chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Abdominal pain upper, Balance disorder, Hypoaesthesia, Mobility decreased
Clinical narrative: This spontaneous report as received from a 54 year old female consumer with acetaminophen allergy and no pertinent medical history reporting on herself who on 07-NOV-2014 was vaccinated with a second dose of RECOMBIVAX HB (dose, lot #, expiration date and route were not reported). There was no concomitant medication. On 08-NOV-2014, reported as the very next morning after receiving the vaccine she woke up and lost her balance. Her legs "gave out" but she did not fall. These events lasted for about a month on approximately December 2014. Also the patient said that the symptoms started changing and she had aches and pains, stiffness in the back, cramps in the stomach, a "welt" or "hive" located on the inside of her thigh. She also mentioned difficulty moving when she would be siting for a while and attempts to get up she would experience a "challenge" at doing so. She also stated that "one part of her stomach is numb" and there was pain right beneath her breast and above her stomach, almost as if was swollen and mentioned that the pain got worse after she ate and drunk. She also experienced "tingles" in her legs and her legs went "numb" as well. No treatment was given for the adverse events. No laboratories diagnostic tests were performed. The patient sought medical attention saw a doctor. The outcome of lost her balance, welt or hive was located on the inside of her thigh, cramps in the stomach, stiffness in the back, she had aches and pains and her legs "gave out" was reported as recovered/resolved. The outcome of difficulty moving when she would be sitting for a while and attempts to get up  she would experience a "challenge", legs go numb and she experienced tingles in her legs was unknown. The outcome of one of stomach is numb and pain right beneath her breast and above her stomach almost as if something is swollen was reported as not recovered/not resolved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Paraesthesia, Urticaria
Clinical narrative: This spontaneous report as received from a 54 year old female consumer with acetaminophen allergy and no pertinent medical history reporting on herself who on 07-NOV-2014 was vaccinated with a second dose of RECOMBIVAX HB (dose, lot #, expiration date and route were not reported). There was no concomitant medication. On 08-NOV-2014, reported as the very next morning after receiving the vaccine she woke up and lost her balance. Her legs "gave out" but she did not fall. These events lasted for about a month on approximately December 2014. Also the patient said that the symptoms started changing and she had aches and pains, stiffness in the back, cramps in the stomach, a "welt" or "hive" located on the inside of her thigh. She also mentioned difficulty moving when she would be siting for a while and attempts to get up she would experience a "challenge" at doing so. She also stated that "one part of her stomach is numb" and there was pain right beneath her breast and above her stomach, almost as if was swollen and mentioned that the pain got worse after she ate and drunk. She also experienced "tingles" in her legs and her legs went "numb" as well. No treatment was given for the adverse events. No laboratories diagnostic tests were performed. The patient sought medical attention saw a doctor. The outcome of lost her balance, welt or hive was located on the inside of her thigh, cramps in the stomach, stiffness in the back, she had aches and pains and her legs "gave out" was reported as recovered/resolved. The outcome of difficulty moving when she would be sitting for a while and attempts to get up  she would experience a "challenge", legs go numb and she experienced tingles in her legs was unknown. The outcome of one of stomach is numb and pain right beneath her breast and above her stomach almost as if something is swollen was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from a pharmacist refers to a female patient of unknown age and ethnicity. Medical history were not reported. On 03-DEC-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H018421 with expiration date 08-Oct-2014, 1 DF, subcutaneous. Other suspect therapies included MMR II lot # H020255, with expiration date 08-Nov-2014. On 03-DEC-2014, 1 day after onset of therapy the patient experienced expired dose and no adverse effect. Concomitant medication were not reported. The outcome of expired dose and no adverse effects is unknown. The reporter considered expired dose to be not related to MMR II and (Oka/Merck) VARIVAX. The reporter considered no adverse effect to be not related to (Oka/Merck) VARIVAX and MMR II. No further information was provided.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: Information has been received on 03DEC2014 from another company who reported that an 86 year old female was vaccinated with PNEUMOVAX 23 (lot # K008410 Expiration date 20FEB2016) (strength, dose, route not reported). The reporter reported that this product had been exposed to temperatures outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. Per the reporter, the patient's arm was in extreme pain. No medical attention was needed. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Local reaction
Clinical narrative: Information has been received on 04DEC2014 from a company representative who learned information from a physician at a conference. The physician states she prescribed ZOSTAVAX to a patient (age and gender not reported). The patient took the script to a pharmacy and received the vaccination. After receiving, the patient experienced a local reaction (severe induration) that lasted two to three weeks and then resolved itself. The physician advised the patient to return to the pharmacy for advice and does not know if any treatment was provided. No PQC was reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65mL (strength and route of administration were not reported). It was reported that on an unknown date the pharmacist did not get the full 0.65ml when reconstituting ZOSTAVAX. He got approximately 0.5mL. Pharmacist stated he was withdrawing all the contents from one sterile water diluent into the syringe for reconstitution, but it came up short. So pharmacist then opens another sterile water diluent and uses more sterile water to equal the 0.65 ml. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 50 year old male patient. The patient's medical history included two shingles outbreaks in face without drug reaction and/or allergies. On 30-DEC-2014 the patient was vaccinated with ZOSTAVAX single dose, lot # K010967, expiration date 16-NOV-2015, subcutaneous (dose was not reported). There was no concomitant medication. On 31-DEC-2014 the patient experienced shingles on his face. He called his pharmacist but did not receive any treatment for the adverse event. There were no laboratory diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a 86 year old male patient. On 20-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # reported as K007733, expiration date: 01-MAY-2015 (dose and route of administration were not reported). Concomitant therapies included influenza virus vaccine inactivated (unspecified) which was received on the same date but was unknown which arm. On an unknown date the patient experienced very swollen right arm which was very painful after receiving PNEUMOVAX 23. Patient revisited the physician's office on 23-OCT-2014. The outcome of the events was unknown. 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 healthcare worker who is an office manager refers to unspecified patients of unknown ages and genders. On an unknown dates the patients were vaccinated with a dose GARDASIL (dose, lot #, expiration date and route were not reported). The doses of the vaccine were exposed to temperatures outside of the recommended range since October 2014. No adverse effects have been reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse concerning a 4 month old patient (gender not specified). On 21JUL2014 the patient was administered a dose of ROTARIX at the age of 2 months. On 24SEP2014, at the age of 4 months old, the patient was vaccinated with ROTATEQ. No adverse event was reported. No additional information was provided. Additional information is expected.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Arm became red, swollen, tender, shoulder to elbow.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: Local reaction-red, warm, tender. No hardened areas or swelling. Taking ibuprofen and applying cool compress-> all symptoms are improving.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain in extremity
Clinical narrative: I was diagnosed with shingles two days ago by my Dr. He gave three prescriptions ... Acyclovir 800 mg five times daily, hydrocodone 325 for pain and a shot .... ZOSTAVAX. The pharmacist administered the injection. My symptoms are worse including extreme back pain and leg pain. Also the breakout blistered areas are much worse. Terrible reaction.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Approximately since January 2015, an unspecified number of patients was vaccinated with PROQUAD (Merck) (lot number, strength, dose, frequency and route was not reported) that had been exposed to a supported temperature excursion and additional doses of PROQUAD (Merck) that had been exposed to additional temperatures outside of the recommended range. No adverse experiences had been reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus, Injection site swelling
Clinical narrative: Information was received from a pharmacist regarding a 61 year old female patient with an allergy to sulfa and ramipril. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (lot # K011003, expiration date November 2015) in an unspecified arm. On an unspecified date in December 2014, the patient experienced a localized injection site reaction, described as a 5 inches by 4 inches raised red infected area in the arm. The pharmacist also reported the injection site reaction was swollen and itchy. The patient visited her physician (no treatment reported). The outcome of the localized injection site reaction/raised red infected area, swollen, itchy was reported as not recovered. No further information is provided. Additional information has been requested.
Age: 0.44
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, PNC13
Symptoms: Incorrect product formulation administered, Wrong drug administered
Clinical narrative: 1-14-15 Pt was given ROTARIX diluent and KINRIX mixed together orally - the KINRIX was mixed instead of the ROTARIX - we called GlaxoSmithKline and CDC - mom aware and pt has received the ROTARIX today 1-16-15 the nurse prepared the MD administered.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, PNC13
Symptoms: Incorrect product formulation administered
Clinical narrative: 1-14-15 Pt was given ROTARIX diluent and KINRIX mixed together orally. The KINRIX was mixed instead of the ROTARIX - we called GlaxoSmithKline and CDC - mom aware and pt has received the ROTARIX today 1-16-15 the nurse prepared and the MD administered.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from another healthcare professional refers to a 2 year old patient of unknown gender. On 17-NOV-2014 the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # 1666AA, 0.5 ml, subcutaneous. Reporter stated that they expiry date was 08-NOV-2014. No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Nausea, Syncope, Tremor
Clinical narrative: Less than one minute after vaccine was given, patient fainted, LOC for 20 seconds. Arms and legs began to stiffen and shake. She then returned to her baseline. (+) nausea, no vomiting. BP 109/69. HR 96.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse who reported that a female was inadvertently administered a dose of PROQUAD (Merck) and a dose of VARIVAX (Merck) on 03-DEC-2014. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information had been received from a pharmacist who reported that on 10-NOV-2014 a male received both ZOSTAVAX and PREVNAR (manufactured unspecified). The manufacturers of PREVNAR indicated to the pharmacist that it is "probably not appropriate to give these 2 vaccines together". No known adverse effects. All of the data here was confirmed with the pharmacist. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Wrong drug administered
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting in herself. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was scheduled to receive ZOSTAVAX but patient was accidentally given with VARIVAX (Merck) (route, dose, lot, batch and expiration date not reported) and developed chickenpox on her face which lasted for a week. A week after receiving VARIVAX (Merck) the patient received ZOSTAVAX. No adverse effects were reported after ZOSTAVAX . Patient spoke with pharmacist about the event. Additional information is not expected because the patient did not wish to provide specific information.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who is an office manager refers to unspecified patients of unknown ages and genders. On an unknown dates the patients were vaccinated with a dose of VAQTA (dose, lot#, expiration date and route were not reported). The doses of the vaccine were exposed to temperatures outside of the recommended range since October 2014. No adverse effects have been reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. 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 healthcare professional concerning a patient of unknown age and gender, who was vaccinated on 05-JAN-2014 with VARIVAX (Merck) (dose number, strength, lot number and expiration dates was not reported), 0.5 ml, subcutaneous, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a female patient of unknown age, who on 23-SEP-2014, was vaccinated with a dose of M-M-R II (lot # J014873, expiration date 21-NOV-2015) that was improperly stored (dosage and route of administration not provided). No adverse effect reported. No further information was available. This is one of seven reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. The pharmacist was informed by an unspecified pharmacist that an unspecified patient was vaccinated with ZOSTAVAX in 2012 and received a second dose of ZOSTAVAX in DEC-2014. No adverse effects were reported. No patient identifying information was available. No further information was provided. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to male patient of unknown age. The pharmacist reported that due to a product defect the patient only received 0.5 ml of ZOSTAVAX (lot#, route of administration not reported) which had excessive foaming. PQC was filed for the excessive foaming. No adverse effect was reported. A follow up call was received from a nurse practitioner later on the same day. The nurse practitioner confirmed that the patient received 0.5 ml of ZOSTAVAX due to the excessive foaming of the product, and that there were no adverse effects for this patient. Follow up PQC information was filed. This is one of two reports for this reporter. See MARRS# 1501USA0005853. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous pregnancy report as received from a consumer refers to herself (patient's age not reported). The patient reported, "on an unspecified date, I received the second dose of GARDASIL and I later found out I was 10-15 days pregnant." No adverse effects were reported. The patient did not wish to provide any further specific information. During the call the patient stated, "I am not sure if I received GARDASIL or CERVARIX". The LMP and EDD is not known. The outcome of "I received the second dose of GARDASIL and later found out I was 10-15 days pregnant is unknown." No further information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 08DEC2014 from a registered nurse who reported that an unspecified number of unspecified patients received doses of improperly stored PNEUMOVAX 23 on unspecified dates. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student (also reported as a healthcare student) on 09DEC2014, regarding a 63-year-old female patient with a history of no drug reactions and no allergies. Medical history and concomitant medications were not specified by the reporter. The patient had been vaccinated on 08DEC2014 subcutaneously with a dose of 0.65 ml (once) ZOSTAVAX (Merck) (Lot # K008883; expiration date 20SEP2015). The pharmacy student reported that the reason for the therapy was "She's in the age group for it." The pharmacy student reported that the patient has now been prescribed ENBREL, after receiving the dose of ZOSTAVAX (Merck). The pharmacy student could not confirm that the patient was prescribed ENBREL for a pre-existing condition. (It was not specified why the patient was prescribed ENBREL). It was not specified if the patient sought medical attention. No further information was provided. (The pharmacy student had reported degree of Pharm D. It was not further specified if she had received the degree or was working toward receiving the degree). Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse event
Clinical narrative: Information was received from a consumer via a letter. The patient was a female (age not specified). Medical history and concomitant medication use was not provided. On 26NOV2010 the patient was vaccinated with PNEUMOVAX 23, intramuscular, in the left arm. Other suspect therapies included AFLURIA. On an unknown date the patient experienced an adverse event (NOS). The outcome of adverse event is unknown. The reporter considered adverse event to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Condition aggravated, Exposure during pregnancy, Hypertension, Pre-eclampsia
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous pregnancy report as received from a physician refers to a 25 year old female patient with polycystic ovary syndrome, PCN allergy, endometriosis, hypertension, migraines, smoker and obesity. The physician reported that on 04-NOV-2014 the patient was vaccinated with GARDASIL. Concomitant therapies included Prenatal vitamins. The physician stated that the patient took a home urine pregnancy test on 20-NOV-2014 and the result was positive. The physician reported that the patient was seen in the office today and that the patient is "about six weeks pregnant." The LMP and EDD is not known. The outcome of vaccine exposure during pregnancy is unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (exact date unspecified, reported as between 26-NOV-2014 through 01-DEC-2014) those patients received an improperly stored VAQTA (dose, units, route of administration, anatomical location, lot number were not reported). No adverse symptoms reported. The temperature excursion for all vaccines was found to be supported with in-house stability data. This is one of several reports from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Feeling hot, Nausea, Syncope
Clinical narrative: Shortly after vaccination patient felt hot and nauseous. Had to lay down. Never fully lost consciousness but was very close. Never had any trouble breathing.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site nodule, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hard knot where vaccine given and swollen red and hot to touch covering all of bicep.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: No adverse reactions per pt. legal guardian. Event - received duplicate varicella dose on same day.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Influenza, Pain
Clinical narrative: About 2-3 days after receiving the shingles vaccine, I experienced some symptoms similar to a low grade flu. I was tired, weak and had aches for approximately two weeks.  I did not have any symptoms of respiratory congestion, cough or stuffy, runny nose. Two weeks prior to the shingles vaccine I had a flu vaccination.  No adverse symptoms to the flu vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain
Clinical narrative: About 2-3 days after receiving the shingles vaccine, I experienced some symptoms similar to a low grade flu. I was tired, weak and had aches for approximately two weeks.  I did not have any symptoms of respiratory congestion, cough or stuffy, runny nose. Two weeks prior to the shingles vaccine I had a flu vaccination.  No adverse symptoms to the flu vaccination.
Age: 81.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Patient received her 3rd of Hepatitis vaccincation injection while she was at dialysis and stated she got fever, chills, weakness. Came to Hospital and was admitted.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Pain
Clinical narrative: Burning gastro intestinal pain, similar to the inflammation caused by a metal allergy (some earring metals cause my ears to inflame).
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Pyrexia, Tenderness
Clinical narrative: Headache, fever, extreme pain at injection site, limited use of arm, arm hurts to touch.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Blood test, Decreased appetite, Dizziness, Head discomfort
Clinical narrative: Pain began in lower spine mimicking spinal meningitis of 2004. Over a period of 2weeks pain moved up to neck left shoulder and eventually mimicked w less severity wn meningitis head pains w pressure dizziness and pain.  10 days following vaccination developed extreme muscle weakness in legs which continued for 4 days and still exists to some degree 1 week later. Also nausea and lack of appetite for 9 days following vaccination and improved after accupuncture.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Muscular weakness, Nausea, Neck pain
Clinical narrative: Pain began in lower spine mimicking spinal meningitis of 2004. Over a period of 2weeks pain moved up to neck left shoulder and eventually mimicked w less severity wn meningitis head pains w pressure dizziness and pain.  10 days following vaccination developed extreme muscle weakness in legs which continued for 4 days and still exists to some degree 1 week later. Also nausea and lack of appetite for 9 days following vaccination and improved after accupuncture.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain
Clinical narrative: Pain began in lower spine mimicking spinal meningitis of 2004. Over a period of 2weeks pain moved up to neck left shoulder and eventually mimicked w less severity wn meningitis head pains w pressure dizziness and pain.  10 days following vaccination developed extreme muscle weakness in legs which continued for 4 days and still exists to some degree 1 week later. Also nausea and lack of appetite for 9 days following vaccination and improved after accupuncture.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling, Vaccination site infection
Clinical narrative: Redness and swelling, pain, hot to touch.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Malaise, Peripheral swelling
Clinical narrative: 102 temp, feeling sick, swelling in arm. Sought doctor and got steroids and antibiotic.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Pt noticed itching, redness & swelling at Rt arm injection site. Area was tight & hard the next day.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Skin tightness
Clinical narrative: Pt noticed itching, redness & swelling at Rt arm injection site. Area was tight & hard the next day.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus, Muscular weakness, Myalgia
Clinical narrative: Large (3x6" oval) red area; some edema in same area; sore & itchy at injection site; persisted several days then started to diminish in size.  Day after injection: generalized muscle weakness and aches (resolved next day). Did not seek treatment.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema
Clinical narrative: Large (3x6" oval) red area; some edema in same area; sore & itchy at injection site; persisted several days then started to diminish in size.  Day after injection: generalized muscle weakness and aches (resolved next day). Did not seek treatment.
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blood test normal, Chest X-ray normal, Chills, Diarrhoea, Fatigue
Clinical narrative: Pt states "body aching and fatigue" "chills overnight, I thought I was going to die". "I drank a lot of hot honey water and ibuprofen then I sweaty soaked all my clothes".  Symptoms reportedly continued like this with fevers of 103-104 for 2 days, by day 3 pt went to Emergency Department and underwent the below diagnostic tests.  Pt currently only reporting "watery stools" but states "I feel better".
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Hyperhidrosis, Influenza virus test negative, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Pt states "body aching and fatigue" "chills overnight, I thought I was going to die". "I drank a lot of hot honey water and ibuprofen then I sweaty soaked all my clothes".  Symptoms reportedly continued like this with fevers of 103-104 for 2 days, by day 3 pt went to Emergency Department and underwent the below diagnostic tests.  Pt currently only reporting "watery stools" but states "I feel better".
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Feeling abnormal, Hyperhidrosis, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Pt states "body aching and fatigue" "chills overnight, I thought I was going to die". "I drank a lot of hot honey water and ibuprofen then I sweaty soaked all my clothes".  Symptoms reportedly continued like this with fevers of 103-104 for 2 days, by day 3 pt went to Emergency Department and underwent the below diagnostic tests.  Pt currently only reporting "watery stools" but states "I feel better".
Age: 37.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Urine analysis normal
Clinical narrative: Pt states "body aching and fatigue" "chills overnight, I thought I was going to die". "I drank a lot of hot honey water and ibuprofen then I sweaty soaked all my clothes".  Symptoms reportedly continued like this with fevers of 103-104 for 2 days, by day 3 pt went to Emergency Department and underwent the below diagnostic tests.  Pt currently only reporting "watery stools" but states "I feel better".
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: LARGE RED CIRCULAR MARK THAT HURTS TO TOUCH-LASTED 4 DAYS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash erythematous, Rash pruritic
Clinical narrative: Itching, burning, red rash typical of Herpes Zoster.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood test abnormal, Chest X-ray abnormal, Dyspnoea, Infectious pleural effusion
Clinical narrative: Nausea in the morning, then around 3:30pm had right shoulder, rib and lower back pain. Thirty minutes later could hardly breathe had to call ambulance, was taken to emergency room hospital. Had xray, blood drawn, it showed I had pneumonia. Was sent home to take pain pill (Norco) and Antibiotic (Azithromycin 250). Follow up with Doctor October 15, took another xray and Doctor sent me back to hospital-emergency room- I had right side lower lobe pneumonia and I had right side pleural effusion/empyema was admitted to hospital and had a chest tube put in October 17, was in hospital for 10 days to drain liquid.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Lobar pneumonia, Musculoskeletal chest pain, Musculoskeletal pain, Nausea, Thoracostomy
Clinical narrative: Nausea in the morning, then around 3:30pm had right shoulder, rib and lower back pain. Thirty minutes later could hardly breathe had to call ambulance, was taken to emergency room hospital. Had xray, blood drawn, it showed I had pneumonia. Was sent home to take pain pill (Norco) and Antibiotic (Azithromycin 250). Follow up with Doctor October 15, took another xray and Doctor sent me back to hospital-emergency room- I had right side lower lobe pneumonia and I had right side pleural effusion/empyema was admitted to hospital and had a chest tube put in October 17, was in hospital for 10 days to drain liquid.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan
Clinical narrative: Nausea in the morning, then around 3:30pm had right shoulder, rib and lower back pain. Thirty minutes later could hardly breathe had to call ambulance, was taken to emergency room hospital. Had xray, blood drawn, it showed I had pneumonia. Was sent home to take pain pill (Norco) and Antibiotic (Azithromycin 250). Follow up with Doctor October 15, took another xray and Doctor sent me back to hospital-emergency room- I had right side lower lobe pneumonia and I had right side pleural effusion/empyema was admitted to hospital and had a chest tube put in October 17, was in hospital for 10 days to drain liquid.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: He reported fever, chills, aches.
Age: 1.0
Sex: M
Vaccine: DTAP, FLUX, HEPA, MMR, VARCEL
Symptoms: Convulsion, Electroencephalogram normal, Eye movement disorder, Injection site bruising, Injection site induration
Clinical narrative: Baby developed petechial appearing rash on arms, legs, and trunk.  He also had large bruise at site of injection. A few days after developing the rash, he had multiple eye rolling upward episodes that appeared to be seizures. An ambulatory (approximately one hour) EEG was performed and was normal. He will be seeing an opthamologist as well.  Currently work-up is in progess.
Age: 1.0
Sex: M
Vaccine: DTAP, FLUX, HEPA, MMR, VARCEL
Symptoms: Petechiae, Rash
Clinical narrative: Baby developed petechial appearing rash on arms, legs, and trunk.  He also had large bruise at site of injection. A few days after developing the rash, he had multiple eye rolling upward episodes that appeared to be seizures. An ambulatory (approximately one hour) EEG was performed and was normal. He will be seeing an opthamologist as well.  Currently work-up is in progess.
Sex: M
Vaccine: RUB
Symptoms: Aggression, Autism, Childhood disintegrative disorder, Crying, Decreased eye contact
Clinical narrative: I was vaccinated in the hospital 2 days after my first son was born. I was told I needed to be revaccinated since my "rubella shot never took" despite telling them I didnt want it many times I was told I had to have it and gave up the fight. I nursed my son for 8 months. He had explosive diarrhea and vomiting daily from when he was a few days old until he was 3 years old and we started interventions. With each vaccine he received he would regress from any progress he'd make. He was speech delayed, throwing 4 hr long tantrums and not making eye contact. He was diagnosed with autism at age 3. One of the vaccinations at 15 months old left him crying until he passed out and his temperature got so high that it broke my thermometer. Last reading was over 105. He developed many food allergies and was at one point up to 20 different foods.
Sex: M
Vaccine: RUB
Symptoms: Diarrhoea, Exposure during breast feeding, Food allergy, Loss of consciousness, Pyrexia
Clinical narrative: I was vaccinated in the hospital 2 days after my first son was born. I was told I needed to be revaccinated since my "rubella shot never took" despite telling them I didnt want it many times I was told I had to have it and gave up the fight. I nursed my son for 8 months. He had explosive diarrhea and vomiting daily from when he was a few days old until he was 3 years old and we started interventions. With each vaccine he received he would regress from any progress he'd make. He was speech delayed, throwing 4 hr long tantrums and not making eye contact. He was diagnosed with autism at age 3. One of the vaccinations at 15 months old left him crying until he passed out and his temperature got so high that it broke my thermometer. Last reading was over 105. He developed many food allergies and was at one point up to 20 different foods.
Sex: M
Vaccine: RUB
Symptoms: Speech disorder developmental, Vomiting
Clinical narrative: I was vaccinated in the hospital 2 days after my first son was born. I was told I needed to be revaccinated since my "rubella shot never took" despite telling them I didnt want it many times I was told I had to have it and gave up the fight. I nursed my son for 8 months. He had explosive diarrhea and vomiting daily from when he was a few days old until he was 3 years old and we started interventions. With each vaccine he received he would regress from any progress he'd make. He was speech delayed, throwing 4 hr long tantrums and not making eye contact. He was diagnosed with autism at age 3. One of the vaccinations at 15 months old left him crying until he passed out and his temperature got so high that it broke my thermometer. Last reading was over 105. He developed many food allergies and was at one point up to 20 different foods.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Patient called the pharmacy inquirying what were the typical adverse events after receiving a Pneumovax and influenza vaccine. She said that she was found on the floor passed out after vomiting after she had returned home from receiving the vaccines.
Age: 0.17
Sex: M
Vaccine: HBHEPB
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever and irritability for the last 3 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Fibromyalgia, Hypoaesthesia oral, Injection site rash
Clinical narrative: Site rash, nub tongue, burning eyes, joint pain especially in knee, fibromyalgia.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Knee arthroplasty, Nuclear magnetic resonance imaging
Clinical narrative: Site rash, nub tongue, burning eyes, joint pain especially in knee, fibromyalgia.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Injection site joint inflammation, Injection site joint warmth
Clinical narrative: Pt reports having had Tdap (L) deltoid on 1/12/15. Pt states on 1/13/15, had lymph node swelling (L) neck 1/14/15. Pt reports (L) elbow -> finger numbness and tingling, (L) elbow is inflamed and warm to touch. Pt has limited movement of (L) arm with weak hand grasp (L). Pt referred to ER.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Paraesthesia
Clinical narrative: Pt reports having had Tdap (L) deltoid on 1/12/15. Pt states on 1/13/15, had lymph node swelling (L) neck 1/14/15. Pt reports (L) elbow -> finger numbness and tingling, (L) elbow is inflamed and warm to touch. Pt has limited movement of (L) arm with weak hand grasp (L). Pt referred to ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Redness, swelling, approximately 1 cm radius bruise.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Pt states she experienced swelling to site of admin, arm was sore. Soreness and swelling went away next day. Pt came in to pharmacy to report on 1/9/15. Pt states didn't come in/call in to report after incident.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Faecal incontinence, Muscle disorder, Pain, Urinary incontinence
Clinical narrative: The morning after woke up with no use of muscles, bowel, bladder - no control, pain in entire body, went to the doctor Thursday following (6 days later) couldn't eat for 5 days. Dr said no flu shots in the future - Patient came to report on 1/16/15. Received physical therapy as a result.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site, red, swollen, hard, and warm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Following shot on Monday afternoon, I had an unusually sore arm, including inability to fully lift my arm without discomfort, very hot around area of shot and redness. By Tuesday, the second day, I experienced muscle soreness, headache and continuation of very, very hot area at site of shot and continued discomfort on lifting arm. On Wednesday, the third day, the muscle aches had reduced, but a slight headache persisted, I was very fatigued, and the very hot area around the shot site had increased and the redness extended down my arm nearly to my elbow. On Thursday and Friday the aches and headache had disappeared, but the hot arm and redness continued. On Saturday the redness changed to hives and itching which persisted on Sunday.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Myalgia, Pain, Pain in extremity
Clinical narrative: Following shot on Monday afternoon, I had an unusually sore arm, including inability to fully lift my arm without discomfort, very hot around area of shot and redness. By Tuesday, the second day, I experienced muscle soreness, headache and continuation of very, very hot area at site of shot and continued discomfort on lifting arm. On Wednesday, the third day, the muscle aches had reduced, but a slight headache persisted, I was very fatigued, and the very hot area around the shot site had increased and the redness extended down my arm nearly to my elbow. On Thursday and Friday the aches and headache had disappeared, but the hot arm and redness continued. On Saturday the redness changed to hives and itching which persisted on Sunday.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Patient developed a large rash around the immunization site of Prevnar 13.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Facial pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Acute pain in left side of face.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Convulsion, Dizziness, Lethargy, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Multiple seizures, shaking, nausea, stiffness, black outs, dizziness, lethargic.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Tremor
Clinical narrative: Multiple seizures, shaking, nausea, stiffness, black outs, dizziness, lethargic.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Pt noticed swelling on the site of injection on the right arm and was advised to take BENADRYL. As of 1/7/2015, pt's arm has a big bruise but pt has itches and hives (body). Pt is advised to consult prmary MD.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site (worse on 1/17 per pt - was better on 1/18).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient reported to the pharmacist that she forgot that she was vaccinated with ZOSTAVAX two years ago (date not specified) and had a second dose given to her at an unspecified physician's office within the last two months (date not specified, report date was DEC2014). The patient also reported that at some point in between the first and second dose of ZOSTAVAX she developed a case of the shingles. The patient did not seek treatment with the pharmacist for the shingles or for any concerns post the second dose of ZOSTAVAX. The patient asked the pharmacist if she should be concerned about receiving 2 doses of ZOSTAVAX. The pharmacist stated that there was no current adverse effect. 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 pharmacy intern refers to a patient of unknown age and unknown gender. On 26-DEC-2014 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot#, Exp and dose/frequency were not provided). No symptoms reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Adverse drug reaction, Arthralgia, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: Patient is a 29-year-old male who presents with a headache. Two days ago he had typhoid and anthrax vaccines. Later on that evening he developed headache, arthralgia, nausea, myalgia, photophobia, and intermittent difficulty breathing. He was seen in this emergency department and had a negative chest x-ray, negative CT, negative BMP, and normal CBC. He was given IV fluids and TORADOL with some improvement in his symptoms, today he was seen by the doctor and a chest x-ray was repeated which was negative. He also had negative labs note is unclear as to what those labs were. He was given XANAX and VICODIN. His symptoms did not improve he presents tonight. He was unable to take the VICODIN due to vomiting. Additional information was received on 11SEP2013 from a physician. The reporter confirmed that on 30JUN2013 the 29 year old male received both BIOTHRAX and typhoid vaccine. On that same day he experienced acute illness with symptoms of arthralgia, myalgia, headache, nausea, and photophobia. The male also experienced fever and chills which had not been previously reported. Subsequently, he recovered from the acute illness with the exception of persistent myalgia and arthralgia. Treatments included anti-inflammatory medications, prednisone, narcotics, muscle relaxants and anti-depressants; all without improvement. The reporter stated that an alternate physician had diagnosed the patient with "reproducible prolonged myalgia/arthralgia syndrome". At the time of the report, he had not recovered.