chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLUX, PNC, FLUX, PNC13
Symptoms: Influenza, Pneumococcal infection, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female contactable consumer (the patient) of unspecified ethnicity received PREVNAR 13 at 0.5 ml single and influenza vaccine, both via an unspecified route of administration on an unknown date in Dec2009 for immunization. The patient was a smoker. Concomitant medications were not reported. The patient received the vaccine and she got pneumococcal infection in Dec2009 (2 to 3 weeks after vaccination). The event required hospitalization in Dec2009 for 10 days. Therapeutic measures, breathing treatments, were taken in response to the event which resolved on an unknown date. The patient stated that the only good thing that came from this was that she quit smoking and had not had a cigarette since Dec2009. She also had not had a flu shot or pneumonia shot since that time and has been relatedly health. The consumer didn't know whether the suspect product was actually Prevnar and not Prevnar 13 (considering that administration date was reported as Dec2009, while Prevnar 13 was launched only on 31Mar2010). Follow-up (08Aug2016): New information from the same contactable consumer includes: medical history, suspect vaccination partial date, concomitant vaccine, updated event outcome, seriousness criterion of hospitalization provided, treatment received information. Follow-up (27Sep2016): New information reported from a contactable consumer included: SAE onset date; hospitalization date; course of events; unknown if Prevnar or Prevnar 13.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Muscular weakness, Myalgia
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 26Aug2016, this case now contains all required information to be considered valid. This is a spontaneous report from the Pfizer-Sponsored Program. A contactable consumer reported a currently 76-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on May2015 at single dose for immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced extreme weakness in all muscles like having severe flu was worse for 10 days and extreme pain in muscles on an unspecified date. The patient was not treated for the events. The patient recovered from the events on an unknown date. Follow-up (19Sep2016): New information from a contactable Physician  included: the reporter is not aware of the events experienced by the patient. Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient of unspecified ethnicity received PREVNAR 13 (Lot# M60993, Expiration Date Jul2017), subcutaneous, on an unspecified date, at 0.5ml single, for immunisation. The patient medical history was not reported. Concomitant medication included ZOSTAVAX, subcutaneous. The patient was administered a dose of pneumococcal 13-val conj vac (dipht crm197 protein) subcutaneously so was administered a repeat injection intramuscularly in the upper arm on the same day. The patient experienced redness and soreness in arm. She also received Zostavax in that arm. Follow-up (27Sep2016): New information received from a contactable pharmacist includes: patient's details, concomitant's route of administration, vaccination site for second dose of Prevnar 13, events added. Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A contactable pharmacist reported a 67-year-old female patient started to receive PREVNAR 13, (lot number: N05077, expiry date: 30Sep2017), intramuscular on 28Sep2016 12:15 at single dose for immunisation and influenza vaccine, via an unspecified route of administration on 28Sep2016 at unknown dose for immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient's arm bubbled up where at the point of vaccination on 28Sep2016 with outcome of recovered.  The action taken in response to the event for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable.  Therapeutic measures were taken as a result of patient's arm blew up like it swelled up really bad.
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 via an unspecified route of administration in Sep2016 for immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date in Sep2016 the patient experienced severe arm pain and extremely limitation of arm movement. Outcome was unknown.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Expected soreness after injection on 9/30. Morning of 10/2 swelling and warmth above elbow. 10/3 swelling and warmth below elbow inside of forearm. 10/4 wife reported its improved, but still present.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Inconsolable crying for >5 hrs; left leg extremely swollen, red, hot to touch.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Ache started at injection point and during the night ache spread to shoulder. By morning on 9/30/2016 aching was down left side of back around left shoulder and down left arm. Aching still exists today 10/4/2016.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hot flush, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Hot flushing feeling. Faint, chills, tingly lips and face. Arm pain with numbness.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Syncope
Clinical narrative: Hot flushing feeling. Faint, chills, tingly lips and face. Arm pain with numbness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site nodule, Injection site pruritus, Injection site warmth, Wheezing
Clinical narrative: Golf ball size knot noted where Menveo was administered on 10/3/16 (L deltoid). Pt woke on 10/4/16 and the knot was 3.5 inches in diameter, itching, and warm to touch. Wheezing also noted on 10/4/16.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Injection site nodule, Productive cough, Resuscitation
Clinical narrative: About 20 minutes after shot, infant began to cough up thick Karo syrup like phlegm. Called MD right away, told to watch. Later night, woke to infant not breathing, resuscitated at home, taken to ER. Large knot on thigh (mom unclear of what one at this time anymore).
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site swelling, Injection site urticaria
Clinical narrative: The injection site bled and swelled instantly. The welt grew to about the size of a quarter over the next 5 minutes.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Warmth and swelling to right leg, from mid-thigh to knee - measuring at 29 cm.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Computerised tomogram head normal
Clinical narrative: The patient developed disequilibrium symptoms lasting for approximately 2 weeks that self resolved. No better explanation for symptoms.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Dizziness, palpitation, shortness of breath, sweating, cramps, flushing, heavy chest.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Palpitations
Clinical narrative: Dizziness, palpitation, shortness of breath, sweating, cramps, flushing, heavy chest.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red, itchy, looks like hives. Treatment: 50mg diphenhydramine.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: Patient reports rash a few hours following vaccine, went to doctor for a steroid shot and medication.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blister, Miliaria, Rash erythematous, Skin exfoliation, Sunburn
Clinical narrative: Patient reports rash a few hours following vaccine, went to doctor for a steroid shot and medication.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Patient reports rash a few hours following vaccine, went to doctor for a steroid shot and medication.
Age: 17.0
Sex: F
Vaccine: MMRV, MNQ, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: na
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient said the area became very painful and had trouble with mobility of the arm. As time went by more pain that went down the arm and up the arm to neck and shoulder area. Patient stated that back side of the arm became hot to the touch with swelling to the area and redness.The reaction occurred on the left arm where Pneumovax was administered.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient said the area became very painful and had trouble with mobility of the arm. As time went by more pain that went down the arm and up the arm to neck and shoulder area. Patient stated that back side of the arm became hot to the touch with swelling to the area and redness.The reaction occurred on the left arm where Pneumovax was administered.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Patient presented to office with rash that began on leg and more spots have begun to develop since onset of rash; initial spot is a chicken pox vesicle; low grade fever while in office.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: RED PATCH AT THE INJECTION SITE ON LEFT SHOULDER.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dyspnoea, Local reaction, Pruritus
Clinical narrative: After receiving the influenza vaccine, the patient experienced a local reaction with associated itching. After returning to the patient's room, the patient began experiencing SOB and appeared very anxious.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Decreased appetite, Syncope
Clinical narrative: Syncope PCP evaluated fluids and food. Patient did not eat for 5 hours.
Age: 48.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Patient complaint of soreness on the right arm, where ADACEL and AFLURIA vaccines was administered and swollen glands on both underarms.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Decreased appetite, Pyrexia, Rash erythematous
Clinical narrative: Mother reports patient developed light red rash on Saturday 9/1/2016. Patient took more naps on Sunday and had a 100.0 fever on Monday. Patient has been eating less, but mother reports drinking normally and normal wet diapers.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Neuralgia, Pain, Toothache, X-ray dental
Clinical narrative: Severe left nerve/facial pain.  Sharp pain only on left side upper and lower teeth, feels like shocking pain, throbbing and unbearable throughout the whole day. Easing up now on day 4!!
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Head injury, Loss of consciousness, Pallor
Clinical narrative: After immunization given patient was crying for approximately 3 minutes. Patient stopped crying while looking for a sticker found one stepped away for his siblings to take stickers and became pale and passed out. Patient hit is head on the ground.  Patient came to and we placed him on an exam table gave him orange juice and crackers and placed a cold pack behind his neck. Patient was examined by provider and found no injuries.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash, Malaise
Clinical narrative: Rash and pain at injection site and down arm. Overall feeling of unwellness for 5 days. Rash has not resolved.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Rash, Swelling face, Visual impairment
Clinical narrative: Patient called and report that she has swelling on face, rash on her arm,vision problems and diarrhea.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood test, Crying, Electroencephalogram, Neurological examination, Pyrexia
Clinical narrative: High fever and uncontrollable crying for first 4 days, continued Seizure like activity until present.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Seizure like phenomena
Clinical narrative: High fever and uncontrollable crying for first 4 days, continued Seizure like activity until present.
Age: 66.0
Sex: M
Vaccine: DTAP, FLU3, PNC13, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient started developing a rash on the right side of his head the day after receiving the immunization. Patient said he went to the clinic and was treated for shingles. He did not mention the specific treated that he was on and it was not filled at our pharmacy.
Age: 1.75
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Injection site arm has nerve pain from shoulder to elbow.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Throat irritation
Clinical narrative: PATEINT RECEIVED VACCINE AND THEN ABOUT 15 MINUTES LATER WE WERE TOLD BY COWORKERS SHE WAS FEELING FAINT.  I CAME OVER TO CHECK ON HER AND SHE WAS COUGHING LIGHTLY AND SITTING DOWN WITH SOME WATER.  I ASKED HER IF HER THROAT FELT TIGHT OR HER CHEST FELT TIGHT AND SHE REPLIED THAT IT REALLY JUST FELT LIKE A TICKLE.  I TOLD HER IF SHE IS HAVING ANY SYMPTOMS LIKE THIS IT IS SERIOUS AND I NEED TO GIVE HER AN EPIPEN SHOT AND CALL 911 FOR HER.  SHE RESPONDED THAT SHE REALLY DID NOT FEEL THAT BAD AND THAT IT WAS MORE LIKE A TICKLE.  I GAVE HER 50 MG ORAL BENADRYL BECAUSE SHE REFUSED AN EPIPEN. I HAD HER REMAIN SEATED FOR 15-20 MINUTES AND THEN SHE GOT BACK UP AND WENT BACK TO HER JOB.  I SAT AT THE COUNTER IN THE BUILDING AND TOLD HER I WAS GOING TO STAY WITH HER UNTIL HER SHIFT WAS OVER.  HER SHIFT ENDED AT 3:45 AND SHE SAID SHE FELT FINE AND SHE LOOKED FULLY HEALTHY.  I TOLD HER THAT IF SHE HAD ANY OTHER SYMPTOMS LIKE COUGHING THAT SHE MUST GO STRAIGHT TO THE ER NO MATTER WHAT!
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Pain
Clinical narrative: Extreme aches, fever. Developed shortness of breath and labored breathing.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Extreme aches, fever. Developed shortness of breath and labored breathing.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
Clinical narrative: After 1st and 2nd doses of HPV, had vomiting and abdominal pain.  Initially thought to be anxiety, but no anxiety triggers and sx resolved a few months after the HPV doses.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin irritation
Clinical narrative: Redness, irritation, may have started earlier than date above, reported to us on 10/4/16.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Balance disorder, Body temperature increased, Erythema, Injection site erythema
Clinical narrative: Patient experienced "extreme pain" in arm, very red from armpit to 3 inches below elbow, Temp 100.4 for 2 days, Temp 99 by day 3. Passed out day after vaccination, reports weakness and unbalance which lasted 5 full days and slight redness remained at shot sight one week later.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: Patient experienced "extreme pain" in arm, very red from armpit to 3 inches below elbow, Temp 100.4 for 2 days, Temp 99 by day 3. Passed out day after vaccination, reports weakness and unbalance which lasted 5 full days and slight redness remained at shot sight one week later.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Severe itching began on the same arm the shot was administered. Itching was localized to an area 2-3 inches below the location of the shot. About an hr later 3 - 4 quarter sized hives formed. At 6:30 PM hives widened and became one large hive when 2 tsp of Benadryl was taken and the itching subsided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Patient had small rash that went away at injection site-when she returned 10/4/16 the rash was back and large-she said arm was very sore and sensitive-saw pcp who circled the rash and told her to watch for it to increase in size-spoke with pt again on evening of 10/4-said it was very sore still but site had not become any larger.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Chills, Localised infection, Oxygen saturation abnormal, Pain
Clinical narrative: Patient said she developed body aches/fever and chills and after 5 hours her son took her to emergency room where she was given an antibiotic for a leg infection and they were unable to get oxygen levels normalized and her blood pressure had dropped so they admitted her.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient said she developed body aches/fever and chills and after 5 hours her son took her to emergency room where she was given an antibiotic for a leg infection and they were unable to get oxygen levels normalized and her blood pressure had dropped so they admitted her.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient received a Pneumovax 23 and her injection site swelled and required antibiotics.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site haemorrhage, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: INJECTION SITE IRRITATION AND ITCHING, SWELLING AT INJECTION SITE AND SOME BLEEDING.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Wound
Clinical narrative: Rash, swelling, and redness starting at least 4 inches below injection site, with fairly clear puncture marks resembling a spider bite. Nevertheless, the urgent care gave cephalexin.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Unable to lift her right arm, the injection arm, without the help of her left arm.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: Patient had swelling, redness, itching, blisters at injection site and some fever and pain.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient had swelling, redness, itching, blisters at injection site and some fever and pain.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Rash generalised
Clinical narrative: Pt started developing rash/hives all over body about an hour after receiving Fluzone high dose vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Patient has large localized redness and warmn to the touch at the site of vaccination.
Age: 18.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Influenza
Clinical narrative: Within the week of my vaccination I got the flu and was not sick before-hand at all. Completely healthy and did not want the shot but was forced to get vaccinated. I was extremely ill from the flu and all of the flu symptoms for 3 weeks. The symptoms were very intense, and almost intolerable. I have read many peer reviewed articles stating that you can not get the flu from the live attenuated vaccine, but I could be that one adverse anomaly that acquired the flu due to the vaccine. I have never been vaccinated ever again and have never had the flu ever again. I also understand that the strains change yearly from antigenic drift and shift so it is unlikely that my vaccine from 7 years ago still has any viable effect on current strains. In addition, my grandfather also was on his death bed after getting the flu vaccine, and had never had the flu in his life. So there may be a familial adverse effect to this shot I am not sure. I just wanted to voice my adverse event.
Sex: F
Vaccine: HEP
Symptoms: Autonomic nervous system imbalance, Pain, Systemic lupus erythematosus
Clinical narrative: This case was reported by a lawyer via other and described the occurrence of systemic lupus erythematosus in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), dysautonomia and pain. On an unknown date, the outcome of the systemic lupus erythematosus, dysautonomia and pain were not recovered/not resolved. It was unknown if the reporter considered the systemic lupus erythematosus, dysautonomia and pain to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's father, who was a well versed attorney by profession. The age at vaccination was not reported. The reporter stated that the Hepatitis B vaccine had serious side effects and GlaxoSmithKline had done nothing to prevent them. The reporter stated that his beautiful daughter was contracted dysautonomia almost 20 years before reporting date and she has been in agony ever since. On the reporting date, the patient was diagnosed with lupus, another autoimmune disorder. The reporter stated that rather than taking up responsibility for the events, GlaxoSmithKline had stonewalled the patient for 20 years. They had packed congressional galleries with your surrogates during investigative hearings. After all these years, the patient had finally resolved her claim. The reporter stated that he had held his tongue for long, but not more. He was embarking on a crusade to expose the corporate greed and deception. He was going to become GlaxoSmithKline's constant gradener and it is scum.
Age: 12.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Chest discomfort, Cough, Food allergy, Milk allergy, Muscle spasms
Clinical narrative: Cough, sneezing, wheezing, tightness chest, nausea cramping 2 hives-cat to progress-BENADRYL, Epi administrated. Symptoms resolved.
Age: 12.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Nausea, Sneezing, Urticaria, Wheezing
Clinical narrative: Cough, sneezing, wheezing, tightness chest, nausea cramping 2 hives-cat to progress-BENADRYL, Epi administrated. Symptoms resolved.
Age: 12.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Chest discomfort, Cough, Muscle spasms, Nausea, Sneezing
Clinical narrative: Cough, sneezing, wheezing, tightness chest, nausea cramping 2 hives-cat to progress-BENADRYL, Epi administrated. Symptoms resolved.
Age: 12.0
Sex: U
Vaccine: DTAP, DTAP
Symptoms: Urticaria, Wheezing
Clinical narrative: Cough, sneezing, wheezing, tightness chest, nausea cramping 2 hives-cat to progress-BENADRYL, Epi administrated. Symptoms resolved.
Sex: F
Vaccine: FLU3
Symptoms: Neuralgic amyotrophy
Clinical narrative: Case PHEH2016US025263 is an initial spontaneous report received from consumer on 30 Sep 2016. This report refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number and expiry date not reported) intramuscularly on 11 Nov 2015. On 30 Nov 2015, the patient had Parsonage Turner Syndrome. The outcome of event was reported as condition improving. The seriousness of the event was reported as disability. The causality of the event was not reported. This case was lost to follow up.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, C-reactive protein increased, Muscular weakness, Pain, Pyrexia
Clinical narrative: Sharp shooting pain in head above temple. Intermittent symptoms for 1 week. Arthritis flare up in hands and muscle weakness in arms and legs. Low grade fever 5 days after injection of high dose FLUZONE.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Gait disturbance, Malaise, Migraine, Tremor
Clinical narrative: By 2pm was very sick: chills, wobbly knees, severe migraine. Was at work so doctor recommended TYLENOL. By night chills were severe, couldn't stop shaking.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had redness and swelling in their arm where the flu vaccine was given. Pt took BENADRYL and was okay per the pharmacist who was working on 10-3-16.
Age: 82.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site inflammation
Clinical narrative: Area around vaccine site is inflamed and red. Nursing is monitoring for increased size, warmth, fever.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Chills, Cough, Dizziness
Clinical narrative: Two hours after Flu shot fast heartbeat dizzy weakness hoarseness cough headache Temp 104.7 chills shaking ok after 72 hours I m a CRHA- have had flu shot with uce yr. - NCUCE
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Headache, Heart rate increased, Tremor
Clinical narrative: Two hours after Flu shot fast heartbeat dizzy weakness hoarseness cough headache Temp 104.7 chills shaking ok after 72 hours I m a CRHA- have had flu shot with uce yr. - NCUCE
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Tachycardia, Tremor
Clinical narrative: Shaking chills, fever, aches, Tachycardia lasted 24 hours.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: Neck pain.a
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Received PNEUMOVAX23 in (R) deltoid approx 12:30. (R) arm sore in afternoon. At 10:30 pm noticed Rt deltoid area quite swollen, warm to touch. Took 2 Ibuprofen. No itching but took BENADRYL. 9-30-16 am swelling now behind shoulder blade.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on forehead. Lt shoulder and abdomen. Treated in emerg. room.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Less than 30 min after vaccine, she felt her throat closing up. Seen in Emergency Dept.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Per niece 30 minutes approximately post shot pt. developed a blister, has rash around area - no rash or blister near injection sits. Blister is size of maybe pinky nail. Pt. took BENADRYL and went to immediate care. Pt. reported some itching near blister areas.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Cyanosis, Skin discolouration
Clinical narrative: Black and blue area. Pt said burning sensation also. Pt showed me 9/30/16.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis
Clinical narrative: Possible shoulder bursitis from flu injections.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Possible shoulder bursitis from flu injections.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Osteitis, Pain, Rotator cuff syndrome, Sleep disorder, Tendonitis
Clinical narrative: Possible shoulder bursitis from flu injections.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: Possible shoulder bursitis from flu injections.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Cough, Dyspnoea, Laboratory test
Clinical narrative: Cough, SOB, rash evaluated at ER. Tx with Nebulizer, IV SOLU-MEDROL, CXR.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pharyngeal oedema, Pyrexia
Clinical narrative: Throat swelling, fever 101 degrees F, Chills about 5 hours after vaccine administration. Symptoms relieved by ibuprofen. Not treated by MD.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: The patient's right arm had a red circle and she said it was very itchy, hot, and hard. This is the place where she received her ZOSTAVAX injection.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Feeling hot
Clinical narrative: redness over legs, arms, face, chest. Feels hot "like I'm burning from the inside".
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Immediate post-injection reaction, Pruritus, Pyrexia, Rash
Clinical narrative: Patient has rash on left arm. The rash is small clusters of blisters. The patient stated he immediately had itching and fever after receiving vaccine. Patient did not come in until Wednesday, went to ER. Given VALTREX.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, pain and warmth spreading in upper left deltoid area is indurated and painful to palpation. Started 12-24 hours after injection and worsened despite ice and BENADRYL. Treated with Cephalexin 250/5ml 10 ml PO BID x 10 day., MD. F/U call 10/4/16 decreased swelling decreased redness no pain, LPN.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient reported couple of hours later, she experienced fever/chills, nausea and vomited once. Patient felt dizzy. On Wednesday 9/28/16 8am (next day) patient felt ok.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Patient stated he experienced runny nose and cough after receiving flu shot.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Pruritus
Clinical narrative: Rec'd shot IIV 9/27/16 11:45 am. Sleeping and woke up with head itching, eye swollen, lips swollen, no problems breathing approximately midnight. She took PO BENADRYL. Went to ED where rec'd IV steroids and D/C home W/steroid dose pack.
Age: 81.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Day 2 of vaccination - redness. Day 3 of vaccination - severe itching, warmness at sight of vaccination. Day 6 of vaccination - no itching but still red.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itching at site-no treatment required.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: Arm that had PNEUMOVAX vaccine is very sore 4 days later. Began 9-24-16 in the evening, taking Ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Onset 5 days after the shot with a headache- I took one ALEVE tablet- Headache continued along with sweats, nausea, vomiting, diarrhea. Slept through the night after vomiting and awoke free of all symptoms (shot 9-22-16) (Flu symptoms 9-27-16).
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dry mouth, Rash erythematous, Skin warm, Throat tightness, Vertigo
Clinical narrative: Red rash, very warm to touch, vertigo, throat felt like it was closing up, cotton mouth.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Peripheral swelling, White blood cell count normal
Clinical narrative: Whole limb swelling of left arm after influenza vaccine.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced a very sore arm day of the injection. the next day the arm - (RC) was swollen, red and angry. She felt weak. She saw her PCP who told her she had an allergic reaction to the vaccine and gave her a steroid injection. the reaction subsided with hours after the steroid. She had no reaction at the flu injection site. Hx of PPV vaccine 11.17.10.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Patient experienced a very sore arm day of the injection. the next day the arm - (RC) was swollen, red and angry. She felt weak. She saw her PCP who told her she had an allergic reaction to the vaccine and gave her a steroid injection. the reaction subsided with hours after the steroid. She had no reaction at the flu injection site. Hx of PPV vaccine 11.17.10.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received vaccine at 2:30pm. Reported hives and itching at 9:45pm followed up at 9am on 9/21/16-Patient is fine today.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red arm lingering for 1 week, patient complain of sore arm and unresolved red spot on arm.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Day 1 of vaccination - itching, chills, body aches, vomiting through day 3. Day 4 - redness, warm to touch.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Day 1 of vaccination - itching, chills, body aches, vomiting through day 3. Day 4 - redness, warm to touch.
Age: 84.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Gait disturbance, Muscle spasms, Pyrexia
Clinical narrative: Fever, chills, muscle cramps, Trouble walking -> went to ER.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Fatigue, Induration, Injection site erythema, Pain
Clinical narrative: Pain, redness, swelling. Tenderness to touch. Reddened area at site. Fatigue and urinary incontinence. Redness/swelling 3inch diameter/indurated/ warm to touch.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Skin warm, Swelling, Tenderness, Urinary incontinence
Clinical narrative: Pain, redness, swelling. Tenderness to touch. Reddened area at site. Fatigue and urinary incontinence. Redness/swelling 3inch diameter/indurated/ warm to touch.
Age: 83.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient wanted ZOSTAVAX. Pt talked with technician about the flu shot the day before, when he came back, Tech. thought he wanted flu shot, the pharmacist gave pt flu shot. No adverse event.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Area around vaccine site is inflamed and red. Nursing is monitoring for increase on size, warmth, fever.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: 30 minutes after receiving injection, acute onset severe stomach cramping and nausea. No fever, vomiting, diarrhea. Symptoms lasted 15-20 mins, then resolved completely.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness, Vertigo
Clinical narrative: Redness, swelling, tender to touch, vertigo.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Patient received vaccine 9/20/16 approximately 7 PM. No reaction after vaccine. Patient called 9/22/16 stating he had a minor seizure 9/21/16 for approximately 10 mins. He is doing okay now.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Peripheral swelling, Pruritus, Rash
Clinical narrative: Itching - rash - swelling (lip, arm) -  trouble breathing - started with itching and progressed to trouble breathing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypotonia
Clinical narrative: Loss of muscle tone/strength from the waist down, symptoms went away on it's own by 9/10/16.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness
Clinical narrative: 9/25-Flu shot given by LPN at Doctor's office. Immediate pain in right shoulder joint. Pain 6/10, increased temperature to touch, nausea, constant burn, weakness of (L) arm. Having existing SX numbness, tingling.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Paraesthesia, Skin warm
Clinical narrative: 9/25-Flu shot given by LPN at Doctor's office. Immediate pain in right shoulder joint. Pain 6/10, increased temperature to touch, nausea, constant burn, weakness of (L) arm. Having existing SX numbness, tingling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rash, Urticaria
Clinical narrative: Next day, fever, chills, rash and hives. Fever and chills lasted 2 days, hives 3 days and still have partial rash.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to touch, swelling.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Employee reported fever, chills, severe muscle pain, muscle spasms, muscle weakness and fatigue.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Employee reported fever, chills, severe muscle pain, muscle spasms, muscle weakness and fatigue.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: 4 x 6 cm red edematous puritic area distal to injection site with 24 hrs of vaccine administration.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3" x 3" area of red raised slightly in area where injection was given on upper left arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Pain in extremity, Tremor
Clinical narrative: Pt has arm and leg tremors and very sore arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Feeling cold, Pain in extremity, Tremor
Clinical narrative: Pt has arm and leg tremors and very sore arm.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Employee received FLULAVAL vaccine on 9/19/16 and the morning broke out in a red itchy rash and hives on arms neck face, back and knees.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Feeding disorder, Fluid intake reduced, Malaise, Vomiting
Clinical narrative: After having been given FLUZONE HD I became very ill. Like the worse case of flu ever. This lasted over 24 hours. I was throwing up all night long could not eat or drink.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Facial pain, Headache, Neck pain, Nerve compression, Spondylitis
Clinical narrative: Years ago after accident had pinch nerve on back of neck and arthritis on neck. Next day after vax had facial pain and pressure headaches. Neck soreness. Pain especially left side above eye brow. On 8/9/16 called doctor and got ibuprofen 400mg. The ibuprofen helped. On 9/7/16 went to doctor. Still has symptoms now but they are more pronounced when lay down.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-SEP-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # K021444, expiration dated 17-SEP-2016). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored VARIVAX (lot # M000997 and expiration date 07-JAN-2018) (lot # M006731 and expiration date 09-FEB-2018) (lot # M027345 and expiration date 06-JAN-2018) (dose and route of administration not reported for all the lots). The administered doses experienced a temperature excursion of 19 Fahrenheit for 18 hours. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was vaccinated with improperly stored VARIVAX lot # L049534, expiry date 08-DEC-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 17-AUG-2016, the patient was vaccinated with M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 29-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, lot # M019232, expiry date 17-OCT-2017, rHA, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F or a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. No adverse effects reported. The outcome of the events was unknown. No product complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX 19400PFU (dose, route of administration, lot # and expiration date were not provided). There were no concomitant medications reported. On an unknown date (reported as "6 months post vaccination"), the patients were diagnosed with shingles. At the reporting time, the outcome of shingles was unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 16-SEP-2016, the patient was vaccinated with a dose of M-M-R II (strength, dose and frequency were unknown; lot number reported as M007279 with expiration date 09-FEB-2018) via the intramuscular route. M-M-R II was prepared using lidocaine as the diluent. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received doses of improperly stored VAQTA lot # L015460 with expiration date: 20-JUL-2017 (dose and route of administration were not reported). Administered doses of VAQTA underwent temperature excursions at 35.3 Fahrenheit degrees, for 7 hours and 21 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The registered nurse reported that on unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, dose and route unknown), PEDVAXHIB (lot # L051124, expiration date 14-OCT-2018, dose and route unknown, captured in 1609USA010855) and M-M-R II (lot # L036851, expiration date 23-SEP-2017, dose and route unknown, captured in 1607USA008489). The temperature excursion information included the highest temperature of 53.2 degrees Fahrenheit for 30 minutes. No adverse effects were reported. Follow up information has been received from the registered nurse on 20-SEP-2016. She said that no patients who received the improperly stored vaccines experienced any adverse symptoms. She said she had no additional information. This is one of the several report received from the same reporter. This report refer to the improperly stored GARDASIL 9. Additional information has been requested. Reporter and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in 2016 (reported as "since August 2016"), the patients were vaccinated with doses improperly stored ROTATEQ (lot #, expiration date, dose and route were unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 24-AUG-2016, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD, rHA, lot # M019232, expiry date 17-OCT-2017, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. On 24-AUG-2016, the patient was vaccinated with (wistar ra 27-3) M-M-R II, rHA, (lot # L030162, expiry date 11-AUG-2017), intramuscularly instead of subcutaneously, 0.5 ml. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.