chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # N000326, expiry date: 14-OCT-2019; lot number: N004799, expiry date: 30-JUL-2018) for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006090: US-009507513-1708USA005593: US-009507513-1708USA006091: US-009507513-1708USA006088.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # M042821, expiry date: 14-JUN-2018) for prophylaxis (Incorrect product storage). Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA005593: US-009507513-1708USA006089: US-009507513-1708USA006091: US-009507513-1708USA006088:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with VAQTA, lot # N008823, expiry date: 26-MAY-2018 for prophylaxis. Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1°C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-1708USA006090: US-009507513-1708USA006089: US-009507513-1708USA005593: US-009507513-1708USA006088:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On multiple unknown dates, the patients received improperly stored LIQUID PEDVAXHIB (lot # N008080, expiry date: 02-DEC-2019) via unspecified routes, for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 32-35 degree Fahrenheit for 24 hours. There were multiple previous temperature excursions: 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 24 hours. No digital data logger was reported. No side effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005455: US-009507513-1708USA006125:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On multiple unknown dates, the patients received improperly stored GARDASIL 9 (lot # N012093, expiry date: 13-JAN-2020) via unspecified routes, for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 32-35 degree Fahrenheit (35F) for 24 hours. There were multiple previous temperature excursions: 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 12 hours, 32 to 35 degree Fahrenheit (35F) for 24 hours. No digital data logger was reported. No side effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005455: US-009507513-1708USA006124.
Age: 19.0
Sex: F
Vaccine: ANTH, MNQ
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site pain, Malaise
Clinical narrative: 19-year-old healthy female who received meningococcal #2 and anthrax #1 to her left deltoid and experienced local site erythema, edema tenderness and possible lymphadenapathy and severe systemic symptoms of fever, malaise, nausea, emesis and headache with a duration of five days.
Age: 19.0
Sex: F
Vaccine: ANTH, MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: 19-year-old healthy female who received meningococcal #2 and anthrax #1 to her left deltoid and experienced local site erythema, edema tenderness and possible lymphadenapathy and severe systemic symptoms of fever, malaise, nausea, emesis and headache with a duration of five days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: Mom describes staring episodes for about 2-3 hours after 2 m vaccines. She would have spells that would last about 10 min each where mom could not get her out of a staring episode pt did not have any episodes after the day of vaccines. Mom did not report until 4 month exam on 8/14/2017.
Age: 6.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Course started 8/8/17. Patient started complaining of headache after dose 2 (on day 3) that responded to ibuprofen. After dose 3 (day 5) complaint of headache returned - more severe this time. On day 6, developed low grade fever (approx. 100 F) and vomiting along with stomach aches and muscle aches.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Moaning, Pallor
Clinical narrative: Patient was given the vaccine in Left deltoid, applied slight pressure, pt started to become pale, became silent then started humming. Smelling salts used and pt came back to and asked "what happened?". Pt did eat a half of tuna sandwich for breakfast. Orange flavored Glucose given to pt and cold pack applied. Asked pt to lay down with feet flat on floor. Felt better. Sent home with mother (driving).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Mother called states left upper arm is with swelling and redness at injection site. States axillary temperature was 99.4  States she gave her ibuprofen which reduced temperature to 97.1. Also stated she is applying cold compresses to left arm. Instructed to continue as she has been.  Instructed to call back for further questions.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain Barre syndrome symptoms 10 days after flu shot. Leading to hospitalization and continued upper extremity weakness.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Discomfort, Exposure during pregnancy, Oral pustule, Pyrexia, Rash
Clinical narrative: This spontaneous prospective pregnancy report has been received from a pharmacist referring to a 23 years old female patient. Information about concomitant medication and medical history was unknown. On 31-JUL-2017, the patient was vaccinated with VARIVAX (dose was not reported), lot # M043581 with expiration date 28-OCT-2018 and M-M-R II (dose was not reported), lot # M039914 with 26-SEP-2018, subcutaneous for prophylaxis. On 03-AUG-2017, the patient presented at another pharmacy complaining about rash. On the same day, the patient's mother explained that "the patient was 7 weeks pregnant and had pustules in mouth and vaginally, was a little feverish and  uncomfortable from the rashes, but otherwise, she's fine". The last menstrual period (LMP) and estimated date of delivery (EDD) were approximately 15-JUN-2017 and 22-MAR-2018. The pregnancy outcome was outcome pending. The outcome of rash, pustule in mouth and vaginally, little feverish and uncomfortable from the rashes was reported as not recovered.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pustular
Clinical narrative: This spontaneous prospective pregnancy report has been received from a pharmacist referring to a 23 years old female patient. Information about concomitant medication and medical history was unknown. On 31-JUL-2017, the patient was vaccinated with VARIVAX (dose was not reported), lot # M043581 with expiration date 28-OCT-2018 and M-M-R II (dose was not reported), lot # M039914 with 26-SEP-2018, subcutaneous for prophylaxis. On 03-AUG-2017, the patient presented at another pharmacy complaining about rash. On the same day, the patient's mother explained that "the patient was 7 weeks pregnant and had pustules in mouth and vaginally, was a little feverish and  uncomfortable from the rashes, but otherwise, she's fine". The last menstrual period (LMP) and estimated date of delivery (EDD) were approximately 15-JUN-2017 and 22-MAR-2018. The pregnancy outcome was outcome pending. The outcome of rash, pustule in mouth and vaginally, little feverish and uncomfortable from the rashes was reported as not recovered.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 03-AUG-2017 the patient was vaccinated with one improperly stored dose of VARIVAX (dose and route were not reported), lot # N001527 with expiration date 13-JAN-2019, and sterile diluent (MERCK STERILE DILUENT) (dose, route, lot# and expiration date were not reported) for prophylaxis.  The vaccines were exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. Data logger was involved. There was no previous temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant via a physician refers to a unspecified amount of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient were vaccinated with improperly stored RECOMBIVAX HB (lot M037248, expiration date 21-FEB-2019; lot N006321, expiration date 08-NOV-2019)(incorrect product storage) for prophylaxis. Temperature was reported as 47°F to 77°F and Time frame was reported as 2 Hours 30 Minutes. Previous temperature excursion was involved. The call was because of a "data logger".  No adverse effects reported. No PQC involved. No further details provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA006276: US-009507513-1708USA006277:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant via a physician refers to a unspecified amount of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9 (lot M044717, expiration date 19-JUL-2019; lot N004799, expiration date 15-NOV-2019) for prophylaxis. Temperature was reported as 47°F to 77°F and Time frame was reported as 2 Hours 30 Minutes. Previous temperature excursion was involved. The call was because of a "data logger". No adverse effects reported. No PQC involved. No further details provided. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1708USA006277: US-009507513-1708USA005419.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient (in her 60's) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, as single dose for immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration, on an unspecified date, as single dose for immunization. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient experienced soreness at injection site, redness at the injection site and purplish bruise around the injection site. It was reported that the patient received the flu vaccine at the same time as the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), but it was unknown if they were administered in the same arm. The clinical outcome of experienced soreness at injection site, redness at the injection site and purplish bruise around the injection site was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Cough, Sneezing
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The medical history and concomitant medications were not reported. The patient experienced cough and sneeze on an unspecified date with outcome of unknown. patient stated "I did have the pneumococcal 13-val conj vac (dipht crm197 protein) last week when I was at the doctor. After that, all I did was cough and sneeze for 4 days".
Age: 32.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: After 2 days patient had soreness in right arm and redness around injection site with bump.
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site abscess, Injection site discharge, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Right leg lesion since vaccines given 6/23/17 per parents. Initially was a nodule, circular and red but since then has remained firm, and over weekend started draining. Does not usually sit in bath but rather is wiped down for bathing. No known MRSA in household. Pt not ill and no fever, is acting normally. Denies other injury or difficulty administering the vaccine. MMR and HiB were given in right leg. Right thigh abscess, draining serous fluid. VAERs reporting. Clindamycin ordered. Recommend daily soak/sit in bathtub. Dressing applied. F/u in office in 3-4 days to assure healing.
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Right leg lesion since vaccines given 6/23/17 per parents. Initially was a nodule, circular and red but since then has remained firm, and over weekend started draining. Does not usually sit in bath but rather is wiped down for bathing. No known MRSA in household. Pt not ill and no fever, is acting normally. Denies other injury or difficulty administering the vaccine. MMR and HiB were given in right leg. Right thigh abscess, draining serous fluid. VAERs reporting. Clindamycin ordered. Recommend daily soak/sit in bathtub. Dressing applied. F/u in office in 3-4 days to assure healing.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Infant was given combination vaccine of DTaP and IPV rather than each vaccine individually. There was no adverse reaction.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: PENNY-SIZED SOLID RED CIRCLES UP LEFT AND RIGHT SIDE OF BODY AND ON FLANK AREA. NO ITCHING OR PAIN ASSOCIATED. PATIENT MENTIONED THAT HE WORKS OUTSIDE FREQUENTLY AND THE REACTION COULD BE ASSOCIATED WITH THAT.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Nausea/vomiting at 0200-self limited. Temp 101 at 7-8 am-ALEVE-resolved. Coughing at 11 am -hot tea, cough drops-resolved. Pain/swelling at injection site-radiated to upper arm/shoulder-progressively diminishing.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Hypotonia, Intensive care, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain abnormal, Ultrasound scan
Clinical narrative: When went to check up at dr office baby went limp no response this happened twice - went to hospital because dr office said was fine - was transported to NICU has spikes in brain that are unexplained.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound skull
Clinical narrative: When went to check up at dr office baby went limp no response this happened twice - went to hospital because dr office said was fine - was transported to NICU has spikes in brain that are unexplained.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Eye swelling
Clinical narrative: Swollen eyes.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, nausea, vomiting, fever of 101.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Rash macular, Vaccination complication
Clinical narrative: Received the shot on the afternoon of the 26th. Upon waking the next morning the right cheek of his face and right thigh near the injection site were covered in a handful of red, blotchy reaction spots. His physician was called, and the parent was given the instruction to bring him in the next morning and otherwise go to the ER. He was taken to the ER that afternoon, the 27th, where emergency staff examined the reaction spots. Those near the injection site were light in the middle with a darker ring around the edges by the time he was examined. The doctor diagnosed the patient with an adverse effect of the DTaP vaccine he had received the day prior and then prescribed BENADRYL and TYLENOL to be given immediately before being discharged. The reaction spots faded slightly by the time he was seen the next morning, the 28th, by his pediatrician. He was given a referral to an allergist to determine the cause of the reaction within the vaccine since there is a family history of autoimmune disorders and ingredient sensitivities. The reaction spots lasted about two weeks before completely fading.
Sex: M
Vaccine: MMR
Symptoms: Heart rate increased, Incorrect route of drug administration, Supraventricular tachycardia, Viral titre decreased
Clinical narrative: This spontaneous report was received from a male nurse of an unknown age, who was also the patient referring to himself. The patient's medical history was not reported. The patient's concurrent conditions included allergy to sulfa, Cipro and cephalexin (KEFLEX). On an unknown date, the patient was vaccinated with the 3rd dose of M-M-R II intravenously (lot # and expiry date were not reported). On an unknown date, on 2011, the patient he was entering nursing school and had a titer drawn for immunity to measles, mumps, rubella even having been vaccinated at an unspecified earlier time in his life. The patient stated that one or more titers showed "low" so he required a third dose of M-M-R II (viral titre decreased). On an unknown date, the patient stated that when the third dose of M-M-R II was administered, it was administered "intravenously" (incorrect route of drug administration) and his heart rate "shot up". At that time, he was treated for elevated heart rate (diagnosed at the time as SVT: supraventricular tachycardia) by an unspecified physician (supraventricular tachycardia). The patient stated that he "had had this heart rate problem ever since, controlled with generic Metoprolol." The outcome of supraventricular tachycardia was reported as not recovered/not resolved. The outcome of incorrect route of drug administration and viral titre decreased was unknown. No causal relationship assessment between the vaccine and the supraventricular tachycardia was provided by the reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002130:
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer sales representative. An 82-year-old male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced the area by injection site was hot to touch and swollen as well as painful. Cellulitis was also seen on arm. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 may have contributed to the occurrence of the reported event Cellulitis on arm.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Redness that was spreading from injection site to armpit, pain with mobility, she described as hard muscle mass at site of injection that was spreading, she tried TYLENOL, ibuprofen, and cold compress with no relief and redness that continued to spread.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Eye swelling, Faeces discoloured, Fatigue, Insomnia
Clinical narrative: So tired could hardly drive home, very sore uvula for 3 hours, chills, slight fever, horrible migraine, swollen bloodshot eyes, swollen left arm from flu vaccine, both sore but left more so, black stool in morning. Completely exhausted.. three hours sleep.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Migraine, Ocular hyperaemia, Oral pain, Pain in extremity, Peripheral swelling
Clinical narrative: So tired could hardly drive home, very sore uvula for 3 hours, chills, slight fever, horrible migraine, swollen bloodshot eyes, swollen left arm from flu vaccine, both sore but left more so, black stool in morning. Completely exhausted.. three hours sleep.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: So tired could hardly drive home, very sore uvula for 3 hours, chills, slight fever, horrible migraine, swollen bloodshot eyes, swollen left arm from flu vaccine, both sore but left more so, black stool in morning. Completely exhausted.. three hours sleep.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I received the shingles vaccination on the 9th and developed hives about 1 cm from the injection site on the 12th.
Age: 74.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around injection site for a week, patient used ice, BENADRYL. Pt. also stated it's very itchy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received KINRIX (batch number 7574T, expiry date 19th May 2019). Concomitant products included PROQUAD. On 1st August 2017, the patient received KINRIX (intramuscular) .5 ml. On 1st August 2017, several hours after receiving KINRIX, the patient experienced injection site erythema and injection site swelling. In August 2017, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema and injection site swelling to be probably related to KINRIX. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The patient received KINRIX on the right thigh. On the same day, the patient concomitantly received PROQUAD (batch number M049122, expiry date 13th June 2018) intramuscularly on the left thigh. In August 2017, less than a week after vaccination, the patient experienced fever. The patient had a scheduled visit on the reporting date for follow up and further evaluation of the injection site. KINRIX was administered to two patients on different days by two different healthcare professionals at different sites (refer case US2017121960).
Age: 26.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated it's very painful, warm, there's swelling and tenderness around site.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Full blood count, Headache, Metabolic function test, Nausea
Clinical narrative: Fever, HA, chills, Body aches, N/V. Started within 12 hours of receiving vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia, Streptococcus test, Vomiting
Clinical narrative: Fever, HA, chills, Body aches, N/V. Started within 12 hours of receiving vaccine.
Age: 16.0
Sex: F
Vaccine: DTAPHEPBIP, MENB, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PEDIARIX given to 16 year old.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Ophthalmological examination, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Lft. arm swelled up, got very hot, red, and itching. Continued to swell overnight.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Around 8pm started experiencing chills, coughing, shortness of breath. Had fever of 101 F, used VENTOLIN inhaler at hand and symptoms subsided.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PATIENT EXPERIENCING INTENSE PAIN ON HER LEFT SIDE FROM HER SHOULDER TO HER ARM. NO FEVER PER PATIENT.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Dyskinesia, Headache, Pyrexia
Clinical narrative: High fever chills jerking motion headache weakness had fever just for a few hours felt weak for two and a half days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Redness at sight (up to softball size) lymph node swelling. Fever.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Patient was given PNEUMOVAX 23 on 8/14/17 at approximately 1430. Around 2300 he reports he began having pain at injection site ((L) Deltoid). Denies redness, swelling, fever. Called office to report 8/15/17 at 10:00. Ice, APAP, Ibuprofen per PCP.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Headache, Pain, Palpitations, Peripheral swelling
Clinical narrative: 2-3 hours after injection-exp palpitations, weakness, HA, arm swelling, pain.
Age: 87.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling, Tenderness
Clinical narrative: Patient experienced itching, swelling, redness, tenderness, and pain hours after vaccination (8/8/17 am).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 18-year-old male patient who received MENVEO (batch number M16133, expiry date 31st July 2018). On 3rd August 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 3rd August 2017, less than a day after receiving MENVEO, the patient experienced fever, vomiting, chills, weakness and headache. On an unknown date, the outcome of the fever, vomiting, chills, weakness and headache were not recovered/not resolved. The reporter considered the fever, vomiting, chills, weakness and headache to be almost certainly related to MENVEO. Additional details were provided as follows: The case was reported by the Physician's Assistant (PA). The patient received MENVEO in the right deltoid. The patient's fever ranged from 102 to 103 degrees C.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). Concomitant products included PROQUAD. On 2nd August 2017, the patient received KINRIX (intramuscular) .5 ml. On 2nd August 2017, several hours after receiving KINRIX, the patient experienced injection site erythema and injection site swelling. In August 2017, the patient experienced fever. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the fever was unknown. The reporter considered the injection site erythema and injection site swelling to be probably related to KINRIX. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The patient received KINRIX in the right deltoid. On the same day, the patient concomitantly received vaccination with PROQUAD (batch number: M049122, expiry date 13th June 2018) in the left deltoid. In August 2017, less than a week after vaccination, the patient experienced fever. KINRIX was administered to two patients on different days by two different healthcare professionals at different sites (refer case US2017121958).
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site atrophy, Injection site erythema, Injection site pain, Injection site swelling, Muscle atrophy
Clinical narrative: Atrophy under delt-outcome-muscle loss/hole where shot was given. After given extremely soreness hurt very sore to touch, red, swelling where shot was given, hard to sleep for 2 months couldn't sleep on left side due to pain. After about 2 months pain subsided but hole in arm by Jan. after months hole became larger lower deltoid has been eaten away huge hole in lower delt arm weakness due to muscle loss.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Sleep disorder, X-ray
Clinical narrative: Atrophy under delt-outcome-muscle loss/hole where shot was given. After given extremely soreness hurt very sore to touch, red, swelling where shot was given, hard to sleep for 2 months couldn't sleep on left side due to pain. After about 2 months pain subsided but hole in arm by Jan. after months hole became larger lower deltoid has been eaten away huge hole in lower delt arm weakness due to muscle loss.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to 12 patients of unknown age. From 08-JUN-2017 to 24-JUL-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis, as follow: lot M036059, expiration date on 03-JUN-2019: 2 doses on 08-JUN-2017, 1 dose on 12-JUN-2017, 2 doses on 16-JUN-2017, and 1 dose on 06-JUL-2017; lot N002720, expiration date on 12-MAY-2019: 1 dose on 06-JUL-2017, 2 doses on 11-JUL-2017, 1 dose on 21-JUL-2017, and 1 dose on 24-JUL-2017; lot reported as M047660, expiration date on 02-DEC-2018: 1 dose on 12-JUL-2017. No adverse effect reported. This is one of two reports received from the same reporter. Lot number M047660 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1708USA005381.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified amount of patients of unknown age and gender. On an unknown date, an unspecified amount of patients were vaccinated with improperly store doses of ROTATEQ orally, (dose was not reported) lot # M031650 with expiration date 16-MAR-2018, lot # M042169, with expiration date 22-JUN-2018, lot# M042822,with expiration date 19-JUN-2018, for prophylaxis. No adverse event was reported. The doses of ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77°F (19 °F) during a time frame of 48 hours (previously reported as 96h). Digital data logger was not involved. No previous temperature excursion was reported. This is one of two cases from the same source (MARRS # 1708USA005357) Sender's Comments: US-009507513-1708USA005357.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site warmth, Product name confusion, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 65 year old female patient. On 07-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 dose 2 for prophylaxis. Other suspect therapies included PREVNAR 13. Concomitant therapies included vitamins (unspecified). On 2016 the patient experienced injection site pain and injection site warmth. On 07-AUG-2017 the patient experienced product name confusion. On 08-AUG-2017 the patient experienced swelling and erythema. The outcome of swelling and erythema was reported as recovering/resolving. The outcome of injection site pain and injection site warmth was reported as recovered/resolved. The outcome of product name confusion is unknown. The reporter considered product name confusion to be not related to PNEUMOVAX 23.
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a 65 year old female patient. On 07-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 dose 2 for prophylaxis. Other suspect therapies included PREVNAR 13. Concomitant therapies included vitamins (unspecified). On 2016 the patient experienced injection site pain and injection site warmth. On 07-AUG-2017 the patient experienced product name confusion. On 08-AUG-2017 the patient experienced swelling and erythema. The outcome of swelling and erythema was reported as recovering/resolving. The outcome of injection site pain and injection site warmth was reported as recovered/resolved. The outcome of product name confusion is unknown. The reporter considered product name confusion to be not related to PNEUMOVAX 23.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient with hypersensitivity. On 08-AUG-2017 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous for prophylaxis. On 09-AUG-2017, 2 days after onset of therapy the patient experienced injection site erythema and injection site urticaria. On 11-AUG-2017 the patient experienced injection site pruritus. The outcome of injection site erythema, injection site pruritus and injection site urticaria was reported as not recovered/not resolved. Additional information is not expected because there is no consent to contact the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This initial spontaneous report was received from an adult female patient of unknown age who submitted information on website. Medical history and concomitant medications were not provided. On an unspecified date, the patient received GARDASIL 9 (dose, route and lot # not provided). Subject of the email was "question about recent orders". Under "question", the following was noted: "adverse event to 9. Adult wants to join an ongoing lawsuit". The patient did not specify what the adverse reaction was or the outcome. Additional information is not expected as there was no contact information.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: Erythema and induration, 2.5 CM diameter, right anterior thigh, has central punctate lesion, no fluctuance, no purulent discharge, + facial grimace with palpation while distracted with a toy.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: 4 hours post vaccination patient complains of headache, lower leg numbness and dizziness.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Irritability, Rash, Rash maculo-papular
Clinical narrative: Received MMR on 7/31/17 was seen in the office on 8/11/17 for rash x24h. Red and maculopapular lesion in the trunk w/upper extremities some face. Fussy!
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Hypotension, Nausea, Pain in extremity, Pallor, Vomiting
Clinical narrative: Approx. 7 AM on 8/10/17 pt. C/O of (R) arm pain. 8/10/17 - pt. became nauseated w/vomiting, pale and hypotension. Was sent to school nurse, Mom picked him up and gave MOTRIN and fluids.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Eye irritation, Feeling abnormal, Pharyngeal oedema
Clinical narrative: Patient stated she felt fine when she got home and about 2 hours later she started to feel funny. Her abdomen became distended, her eyes felt funny and her esophagus felt like it was a little swollen. The patient waiting several hours after the symptoms began to see if they would go away but headed to the emergency that evening when the symptoms didn't resolve. She was treated with IV steroids and BENADRYL. She immediately started feeling better and when I followed up with the patient this morning (8/15) she was at home.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Tremor
Clinical narrative: High fever, slightly shaky.
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Gait inability, Vomiting
Clinical narrative: Patient was very nervous about vaccines when being called to the exam room. After vitals were taken and she was in the room she was nervous and getting herself upset. Spoke with Dr. about her nervousness and Dr. reviewed their charts and said to go ahead and give the vaccines to get them over with so she could then calm down. Patient was given her Tdap, MENACTRA, and HPV vaccines. Afterward she asked to sit with her grandmother, which she did in the exam room. She at that point said she felt fine. The MA left the room for 5-10 minutes, and patient's mother came out of the room saying that patient is vomiting and she can't walk. The MA and doctor went into the room and had patient lie down on the exam table. Dr. was able to finish her exam and patient returned to baseline by the end of the visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-08-11.
Age: 52.0
Sex: M
Vaccine: HIBV, MNQ, PNC13, UNK
Symptoms: Adverse event
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-08-10.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Induration, Nodule, Pruritus
Clinical narrative: Patient experienced itching, burning with red hard knot approximately 4 inches in diameter.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a consumer refers to a 20 year old male patient. In MAY 2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. In July -2017 the patient experienced anogenital warts. The outcome of anogenital warts was reported as recovering/resolving.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of unknown patients. On an unknown dates on or after 09-AUG-2017, patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot number and expiration date not reported) for prophylaxis which were stored in the range of 78 Fahrenheit degrees to 79 Fahrenheit degrees for 120 hours. No previous temperature excursion was reported. No adverse effects were reported. It was unknown by reporter if a digital data logger was involved.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Full blood count, Muscle spasms
Clinical narrative: Muscle Spasms, Joint Pain, Arm Pain, Weakness Overall, Dizziness, Nausea Seen in ER on 08/11/2017 given PEPCID AC as an antihistamine. Seen at clinic 08/14/2017 told to take BENADRYL as an antihistamine. As of 08/15/2017 symptoms have not subsided and the overall weakness seems to be increasing.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Nausea, Pain in extremity
Clinical narrative: Muscle Spasms, Joint Pain, Arm Pain, Weakness Overall, Dizziness, Nausea Seen in ER on 08/11/2017 given PEPCID AC as an antihistamine. Seen at clinic 08/14/2017 told to take BENADRYL as an antihistamine. As of 08/15/2017 symptoms have not subsided and the overall weakness seems to be increasing.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Arthralgia, Asthenia, Dizziness, Muscle spasms, Nausea
Clinical narrative: Muscle Spasms, Joint Pain, Arm Pain, Weakness Overall, Dizziness, Nausea Seen in ER on 08/11/2017 given PEPCID AC as an antihistamine. Seen at clinic 08/14/2017 told to take BENADRYL as an antihistamine. As of 08/15/2017 symptoms have not subsided and the overall weakness seems to be increasing.
Age: 55.0
Sex: F
Vaccine: TDAP, TDAP, TDAP, TTOX
Symptoms: Dizziness, Muscle spasms, Muscular weakness, Nausea
Clinical narrative: Muscle Spasms, Joint Pain, Arm Pain, Weakness Overall, Dizziness, Nausea Seen in ER on 08/11/2017 given PEPCID AC as an antihistamine. Seen at clinic 08/14/2017 told to take BENADRYL as an antihistamine. As of 08/15/2017 symptoms have not subsided and the overall weakness seems to be increasing.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Parent reported moderate to severe vomiting within 5 hours of vaccination. Vomited 4 separate times and experienced mild diarrhea all within 24 hours of vaccination. Patient is acting himself and still hydrated. MOC will continue to monitor him and requested this be reported.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT'S RIGHT ARM BECAME RED AND SWOLLEN, PATIENT SAID SHE TOOK BENADRYL CAME INTO PHARMACY ON 8/15/2017 I OBSERVED ARM STILL APPEARED RED BUT SWELLING HAD GONE DOWN.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Sudden onset of Urticaria from the neck down with itching., approx. 24 hours later.  Treated with hydroxyzine.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: PT FAINTED FOR A VERY SHORT PERIOD OF TIME AFTER RECEIVING BOTH DOSES OF VACCINE. TOTAL TIME APPROXIMATELY 30-45 SECS. PT RECOVERED PROMPTLY, WAS GIVEN WATER AND SENT HOME AFTER A PERIOD OF OBSERVATION.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chest injury, Loss of consciousness
Clinical narrative: Pt was administered the vaccination. When he went to stand to leave he lost consciousness and was caught by his father although he struck his chest on the table. The pt was laid on the floor until he regained consciousness. Meanwhile 911 was called. After EMT personnel arrived approx 5 min later, the pt tried to stand again and again lost consciousness. The pt was then taken by squad to the ER. Pt was given a liter of fluid and monitored until his blood pressure was stable then discharged from the ER.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Pain, Pyrexia, Rash, Tremor
Clinical narrative: Pt reported getting shakes, fever, chills, and aches the Friday night after receiving the vaccinations. She reports taking TYLENOL and by the next day on Saturday she was only experiencing aches and fever. Today on 8/15/17 she said her aches, shakes, fever, and chills are all gone, but she now has a rash on her left arm. She did not know when the rash started but she only noticed it since this morning.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Bone pain
Clinical narrative: Patient complained of pain in the right collarbone, she called when she got home and said the pain had resolved. No further complaints.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: I am recounting this as best as my wife can remember as I was not present: At about 3:15 pm my son was given two vaccines, the HPV (type unknown to us) and the MCV4P Meningococcal vaccines. Both were injected into his right arm. Within about 10 - 15 seconds my wife noticed his eyes looked sleepy, and he began to slouch forward toward the floor. My wife pushed him back onto the examining table and noticed he began to shake and his skin color was a pale yellow. He appeared to her to be unconscious but shaking with all his muscles tense. The nurse immediately left to get a doctor. My wife went after a several seconds to see if they were coming. Once they returned to the room was still shaking but coming to. He was very startled and wanted to know what was going on.  The medical staff put him on oxygen and monitored him for several minutes. After another examination pt said he was feeling better was comfortable to leave. This morning patient awoke tired, dizzy, and nauseous. He did not have much to eat; just some chicken soup. He was very lethargic and was running a mild fever or 100 degrees. We called the ask a nurse line provided by my healthcare provider and spoke with the nurse who had patient try to touch his chin to his chest. Patient's head tilted forward about 45 degrees and he jerked it back up in pain. Patient was also complaining of a headache. The nurse suggested patient drink plenty of fluids and we provided him some Tylenol. My wife intends on contacting the clinic again in the morning to follow up.