chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Received shingle vaccine 4/28/16 (R) arm. 4/29/16 noticed sore red spot (R) arm. 4/30/26 fell fatigued and slept all day with decreased appetite and headache. 5/1/16 less soopy yellow drainage. Seen in office 5/2/16 3 cm area of area of bright pink erythema with surround of 20cm erythema. Rx KEFLEX 500 Q 10X 10dy. for cellulitis.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Purulent discharge
Clinical narrative: Received shingle vaccine 4/28/16 (R) arm. 4/29/16 noticed sore red spot (R) arm. 4/30/26 fell fatigued and slept all day with decreased appetite and headache. 5/1/16 less soopy yellow drainage. Seen in office 5/2/16 3 cm area of area of bright pink erythema with surround of 20cm erythema. Rx KEFLEX 500 Q 10X 10dy. for cellulitis.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site discharge, Injection site erythema
Clinical narrative: Received shingle vaccine 4/28/16 (R) arm. 4/29/16 noticed sore red spot (R) arm. 4/30/26 fell fatigued and slept all day with decreased appetite and headache. 5/1/16 less soopy yellow drainage. Seen in office 5/2/16 3 cm area of area of bright pink erythema with surround of 20cm erythema. Rx KEFLEX 500 Q 10X 10dy. for cellulitis.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Malaise, Skin lesion
Clinical narrative: Received shingle vaccine 4/28/16 (R) arm. 4/29/16 noticed sore red spot (R) arm. 4/30/26 fell fatigued and slept all day with decreased appetite and headache. 5/1/16 less soopy yellow drainage. Seen in office 5/2/16 3 cm area of area of bright pink erythema with surround of 20cm erythema. Rx KEFLEX 500 Q 10X 10dy. for cellulitis.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient stated he started with arm soreness and fever with body aches. Patient noted arm getting red with swelling and hot to touch. Pt. took ADVIL only. Pt. stated redness and swelling was getting better since yesterday when he reported to clinic.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Patient stated he started with arm soreness and fever with body aches. Patient noted arm getting red with swelling and hot to touch. Pt. took ADVIL only. Pt. stated redness and swelling was getting better since yesterday when he reported to clinic.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Localized redness/warmth at injection site (Rt deltoid). Diminished erythema as of this date. No c/o's discomfort today.
Age: 69.0
Sex: M
Vaccine: TD
Symptoms: Discomfort, Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection site (L upper arm) pain started the evening after receiving injection. Pain worsened to a point where mobility affected by discomfort. Tx - ice, rest and pain medication. Will follow up in clinic in 1 week.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 18-APR-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details, route of administration were not reported) lot#M010212, expiry:21-JAN-2019. It was reported that the vaccines were exposed to the temperature 49F during a time frame of 49 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were unknown. On 08-JAN-2016, the patient was vaccinated with first dose of M-M-R II, VARIVAX  and VAQTA (Merck). On 28-APR-2016 the patient was vaccinated with second doses of M-M-R II lot # L026553 expiry date 16-JUL-2017, VARIVAX (Merck) lot # L0423622 expiry date 03-NOV-2017 and VAQTA lot # L045713 expiry date 14-JAN-2017 earlier than recommended dosing schedule. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition included left elbow pain and unspecified joint pain. On 22-APR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L033311, expiration date: 01-DEC-2016, dose and router were unknown). In April 2016, the patient developed a red raised bump at the injection site after receiving ZOSTAVAX. It also reported that the left elbow pain and unspecified joint pain increased after vaccination. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 7 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (which had the lot number of L017407, expiration date: 15-AUG-2017) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route not provided, lot number # L037565, expiration date 29-SEP-2017 and lot number # reported as L048466, expiration date 02-DEC-2017). No adverse effects were reported. There was no product quality issue (PQC) involved. VARIVAX, L037565, exp. 29-SEP-2017; L048466, exp. 02-DEC-2017. Temperature: 14F; Time frame: 2 hours, 15 minutes; Was back in range? Yes' Was previous temperature excursion? No; Was call because of a data logger? No; This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Pain in extremity, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to four patients of unknown demographics. The concurrent condition and medical history was not reported. On 14-APR-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route, frequency and lot details were unknown) at a vaccine clinic. The concomitant medication was not reported. On the same day, all the patient's arms were swollen twice the size at the injection site and their arms were painful and discolored from the injection site down to their hands. The patients sought medical attention by contacting the pharmacist and no treatment was rendered for the event. The action taken with the vaccine was not applicable. The outcome of the events was reported as not resolved. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. The patient was vaccinated on three separate times with a dose of RECOMBIVAX HB (dose, route of administration, lot #, expiration date and therapy type were unknown), on 10-MAR-2016, followed by 11-APR-2016 and finally on 02-MAY-2016, respectively. However, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On 20-APR-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left arm (reported lot # L038926 with expiration date of 06-JAN-2017). The patient's concomitant medications were not reported. On 21-APR-2016, the patient developed a small orange raised spot at the injection site on the left arm, additionally the spot was itchy and no blisters or shingles were reported. On 22-APR-2016, the patient sought for attention on the pharmacy. Due to the event, the pharmacist advised the patient to use an unspecified cream for the itchiness. The pharmacist stated that the patient's husband was also vaccinated with ZOSTAVAX but no adverse effect was reported. Furthermore, no product quality issue was involved. At the time of the report, the outcome of injection site mass and pruritus were unknown. The relatedness between the adverse events and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 02-MAY-2016, the patient was subcutaneously vaccinated with a 0.5 ml expired dose of M-M-R II (which had a lot # of K000738 and expiration date of 16-JAN-2016; however dosage number, therapy type and anatomical location were not reported). No concomitant medications were reported. Despite getting vaccinated with an expired dose, no adverse effects were reported. Additionally, no product quality complaint was involved. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 02-MAY-2016, the patient was subcutaneously vaccinated with 0.65 ml expired dose of ZOSTAVAX (which had a lot # of L000447 and expiration date of 08-MAR-2016; however dosage number and anatomical location were not reported). No concomitant medications were reported. Despite getting vaccinated with an expired dose, no adverse effects were reported. Additionally, no product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Chills, fever, headache, increased B/P, dizzy, fatigue. 4/30/16 Ambulance to ER (hospital) x 7 hours then 2 days later (L) arm red, swollen, hot to touch, painful.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Laboratory test, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Chills, fever, headache, increased B/P, dizzy, fatigue. 4/30/16 Ambulance to ER (hospital) x 7 hours then 2 days later (L) arm red, swollen, hot to touch, painful.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Chills, fever, headache, increased B/P, dizzy, fatigue. 4/30/16 Ambulance to ER (hospital) x 7 hours then 2 days later (L) arm red, swollen, hot to touch, painful.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Body temperature increased
Clinical narrative: Given PREVNAR 13 on 4-15-16. Woke up next AM with temp 100.2, weakness. Called 911 and patient transferred to hospital where he was admitted x 5d. Placed on LEVAQUIN.
Age: 62.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Pain
Clinical narrative: Weakness, Body Aches, Redness and Soreness at injection site.
Age: 62.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Inappropriate schedule of drug administration, Pain
Clinical narrative: Weakness, Body Aches, Redness and Soreness at injection site.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm became red, hot to touch and raise area formed at injection site size of baseball. Did not run a fever. Symptoms disappeared in 5 days.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; six loose watery bowel movements through to 10 PM.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Nausea, Vomiting
Clinical narrative: EMPLOYEE STATED SHE FELT CLAMMY 10 MINS AFTER INJECTION. DONOR THEN STATED SHE FELT NAUSEOUS AND VOMITED.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching at injection site, "hard knot" at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After receiving vaccines patient complained of lightheadedness. Lasted approx. 5 minutes. Patient laid on exam table, legs propped up. Cup of water given.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Pruritus, Rash
Clinical narrative: Received PREVNAR in left deltoid on 4/21. Per MD at end of day she noticed swelling to elbow and by next AM to wrist. Had modest pruritus and papillary rash over entire arm. Pt said took BENADRYL PO and used steroid cream. MD just prescribed prednisone x 9 day. Still being treated w prednisone.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Lymphadenopathy, Peripheral swelling, Pruritus
Clinical narrative: PATIENT  REORTED TODAY, 5/3/2016, THAT ON 4/28/16 SHE WOKE UP AND HER LEFT ARM WAS ITCHY. SHE LOOKED AT HER LEFT ARM AND SAW A RASH AROUND THE AREA THAT SHE RECIEVED THE TDAP IMMUNIZATION IN ON 4/26/2016. SHE THEN SAID DURING THE DAY HER ARM SWELLED AND SHE FELT LIKE A GLAND UNDER ARM WAS ALSO SWOLLEN. SHE USED BENADRYL CREAM TO THE RASH AREA WHICH HELPED THE ITCHING AND SHE STARTED ALSO TAKING ORAL BENEDRYL. SHE CONTINUED TO USE BENEDYL SINCE TO PRESENT AND SHE STATES TODAY, 5/3/16, THAT THE AREA IS MUCH BETTER AND THE REDDNESS, SWELLING, AND ITCHING HAD ALMOST FULLY GONE AWAY. SHE STATES THAT SHE HAS NEVER HAD A REACTION LIKE THIS TO TETANUS IN THE PAST.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: Diarrhea; soreness at injection site.
Age: 15.0
Sex: F
Vaccine: MNQHIB
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Swelling
Clinical narrative: Pain, swelling, itching, redness, heat, hives.
Age: 15.0
Sex: F
Vaccine: MNQHIB
Symptoms: Urticaria
Clinical narrative: Pain, swelling, itching, redness, heat, hives.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Approximately 30-50 vesicular lesions diffusely over body.
Age: 74.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and slight swelling around inject site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: I woke up after laying on the arm that was vaccinated, because of the pain in the upper arm and shoulder. Took 2 ibuprofen and went back to bed.
Age: 47.0
Sex: M
Vaccine: IPV, PPV, TD
Symptoms: Ear pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: After receiving infusions I usually take it slow for the day. I was resting and when I went to reach for something on end table I felt sharp pain followed by an inability to move my arm and a steady throbbing from behind my right ear down my arm to my fingers.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Syncope
Clinical narrative: Gave Hepatitis A imminization, patient was fine, seated, remained seated after shot. I talked to him then returned to pharmacy then he fell off chair for less than 30 seconds. Syncope. He came to and waited for about 20 minutes gave him some cool cloths talked to hime and he was fine. I ask him to wait 15 minutes after the injection and he did.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient called complaining of tenderness, redness, pain, and swelling around the injection site. Stated it hurt to move arm and the pain and swelling had been getting progressively worse as the day went on. I had patient come back in to pharmacy to look at the injection site and determined patient experienced an adverse reaction.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient had small heated patches around the injection site that were warm to touch. NO itching or pain.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Presyncope, Unresponsive to stimuli
Clinical narrative: Child was sitting in chair after his vaccinations at 1145.  As he arose he paled and fell into the chairs with a vasovagal reponse.  Child awake, but not repsonive to voice commands, HR 45 RR 10.  Not responsive to sternal rub.  Called 911 1258 HR 90 RR 15,  EMT arrived 1300, child still not responsive to voice, but awake.  Mother informed EMT's child had not eaten breakfast. VS taken with BS 68 Sats 99%, HR 100.  Child does not take medications and has no significant history other than mild asthma. Child showed moderate improvement and able to communicate at 1320  Mother declined transport to ED.  Mother to follow up as needed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain
Clinical narrative: Pain in my back started 4 days after receiving the shingles vaccine, and then a rash emerged 2 days later. I've gone to a doctor who confirms that I have shingles, one week after receiving the shingles vaccine.
Age: 12.0
Sex: F
Vaccine: MENHIB, UNK
Symptoms: Acne, Alopecia, Depression, Erythema, Hot flush
Clinical narrative: Hot flashes, irritability, cold hands and feet, hypersensitive to noise, severe acne, yellow eyes, hair loss, depression, red feet.
Age: 12.0
Sex: F
Vaccine: MENHIB, UNK
Symptoms: Hyperacusis, Irritability, Ocular icterus, Peripheral coldness
Clinical narrative: Hot flashes, irritability, cold hands and feet, hypersensitive to noise, severe acne, yellow eyes, hair loss, depression, red feet.
Age: 1.69
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Crying, Decreased appetite, Irritability, Somnolence, Vomiting
Clinical narrative: Crying, fussiness, vomiting, loss of appetite, sleepiness.
Age: 17.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Full blood count abnormal, Leukopenia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of leukopenia in a 17-year-old male patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). Concomitant products included HPV Vaccine. In March 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In March 2016, 1 day after receiving BEXSERO, the patient experienced leukopenia (serious criteria GSK medically significant and other; serious as per reporter) and fever. On an unknown date, the outcome of the leukopenia and fever were recovered/resolved. The reporter considered the leukopenia to be probably related to BEXSERO. The reporter considered the fever to be possibly related to BEXSERO. Additional details were provided as follows: The reporter stated the patient did not have a history of cancer. The patient received the 1st dose of BEXSERO in a series of 2 doses. The exact date of vaccination was unknown but was sometime in March 2016. On the same day, the patient also received a HPV vaccine (non-GSK) in a separate arm. Within 24 hours (unknown if it was after vaccination or event onset), the patient visited an urgent care where it was discovered he had febrile leukopenia with a complete blood count (CBC) at 2.9. The physician had seen the patient since administration and the adverse event was resolved. The physician reported that he knew that the patient did not have any reaction to an other previous vaccination. It was not known if the patient was on any other medications.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Thrombosis
Clinical narrative: Information was received on 29-APR-2016 from a litigation consultant for a third party claims management service regarding a 72 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant therapies. The patient and her attorney are alleging that on 26-JAN-2016 (also reported 27-JAN-2016), the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L-22795, expiration date not reported) intramuscularly in the right upper arm and developed a blood clot. She is now unable to move her right arm. Upon internal review the events of blood clot and unable to move her arm were determined to be medically significant. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: Hib vaccine "diluent only" given without the actually vaccine power mixed in.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Left deltoid pain, difficulty lifting left arm, started 5/2/16. Fever 101 degrees F, chills and headache - started 5/3/16.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MEN, MEN
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 25-APR-2016, the patient was vaccinated with improperly stored GARDASIL 9 (which had a lot # reported as M003659 and an expiration date of 20-SEP-2017; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Along with GARDASIL 9, (intramuscular injection) PEDVAXHIB, M-M-R II and ROTATEQ also appeared in the list products whose temperature stability was called into question. However, no doses of these vaccines were administered to any patients. The vaccines experienced a temperature excursion of 30.2 F for a time frame of 7.18 hours. There were, reportedly, no previous temperature excursions and the call for the aforementioned one was because of a data logger. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients who might on unspecified dates have been administered with an unspecified number of unspecified doses of improperly stored GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017, route unknown). The GARDASIL 9 was stored at 30.4 F for 8 hours 30 minutes. There was no previous excursions. No data logger reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Interchange of vaccine products, Underdose, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 6-month-old female patient who received ROTARIX (batch number A41CB543A, expiry date 24th February 2017). Co-suspect products included ROTATEQ. Previously administered products included ROTATEQ (1st dose received on 14th December 2015). On 20th April 2016, the patient received ROTARIX 1 ml. On an unknown date, the patient received the 2nd dose of ROTATEQ. On 20th April 2016, 1 hr after receiving ROTARIX, the patient experienced vomiting, underdose and interchange of vaccine products. On an unknown date, the outcome of the vomiting, underdose and interchange of vaccine products were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details provided were as follows: This case was identified as a duplicate of case US2016056503. Case US2016056503 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient. On 14th December 2015, the patient received a dose of ROTATEQ vaccine. On 20th April 2016, the patient received a dose of ROTARIX, which led to an interchange of vaccine products. About an hour after receiving a dose of ROTARIX, the patient spitted out the dose. This led to an underdose. No further information was reported regarding the event.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Influenza, Malaise, Nasal congestion
Clinical narrative: This case was reported by a consumer and described the occurrence of nasal congestion in a 65-year-old male patient who received FLUARIX. In November 2015, the patient received FLUARIX. On an unknown date, less than a month after receiving FLUARIX, the patient experienced nasal congestion, flu and sickness. On an unknown date, the outcome of the nasal congestion, flu and sickness were unknown. It was unknown if the reporter considered the nasal congestion, flu and sickness to be related to FLUARIX. Additional details were as follows: This case was linked to a case US2016GSK028216 for which upon the receipt of follow up information the present case for the suspect vaccine was created. The patient received follow up and he planned to return form but preferred no contact to his treating physician. The patient reported being sick after vaccination with the Flu while on VENTOLIN HFA (see linked case). The patient also reported congestion during the sickness. Sickness or flu occurred about 2 weeks after receiving the Flu vaccine. The patient attributed this flu vaccine to a lack of effect or coverage of the 2015-2016 influenza shot he received. The patient felt as though the shot was not formulated to cover the correct strains. The patient was unable to provide manufacturer or brand name of the flu shot. The patient declined to provide further details for follow up safety report.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Drug ineffective, Influenza, Malaise, Nasal congestion, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of nasal congestion in a 65-year-old male patient who received FLUARIX. In November 2015, the patient received FLUARIX. On an unknown date, less than a month after receiving FLUARIX, the patient experienced nasal congestion, flu and sickness. On an unknown date, the outcome of the nasal congestion, flu and sickness were unknown. It was unknown if the reporter considered the nasal congestion, flu and sickness to be related to FLUARIX. Additional details were as follows: This case was linked to a case US2016GSK028216 for which upon the receipt of follow up information the present case for the suspect vaccine was created. The patient received follow up and he planned to return form but preferred no contact to his treating physician. The patient reported being sick after vaccination with the Flu while on VENTOLIN HFA (see linked case). The patient also reported congestion during the sickness. Sickness or flu occurred about 2 weeks after receiving the Flu vaccine. The patient attributed this flu vaccine to a lack of effect or coverage of the 2015-2016 influenza shot he received. The patient felt as though the shot was not formulated to cover the correct strains. The patient was unable to provide manufacturer or brand name of the flu shot. The patient declined to provide further details for follow up safety report.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site swelling, Local swelling
Clinical narrative: Patient complaint rash, pain and swelling to left upper out arm. Localized redness and swelling observed.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Serology test
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old female patient. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with first and second doses of M-M-R II injection. On 25-FEB-2016 the patient was vaccinated with third dose of M-M-R II injection (dose, route, site of administration not reported). On 21-APR-2016, the patient sought medical attention, visited physician's office and underwent serologic testing (via an unspecified blood test) for evidence of immunity which revealed that the patient was serologically too low to be considered immune to the measles component of the vaccine. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 0.89
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Oral candidiasis, Pyrexia
Clinical narrative: Fever onset right after vaccine and continue 102-103 fever for three days, swelling at injection site, also has mild thrush to mouth which I think is unrelated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients who might on unspecified dates have been administered with an unspecified number of unspecified doses of improperly stored RECOMBIVAX HB (lot # L044707, Expiration Date 06-OCT-2018, route unknown). The RECOMBIVAX HB was stored at 30.4 F for 8 hours and 30 minutes. There was no previous excursion. No data logger reported. this is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient given vaccination in left arm where she previously had a partial breast removed. Patient did not tell vaccinator not to administer in that arm. Patient still experiencing pain in vaccination arm.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 64-year-old male patient who received FLUARIX Quadrivalent (batch number 7A54E, expiry date 30th June 2016). The patient's past medical history included heart disease, unspecified. Previously administered products included BOOSTRIX (one dose, 0.5 ml received on 24th February 2015 in left deltoid intramuscularly, lot number: FB942, expiry date: 3rd December 2017) and ZOSTAVAX (one dose, 0.5 ml received on 6th October 2009 in right deltoid subcutaneously, lot number: L035286, expiry date: 15th December 2016). On 7th August 2015, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml. On 29th December 2015, 144 days after receiving FLUARIX Quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX Quadrivalent. Additional details provided were as follows: This case was reported by a pharmacy via a pharmacy claims management company.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 48 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (35 patients with doses of the lot number: L020189, expiration date 30-JUN-2017, 3 patients with doses of lot number: L015282, expiration date: 30-APR-2017, 10 patients with doses of lot number: L030872, expiration date: 11-JUN-2018) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to a 5 month old male patient. The patient did not have concurrent condition, medical history or drug reactions. On 20-APR-2016, the patient was vaccinated with the second dose of ROTATEQ orally, lot # L039297 and expiration date on 19-JUN-2017 (strength was not provided), date of first dose of ROTATEQ was unspecified. The patient did not take concomitant medications. The reporter states the patient experienced blood in his stools on 21-APR-2016. The patient's parents brought him to the doctor's office on 22-APR-2016. The reporter stated the physician was examining the patient and had not ordered any treatment. The case did not involve cancer or overdose. The outcome of haematochezia was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: DTAP, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 22-APR-2016, the patient was vaccinated with improperly stored GARDASIL 9 (which had a lot # reported as M003659 and an expiration date of 20-SEP-2017; however, dose, dosage number, route of administration and anatomical location were not reported). No concomitant medications were reported. Along with GARDASIL 9, PEDVAXHIB, M-M-R II and ROTATEQ also appeared in the list products whose temperature stability was called into question. However, no doses of these vaccines were administered to any patients. The vaccines experienced a temperature excursion of 30.2 F for a time frame of 7.18 hours. There were, reportedly, no previous temperature excursions and the call for the aforementioned one was because of a data logger. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to 11 to 18 year old female patients. There were no concurrent condition and medical history. On an unknown dates, the patients were vaccinated with GARDASIL (lot number, dose and route were not reported). There was no concomitant therapy. The physician reported regarding patients who between 2006 to 2012, fainted when they received vaccination with GARDASIL. The physician reported that the incidence of fainting occurred 1 in 30 girls. The pediatrician would then have the patients leg elevated, recover and watch the patient for 15-20 minutes before letting them go. This event did not prevent the administration of second and third doses. The outcome of event was reported to be recovering/resolving. The physician stated that now her practice reminds patients to eat before vaccine and had them sit in office for 15. The physician did not see this adverse event with GARDASIL 9. The physician considered fainting to be non-serious and related to GARDASIL. This case is one of the two reports from same reporter. Additional information is not expected since the physician does not wish to be further contacted.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner referring to a 30 year old female patient. Information about concurrent condition, medical history and concomitant therapy was not reported. On 29-APR-2016 the patient was vaccinated with 1 shot of VARIVAX (Merck) (lot# and dose not reported) subcutaneous. The patient stated that the injection was burned while being administered. On the same day, she developed a hot, swollen and red spot at the injection site. The patient sought unspecified medical attention and was given ice to apply to the spot. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Patient received FLUZONE HIGH DOSE in right arm on 11/26/15. Patient calls 5/3/16 saying shot made her sick, had chills, caused pain in arm, can't raise arm, pick up anything, gets worse every day. She didn't seek treatment or medical attention and still hasn't to date.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 1 or 2 patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (Lot # L007560; expiration date: 15-JUN-2017) (dose and route not provided). Concomitant therapies were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 10 degrees C for 552 hours (23 days). No previous temperature excursion was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a unspecified number of patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (which had the lot number of: L019836, expiration date: 24-MAR-2017) (doses, anatomical sites and routes were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint. This is one of several cases from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pt. received vaccine 4/4/16. He came back to health center having symptoms severe pain to (L) deltoid, muscle aches, fever, and upper arm very red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pustular, Varicella
Clinical narrative: Information has been received from the patient's sister referring to a 67 years old female patient with hypothyroidism. The patient had drug reactions/allergies: ACHROMYCIN. In the third week of March 2016, the patient was vaccinated with a dose of ZOSTAVAX (1 shot) subcutaneously. Concomitant medication included Thyroid medication. On 11-APR-2016 (reported as 3 weeks ago) (also reported as subsequently), the patient broken out with what appears to be a case of Chickenpox. The outbreak started slowly, about two weeks after the vaccine was administered. She had originally had a few pustules, which she attributed to being common acne pimples. Within a few days, the pustules appeared more and more, eventually covering her face. She hadn't had any new blotches in 4 days, and they were drying up, but not necessarily draining. The blisters were only localized on the face. She had visited her doctor on the 25-APR-2016, and he had prescribed unspecified antivirals for the infection. No lab diagnostics studies were performed. The outcome of the event was reported as recovering/resolving. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 105 patients of unknown ages and genders. The medical history of the patients or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (15 patients with doses of lot number: L013203, expiration date: 28-JAN-2017, 10 patients with doses of lot number: L004456, expiration date: 07-AUG-2016, 50 patients with doses of lot number: L006184, expiration date: 13-DEC-2016, 30 patients with  doses of lot number: L027067, expiration date: 06-APR-2017) orally (doses and anatomical sites were not reported). Concomitant medication of the patients were not provided. Additionally, no adverse effects were reported and there was not product quality complaint involved. This is one of several cases 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 certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route not provided, lot number # reported as M0025058, expiration date 11-JUL-2017). No adverse effects were reported. There was no product quality issue (PQC) involved. PROQUAD, M0025058, exp. 07/11/2017. Temperature: 14F. Time frame: 2 hours, 15 minutes. Was back in range? Yes. Was previous temperature excursion? No. Was call because of a data logger? No. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients who might on unspecified dates have been administered with an unspecified number of unspecified doses of improperly stored ROTATEQ (lot # L027067, Expiration Date 06-APR-2017) orally. The ROTATEQ was stored at 30.4 F for 8 hours 30 minutes. There was no previous excursions. No data logger reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degree F, time frame of 3.75 hours) of M-M-R II rHA, lot # L024268 with expiration date 01-JUL-2017 and lot # L027432 with expiration date 22-JUL-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.73
Sex: F
Vaccine: DTAP
Symptoms: Crying, Irritability
Clinical narrative: Patient was crying excessively and very irritable for 2 full days from the time the dose was administered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with no known drug allergies. The patient had no concomitant medication or pertinent medical. On 17-NOV-2015 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L017165 and expiration date 13-AUG-2016), subcutaneously. The patient came to the pharmacy on 26-APR-2016 reporting that, 48 hours after being administered the ZOSTAVAX (approximately on 19-NOV-2015), she experienced a feeling of burning up, profusely sweating, vomiting and losing consciousness for a bit. The patient called her physician to report what she experienced, but was not seen by the physician. No lab diagnostics studies were performed. No treatment was given for the events. The patient reported that after what she experienced she was completely fine and without further symptoms on 19-NOV-2015. The causal relationship between the events and ZOSTAVAX were not provided. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess sterile, Cellulitis, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Erythematous rash around injection site (65 x 100 mm); warm at touching. Looks like a cellulitis vs a sterile abscess.
Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: Severe pain for 1 week, stiffness of arm. I was given shot high in arm not normal. I had shots many times before administer, hit something high in arm and wiggled it.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Initial unsolicited report received from a consumer on 20-Apr-2016. This case involves a 66-year-old female patient, who was vaccinated with a first dose of FLUZONE HD (batch number, expiry date and route of administration: not provided) in left deltoid on 25-Nov-2015. Patient's illness at the time of vaccination was reported as none. Patient denied pre-existing physician diagnosed allergies, birth defects, medical conditions and patient was reported to be in perfect health. Patient had not taken any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 25-Nov-2015, same day after vaccination, the patient felt funny, fell over her bed, had difficulty in breathing and felt like her heart stopped, she also had difficulty moving her mouth. Patient was advised to stay in bed and rest for few days by the pharmacist. Gradually the weakness worsened and the patient was sent to hospital on 23-Dec-2015 and at that point, 28 days after vaccination patient had developed itching and stinging from her toes to her face. Patient had no rash. She reported that she had continued difficulty in breathing. Patient was admitted on the same day and was suspected with Guillain-Barre. Patient was discharged on 24-Dec-2015 and was later readmitted to hospital that night and stayed for 7 days. Total duration of hospitalization was reported as 9 days. After about 6 weeks, on an unspecified date, patient had seizures. At the time of reporting patient still needed walker to walk. Laboratory nvestigations included spinal tap which confirmed Guillain-Barre. Patient also had performed other laboratory test (unspecified). Patient received corrective treatment with IVIG (intravenous immunoglobulin) and physical therapy. She also received Neurotin for seizures and it helped. The outcome of the event seizures was reported as recovering and the outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a consumer reported case on social media regarding Guillain Barre syndrome post vaccination of INFLUENZA USP TRIVAL A-B DOSE SUBVIRON VACCINE. Since there is no complete information available, the case cannot be completely analyzed and also role of vaccine cannot be assessed.