chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender. No current condition, medical history or drug/allergies were reported. On 19-MAR-2015 the patient was vaccinated with PNEUMOVAX23 injection (strength, dose number and route unknown) lot # K005957 which was expired on 08-MAR-2015. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose volume, route of administration, lot number, expiry date were not reported). On 10-MAR-2015 the patient experienced swelling and itching on her hands. On 11-MAR-2015, when she woke up, she was experiencing unbearable itching on her feet. The patient did not seek a medical attention. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because the patient's and physician's contact details were not provided.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Right arm rash and swelling to VZV vaccine. Not reported for two weeks.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No current condition, medical history or drug/allergies were reported. On 13-MAR-2015 the patient was vaccinated with first dose of GARDASIL injection (strength, dose number, route, lot number and expiry date unknown). No concomitant therapy was reported. On 20-MAR-2015 (also reported as today), the patient was vaccinated with second dose of GARDASIL. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old male patient. None pertinent medical history or drug reactions or allergies were reported. On 22-JUN-2001 the patient was vaccinated with a first dose of VARIVAX (lot#, strength, dose and route was not reported). None of concomitants medication were reported. The physician reported that the child developed thrombocytopenia following the administration of VARIVAX. The child sought medical attention in the physician's office. The thrombocytopenia was diagnosed via a Complete Blood Count (CBC) that was drawn on 29-JUN-2001, which exhibited a platelet count of 52000 (unspecified unit of measure). The physician reported that no treatment was given to the patient. On 06-JUL-2001 the CBC exhibited "a normal platelet count' of 308,000 (unspecified unit of measure). The outcome of thrombocytopenia was reported as recovered/resolved. The relatedness between therapy with VARIVAX and the patient's event was not reported. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Body temperature increased
Clinical narrative: Increased temp 104.5 - was seen by Dr. in ER. Increased temp because of vaccines or possible ear infection. Alternate TYLENOL and Ibuprofen. Start antibiotic on Monday if needed (3/23/15).
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Decreased appetite, Full blood count normal, Insomnia, Lethargy
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old female patient. Patient had none relevant medical history. No drug reactions or allergies were reported. On 12-FEB-2015, the patient was vaccinated with a first dose of MMR II (lot # K011317, expiration date: 13-AUG-2016) dose 1, 0.5 ml, subcutaneously. Concomitant medication was not reported. On 12-FEB-2015, also reported as "over the weekend", the patient developed a fever of 103.4F, she was lethargic with no appetite and was unable to sleep. The patient's mother called the office and spoke with the physician, but any recommended treatment was unspecified. She stated that the patient developed a rash on her torso, which spread to her back, abdomen and then her face. She stated that the physician performed "blood work and tested her CBC, which came back normal" (on an unknown date in February 2015). No product quality complaint (PQC) was involved. On 23-FEB-2015, the patient recovered from fever (the patient's fever was gone). The outcome of the other events was reported as recovering. The reporting nurse stated that the rash was still present but was very "faint". The relatedness between the events and MMR II was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old female patient. Patient had none relevant medical history. No drug reactions or allergies were reported. On 12-FEB-2015, the patient was vaccinated with a first dose of MMR II (lot # K011317, expiration date: 13-AUG-2016) dose 1, 0.5 ml, subcutaneously. Concomitant medication was not reported. On 12-FEB-2015, also reported as "over the weekend", the patient developed a fever of 103.4F, she was lethargic with no appetite and was unable to sleep. The patient's mother called the office and spoke with the physician, but any recommended treatment was unspecified. She stated that the patient developed a rash on her torso, which spread to her back, abdomen and then her face. She stated that the physician performed "blood work and tested her CBC, which came back normal" (on an unknown date in February 2015). No product quality complaint (PQC) was involved. On 23-FEB-2015, the patient recovered from fever (the patient's fever was gone). The outcome of the other events was reported as recovering. The reporting nurse stated that the rash was still present but was very "faint". The relatedness between the events and MMR II was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Infection, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warmth, redness and itching around inj site and down to elbow starting 3/14 to present. Applied cold packs, was seen by PCP 3/16 who is treating as an infection and put on antibiotics. I believe looks like allergy reaction further suggested antihistamine and ice.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Patient states that on 3/18/15 evening his left arm started throbbing-came in today 3/19-left arm edematous, red, warm-Cephalexin 500mg 1 tab BID x 10 days.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash developed approximately 6 days after MMRV (PROQUAD) vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Left leg 5cm inoculation reaction to the upper left thigh with moderate erythema.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Erythema, Loss of consciousness, Pallor, Syncope
Clinical narrative: Had syncopal episode, became pale, lips blue, passed out approx 15-20 secs after HPV immunization. Was sitting in chair. Moved to lying position on floor with legs elevated. "Came to" prior to moving to floor. Apple juice given O2 Sat 99-100% at 3:20 pm. Mild erythema noted (R) side of face which resolved prior to leaving office.
Age: 70.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Sore and stiff hips, sore calf muscles. Sore and stiff shoulders. Arms, wrist and hand pain.
Age: 70.0
Sex: M
Vaccine: RAB
Symptoms: Pain in extremity
Clinical narrative: Sore and stiff hips, sore calf muscles. Sore and stiff shoulders. Arms, wrist and hand pain.
Age: 24.0
Sex: M
Vaccine: MNQ, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Pt stated small spots appeared on some parts of the body but has disappeared. Injection site of yellow fever is red and somewhat swollen.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given 2 mo immunizations at 39 days of age. PENTACEL, PREVNAR 13, ROTATEQ should not have been given until 6 weeks of age (42 days). Hep B was also given but dates ok.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old male patient. Patient current condition includes alpha-galactosidase allergy from a tick bite and red meat intolerance. Patient historical drug includes alpha-galactosidase. On 16-MAR-2015 the patient was vaccinated with ZOSTAVAX (lot # K016326 and expiry date 24-DEC-2015), dose 0.65 ml via subcutaneous. Other co-suspects were not reported and concomitant therapies included metformin (manufacturer unknown). On 16-MAR-2015 within two to three hours after administration of the ZOSTAVAX, the patient developed swelling around the injection site. The patient came back into the pharmacy on 16-MAR-2015 and showed the swollen area to the pharmacist. The pharmacist described it as a large area from the shoulder to elbow. The swollen area was red, warm to the touch and was oblong in shape and localized to that arm the patient received the ZOSTAVAX. Reporter stated that the swollen area had decreased in size but the area was still sore. The patient sought medical attention and visited pharmacist. The patient received treatment, reported as pharmacist advised the patient to take TYLENOL as well as the BENADRYL as needed. Reporter stated that in the past on an unspecified dates, after administering ZOSTAVAX to unspecified patients, the patients complained of a quarter size swollen area at injection site on unspecified dates. Cancer and overdose was not reported. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a approximately 11 year old patient of unknown sex. On 04-MAR-2015, the patient was vaccinated with expired dose of VARIVAX, lot number- J002318, expiration date- 22-FEB-2015, .5 ml, subcutaneous. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. It was reported that potency was supported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a approximately 5 year old patient of unknown sex. On 04-MAR-2015, the patient was vaccinated with expired dose of VARIVAX, lot number- J002318, expiration date- 22-FEB-2015, .5 ml, subcutaneous. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. It was reported that potency was supported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a market research program from a consumer refers to a 38 year old male patient. On an unknown date the patient was vaccinated with PPV23 (manufacturer unknown) (dose, lot no. unknown). On an unknown date the patient reported bad experience. The outcome of event was unknown. The causality of event was not reported. Additional information is not expected because the patient did not give consent for follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 53 years old female patient. On 02-MAR-2015, the patient was vaccinated with ZOSTAVAX lot # K012785, expiration date 28-NOV-2015, 0.65 ml, subcutaneous. In approximately March 2015, the patient experienced fever as well as itching and redness of the injection site of her left arm after receiving ZOSTAVAX. The size of the redness at the injection site was measured to be 4.5 cm by 1 cm on an unspecified date, approximately in March 2015 and the redness increased to 20cm by 12cm on an unspecified date, approximately in March 2015. The patient was seen by her unspecified physician on 06-MAR-2015. The patient was administered a DECADRON shot (manufacturer unspecified) on 06-MAR-2015 by her unspecified physician and the patient was informed by the unspecified physician to take ibuprofen. The outcome of pyrexia, vaccination site erythema and vaccination site pruritus was unknown. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A few days after administration patient experienced redness/swelling/and itchiness to the injection site only.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified number of patient of unknown demographics. The health professional reported that all these unspecified patients were administered 13 improperly stored doses of GARDASIL (Lot # K005881, expiry date: 14-JAN-2017) on the following dates: 1 dose on 17-FEB-2015, 1 dose on 18-FEB-2015, 1 dose on 24-FEB-2015, 4 doses on 25-FEB-2015, 1 dose on 26-FEB-2015, 2 doses on 02-MAR-2015, 1 dose on 03-MAR-2015, 1 dose on 04-MAR-2015 and 1 dose on 11-MAR-2015. No adverse effects were reported. Outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports from the same reporter (MARRS # 1503USA011669). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients on an unspecified date received improperly stored GARDASIL (lot No, dose and route of administration not provided). No adverse effects reported. 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 Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients on an unspecified date received improperly stored MMR II (lot no, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients of an unspecified date received improperly stored VAQTA (lot No, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, PPV
Symptoms: Extensive swelling of vaccinated limb, Gait disturbance, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received INFANRIX. Concurrent medical conditions included egg allergy, food allergy and peanut allergy. Concomitant products included PCV11 and polio vaccine. On 9th February 2015, the patient received INFANRIX (intramuscular). On 10th February 2015, 1 day after receiving INFANRIX and an unknown time after starting BENADRYL ALLERGY, the patient experienced extensive swelling of vaccinated limb, pain, walking difficulty and pruritus. The patient was treated with steroid (unspecified) and BENADRYL ALLERGY. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain and pruritus were recovering/resolving and the outcome of the walking difficulty was recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain, walking difficulty and pruritus to be related to INFANRIX. Additional information was provided: The injection site swelled to about 5 to 6 inches in diameter.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of numbness in a 24-year-old female patient who received ENGERIX B (batch number 7S29F, expiry date 24th January 2017). Concomitant products included EXCEDRIN. On 10th February 2015, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 10th February 2015 00:05, 5 min after receiving ENGERIX B, the patient experienced numbness and tingling. On an unknown date, the outcome of the numbness and tingling were recovering/resolving. It was unknown if the reporter considered the numbness and tingling to be related to ENGERIX B.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse action, but error on medical assistant, given MMR/V in addition to MMR.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling of left arm, redness and itching 3 days after PREVNAR injection.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Abscess sterile, Cough, Erythema, Induration, Injection site erythema
Clinical narrative: Was in office 3/11, had 12 m shots and developed little fever, then a couple days ago (3/19/2015) started to develop a red bump where VARIVAX vaccine was given, 3/21/2015 also has cold symptoms and a bad cough also-was evaluated in office found to have left thigh mid lateral region with 4 x 1.6 cm diam area of erythema, sl induration, tender to palpation, no fluctuance, no streaking erythema-found to have sterile abscess after vaccine-plan to monitor closely, refer to surgery for eval if increases. Followed up on 3/24/2015 and abscess is getting smaller and less red.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Nasopharyngitis, Pyrexia, Tenderness
Clinical narrative: Was in office 3/11, had 12 m shots and developed little fever, then a couple days ago (3/19/2015) started to develop a red bump where VARIVAX vaccine was given, 3/21/2015 also has cold symptoms and a bad cough also-was evaluated in office found to have left thigh mid lateral region with 4 x 1.6 cm diam area of erythema, sl induration, tender to palpation, no fluctuance, no streaking erythema-found to have sterile abscess after vaccine-plan to monitor closely, refer to surgery for eval if increases. Followed up on 3/24/2015 and abscess is getting smaller and less red.
Age: 1.34
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased activity, Fatigue, Febrile convulsion, Pyrexia
Clinical narrative: Fever x 5 days. Vaccines administered 3 pm that night had febrile seizure while sleeping lasting approx 1 minute. Had been tired, low activity until Day 6.
Age: 1.16
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning a 60 week old child. On 16-MAR-2015 the patient was vaccinated with a 0.5 ml dose of MMR II (lot # J002866, expired date 12-MAR-2015) subcutaneously in the left lower thigh. No adverse effects reported at this time. Additional information is not expected as we were not permitted to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored VARIVAX (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored M-M-R II (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored VAQTA (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient's medical history was not reported. On 30-JAN-2015, the patient was vaccinated with the first dose of MMR II lot # K002528 (expiration date and albumin status were not reported). No concomitant medication was reported. In February 2015, a week to 10 days after receiving the vaccine, the patient experienced fever of 103.5 F and an unspecified rash. On an unspecified date, when patient visited physician's office, her body temperature decreased to 97.9 F. The outcome of fever and rash was unknown. The relatedness between the events and MMR II was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient's medical history was not reported. On 30-JAN-2015, the patient was vaccinated with the first dose of MMR II lot # K002528 (expiration date and albumin status were not reported). No concomitant medication was reported. In February 2015, a week to 10 days after receiving the vaccine, the patient experienced fever of 103.5 F and an unspecified rash. On an unspecified date, when patient visited physician's office, her body temperature decreased to 97.9 F. The outcome of fever and rash was unknown. The relatedness between the events and MMR II was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dizziness, Syncope
Clinical narrative: After receiving the first dose of Gardisil HPV, I felt dizzy and then fainted. I woke up and did not know where I was. Dr. had me lie down and watched over me for about 30 minutes until I felt better.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Chills, Decreased appetite, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Side effects are pain, redness, swelling at my injection site, on the left arm my limitation of arm movement in injunction site, muscle pain, decreased appetite, chills.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Side effects are pain, redness, swelling at my injection site, on the left arm my limitation of arm movement in injunction site, muscle pain, decreased appetite, chills.
Age: 38.0
Sex: M
Vaccine: HEPAB, PNC13
Symptoms: Chest discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Side effects are pain, redness, swelling at my injection site, on the left arm my limitation of arm movement in injunction site, muscle pain, decreased appetite, chills.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Large red patch around area of injection which lasted approximately a week. Very little itching.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Flatulence, Gastrointestinal sounds abnormal, Pyrexia
Clinical narrative: RotaTeq vaccine: 100 degree fever at approx. 8:30 AM following administration.  Gastrointestinal gurgling sounds and forced/loud gas throughout night (not normal for this child).
Age: 0.44
Sex: F
Vaccine: DTAP
Symptoms: Crying, Injection site swelling, Irritability, Vaccine positive rechallenge
Clinical narrative: Crying nonstop for 4 hours. Very irritable and difficult to console. Also, swelling at the injection site. This occurred both times the vaccine was administered, and was worse the second time.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Left arm at site of vaccination erythemous and warm to touch. Area of erythema about the size of a softball.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: N/a - none.  Expired vaccine was given (8 days expired) without an adverse reaction, or event, with the exception of the patient needing to be re-vaccinated.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with ROTATEQ (orally, dose frequency and indication were not provided). In July 2014 the patient completed series of ROTATEQ. The nurse provided lot numbers: reported as J010928; J004944 (expiration date: 12-NOV-2014); J001815 (expiration date: 06-JUL-2014); J001257 (expiration date: 27-AUG-2014); H016249 (expiration date: 27-MAR-2014); H012981 (expiration date: unknown); H011458 (expiration date: 04-DEC-2013). On an unknown date the patient was diagnosed with rotavirus and was hospitalized approximately in March 2015 (reported as "in the last two weeks") (at the time of report, 20-MAR-2015 the patient was discharged). The outcome of rotavirus infection was unknown. The relatedness between rotavirus infection and vaccination with ROTATEQ was not reported. This is one of several report received from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Loss of consciousness, Seizure, Tremor
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to 11 or 12 year old female patient. No medical history was reported. On an unknown date, the patient was vaccinated with her second or third dose of GARDASIL lot # K005881, dose 0.5 ml, intramuscular. Other suspect therapy included intranasal FLUMIST which was co-administered on the same date. The patient experienced seizure, with full body shaking and loss of consciousness after she received the dose of GARDASIL. The patient recovered spontaneously in the office on the same day without any intervention. When the patient regained consciousness, she did not have any memory of the event. The reporter causality assessment was not provided. Upon internal review, the event of seizure was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 12-FEB-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: TYP
Symptoms: Lymphadenopathy, Nausea, Pyrexia, Vomiting
Clinical narrative: Swollen glands, feverish, feeling nausea, threw up the next morning.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 13-JAN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Quarter size red area at the injection site with larger reddened area surrounding. Erythema, painful to touch, swollen, painful when moving arm. Started on Keflex today.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Quarter size red area at the injection site with larger reddened area surrounding. Erythema, painful to touch, swollen, painful when moving arm. Started on Keflex today.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Angioedema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, itchy and sore giant hive at site size of baseball.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash, Mass
Clinical narrative: Lump, pain, itchy.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus
Clinical narrative: Lump, pain, itchy.
Age: 2.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Decreased appetite, Emotional disorder, Psychomotor hyperactivity, Vaccine positive rechallenge, Vision blurred
Clinical narrative: Inability to focus. Hyperactivity. Loss of appetite. Loss of emotional control. All events lasted for about 2-3 weeks before tapering off. These events occur with every vaccine she has ever received.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, swelling, firm/hardness around area of injection.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Headache, Macule, Rash pustular
Clinical narrative: Patient received primary vaccination 14 MARCH 2015 and 9 days later, he noticed disseminated small pustules/ macules on an erythematous base to trunk, arms and legs. Pt denies fever, chills, nausea or vomiting. Describes initially 6-7/10 headache yesterday and today, about a 3/10 rating. No cough, chest pain or shortness of breath. Vaccination site is clean and healing well; no necrosis or satellite lesions.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Headache, Myalgia, Pruritus, Rash generalised
Clinical narrative: Patient received primary vaccination 14 MARCH 2015 and 9 days later, he noticed disseminated small pustules/ macules on an erythematous base to trunk, arms and legs. Pt denies fever, chills, nausea or vomiting. Describes initially 6-7/10 headache yesterday and today, about a 3/10 rating. No cough, chest pain or shortness of breath. Vaccination site is clean and healing well; no necrosis or satellite lesions.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: Patient received primary vaccination 14 MARCH 2015 and 9 days later, he noticed disseminated small pustules/ macules on an erythematous base to trunk, arms and legs. Pt denies fever, chills, nausea or vomiting. Describes initially 6-7/10 headache yesterday and today, about a 3/10 rating. No cough, chest pain or shortness of breath. Vaccination site is clean and healing well; no necrosis or satellite lesions.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom noted itching of R deltoid area as well as heat in the evening.  This morning, noted that it persisted.  Seen today for PPD read.  PPD negative, but also noted to have persistent itching, redness, swelling near R deltoid area measuring about 9.5x 9 cm.  Non-tender, warm to touch.  Otherwise, normal exam.  Treated mainly with ice at home.  Started treatement with oral anithistamines after clinic visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lethargy, Pyrexia, Seizure
Clinical narrative: Lethargic, seizure with fever of 102. Mom gave Motrin at 3:00am. Took child to the ER approximately 8:45am. According to mom ER gave fever reducer and sent child home in stable condition.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised, Pyrexia
Clinical narrative: Client complained that she had fevers and generalized itching after receiving her Hepatitis B Vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling with some pain to the touch at injection site. Size about the size of two quarters.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash started on ears bilaterally, then spread to cheeks and upper arms over next several days.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient reports that three days after having varicella vaccine, she broke out in a rash on her shoulder and antecubital fossa area and two days after that, three bumps were on her back and two on the right side of her body.  She reports the bumps went away, but the rash did not.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: Severe rash all over body, Erythema Multiforme.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: LOCAL REACTION:  SWELLING, REDNESS AND WARMTH OF LEFT UPPER DELTOID WHERE VACCINE WAS ADMINISTERED.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Blister, Dysphonia, Headache, Pain, Pruritus
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash erythematous, Rash generalised, Secretion discharge
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash, Rubella antibody negative
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Blister, Blood pressure increased, Crying, Dysphonia, Feeling hot
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Headache, Hyperhidrosis, Pain, Pruritus, Rash erythematous
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 50.0
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rash generalised, Rubella antibody test, Scab, Urticaria
Clinical narrative: Employee states itching to left hand began Wednesday afternoon, no rash noted. Thursday AM woke up with headache, rash on nose cheek, and left hand. Not reported to Employee health until employee presented Friday @ 9;45 am. Presented with red rash to left cheek, nose, around mouth. Itching to scalp, rash with blisters to left hand. Employee stated itching was intensifying and felt achy along with having a headache. Employee states felt voice was raspy and maybe needed her inhaler. Employee not in acute respiratory distress. Resps easy and regular. Employee sent to ED for medical evaluation and treatment of symptoms. On 3/25 Employee reports she saw PCP after rash worsened and became more generalized despite completing Medrol pack prescribed in ED. Employee states she was referred to Dermatologist where she received a steroid shot and cream. States MD said rash may be related to vaccine but was not certain. Employee states rash generalized to extremities trunk and face with weeping to some areas.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt came into the office with and was diagnosed with cellulitis at the injection site.
Age: 1.11
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Tiny red bumps on torso, buttock, chin, legs and arms.  Looks like he was poked with a needle all over.  Heat made rash worse, per mother. 03/23/15: Pediatric Exam: GENERAL APPEARANCE: alert, active, no distress, well hydrated. SKIN: macular papular eruption primarily trunk but evidence on face and extremities. No bruising. EARS: TMs pearly grey. NECK: no lymphadenopathy. No treatment.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Erythema, Headache, Injection site nodule
Clinical narrative: Chills, fever; arm pain with beginning rash at left upper arm injection site; swelling of area above elbow 2 1/2 inches long by 1 inch wide with hardened knot below skin; slight headache; diminished appetite next day; painful lymph nodes in left armpit.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Lymph node pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever; arm pain with beginning rash at left upper arm injection site; swelling of area above elbow 2 1/2 inches long by 1 inch wide with hardened knot below skin; slight headache; diminished appetite next day; painful lymph nodes in left armpit.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Glossodynia, Heart rate increased, Immediate post-injection reaction, Injection site discomfort
Clinical narrative: Initial unsolicited case received on 17 March 2015 from a consumer. A 56 year old female patient with a history of allergies to Sulfa, penicillin, IV contrast dye and elevated blood pressure was vaccinated intramuscularly on 03 December 2014 with FLUZONE QUADRIVAL, batch U5036AA, site not reported. The patient has received other unidentified flu vaccines in the past. The patient reported an immediate feeling of burning and discomfort at the injection site and burning sensation of the tongue. Since then she has also experienced burning sensation of mouth and throat and has had episodes of a rapid heart rate and slight chest pain that continues at the time of the report. The patient has been hospitalized at different hospitals four times, dates and reason not reported. The patient received the vaccination at another facility to the reporter. The patient was seen by a cardiologist, but "nothing has been found". Laboratory tests were not reported. The patient outcome is not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Oral discomfort, Throat irritation
Clinical narrative: Initial unsolicited case received on 17 March 2015 from a consumer. A 56 year old female patient with a history of allergies to Sulfa, penicillin, IV contrast dye and elevated blood pressure was vaccinated intramuscularly on 03 December 2014 with FLUZONE QUADRIVAL, batch U5036AA, site not reported. The patient has received other unidentified flu vaccines in the past. The patient reported an immediate feeling of burning and discomfort at the injection site and burning sensation of the tongue. Since then she has also experienced burning sensation of mouth and throat and has had episodes of a rapid heart rate and slight chest pain that continues at the time of the report. The patient has been hospitalized at different hospitals four times, dates and reason not reported. The patient received the vaccination at another facility to the reporter. The patient was seen by a cardiologist, but "nothing has been found". Laboratory tests were not reported. The patient outcome is not recovered. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received Influenza vaccine. Previously administered products included seasonal flu vaccine with no reaction on previous exposure (annually for many years). On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced pain in arm and mobility decreased. The patient was treated with SOLUMEDROL. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Influenza vaccine. Additional information was provided: The patient experienced severe pain in the upper arm that has not resolved for months. The physician reported that the patient had limited use of the arm, and continued to avoid using his arm at all. The physician conducted all the usual assessments and tests (all WNL), and had also administered SOLUMEDROL IM to the area which did not change the pain level.