chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L031271, expiration date 19-NOV-2016 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received 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 was received from a nurse and refers to unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and allergies were not reported. On unspecified dates since 14-DEC-2015, the unspecified patients were vaccinated with doses of (Oka/Merck) VARIVAX lot number L018002 with expiration date: 19-MAY-2017, lot number L025209 with expiration date: 07-JUL-2017, lot number L028277 with expiration date: 28-JUL-2017, lot number L023587 with expiration ate: 26-JUN-2017, and lot number L015048 with expiration date: 29-APR-2017, (strength, dose, frequency, route and anatomical location were not reported), which were exposed to temperatures outside the recommended range. Other suspect and concomitant therapies were not reported. Not adverse events were reported, and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (Lot # L029482, expiration date 06-NOV-2016) dose, route and anatomical location were not provided. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse in physician's office via a company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 11-AUG-2015, the patient was vaccinated with the first dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). On 30-OCT-2015, the patient was vaccinated with the second dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). On 06-JAN-2015, the patient was vaccinated with the third dose of unidentified Merck human papillomavirus (HPV) vaccine (route of administration, dose and lot number were not reported). The company representative was not aware if unidentified Merck human papillomavirus (HPV) vaccine was GARDASIL or GARDASIL 9. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 13 year old female patient. No medical history or concurrent conditions were reported. The patient was vaccinated with GARDASIL (dosage, frequency and route of administration were not reported) on the following dates: 22-JUN-2011 (lot # and expiry date were not reported), 27-JUN-2012 (lot # and expiry date were not reported) and 03-DEC-2015 (lot # K008931 and expiry date of 04-MAR-2017) (inappropriate schedule of drug administration). On an unknown date, the patient became pregnant with a Last Menstrual Period (LMP) of 15-NOV-2015 and an Estimated Date of Delivery (EDD) of 21-AUG-2016. The pregnancy outcome was pending. On 03-DEC-2015, the patient denied sexual activity and hence a pregnancy test was not performed. The patient had not reported any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and allergies were not reported. On unspecified dates since 14-DEC-2015, the unspecified patients were vaccinated with doses of PROQUAD (Merck) lot # L034930, expiration date: 03-MAR-2017, (strength, dose, frequency, route and anatomical location were not reported), which were exposed to temperatures outside the recommended range (incorrect product storage). Other suspect and concomitant therapies were not reported. No adverse events were reported, and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 04-AUG-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: 20-50 papular lesion 10/11 days post vaccinations.
Age: 12.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 12 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, a dose of ZOSTAVAX (dose, frequency, strength, route and lot number were not reported) was inadvertently administered to the patient instead of VARIVAX. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not reported. On 14-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, lot # K020181 with expiration ate 24-JUN-2016. Concomitant medication was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 04-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with a dose of improperly stored ROTATEQ, orally, (dose and frequency were not reported), lot number K007247, expiration date 17-MAR-2016, 10 doses, lot number K023537, expiration date 22-JUN-2016, 10 doses and lot number K016263, expiration date 26-JUN-2016 25 doses. No adverse effects were reported. There was no concomitant medication reported. This is one of two reports from the same reporter (case # 1601USA002504). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 06-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Information about the patients medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 01-SEP-2015, 02-SEP-2015, 03-SEP-2015, 04-SEP-2015, 08-SEP-2015, 09-SEP-2015, 10-SEP-2015, 11-SEP-2015, 15-SEP-2015, 16-SEP-2016, 17-SEP-2015, 18-SEP-2015, 21-SEP-2015, 22-SEP-2015, 23-SEP-2015, 24-SEP-2015, 25-SEP-2015, 28-SEP-2015, 30-SEP-2015, the patients were vaccinated with a dose of improperly stored MMR II, (dose, route and anatomical location were not reported), lot number J016233, expiration date 19-DEC-2015, 30 and also on 04-SEP-2015 and 15-SEP-2015, lot number K002816, expiration date 25-FEB-2016, 18 doses. No adverse effects were reported. There was no concomitant medication reported. This is one of two reports from the same reporter (case # 1512USA011935). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician referring to a 14 year old female patient, whose medical history and concurrent conditions were not provided. On 16-DEC-2015, the patient was vaccinated with GARDASIL 0.5 ml, intramuscular in the left arm, first dose, lot # K010215, expiration date 05-MAY-2017. Concomitant therapies included ABILIFY. On 16-DEC-2015, 10 minutes after the administration of GARDASIL the patient experienced loss of consciousness, reported as the patient "stood up and passed out". The patient was placed in observation for 45 minutes and was given water and sugar as treatment. At the time of the event the patient was in the physician office. At the time of the report, the outcome of loss of consciousness was reported as recovered on 16-DEC-2015. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral solution (lot# L013202 with expiration date 27-JAN-2017; dose was not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 9 months old patient of unknown gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 05-JAN-2016, the patient was inadvertently vaccinated (drug administered to patient of inappropriate age) with a dose of VAQTA, lot number K012457, expiration date 04-JUN-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K010215 with expiration date 05-MAY-2017; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from the patient's mother referring to her 11 year old daughter with no history of drug reaction or allergies. Another concurrent conditions and medical history were not provided. On an unknown dates reported as "in 2006 or 2007", the patient had her 3 doses of GARDASIL injection, 0.5 ml (route, anatomical site of vaccination, lot number and expiration date were not provided). The patient did not had concomitant therapies. On an unknown dates reported as "in 2006 or 2007" and each time the patient received a dose of GARDASIL the patient experienced injection site pain. The reporter stated that on an unknown dates in 2006 or 2007 and after each injection of GARDASIL the patient recovered from the injection site pain and that the patient did not receive any treatment for the adverse event. On 29-DEC-2015, the patient was vaccinated inadvertently with a 4th dose of GARDASIL and in the same date experienced injection site pain. At the time of the report, the outcome of injection site pain was reported as unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot # K018960 with expiration date 15-OCT-2016; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # K010535 with expiration date 27-AUG-2016; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA injection (lot # L039659 with expiration date 15-MAR-2017; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a non dialytic patient of unknown age or gender. The pertinent medical history or drug allergies/drug reactions were not reported. On 23-NOV-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (40 microgram) (Lot number, expiration date and route of administration were not reported) 40 Microgram. On 26-DEC-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (40 microgram) (Lot number, expiration date and route of administration were not reported) 40 Microgram. There was no concomitant medication reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 30-DEC-2015, the patient was vaccinated with an expired dose of M-M-R II subcutaneous injection (lot # J016234 and expiration date on 19-DEC-2015) (strength, dose, frequency) were not reported. There was no concomitant medication reported. The nurse reported that there was not known adverse effects. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Conjunctivitis, Hypersensitivity, Vision blurred
Clinical narrative: Anaphylactic reaction. Allergic reaction caused by drug. Conjunctivitis. Blurred vision.
Age: 22.0
Sex: F
Vaccine: BCG
Symptoms: Burning sensation, Peripheral swelling
Clinical narrative: Patient felt burning in her arm and the arm started to swell. This occurred for approx. 30 minutes. Patient iced arm for approx. 10 min and took Benadryl to subside swelling.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Moderate pain at injection site, limited arm motion, treated with Ibuprofen and heat compress.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: (Left) Arm/muscle pain at site of injection of PPSV23. Eventual red, splotchy skin rash near site of injection that eventually subsided.  Continued muscle pain in left arm to date (1/9/2015) with some restricted movement that was not present before injection of this vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient reported that at the site of injection she had a red bullseye, warm, hard nodule. She said it start the day after the injection and it was now day 5 since injection and still had symptoms. She did apply ice. She did visit local walk in clinic on 1/9/2016. She told me the doctor looked at it and said she is fine just reaction at site from vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: PATIENT SAYS SHOULDER IS STILL SORE AFTER IMMUNIZATION WAS GIVEN.  HAS A HARD TIME LIFTING HIS ARM AND MOVING IT WITHOUT HAVING SHOULDER PAIN.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: Extreme loss of strength in lower extremities for 2 days that resolved spontaneously.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: After vaccine the patient tried to stand up and passed out. 911 was called and an EPIPEN was administered to the patient. She recovered after the administration of the EPIPEN. The ambulance arrived and took the patient to the hospital.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site induration, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: 2 day fever, itching, swelling of the injection site, injection site induration, some dizziness when arrived home.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Infectious mononucleosis, Lymphadenopathy, Mobility decreased, Pyrexia
Clinical narrative: Pt not treated for rxn here but reports she couldn't put her arm down for 5 days, had swollen lymph nodes down arm and a high fever. She also reports dx. of mono during this time.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Pt. reported a generalized rash that was itchy and appeared to have welts and what appeared to look "like bug bites" over her body which started 48 hours after the vaccine. Recommended pt. call MD and use BENADRYL.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site discolouration, Injection site erythema
Clinical narrative: Patient came to the pharmacy to receive her Prevnar 13 vaccination.  She had previously received Pneumovax 23 a few years prior and it was recommended to her by her physician to receive the Prevnar 13.  She had indicated that she had no known drug/latex allergies.  The patient reported that 3 to 4 days after the injection of Prevnar 13, the site of injection began to turn purple in color.  Subsequent to that, a redness also appeared on or around the purple coloration and has grown incrementally since it appeared.  She has reported no extraordinary pain or swelling at the site of injection. She currently does not experience any pain or swelling at the site.  She did report feeling fatigued for at least 4 days post injection and is still slightly fatigued.  She has not applied any ice or used any anti-inflammatories since the injection.  Upon being notified of the event, the pharmacist interviewed the patient over the phone to record the pertinent information as well as to encourage the patient to contact her physician with regard to this event.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Dizziness, Headache, Nausea
Clinical narrative: The patient reported nausea, headache, weakness, and dizziness. Treatment included sending the patient to the nearest Emergency Dept.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Rash
Clinical narrative: Very sore at injection area, unable to lift arm without a lot of pain, which is still going on. Then on the 9th the rash started.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: PATIENT HAS UNUSUAL MUSCLE SORENESS AND A REDDENDED, WARM PATCH OF SKIN NEAR THE INJECTION SITE.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm achy (arthritic-like pain) from shoulder to hand. No bruising. No numbness. Ibuprofen helps but does not completely remove pain. Still in pain 3 months later.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Inflammation, Injection site injury, Mobility decreased
Clinical narrative: Patient has severe inflammation. She went to her PCP and he gave her Mobic. Her condition was worsening. She had no use of her arm. Mobic didn't help and she was referred to an orthopedist. He said that she has SIRVA (shoulder injury related to vaccine administration). This injury is commonly seen now. The orthopedist gave her a cortisone shot, after that she had to ice it, and she must get physical therapy for 1 year. On top of this the orthopedist said that she never received the flu shot.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursitis, Immediate post-injection reaction, Injection site reaction, Insomnia, Mobility decreased
Clinical narrative: Patient has severe inflammation. She went to her PCP and he gave her Mobic. Her condition was worsening. She had no use of her arm. Mobic didn't help and she was referred to an orthopedist. He said that she has SIRVA (shoulder injury related to vaccine administration). This injury is commonly seen now. The orthopedist gave her a cortisone shot, after that she had to ice it, and she must get physical therapy for 1 year. On top of this the orthopedist said that she never received the flu shot.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Tendon rupture, X-ray
Clinical narrative: Patient has severe inflammation. She went to her PCP and he gave her Mobic. Her condition was worsening. She had no use of her arm. Mobic didn't help and she was referred to an orthopedist. He said that she has SIRVA (shoulder injury related to vaccine administration). This injury is commonly seen now. The orthopedist gave her a cortisone shot, after that she had to ice it, and she must get physical therapy for 1 year. On top of this the orthopedist said that she never received the flu shot.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Vaccination site induration, Vaccination site nodule, Vaccination site pain
Clinical narrative: The location of my arm started to itch profusely 4 days after I had the vaccine. By the end of day 4 there was a big, hard, painful knot where the vaccine was given, which was also covered by a 4" area of red skin.  NO RASH, just red.  Finally, 4 days later approximately 10pm,(which is 8 days post vaccine) the symptoms were gone.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Gait disturbance, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Fever, Dizziness, Nausea, Leg cramps so severe he still has trouble walking.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient's left upper arm where vaccination was given had localized redness, swelling, and warmth to touch. Patient denied pain but reported that site was painful for 2 days after receiving vaccination. Patient was encouraged to apply warm/cool packs and to notify provide if signs/symptoms do not resolve. Injection site reactions.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Product use issue
Clinical narrative: This spontaneous report has been received from a physician referring to a 65-70 year old male patient who was involved in a market research. Historical condition and concurrent condition were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX injection (dose, route and lot# not reported) (Drug use for unapproved indication). Concomitant therapy was not reported. The physician mentioned that the patient complained of having some body aches "a few days" (in approximately 2014, reported as "1-1.5 years ago") after receiving ZOSTAVAX. There were no diagnostic tests. At the time of reporting, the outcome of the patient was reported as recovered/resolved with sequelae. Additional information is not expected as the physician would not give consent to provide contact information.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye pruritus, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Received flu vaccine 10/29/15. Next AM woke with (L) arm red. Site not swollen or hot. Gradually whole body covered with red, itchy rash. Scalp itchy. Rash went to mid thighs. No throat or breathing complaints. Eyes itchy. Treated with prednisone x 3d and sx resolved.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Received flu vaccine 10/29/15. Next AM woke with (L) arm red. Site not swollen or hot. Gradually whole body covered with red, itchy rash. Scalp itchy. Rash went to mid thighs. No throat or breathing complaints. Eyes itchy. Treated with prednisone x 3d and sx resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt presents rash that looks like a fried egg, it is a dark red round spot surrounded by uneven pink rash that has a white line around all of it. She says it is very painful. It is on her left upper posterior arm. It is raised and warm to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt presents rash that looks like a fried egg, it is a dark red round spot surrounded by uneven pink rash that has a white line around all of it. She says it is very painful. It is on her left upper posterior arm. It is raised and warm to touch.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Apathy, Arthralgia, Confusional state, Dry eye, Fatigue
Clinical narrative: Neck pain, head pain, face stiffness, tiredness, confusion, dry eyes, joint pain, pain in shoulder, swelling of glands, apathy.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lymphadenopathy, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck pain, head pain, face stiffness, tiredness, confusion, dry eyes, joint pain, pain in shoulder, swelling of glands, apathy.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Blister rupture, Erythema, Irritability
Clinical narrative: Raw, open, reddish blister on both buttocks, excessive irritability.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Severe pain, swelling from shoulder at injection site down to wrist. Lasted for 1 week. Took non-steroidal anti-inflammatory medications. Patient is a physician.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives, 4 or 5 on my chest. Later that day into the next day more hives on my face, neck, and the top of my head.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Fatigue, Immune thrombocytopenic purpura, Pyrexia
Clinical narrative: Red bumps/rash covering legs. Next day (1/9/16) spread to arms with fever, cough, runny nose, lack of appetite, fatigue. 1/11/16, idiopathic thrombocytopenic purpura shows up on legs, arms, and face and continuation of all other symptoms.
Age: 1.16
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: Red bumps/rash covering legs. Next day (1/9/16) spread to arms with fever, cough, runny nose, lack of appetite, fatigue. 1/11/16, idiopathic thrombocytopenic purpura shows up on legs, arms, and face and continuation of all other symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous non-valid report as received from an unknown source via Twitter refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced death (reported as "GARDASIL is killing"). The reporter considered death to be related to GARDASIL. Additional information is not expected as there were no contact details provided.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture, Blood lactic acid, Cellulitis, Erythema, Full blood count
Clinical narrative: Swelling, induration and redness led to total upper arm swelling, cellulitis and bacterial skin infection. Saw doctor who rx'd Levofloxacin but the ER on 01/09/2016 for Vancomycin IV, cultures, etc.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Induration, Metabolic function test, Peripheral swelling, Skin bacterial infection
Clinical narrative: Swelling, induration and redness led to total upper arm swelling, cellulitis and bacterial skin infection. Saw doctor who rx'd Levofloxacin but the ER on 01/09/2016 for Vancomycin IV, cultures, etc.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Inadequate aseptic technique in use of product, Pruritus, Swelling
Clinical narrative: Swelling, induration and redness led to total upper arm swelling, cellulitis and bacterial skin infection. Saw doctor who rx'd Levofloxacin but the ER on 01/09/2016 for Vancomycin IV, cultures, etc.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Not complete. Already called the patient for more information. Waiting for her to call us back.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient came in to pharmacy to pick up prescriptions. She complained of a flu shot given to her previously on 11/19/15 (FLUZONE HD). She has previously complained to another pharmacy but never complained/reported to our pharmacy personnel previously. Pt is requesting compensation - to see a doctor for flu shot pain.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Marked pain of left arm at site of injection with inability to lift arm associated with localized swelling and erythema around shot site.
Age: 63.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site rash, Injection site swelling
Clinical narrative: Started the evening of the injection with a temp. of at least 101 - lasted for approximately 48 hours.  Injection site started to swell and resulted in a rash from shoulder to elbow that lasted for one week.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Dizziness postural
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ear haemorrhage, Epistaxis, Headache, Hypoaesthesia, Impaired driving ability
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Thirst, Vertigo
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Ear congestion
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Nausea, Pyrexia, Vertigo, Vomiting
Clinical narrative: Very thirsty, sore throat, then extreme dizziness when lie down or when get up with ceiling rotating.  12/27/2015 I woke up with severe stomach ache, vomiting twice, didn't eat until 4 pm.  The entire body hurt, vertigo.  12/28/2015  woke up with dizziness, vomited again, didn't eat until 2 pm.  12/29/2015 nose bled, ear bled, with a fever that continued for one week.  Severe headache, head felt numb, body in tremendous pain, worse than any flu.  Severe vertigo, dizziness when stand up, spilled water at dinner time last night 01/10/2015.  Still dizzy & my head hurts as I type this.  Have a tummyache & diarrhea ever since 12/26/15, which is about a week after the flu shot on 12/19/15.  I can't drive, and when I turn my head, it hurts & get dizzy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Began with mild itching, now it is red and inflamed almost all the way around upper arm and warm to the touch.
Age: 0.17
Sex: M
Vaccine: DTPIHI, RVX
Symptoms: Crying
Clinical narrative: Inconsolable crying for 6 hours.
Sex: M
Vaccine: SMALL
Symptoms: Eye pruritus, Eye swelling, Laceration, Localised infection, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a consumer on 26-Dec-2015. This case involves male patient (age was not reported) who was vaccinated with a dose of ACAM2000 (manufacturer: Sanofi, batch number was unknown and route was not reported) in the left arm on an unspecified date. Patient illness at the time of vaccination was reported as unknown. Other medical history and concomitant medications were not reported. On an unspecified date after vaccination (reported as few days ago), patient had a cut in his right finger then touched the smallpox site. The right finger was swollen and "infected looking". He also touched his eyes which got itchy, red and swollen. He went to the ER in his town. He felt that his symptoms were worsened. Patient required ER/doctor visit. Lab tests were not reported. Patient received pain medication in emergency room. Patient had not recovered from the events and advised to go back to the ER. Upon internal review, case was considered as serious due to important medical events: infected looking finger, right finger swollen, itchy eyes, swollen eyes and eye redness. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 26-Dec-2015. This case involves male patient (age was not reported) who was vaccinated with a dose of ACAM2000 (manufacturer: Sanofi, batch number was unknown and route was not reported) in the left arm on an unspecified date. Patient illness at the time of vaccination was reported as unknown. Other medical history and concomitant medications were not reported. On an unspecified date after vaccination (reported as few days ago), patient had a cut in his right finger then touched the smallpox site. The right finger was swollen and "infected looking". He also touched his eyes which got itchy, red and swollen. He went to the ER in his town. He felt that his symptoms were worsened. Patient required ER/doctor visit. Lab tests were not reported. Patient received pain medication in emergency room. Patient had not recovered from the events and advised to go back to the ER. Upon internal review, case was considered as serious due to important medical events: infected looking finger, right finger swollen, itchy eyes, swollen eyes and eye redness. Documents held by sender: none.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Malaise, Pericardial effusion, Pneumonia, Renal failure
Clinical narrative: Initial unsolicited report received from a consumer (Patient's daughter) via other company (Pfizer) on 30 December 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA vaccine (batch number, route and site of administration were not reported) and also received a dose of PREVNAR 13, manufacturer: Pfizer (batch number, route and site of administration were not reported) (on same day) on an unspecified date in the 'last month'. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced double pneumonia, water around his heart, kidney failure, had been sick for over 30 days. It was reported that, the patient was hospitalized since he experienced the adverse events. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Nerve conduction studies, Neuralgic amyotrophy
Clinical narrative: Pain/burning in (L) arm at injection site. Limited motion (L) arm. Weakness (L) arm. TX P.T, MRI, ultrasound guided cortisone injection, Xrays, nerve conduction test x2.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Ultrasound scan, X-ray
Clinical narrative: Pain/burning in (L) arm at injection site. Limited motion (L) arm. Weakness (L) arm. TX P.T, MRI, ultrasound guided cortisone injection, Xrays, nerve conduction test x2.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, swelling at injection site. Indicates at the Clinic evaluation that she has an Epi-Pen for possible allergen to ibuprofen or food allergen several weeks prior.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Paralysis
Clinical narrative: Vaccine given 10/8/15. Patient's husband states patient had sore arm and neck within 2 days. Dr visit on 10/30/15. Paralysis from neck down.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt received ZOSTAVAX on 1/6/16. Pt came in on 1/10/16 - saying arm - hurt. Arm more red and slightly swollen and warm to touch. Advise pt to take BENADRYL and be seen by MD to rule out infections. Pt already applying ice.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 1 deltoid red and warm to touch, 2 days after injection. Ice pack applied at office.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pruritus, Skin warm
Clinical narrative: Started "w/ hot, itchy lump under clot has approximately size of silver dollar". Pt put ice on it which helped. Next day 1-10-16 says double size less re more pinkish color a bit itchy. Tried ice again and BENADRYL monitoring will seek med attention if worsens other wise will check in w/PCP 1-11-16. No other sxs just local.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and pharmacy intern refers to unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 19-DEC-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection, lot# K026666 with expiration date 22-OCT-2015 or lot# L019298 with expiration date 22-JUN-2017 (dose, route, lot # and expiration date were not reported). No adverse symptoms/effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Area around where ZOSTAVAX was administered on rt. arm was red, swollen, painful. Patient said started out as large area and got better once ice was applied. Patient stated that it itched, too. She stated today that she is very sensitive to vaccines.
Age: 1.02
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Lethargy, Pyrexia, Tremor
Clinical narrative: Per parent child had high fever with lethargy and shaking. Called ambulance at 0100 in am. ER doctor gave fluids and medication that Mom doesn't remember were.