chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 2 unspecified patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On 10-MAR-2015, the patients were vaccinated with a dose of M-M-R II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting nurse stated that the vaccines were reconstituted using an expired diluent (lot number: H015687 and expiration date: October 2014). The nurse also confirmed that the vaccines were not expired. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, at 1 year of age, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot# and expiration date were not reported). At 4 years of age, the patient was vaccinated with the second dose (dose, route of administration, anatomical location, lot# and expiration date were not reported), 3 weeks after the second dose the patient received the third dose (dose, route of administration, anatomical location, lot# and expiration date were not reported). Thus, the patient received a total of 3 doses of VARIVAX (Merck) on unspecified dates. No adverse effects were reported. Additional information is not expected, no contact details were provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. It was unknown if she had any relevant medical or drug history. On 01-APR-2015 the patient received a one time standard dose of ZOSTAVAX (dose or amount unknown, route unknown, lot # K016325, expiry date: 24-DEC-2015). It was unknown if she took any relevant concomitant medications. The ZOSTAVAX was given at the pharmacy and a prescription for the ZOSTAVAX was not issued by her physician. On an unknown date in April 2015 the patient experienced pain at the injection site. On 03-APR-2015 she noticed a rash at the injection site characterized by redness and yellow vesicles or pimples. She had the rash only at the injection site, it was not spreading and she did not have the rash in any other areas. No tests were performed regarding the events. As of 04-APR-2015 she was no longer on ZOSTAVAX and the redness was better but it was unknown if the vesicles or pimples and injection site pain were better. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. It was unknown if she had any relevant medical or drug history. On 01-APR-2015 the patient received a one time standard dose of ZOSTAVAX (dose or amount unknown, route unknown, lot # K016325, expiry date: 24-DEC-2015). It was unknown if she took any relevant concomitant medications. The ZOSTAVAX was given at the pharmacy and a prescription for the ZOSTAVAX was not issued by her physician. On an unknown date in April 2015 the patient experienced pain at the injection site. On 03-APR-2015 she noticed a rash at the injection site characterized by redness and yellow vesicles or pimples. She had the rash only at the injection site, it was not spreading and she did not have the rash in any other areas. No tests were performed regarding the events. As of 04-APR-2015 she was no longer on ZOSTAVAX and the redness was better but it was unknown if the vesicles or pimples and injection site pain were better. Causality assessment was not provided. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Tremor
Clinical narrative: 4/7/15 at 2:27 pm Patient reported shaking uncontrollably. Her son called ambulance to go to ER. Pt says she also started having difficulty breathing. Contacted and spoke with patient 4/7/15 at 7:28pn; Pt says she declined ER eval. Sxs resolved with taking her lorazepam. Pt believes symptoms were related to the PREVNAR 13 immunization. Pt says she is fine now.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unspecified date in 2012 the patient was vaccinated with the first dose of GARDASIL injection (dose, frequency, route and lot# were not reported). And in January 2015, the patient received the second dose of GARDASIL. The reported also reported that the patient was "currently" in the office on 17-MAR-2015, and would receive dose three of the GARDASIL series. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of COMVAX injection (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1503USA005652) from the same reporter. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Vaccinia virus infection
Clinical narrative: Local vaccinia reaction on left arm and trunk with fever.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a patient of unknown demographics. On an unspecified date the patient inadvertently received a fourth dose of GARDASIL (dose/frequency and route unspecified) (Extra dose administered). No adverse effects were reported. Outcome of event, extra dose administered was unknown. Reporting physician considered the event to be not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that on unspecified date, unspecified number of patients (age and genders not reported) at her clinic were vaccinated with dose two of GARDASIL, intramuscular outside the recommended time frame. No adverse events reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant via a Poison and Drug Center (PDC) refers to a 14 year old male patient. The patient's relevant medical history and past drug history were unknown. On 01-APR-2015, the patient was vaccinated with a dose of GARDASIL (0.5ml, once, intramuscularly, lot # K006960, expiration date 19-FEB-2017), that had been stored outside of labeled storage range at 52.5 degrees Fahrenheit for two hours. The patient's concomitant medications were unknown. The patient had had no relevant laboratory data performed. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Bone pain, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Pt c/o swelling, tenderness, reddened upper arm occurring after vaccine, with radiation and pain to collar bone.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: Pt started with a lopsided smile that got worse same evening not getting any worse dx Bells Palsey.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. Patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date in 2010 the patient was vaccinated with one single shot of ZOSTAVAX (lot#, expiry date and route were not provided). On an unspecified date after receiving ZOSTAVAX the patient developed shingles. The patient spoke with the pharmacist for medical attention and received antiviral medication (name/dosage/frequency/manufacturer unknown) as treatment. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been receive from the patient's mother concerning a female patient. On 04-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose and route not reported). On 07-OCT-2013 the patient was vaccinated with a second dose of GARDASIL (lot#,expiration date, dose and route not reported). Because the injection was unavailable at the physician's office, the patient received only two doses of a three dose series of GARDASIL. The patient did not experience any side effects. The patient did not seek medical attention and her present status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # K020802, exp. date: 31-JAN-2016, subcutaneous, dose, strength, site of administration not reported). On an unknown date the patient experienced knot, forming at the injection site, immediately, after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (date of recovery not reported). The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX subcutaneous (lot, dose, strength, site of administration not reported). On an unknown date the patient experienced knot, forming at the injection site immediately after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (date of recovery not reported). The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age. Medical history and concurrent conditions were not reported. In March 2014, reported as last week, the patient was vaccinated with the second dose of RECOMBIVAX HB 5mcg/0.5ml, pediatric formulation (incorrect product formulation administered). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse events were reported. It was confirmed with the reporter that this medication error was not related to label confusion. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered 3/27/15. That day, small, tender lump appeared at injection site. 3/28, more pain and swelling. 3/29 red, swollen, painful, went to urgent care. Put on doxycycline x 10 days. Area enlarged to 10 x 15 cm at f/u on 4/8/15. Improved area now soft and faded.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Left arm muscle and shoulder severe pain which started 3 days after injection (1/20/15) has continued.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4 cm diameter in duration/redness on upper 1/3 R thigh.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Phone call received 4/8/2015.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Gianotti-Crosti syndrome, Papule, Rash papular
Clinical narrative: Papules on hands, increased next day to include hands, feet and face, seen 4/6/15 in office with papular vesicular rash face, hands, feet primarily, few on neck and trunk, buttock. Diagnosed Gianotti Crostti.
Age: 69.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Cellulitis, Contusion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states he had a severe local reaction following vaccination with Tdap, with red, swollen, painful right arm from shoulder to elbow, swollen axillary lymph nodes, and a streak of bruising following a superficial vein down to his wrist.
Age: 69.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Local reaction, Lymphadenopathy
Clinical narrative: Patient states he had a severe local reaction following vaccination with Tdap, with red, swollen, painful right arm from shoulder to elbow, swollen axillary lymph nodes, and a streak of bruising following a superficial vein down to his wrist.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: EMPLOYEE STARTED FEELING A HEADACHE SHORTLY FOLLOWED BY NAUSEA. EMPLOYEE VOMITED TWICE AT 3:30 PM.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Joint crepitation, Mastication disorder, Muscular weakness, Pain in extremity
Clinical narrative: Woke next day with entire arm painful. The following day had pain all the way across his chest that lasted for 10 days along with the arm pain. Pain constant and unwavering. He was "laid up" for 10 days.  After 10 days pain resolved but then noticed cracking and popping of joints. Difficulty chewing due to jaw pain. Knees give out on him. Lasted 3-4 wks. Did see chiropractor.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in jaw
Clinical narrative: Woke next day with entire arm painful. The following day had pain all the way across his chest that lasted for 10 days along with the arm pain. Pain constant and unwavering. He was "laid up" for 10 days.  After 10 days pain resolved but then noticed cracking and popping of joints. Difficulty chewing due to jaw pain. Knees give out on him. Lasted 3-4 wks. Did see chiropractor.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: ITCHING ON BOTH ARMS.
Age: 63.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Pt reported dizziness and chest discomfort. Pt medications she was taking are Linsinopril, Zocor and Synthroid. Pt requested MMR/VZV/Td or Tdap to fullfill requierments for a green card.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Insomnia, Middle insomnia
Clinical narrative: Upper left arm where shot was administered is still sore 6 months later. Sometimes hurts so bad at night it wakes me up and have difficult time falling back to sleep because of the pain.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Initial insomnia, Injection site pain, Middle insomnia
Clinical narrative: Upper left arm where shot was administered is still sore 6 months later. Sometimes hurts so bad at night it wakes me up and have difficult time falling back to sleep because of the pain.
Age: 9.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Erythema, Pruritus, Pyrexia, Rash, Vomiting
Clinical narrative: Typhoid shot provided at 11am. Rash, vomiting, itch, fever and redness at 2pm. Took patient back to medical center hospital to see physician and was prescribed steroids, anti histamine and anti nausea medicine in emergency room.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site pain, Injection site warmth, Rash erythematous, Vaccination site nodule, Vaccination site swelling
Clinical narrative: Vaccination site has swollen into a knot with a red rash, the size of the rash is large covering my entire back side of the arm. The injection site constantly stings and is warm to the touch. It has been two days since the shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Headache
Clinical narrative: Headache.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: Very painful shot, felt like a double jab following morning much discomfort on shot site, and stiffness and sore upper arm, shot was given on top of shoulder.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal stiffness
Clinical narrative: Very painful shot, felt like a double jab following morning much discomfort on shot site, and stiffness and sore upper arm, shot was given on top of shoulder.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site discomfort, Musculoskeletal disorder, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Very painful shot, felt like a double jab following morning much discomfort on shot site, and stiffness and sore upper arm, shot was given on top of shoulder.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Swelling
Clinical narrative: Very painful shot, felt like a double jab following morning much discomfort on shot site, and stiffness and sore upper arm, shot was given on top of shoulder.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Local swelling, redness, warmth and mild itching at vaccine site.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Hypersensitivity, Nausea, Swelling face
Clinical narrative: Case number PHHY2015US037684, is an initial literature report received on 25 Mar 2015. The authors discussed about evaluation and subsequent safe administration of rabies vaccine to a child presumably allergic to the gelatin content of PCECV RABAVERT. This report refers to a 07 years old male patient. His medical history revealed no ancillary atopic problems to date. Specifically, he had no history of atopic dermatitis, asthma, allergic rhinitis, food and drug allergy. His growth and development were appropriate for his chronological age. He ate chicken frequently but did not care for egg although he could eat egg without obvious adverse effects. He had a history of eating gelatin-containing foods such as Jell-O without adversity. His family history was negative for atopic disease. His vaccination history included administration of all childhood immunizations including MMR (manufacturer and batch number unknown) and varicella vaccines (manufacturer and batch number unknown) without adverse reactions. On an unknown date, he was bitten by feral cat. Immediately after cat bite, he was vaccinated with first dose of PCECV RABAVERT (batch number: unknown) with concurrent administration of rabies immune globulin and amoxicillin at local emergency department. At home, within 1 hour of RABAVERT administration, he complained of chest discomfort, nausea and facial swelling. The symptoms resolved without intervention and he continued his prescribed amoxicillin without incident. The authors concluded that gelatin can cause IgE-mediated or non IgE-mediated reactions. Hence it was important to know the components of vaccines and be aware of the potential for reactions. Desensitization can be considered for vaccine administration in certain cases. Seriousness assessment of chest discomfort, nausea and facial swelling was upgraded based on information in the source document. On an unknown date, 3 days after first dose, he was vaccinated with second dose of RABAVERT (batch number: unknown) and experienced acute allergic reaction (see case: PHHY2015US038494).                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unspecified date in 2015, the patients were vaccinated with doses of GARDASIL (administration routes, lot numbers and expiration dates were not provided), which were exposed to a temperature outside of the recommended range since an unspecified date in "early February 2015". No concomitant therapies were reported, neither was any adverse effect. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report was received from a pharmacist refers to an 18 year old female patient. Patient was not pregnant. The patient's concurrent conditions and medical history were not reported. The patient had completed her childhood M-M-R II series. Upon entering college, the patient was vaccinated with an additional dose of M-M-R II (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, after her additional dose, the patient's titer levels were low (unspecified lab test was performed). The reporter stated that they were less than one. Patient sought medical attention and contacted pharmacist. No treatment was given for the event. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of PEDVAXHIB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 60 year old female patient with depression, regarding herself. The patient's medical history was not reported. On 24-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration dates were not provided). Concomitant therapies included ZOLOFT. On 25-MAR-2015, 2 days after onset of therapy the patient experienced a raised bumpy rash on her arms and legs. The patient reported having called seeking medical attention. The outcome of the rash was unknown. Additional information is not expected, since there is no contact details to follow up.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 50-year-old male patient who received TWINRIX (adult). Concomitant products included HAB. On 12th December 2014, the patient received the 2nd dose of TWINRIX adult (unknown) 1 ml. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long was unknown. Additional information was provided as follow: The 2nd dose of TWINRIX was delayed by 2 months. The 1st dose was given on 09 September 2014 and the 2nd dose was given on 12 December 2014. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of M-M-R II, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three 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 nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of GARDASIL, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 23-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, frequency, route, anatomical location and lot number were not reported), which was expired. The expiration date was 06-MAR-2015. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot # J000366, expiration date: 22-AUG-2015, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pustule
Clinical narrative: Pt seen on 3/23/15 for physical PREVNAR 13 given on (R) deltoid pt states after 6 days red pustules and pain at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: (L) arm swollen, red starting about 24 hr after injection, extending from shoulder to mid lower arm, initially tight, improved by the time I saw him, no cellulitis. No fever. Impressive swelling no compartment syndrome.
Age: 0.2
Sex: M
Vaccine: HEPA, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given a Hep A vaccination instead of a Hep B on 1-16-15. Patient had no reaction that was reported by parent and patient's next appointment was on 3-24-15 for a well visit.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Dysuria, Nausea, Pyrexia, Urine analysis
Clinical narrative: Fever 101 degrees F, chills, difficulty urination, nausea when he went home after visit.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Pain at injection site. Shoulder pain, stiffness, restricted ROM.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Child had hour long nose bleed at school the next day. Fully recovered without need for intervention.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large area on his LL that is red swollen and bigger then a 50 cent piece. He was given 2 vaccines on this leg. Upper area SQ polio and lower LVL PROQUAD SQ.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt came in pharmacy on 4/8/15 (after 7 dys of administration). Pain arm/shoulder, big red bruise on injection site, mild, itching. There was mild pain since 04/01/15.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored M-M-R II (dose, strength and route were not reported, lot number K002528, expiration date 18-FEB-2016). No adverse effects reported. This case was one of the three reports received from the same reporter. The other two lot # for M-M-R II was captured in case 1502USA005910 and 1504USA002730. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. No relevant medical history was provided. Since 12-MAR-2015 these patients were vaccinated with 12 doses of VARIVAX (Merck) (dose and route not reported) which were improperly stored. No adverse events were reported. This is one of two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of VAQTA (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1504USA003190, 1503USA005652 and 1504USA003189) from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored M-M-R II (dose, strength and route were not reported, lot number K001230, expiration date 27-JAN-2016). No adverse effects reported. This case was one of the three reports received from the same reporter. The other two lot # for M-M-R II was captured in case 1502USA005910 and 1504USA002731. Additional information has been requested. Therapy information and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to unspecified patients. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # K007828, expiration date, route and dose unspecified). No adverse event were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008932, expiration date:04-MAR-2017, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # J008427, expiration date: 09-APR-2016, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses od PROQUAD (Merck) (lot # K025760, expiration date: 08-JUN-2016, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot# K010222, expiration date: 12-MAY-2016, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified patient of unknown age. On 30-MAR-2015 the patient received an expired dose of M-M-R II (lot# J002867, expiration date:08-MAR-2015, strength, route and dose were unknown). No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Gait disturbance, Limb discomfort
Clinical narrative: This spontaneous report was received from a 70 year old male patient who is a physician and refers to himself. There was no patient's medical history and no drug reactions or allergies reported. On 06-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (expiration date, dose and route were not reported) lot # K011004. Concomitant therapies included losartan potassium (manufacturer unknown), aspirin and FLOMAX. On 08-JAN-2015 (reported as "2 days later"), the patient developed numbness in his right leg. The physician stated the numbness occurred when he was either sitting or walking and it was difficult for him to walk and at the time of the report he could no longer garden because he could not sit on his right leg. The physician stated he had a Magnetic resonance imaging (MRI), of his head, performed on an unspecified date in 2015 to rule out a stroke. The physician stated the MRI "didn't show anything". There was no treatment given for adverse events. The physician thought that adverse events caused significant disability because he liked to garden, it was a part of his life and at the time of the report he could no longer do it. The physician stated that at the time of the report adverse events happened if he was sitting for 30 minutes to an hour but he felt like it was getting worse. Relatedness between adverse events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This spontaneous report was received from a 70 year old male patient who is a physician and refers to himself. There was no patient's medical history and no drug reactions or allergies reported. On 06-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (expiration date, dose and route were not reported) lot # K011004. Concomitant therapies included losartan potassium (manufacturer unknown), aspirin and FLOMAX. On 08-JAN-2015 (reported as "2 days later"), the patient developed numbness in his right leg. The physician stated the numbness occurred when he was either sitting or walking and it was difficult for him to walk and at the time of the report he could no longer garden because he could not sit on his right leg. The physician stated he had a Magnetic resonance imaging (MRI), of his head, performed on an unspecified date in 2015 to rule out a stroke. The physician stated the MRI "didn't show anything". There was no treatment given for adverse events. The physician thought that adverse events caused significant disability because he liked to garden, it was a part of his life and at the time of the report he could no longer do it. The physician stated that at the time of the report adverse events happened if he was sitting for 30 minutes to an hour but he felt like it was getting worse. Relatedness between adverse events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Hypoaesthesia, Intermittent claudication, Limb discomfort
Clinical narrative: This spontaneous report was received from a 70 year old male patient who is a physician and refers to himself. There was no patient's medical history and no drug reactions or allergies reported. On 06-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (expiration date, dose and route were not reported) lot # K011004. Concomitant therapies included losartan potassium (manufacturer unknown), aspirin and FLOMAX. On 08-JAN-2015 (reported as "2 days later"), the patient developed numbness in his right leg. The physician stated the numbness occurred when he was either sitting or walking and it was difficult for him to walk and at the time of the report he could no longer garden because he could not sit on his right leg. The physician stated he had a Magnetic resonance imaging (MRI), of his head, performed on an unspecified date in 2015 to rule out a stroke. The physician stated the MRI "didn't show anything". There was no treatment given for adverse events. The physician thought that adverse events caused significant disability because he liked to garden, it was a part of his life and at the time of the report he could no longer do it. The physician stated that at the time of the report adverse events happened if he was sitting for 30 minutes to an hour but he felt like it was getting worse. Relatedness between adverse events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal, Pain in extremity, Peripheral venous disease
Clinical narrative: This spontaneous report was received from a 70 year old male patient who is a physician and refers to himself. There was no patient's medical history and no drug reactions or allergies reported. On 06-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (expiration date, dose and route were not reported) lot # K011004. Concomitant therapies included losartan potassium (manufacturer unknown), aspirin and FLOMAX. On 08-JAN-2015 (reported as "2 days later"), the patient developed numbness in his right leg. The physician stated the numbness occurred when he was either sitting or walking and it was difficult for him to walk and at the time of the report he could no longer garden because he could not sit on his right leg. The physician stated he had a Magnetic resonance imaging (MRI), of his head, performed on an unspecified date in 2015 to rule out a stroke. The physician stated the MRI "didn't show anything". There was no treatment given for adverse events. The physician thought that adverse events caused significant disability because he liked to garden, it was a part of his life and at the time of the report he could no longer do it. The physician stated that at the time of the report adverse events happened if he was sitting for 30 minutes to an hour but he felt like it was getting worse. Relatedness between adverse events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a 70 year old male patient who is a physician and refers to himself. There was no patient's medical history and no drug reactions or allergies reported. On 06-JAN-2015, the patient was vaccinated with a dose of ZOSTAVAX (expiration date, dose and route were not reported) lot # K011004. Concomitant therapies included losartan potassium (manufacturer unknown), aspirin and FLOMAX. On 08-JAN-2015 (reported as "2 days later"), the patient developed numbness in his right leg. The physician stated the numbness occurred when he was either sitting or walking and it was difficult for him to walk and at the time of the report he could no longer garden because he could not sit on his right leg. The physician stated he had a Magnetic resonance imaging (MRI), of his head, performed on an unspecified date in 2015 to rule out a stroke. The physician stated the MRI "didn't show anything". There was no treatment given for adverse events. The physician thought that adverse events caused significant disability because he liked to garden, it was a part of his life and at the time of the report he could no longer do it. The physician stated that at the time of the report adverse events happened if he was sitting for 30 minutes to an hour but he felt like it was getting worse. Relatedness between adverse events and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Pt received HPV immun and fever spiked to 104 degrees at night with no other symptoms.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported; pt received an expired vaccine, but Merck was contacted and their response was that dose was to be counted.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Axillary pain, Brachial plexopathy, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable physician's assistant. A 57 year-old male patient received PREVNAR 13 (lot J67646, expiry date 01Mar2016) intramuscular in the left deltoid and MENOMUNE (lot UH537AA, expiry date 20May2016) subcutaneous in the right deltoid, both on 30Jan2015 at 1:20 pm at 0.5 ml single. The patient was HIV positive since 2009 and he has been on anti-viral therapy for a long time, other relevant medical histories included ongoing hepatitis C since 2012, ongoing allergy to latex, ongoing syphilis diagnosed on 30Jan2015. The patient underwent laboratory tests and procedures which included syphilis test: 1-4 on 11Feb2015 and for that on 17Feb2015 he received BICILLIN LA. The patient's concomitant medications were not reported. The patient had previously taken KEFLEX and had experienced blood pressure fluctuations and heart rate abnormal, meperidine and he had experienced hiccups. On 02Mar2015 the patient experienced brachial plexitis from which he was not recovered, right shoulder pain and numbness in right middle fingers, deep pain in right scapula and pain persisted in right hand because of weakness and numbness, all with unknown outcome. Due to the events the patient had seen a neurologist at a tertiary care center, he had a phone call with a specialist neurologist on 06Mar2015 and he visited him on 27Mar2015. On 27Mar2015 pain moved into this right armpit and inside of right arm; pain was right subscapular and he still had right hand weakness especially right index finger, from which he was not recovered. The neurologist believed that the adverse reactions were from either one of the vaccines. The patient was on anti-viral therapy but it was a stable regimen and the reporter did not think the above was due to that.
Age: 57.0
Sex: M
Vaccine: MEN, PNC13, MEN, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician's assistant. A 57 year-old male patient received PREVNAR 13 (lot J67646, expiry date 01Mar2016) intramuscular in the left deltoid and MENOMUNE (lot UH537AA, expiry date 20May2016) subcutaneous in the right deltoid, both on 30Jan2015 at 1:20 pm at 0.5 ml single. The patient was HIV positive since 2009 and he has been on anti-viral therapy for a long time, other relevant medical histories included ongoing hepatitis C since 2012, ongoing allergy to latex, ongoing syphilis diagnosed on 30Jan2015. The patient underwent laboratory tests and procedures which included syphilis test: 1-4 on 11Feb2015 and for that on 17Feb2015 he received BICILLIN LA. The patient's concomitant medications were not reported. The patient had previously taken KEFLEX and had experienced blood pressure fluctuations and heart rate abnormal, meperidine and he had experienced hiccups. On 02Mar2015 the patient experienced brachial plexitis from which he was not recovered, right shoulder pain and numbness in right middle fingers, deep pain in right scapula and pain persisted in right hand because of weakness and numbness, all with unknown outcome. Due to the events the patient had seen a neurologist at a tertiary care center, he had a phone call with a specialist neurologist on 06Mar2015 and he visited him on 27Mar2015. On 27Mar2015 pain moved into this right armpit and inside of right arm; pain was right subscapular and he still had right hand weakness especially right index finger, from which he was not recovered. The neurologist believed that the adverse reactions were from either one of the vaccines. The patient was on anti-viral therapy but it was a stable regimen and the reporter did not think the above was due to that.