also, started with clear nasal drainage on 3/23/15. Pt seen in office on 3/26/15, afebrile. No changes with rash.
Sex: F
Vaccine: TDAP
Symptoms: Mouth swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen mouth in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (unknown). On an unknown date, 2 min after receiving BOOSTRIX, the patient experienced swollen mouth. On an unknown date, the outcome of the swollen mouth was unknown. It was unknown if the reporter considered the swollen mouth to be related to BOOSTRIX. Additional information received: A patient reported that she received a whooping cough shot 2 or 3 years ago. When asked if she received pertussis, the patient confirmed. To her knowledge she had just received pertussis by itself. Within less than 2 minutes of receiving the whooping cough shot she experienced a reaction where her mouth was swollen. The patient wondered whether it was because the shot had a rubber latex tip on the end.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of M-M-R II (lot#, dose, route not reported), that were exposed to temperatures of 0 degree C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. medical history and concurrent condition of the patient were not reported. On 08-AUG-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose was unknown) intramuscularly and on 13-FEB-2015, the patient was vaccinated another dose was unknown) intramuscular and on 13-FEB-2015, the patient was vaccinated another dose of VAQTA (lot# J015882, expire date 22-OCT-2015; dose unknown) intramuscularly, both of which underwent an unsupported temperature excursion. No adverse effects reported. The lot number 5B23A is an invalid lot number for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. medical history and concurrent condition of the patient were not reported. On 08-AUG-2014 the patient was vaccinated with one dose of VAQTA (lot number reported as 5B23A, dose was unknown) intramuscularly and on 13-FEB-2015, the patient was vaccinated another dose was unknown) intramuscular and on 13-FEB-2015, the patient was vaccinated another dose of VAQTA (lot# J015882, expire date 22-OCT-2015; dose unknown) intramuscularly, both of which underwent an unsupported temperature excursion. No adverse effects reported. The lot number 5B23A is an invalid lot number for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Local swelling, Myalgia, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of local swelling in a 50-year-old female patient who received ENGERIX B. Co-suspect products included DTPA and Influenza vaccine. Concomitant products included levothyroxine. On 24th December 2014 13:00, the patient received the 1st dose of ENGERIX B (intramuscular), DTPA and Influenza vaccine. On 24th December 2014, less than a day after receiving ENGERIX B, DTPA vaccine and Influenza vaccine, the patient experienced local swelling, neck pain and pain in arm. ENGERIX B was continued with no change. DTPA vaccine was continued with no change. Influenza vaccine was continued with no change. In January 2015, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the local swelling and neck pain were not recovered/not resolved. The reporter considered the local swelling and pain in arm to be related to ENGERIX B and Influenza. It was unknown if the reporter considered the neck pain to be related to ENGERIX B and Influenza. The reporter considered the local swelling and neck pain to be related to DTAP. It was unknown if the reporter considered the pain in arm to be related to DTAP vaccine. See case US2015GSK043727 for details following vaccinations. Additional information was provided: A patient received her first shot of ENGERIX-B on December 24th. At the same time she received an influenza shot and a Tap shot (details and manufacturers unknown). Beginning 3 hours after the patient received the ENGERIX-B her muscles became sore. Later that day she then felt a ball at the back of her neck (or top of spine) and it was also sore. She felt like all the medicine from the ENGERIX-B went straight to her neck. The patient told the office about being sore and they told her that was normal.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 73-year-old female patient who received BOOSTRIX. On 11th March 2015, the patient received BOOSTRIX (unknown). On 14th March 2015, 3 days after receiving BOOSTRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was not recovered/not resolved. The reporter considered the injection site lump to be possibly related to BOOSTRIX.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash at injection site. Became red and warm to the touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3-30-15 noted at bedtime. 4-1-15 11:45 call to office. Localized redness and swelling at inj site. Seen at 2 PM.
Age: 0.32
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 4 month old male patient with no pertinent medical history or drug reaction/allergies. On 13-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot# and expiration date not provided), 0.5 ml, intramuscularly. There was no concomitant therapy. On 18-MAR-2015, the patient developed a fever of 100.5 Fahrenheit degree (F). The patient's mother contacted the office by phone to seek medical attention on that date. No treatment was prescribed for the event. No other lab diagnostics studies were performed except body temperature. The outcome of fever was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Skin reaction
Clinical narrative: Local skin reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (pharmacy technician) refers to a patient of unknown age and unknown gender. On 20-MAR-2015 the patient was vaccinated with an expiry dose of ZOSTAVAX (lot # K000996 and expiry date: 13-MAR-2015). No adverse experience was observed or reported. No product quality complaint was reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. On 27-FEB-2015, the patient was vaccinated with an expired dose of M-M-R II (dose 0.5 ml, subcutaneous, lot # H018948, expiration date 18-OCT-2014). No adverse effect was reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site streaking, Injection site urticaria, Local reaction
Clinical narrative: Localized reaction to both arms. Rt deltoid baseball size red area. Lt deltoid dime size area that had streaks down the arm. Urticaria large, tense area on rt delt and smaller one on lt deltoid. No angitis or cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin tightness
Clinical narrative: Localized reaction to both arms. Rt deltoid baseball size red area. Lt deltoid dime size area that had streaks down the arm. Urticaria large, tense area on rt delt and smaller one on lt deltoid. No angitis or cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Cellulitis left shoulder vs allergic reaction to Tdap vaccine. Pt unsure if she had pain or edema until 2 days later. She reports pain, and progressive edema, erythema and tenderness in the area. Doxycycline 100 mg BID.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Ecchymosis, Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Child developed severe thrombocytopenia (ITP) (platelet count 1,000) with petechiae and ecchymosis - diagnosed 4/1/15 21 days after MMR-V admin. (Given on 3/10/15) - admitted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL that had been improperly stored (dose, route, lot # not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warm at injection site - 6 x 6 mm, 55 x 40 mm, (+) tender, no D/C. Noted 4-1 by mother. Rx KEFLEX 250mg/5ml 5 ml 4x1d x 7D, cool compresses, f/u 5D, if worse -> ED.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: After receiving flu vaccination - in the evening became nauseous, had headache, achy and fatigue.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Nausea, Photophobia, Vomiting
Clinical narrative: Metallic taste. Nausea. Light sensitivity. Vomiting. 72 hours post injection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysgeusia, Injection site rash, Injection site warmth, Photophobia
Clinical narrative: Metallic taste. Nausea. Light sensitivity. Vomiting. 72 hours post injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site of injection, large as peach, red, warm to touch, hard bump. Seen by doctor on 4/2/15 given cephalexin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened area approx. 3 in wide and 2 1/2 in long, warm to touch surrounding injection site of the left upper arm.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Laboratory test normal, Lethargy, Pyrexia, Seizure
Clinical narrative: Fever 99.5-101.5. Seizure. Lethargy, decreased appetite x 1-3 days.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Pt had vaccines on 3/27/15 and broke out in a rash on her torso and thighs on 3/30/15.
Age: 0.53
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Fever, rash, diarrhea.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Developed sore throat and cough on 10/28/14 at night including nasal and chest congestion. Felt fatigued.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Mobility decreased, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 21 years old female patient with a medical history of asplenia. In approximately February 2005, at the patient's age of 21 years, the patient was administered the first dose of PNEUMOVAX 23. In February 2015, at the patient's age of 31 years, the patient was vaccinated with the second dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). On an unknown date in 2015, after the second vaccination, the patient experienced a really bad cough, a really high fever, chills and body aches. The patient was unable to speak due to the severity of coughing and unable to move the arms due to the severity of the body aches. The patient went to the emergency room. It was not specified whether the patient was admitted. The patient's illness lasted 2 weeks until resolving on an unspecified date, in approximately 2015. The relatedness between the vaccination with PNEUMOVAX 23 and the adverse events was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Speech disorder
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 21 years old female patient with a medical history of asplenia. In approximately February 2005, at the patient's age of 21 years, the patient was administered the first dose of PNEUMOVAX 23. In February 2015, at the patient's age of 31 years, the patient was vaccinated with the second dose of PNEUMOVAX 23 (route of administration, lot number and expiry date were not reported). On an unknown date in 2015, after the second vaccination, the patient experienced a really bad cough, a really high fever, chills and body aches. The patient was unable to speak due to the severity of coughing and unable to move the arms due to the severity of the body aches. The patient went to the emergency room. It was not specified whether the patient was admitted. The patient's illness lasted 2 weeks until resolving on an unspecified date, in approximately 2015. The relatedness between the vaccination with PNEUMOVAX 23 and the adverse events was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had none pertinent medical history and none drug reactions and allergies. On 16-MAR-2015, the patient was vaccinated with ZOSTAVAX, lot # reported as K016318, expiration date: 24-DEC-2015, 0.65 ml, subcutaneous. No information regarding concomitant medications was reported. The pharmacist reported that, in March 2015, a couple of days after receiving ZOSTAVAX, the patient developed a lump the size of a baseball under the injection site that was red, inflamed and itched. The patient sought medical attention by visiting an unspecified physician, who prescribed her BENADRYL for treatment. The outcome of the events was reported as recovered/resolved on an unspecified date in March 2015. The relatedness between the events and the vaccination with ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Fatigue
Clinical narrative: Information has been received from a pharmacy manager who was also a pharmacist, via a field representative referring to an unknown number of patients. On unknown dates, the patients was vaccinated with PNEUMOVAX23, (lot number, expiry date, route, dose and frequency were not reported). On an unknown dates, the patients experienced a general feeling of being worn down after receiving PNEUMOVAX23. The outcome of the event was unknown. The patients sought unspecified medical attention. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoeic attack, Blood culture negative, Breath holding, Choking, Crying
Clinical narrative: Former 32 week preemie, received PENTACEL, ROTATEQ and PREVNAR 3/31/15. Red, hot swollen leg noted 4 hrs later, through evening pt had 3 episodes of very exaggerated startle reflex, one episode myoclonus. No fever at that time but developed fever to 102 next AM. Had several spells of choking, turning blue, apneic x 20 min with AM feed. The patient is a 12 week old female who presents for a follow up. This is a follow up visit for other (she was here yesterday for her 2 mo immunizations). Received PENTACEL in right leg, PREVNAR in left leg, and ROTATEQ by mouth. Right leg with some swelling, redness and warmth yesterday. Then last night mom noticed 3 episodes, about 15 secs apart, where patient had "stiffening of her legs and arms", and eyes rolled back in her head. Mom states that it was almost like an exaggerated startle reflex. Episodes lasted about 3 secs each. About 4 AM today, her left leg straightened, and then Dad saw some bouncing of her leg. This AM she woke up with a fever of 102. Her breathing has also been faster, louder, and more irregular than usual. Also, this AM she has had about 6 episodes of breath holding, and turning blue while taking her MBM bottle. Mom has blown in her face, and then she breathes again. She's been spitting up more forcefully and frequently than she did before yesterday. Child seemed perfectly well before getting vaccines yesterday AM, no fever, feeding well and gaining well. Parents are medical professionals (dad general surgery, mom RN) with no vaccine prejudices; older brother is fully vaccinated without any problems. As per yesterday's notes, after getting PENTACEL, PREVNAR and ROTATEQ developed marked fussiness, right thigh (site of PENTACEL) was red, hot and swollen. She did have an unusually loud cry and was very difficult to console. I saw her back in the office about 5 hours later and did confirm all the above findings. Afebrile on both visits. She continued to be very fussy through the night and did get BENADRYL and TYLENOL at about 6 PM. Increased salivation noted. At 9 PM mom started to change her diaper and patient had an unusual movement "like an exaggerated startle reflex" in which she stiffened, arms flew out in front of her with fingers spread, legs stiffened and toes pointed down, and her eyes grew very wide, then rolled back in her head. This only lasted about a second but was repeated 3 times over a minute. Then at midnight dad observed "myoclonic jerking" of left leg for a few seconds. She did vomit once last PM and has continued to spit up more than usual this AM. Temp of 102 at 8 AM today; mom was monitoring temperatures yesterday and those were normal. No fever noted at the time of the unusual motor movements. At 8:30 feed this AM child was fussy, crying and choking with feeds to the point of turning blue, apnea lasted for about 20 seconds. Several times mom had to withdraw bottle, blow in child's face and stimulate her to resume breathing. Last TYLENOL at 8 AM this AM, no fever here. Fed ok at 12:30 today.