chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Chest pain, Crying, Headache, Somnolence
Clinical narrative: AT 9:45 patient was administered their 2ND dose of the GARDASIL 9 VACCINE. Parents were aware that patient would need to wait 15 min. After administration to monitor for any kind of adverse reaction. Mother and father gave verbal  understanding.  AT 09:55 I went back into the room to  look at the supper bill. I found  the patient sitting on the chair in the room trying to vomit but very little was coming up. I asked the  father if the patient started feeling upset to his stomach when the blood was being drawn from the sibling or if it was all of a sudden. Father stated that patient had said he felt very sleepy and then sat down in the floor so the dad picked him up in to the chair and that is when he started vomiting. I OPENED THE DOOR TO THE ROOM AND HAD employee GO ASK DR TO COME TO THE ROOM. I STOOD BY THE PATIENT AND THE PATIENT WAS SITTING UP BUT SUDDENLY ALMOST FELL TO THE FLOOR, I GRABBED HIM UNDER HIS ARMS FROM BEHIND. DR WALKED IN AND PT WANTED ME TO LET GO, I EXPLAINED WHAT WAS GOING ON TO DR AND EXPLAINED IF I LOOSEN MY GRIP ON THE PT THAT HE STARTS TO SLIDE OFF THE CHAIR. DR ASSISTED ME IN MOVING THE PT TO THE EXAM TABLE WHERE WE PLACED HIM IN A SIDE LYING POSITION. PT STATED HIS CHEST WAS HURTING THEN VOMITED ALMOST IMMEDIATELY. PT WAS ASSESSED BY DR AND WAS IN A STABLE CONDITION. PT WENT TO SLEEP HOWEVER STABLE CONDITION REMAINED. PARENTS WERE ADVISED TO STAY IN THE ROOM SO WE COULD MONITOR THE PT AND WE STEPPED OUT. AT 10:20 PT WAS STILL ASLEEP AND IN STABLE CONDITION. AT 10:25 employee TOLD ME PARENTS SAID PT HEAD WAS HURTING. I WENT TO THE ROOM AND PATIENT WAS LYING ON BACK HOLDING HEAD AND CRYING SAYING HIS HEAD HURT REALLY BAD. PT WAS COUGHING WHAT SOUNDED LIKE HE WAS TRYING TO THROW UP SO I IMMEDIATELY TURNED HIM ONTO THE SIDE AND DR CALLED BACK TO ROOM. DR CAME IN AND ASSESSED PT, PT WAS STILL CRYING AND WOULD NOT RESPOND TO ANY QUESTIONS ASKED AND SUDDENLY FELL ASLEEP AGAIN. 02 STATS WERE WITHIN NORMAL LIMITS AND VARIED FROM 97-99% AND HEART RATE VARIED FROM 67-78 BEATS PER MIN. MADE SURE PT WAS STABLE AND ADVISED PARENTS TO WAIT IN ROOM. DR EXPLAINED TO PARENTS PT WAS STABLE BUT WAS HAVING BAD REACTION TO VACCINE. HE STATED THAT IF PT WOKE UP WITH HEAD HURTING LIKE BEFORE TO SEND HIM TO THE EMERGENCY ROOM, MOTHER GAVE VERBAL UNDERSTANDING. AT 10:40 employee INFORMED ME THAT PATIENT HAD LEFT THE ROOM. Employee AND DR FOUND THE PT AND ASSESSED HIM BEFORE LEAVING. PT WAS SAID TO BE IN STABLE CONDITION. LVN 5/24/17 3:42PM. INCIDENT AS REPORTED ABOVE BY LVN; ALL INFORMATION OF INCIDENT REVIEWED AND ACCOUNTED FOR CORRECTLY PATIENT DID LEAVE ON OWN W PARENTS BEFORE WE WERE READY FOR THEM TO LEAVE. WE DID ENCOUNTER THEM IN THE PARKING LOT. Patient WAS AWAKE, ALERT AND ORIENTED. HE SAID HE FELT BETTER AND HEAD NO LONGER HURTING. REVIEWED W PARENTS THAT HE SEEMS TO HAVE HAD AN ADVERSE REACTION TO THE VACCINE. HE LOOKED OK TO GO HOME. ADVISED IF INTENSE HEADACHE RECURRED HE SHOULD BE TAKEN TO ER FOR RE-EVAL. PARENTS EXPRESSED UNDERSTANDING AND NO FURTHER QUESTIONS. MD 5/24/17 10:36AM.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: AT 9:45 patient was administered their 2ND dose of the GARDASIL 9 VACCINE. Parents were aware that patient would need to wait 15 min. After administration to monitor for any kind of adverse reaction. Mother and father gave verbal  understanding.  AT 09:55 I went back into the room to  look at the supper bill. I found  the patient sitting on the chair in the room trying to vomit but very little was coming up. I asked the  father if the patient started feeling upset to his stomach when the blood was being drawn from the sibling or if it was all of a sudden. Father stated that patient had said he felt very sleepy and then sat down in the floor so the dad picked him up in to the chair and that is when he started vomiting. I OPENED THE DOOR TO THE ROOM AND HAD employee GO ASK DR TO COME TO THE ROOM. I STOOD BY THE PATIENT AND THE PATIENT WAS SITTING UP BUT SUDDENLY ALMOST FELL TO THE FLOOR, I GRABBED HIM UNDER HIS ARMS FROM BEHIND. DR WALKED IN AND PT WANTED ME TO LET GO, I EXPLAINED WHAT WAS GOING ON TO DR AND EXPLAINED IF I LOOSEN MY GRIP ON THE PT THAT HE STARTS TO SLIDE OFF THE CHAIR. DR ASSISTED ME IN MOVING THE PT TO THE EXAM TABLE WHERE WE PLACED HIM IN A SIDE LYING POSITION. PT STATED HIS CHEST WAS HURTING THEN VOMITED ALMOST IMMEDIATELY. PT WAS ASSESSED BY DR AND WAS IN A STABLE CONDITION. PT WENT TO SLEEP HOWEVER STABLE CONDITION REMAINED. PARENTS WERE ADVISED TO STAY IN THE ROOM SO WE COULD MONITOR THE PT AND WE STEPPED OUT. AT 10:20 PT WAS STILL ASLEEP AND IN STABLE CONDITION. AT 10:25 employee TOLD ME PARENTS SAID PT HEAD WAS HURTING. I WENT TO THE ROOM AND PATIENT WAS LYING ON BACK HOLDING HEAD AND CRYING SAYING HIS HEAD HURT REALLY BAD. PT WAS COUGHING WHAT SOUNDED LIKE HE WAS TRYING TO THROW UP SO I IMMEDIATELY TURNED HIM ONTO THE SIDE AND DR CALLED BACK TO ROOM. DR CAME IN AND ASSESSED PT, PT WAS STILL CRYING AND WOULD NOT RESPOND TO ANY QUESTIONS ASKED AND SUDDENLY FELL ASLEEP AGAIN. 02 STATS WERE WITHIN NORMAL LIMITS AND VARIED FROM 97-99% AND HEART RATE VARIED FROM 67-78 BEATS PER MIN. MADE SURE PT WAS STABLE AND ADVISED PARENTS TO WAIT IN ROOM. DR EXPLAINED TO PARENTS PT WAS STABLE BUT WAS HAVING BAD REACTION TO VACCINE. HE STATED THAT IF PT WOKE UP WITH HEAD HURTING LIKE BEFORE TO SEND HIM TO THE EMERGENCY ROOM, MOTHER GAVE VERBAL UNDERSTANDING. AT 10:40 employee INFORMED ME THAT PATIENT HAD LEFT THE ROOM. Employee AND DR FOUND THE PT AND ASSESSED HIM BEFORE LEAVING. PT WAS SAID TO BE IN STABLE CONDITION. LVN 5/24/17 3:42PM. INCIDENT AS REPORTED ABOVE BY LVN; ALL INFORMATION OF INCIDENT REVIEWED AND ACCOUNTED FOR CORRECTLY PATIENT DID LEAVE ON OWN W PARENTS BEFORE WE WERE READY FOR THEM TO LEAVE. WE DID ENCOUNTER THEM IN THE PARKING LOT. Patient WAS AWAKE, ALERT AND ORIENTED. HE SAID HE FELT BETTER AND HEAD NO LONGER HURTING. REVIEWED W PARENTS THAT HE SEEMS TO HAVE HAD AN ADVERSE REACTION TO THE VACCINE. HE LOOKED OK TO GO HOME. ADVISED IF INTENSE HEADACHE RECURRED HE SHOULD BE TAKEN TO ER FOR RE-EVAL. PARENTS EXPRESSED UNDERSTANDING AND NO FURTHER QUESTIONS. MD 5/24/17 10:36AM.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Upper arm at the vaccinated site was swollen, tender to touch.  Pt has no fever. Suggested pt to take ibuprofen 600mg every 6 hours, and benadryl 25mg every 6 hours, also icing the site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route and anatomical location were not reported), strength of 10/1.0 micro-gr/ml, lot # L038018 and expiration date on 13-SEP-2017, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001034: US-009507513-1706USA001035: US-009507513-1706USA001033.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Headache, Pain in extremity, Rash
Clinical narrative: Information was received from a 64 year old female patient with diabetes, high blood pressure, high cholesterol, asthma, and no known allergies. The patient stated "she is on several medications" (unspecified). On 06-MAR-2017, the patient was vaccinated with ZOSTAVAX injection, "one time vaccine," (lot number, dosage, and route of administration not provided) to prevent shingles. On approximately 20-MAR-2017 (reported as two weeks after getting the vaccine), the patient had very bad pain in her right arm. She then developed a rash on her right arm (specific onset unknown).  The pain in her right arm subsided somewhat and was not as painful. Then on approximately 17-MAY-2017 (reported as two days ago), the patient developed a sharp pain on the right side of her head. The patient sought medical attention on an unknown date and was prescribed valacyclovir for the pain in her head. She reported having a blood test done on approximately 28-APR-2017 (reported as 3 weeks ago; results not provided). The outcome of the rash and sharp pain on the right side of her head is unknown. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 30-MAY-2017, the patient was vaccinated with the first and expired dose of GARDASIL, with lot # K007264 and an expiration date on 02-MAR-2017 (strength and dose were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red rash and pain/heat on the upper arm near injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination complication
Clinical narrative: Localized nonpainful swelling and redness surrounding area of vaccination. Uncertain if in area of PROQUAD or KINRIX.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dysgraphia, Erythema, Flushing, Grip strength decreased, Hypersensitivity
Clinical narrative: Late Friday night, noticed rash and redness on arms. Early Saturday morning around 1:00 AM, woke up to increased rash and redness and swollen lips. Later Saturday morning, woke up to numbness and swelling of fingers and hands which made it difficult and slightly painful to grip objects and write. On Sunday morning, rash and redness increased even more and spread to body and upper thighs, flushed face, and fingers/hands still numb and swollen. Went to doctor's office around 11:00 AM, and doctor stated symptoms as an allergic reaction to BEXSERO. Doctor prescribed steroids for four days, Claritin, and Benadryl. Symptoms started to slowly decrease on Tuesday and throughout the week.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Lip swelling, Peripheral swelling, Rash
Clinical narrative: Late Friday night, noticed rash and redness on arms. Early Saturday morning around 1:00 AM, woke up to increased rash and redness and swollen lips. Later Saturday morning, woke up to numbness and swelling of fingers and hands which made it difficult and slightly painful to grip objects and write. On Sunday morning, rash and redness increased even more and spread to body and upper thighs, flushed face, and fingers/hands still numb and swollen. Went to doctor's office around 11:00 AM, and doctor stated symptoms as an allergic reaction to BEXSERO. Doctor prescribed steroids for four days, Claritin, and Benadryl. Symptoms started to slowly decrease on Tuesday and throughout the week.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Muscle rigidity, Syncope, Tremor
Clinical narrative: I RECEIVED THE VPH VACCINE AND THE CAPE OF 3 TO 5 MIN, THERE WAS A MUSCULAR DISMOUNTING AND PARALYSIS WITH BRUSH MOVEMENTS.  RECEIVED THE VACCINE AND 3-5 MINUTES AFTER MY DAUGHTER FAINTED PRESENTING SUDDEN TREMORS AND MUSCLE RIGIDITY, FOR ALMOST 1 MIN.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 101.4 after imms. No swelling or redness at inj. sites. Day of imms. Temp down to 99.9 the following day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Differential white blood cell count, Full blood count, Headache, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: Headache x 6 days. Fever x 5 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mycoplasma test, Pyrexia
Clinical narrative: Headache x 6 days. Fever x 5 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (R) upper arm, 0.5cm papule mid arm. No fever. RX for BENADRYL every 6 hours given.
Age: 18.0
Sex: F
Vaccine: HEPA, MEN, MENB
Symptoms: Full blood count normal, Pruritus, Urticaria
Clinical narrative: Hives and itching 5 days after vaccines.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, chills, N/V, redness and soreness at site of injection.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Fever, chills, N/V, redness and soreness at site of injection.
Age: 45.0
Sex: M
Vaccine: MMR, TYP
Symptoms: Cellulitis, Nodule
Clinical narrative: Developed nodule on triceps 4 days following MMR 2 and typhoid fever 3 that persisted until 16 May. Treated on 25 April with CLEOCIN for suspected cellulitis, however my exam did not suggest that.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: Patient received MENACTRA and TDaP vaccines. Within 20 minutes developed symptoms of anaphylaxis i.e. throat closing, tongue swollen, difficulty swallowing, breathing and received Epinephrine 0-3 mg IM.
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site rash, Pyrexia, Rash maculo-papular
Clinical narrative: Mother reports today 6/2/17 that patient has had a fever every day since vaccine was given. Last was today up to 101 degrees. Pt has scattered maculopapular rash to trunk and extremities. Concentrated rash to injection site of left lateral upper thigh.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling
Clinical narrative: Patient arm was swollen and patient was in a lot of pain.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram head abnormal, Contusion, Extradural haematoma, Haemorrhage, Intensive care
Clinical narrative: Pt fainted in office hall 1 min after vaccine given; LOC; to ER pt now in ICU-skull fx, contusion, hemorrhage. Still in ICU.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Skull fracture, Syncope
Clinical narrative: Pt fainted in office hall 1 min after vaccine given; LOC; to ER pt now in ICU-skull fx, contusion, hemorrhage. Still in ICU.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash to injection sites, itchiness.  BENADRYL allergy. Cephalexin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth of upper arm consistent with cellulitis at injection site.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, Moderate Level Headache which is still going on at 8:00 PM 06/02/2017 from about 10:30 AM (about 30 minutes after the administration of the MENACTRA (Meningococcal conjugate vaccine), and mild fever.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Headache, Injection site pain, Nausea
Clinical narrative: Tenderness at injection site, chills, fever of 100.3 by the morning (June 1), strong body aches, nausea on the morning of June 1, headache on the morning of June 1. On June 1 took a total of 4 Tylenols (500 mg). One at 6AM, one at 11AM and one at 3PM and lastly one at 7PM. By June 2nd I felt much better.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Tenderness at injection site, chills, fever of 100.3 by the morning (June 1), strong body aches, nausea on the morning of June 1, headache on the morning of June 1. On June 1 took a total of 4 Tylenols (500 mg). One at 6AM, one at 11AM and one at 3PM and lastly one at 7PM. By June 2nd I felt much better.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient had BEXSERO vaccine, two day later patient stated arm was red, swollen and warm to touch.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Musculoskeletal pain, Myalgia
Clinical narrative: Within 2 hours of administration, pt c/o back pain between shoulder blades. Pain increased to involve entire back, especially rt paraspinal muscle, which is tight and spasmodic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Discomfort, Erythema, Skin warm, Tenderness
Clinical narrative: Within 24 hours of vaccination developed 14x14 cm diameter area of redness, warmth, tenderness, Administered BENADRYL by mouth every 6 hours and TYLENOL for discomfort.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Abscess drainage, Abscess rupture, Cellulitis, Erythema
Clinical narrative: "Large lump" (cellulitis/abscess). Redness, pain, rupture and drainage. Course of 8 days. F/U visit w/doctor, antibiotics given.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Pain
Clinical narrative: "Large lump" (cellulitis/abscess). Redness, pain, rupture and drainage. Course of 8 days. F/U visit w/doctor, antibiotics given.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Sinusitis
Clinical narrative: Sinus infection.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cough, Pneumonia
Clinical narrative: Pneumonia, cough.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain
Clinical narrative: I got the Shingles Vaccine on May 1, 2017. On May 27, 2017 I had shingles on my face and was diagnosed by a healthcare professional and prescribed medications. The shingles are a lighter case as shingles go - pain and redness but no blistering.
Age: 23.0
Sex: F
Vaccine: TYP, YF
Symptoms: Erythema, Limb discomfort, Local swelling, Lymph node pain, Pain in extremity
Clinical narrative: Red raise itchy and hot to the touch after yellow fever. Pain and discomfort throughout whole arm and lymph node.
Age: 23.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pruritus, Skin warm
Clinical narrative: Red raise itchy and hot to the touch after yellow fever. Pain and discomfort throughout whole arm and lymph node.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Oropharyngeal pain
Clinical narrative: I received ZOSTAVAX vaccine with no problems, but 2 days later I began having 1 or 2 mouth blisters per day for about 2 weeks. Then I also had a sore tonsil for 1 day. After that everything is OK.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Vaccine side effects. Receive ZOSTAVAX vaccination on 5/16/17 on the same day as Tdap (left arm). Both injection sites were tender that day but that was all that day. The next day the tetanus site was still tender but the shingles vaccine side started to swell and turn red and was warm. Swelling was an oval about 2" x 1" and stay that way for a week. On May 24 the swelling was down and the site was just tender but beginning to itch. On May 25 they started to have flulike symptoms: sore throat and diarrhea. The itching in food like symptoms continue today.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Vaccine side effects. Receive ZOSTAVAX vaccination on 5/16/17 on the same day as Tdap (left arm). Both injection sites were tender that day but that was all that day. The next day the tetanus site was still tender but the shingles vaccine side started to swell and turn red and was warm. Swelling was an oval about 2" x 1" and stay that way for a week. On May 24 the swelling was down and the site was just tender but beginning to itch. On May 25 they started to have flulike symptoms: sore throat and diarrhea. The itching in food like symptoms continue today.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000302: US-009507513-1705USA000847: US-009507513-1706USA000303: US-009507513-1706USA000300.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Dyspnoea
Clinical narrative: Anaphylactic reaction to yellow fever vaccine (YF-VAX), symptom onset in 10-15 minutes, breathing difficulty, low oxygen saturations (80ies reported), rhinorrhea, swelling of eye lids and lips, behavioral change (appeared less coherent to mother), no reaction at injection site; treated in ER with nebulized albuterol, i.v. steroids and Pepcid.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Abnormal behaviour, Anaphylactic reaction, Dyspnoea, Eyelid oedema, Incoherent
Clinical narrative: Anaphylactic reaction to yellow fever vaccine (YF-VAX), symptom onset in 10-15 minutes, breathing difficulty, low oxygen saturations (80ies reported), rhinorrhea, swelling of eye lids and lips, behavioral change (appeared less coherent to mother), no reaction at injection site; treated in ER with nebulized albuterol, i.v. steroids and Pepcid.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Lip swelling, Oxygen saturation decreased, Rhinorrhoea, Skin test negative, Urticaria
Clinical narrative: Anaphylactic reaction to yellow fever vaccine (YF-VAX), symptom onset in 10-15 minutes, breathing difficulty, low oxygen saturations (80ies reported), rhinorrhea, swelling of eye lids and lips, behavioral change (appeared less coherent to mother), no reaction at injection site; treated in ER with nebulized albuterol, i.v. steroids and Pepcid.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: WHOLE UPPER ARM SWELLING, INFLAMMED, AND REDNESS.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Pyrexia
Clinical narrative: High fever -103 degrees.  Tiredness.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Lethargy, Pyrexia, Rash
Clinical narrative: Fever for 2.5 days. Severe rash after the fever. Extremely irritable. Lethargic.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: Woke up, extreme sore throat-closing, chills/sweating, dizzy, horrible H/A, body aches. Friend picked up and took to urgent care. Treated with Abx, tested for strep throat=result negative.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Pain, Streptococcus test, Throat tightness
Clinical narrative: Woke up, extreme sore throat-closing, chills/sweating, dizzy, horrible H/A, body aches. Friend picked up and took to urgent care. Treated with Abx, tested for strep throat=result negative.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Lip swelling, Pruritus, Urticaria
Clinical narrative: Hives itching difficulty breathing swollen lips.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Pharyngeal oedema, Wheezing
Clinical narrative: Hives itching difficulty breathing swollen lips.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness at site; on 6/2/2017 doctor's visit, she was informed that the site looked worse than it should.
Age: 31.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Burning sensation, Induration, Pruritus, Rash erythematous, Swelling
Clinical narrative: Patient Sx: burning, itchiness, spreading red rash, hardness to skin and swelling.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, swelling, warmth, itching.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: BIG RED ITCHY RASH ON THE ARM BUT NOT PAINFUL, PATIENT ADVISED TO TAKE BENADRYL, APPLY ICE ON THE AREA AND LET US KNOW IF IT GETS WORSE.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Swelling face, Vomiting
Clinical narrative: Swollen face with red rash on face and neck. Red rash on left thigh where 2 shots were given. Started throwing up 06/03/2017 at 10 AM, and could not keep food or liquid down until 5:30 PM. Took him to ER at 12:15 PM on 06/03/2017, where he was given 5 ML of Benadryl for swelling and 2 MG zofran for vomiting.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Ear infection, Respiratory arrest
Clinical narrative: Stopped breathing, double ear infection from the first shot the month previous.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test negative, Headache, Loss of personal independence in daily activities, Migraine
Clinical narrative: Patient went to her doctor for her yearly well check-up. She was a healthy 14 year old who rarely was sick. She received the first dose of the HPV Vaccine on August 10, 2016. Within 24 hours of receiving the vaccine patient developed a headache that would not go away. At first we tried ADVIL, ALEVE and other over the counter medicine that in the past has worked for headaches she would get occasionally. This headache she had was a constant headache 24 hours a day. She woke up with it and went to bed with it. We brought her back to the doctors to help get treatment for these headaches. She was given a steroid pack at first, did nothing to relieve the pain. She was tested for Lyme disease which was negative. I asked the doctor if this could be a side affect of the HPV vaccine and was told no. Then we were sent to headache clinic. I asked again if this could be a vaccine injury and was told no again. We were immediately told at Clinic that she had chronic migraines and would begin taking medications until the right one was found. I told them patient never had a migraine before and now all of a sudden after that vaccine she develops chronic migraines. Didn't make sense to me but went along with their recommendations for patient to begin meds. This was in September. Her headaches at this time were 8-9 on a scale of 10. From September through December, patient was on 9-10 different medications, was given IV treatments twice, had 2 MRI's and nothing stopped the headaches. Then we were told this was all in patient's head and she needed to see a pain psychologist. She went to all of the visits and followed through with the psychologists recommendations and still the headaches persisted. In late December patient had about 33 shots of BOTOX in her head to help with the pain. Again, didn't help at all. At this point, we were completely frustrated and feeling hopeless. My daughter went from being very active every day, playing spots, hanging out with her friends to coming home from school; sleeping, getting up for dinner and going back to sleep. Sleeping was the only time she didn't have to deal with the pain. She was a completely different person than before she got this shot. Needless to say I never took her for the 2 and 3rd shots after experiencing what just one did to her. After yet another day of IV treatments in January at Clinic and getting a second opinion at another clinic I decided to take her to a Homeopathic Doctor. He has been able to give her supplements that have brought her head pain down to a manageable level at times but she is still suffering from headaches - some severe.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The patient got vaccinated on her left arm. Next day, she developed flu like symptoms with body aches, fever (101 F) for 2 days. On 3rd day, her left arm became red, swollen, hot, painful from shoulder to elbows and lasted for 2 days. Pt recovered after 5 days of reaction. Patient did report to her MD. No medication taken. The reactions were resolved by itself.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: The patient got vaccinated on her left arm. Next day, she developed flu like symptoms with body aches, fever (101 F) for 2 days. On 3rd day, her left arm became red, swollen, hot, painful from shoulder to elbows and lasted for 2 days. Pt recovered after 5 days of reaction. Patient did report to her MD. No medication taken. The reactions were resolved by itself.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood potassium decreased, Cold sweat, Dizziness, Hypoaesthesia, Muscle rigidity
Clinical narrative: Syncope event - pt felt light headed - clammy skin - rapid breathing - pt never experienced hives/redness/difficulty breathing/speaking/maintained an open airway - pt did experience rigidity and numbness in hands and fingers.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Respiratory rate increased, Syncope
Clinical narrative: Syncope event - pt felt light headed - clammy skin - rapid breathing - pt never experienced hives/redness/difficulty breathing/speaking/maintained an open airway - pt did experience rigidity and numbness in hands and fingers.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Significant swelling, and redness on upper arm extending to should to elbow.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Disturbance in attention, Dizziness, Feeling cold, Nausea, Syncope
Clinical narrative: Dizzy, nauseated, fainted, felt cold couldn't concentrate. Effect lasted for 15 mins.
Age: 2.0
Sex: F
Vaccine: HEP, HIBV
Symptoms: Abdominal pain upper, Asthenia, Back disorder, Fall, Pain
Clinical narrative: Patient puked, has high fever, stomach ache, has been walking on tip toes often falling over with a hunched back.  Went to ER, they gave Motrin and monitored her and checked urine.  She still is walking with aches, has a stomach ache, intermittent fever and low energy.
Age: 2.0
Sex: F
Vaccine: HEP, HIBV
Symptoms: Pyrexia, Toe walking, Urine analysis abnormal, Vomiting
Clinical narrative: Patient puked, has high fever, stomach ache, has been walking on tip toes often falling over with a hunched back.  Went to ER, they gave Motrin and monitored her and checked urine.  She still is walking with aches, has a stomach ache, intermittent fever and low energy.
Age: 10.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Blood test, Chills, Pyrexia, Vomiting
Clinical narrative: Chills and vomiting on the same day. Two days later fever vomiting and stomach pains.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Red swelling and hard knotting around the injection site, patient was told to ice area and take oral antihistamine.
Age: 54.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness, swelling, warmth and a lump at the site of the injection that started shortly after administration according to the patient and is noted on exam today. Started patient on antibiotic for possible cellulitis related to the injection.
Age: 47.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Painful rash in armpit bilateral. Injection site swelling bruising and hot.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: PATIENT COMPLAINED OF PAIN AND SWELLING THE NIGHT OF THE VACCINE. THE NEXT DAY FOLLOWING VACCINE HIS ARM WAS RED FROM THE SITE DOWN TO HIS ELBOW.  DR PUT HIM ON ANTIBIOTICS.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Contusion, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid: 2.5 inch diameter redness and swelling. muscle felt knotted. Left back of arm: 1.5 inch diameter redness and swelling. both spots warm to touch. Pt not treating at this time, just monitoring for further change. Vaccine given PM of 6/2 and her friend noticed arm appeared bruised on 6/3 afternoon.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Rash erythematous, Rash pruritic
Clinical narrative: Large egg shaped welt appeared at injection site. Rash was itching and red. Pharmacist recommended antihistamine therapy and Hydrocortisone cream.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Crying, Discomfort, Middle insomnia, Pyrexia, Rash
Clinical narrative: Patient woke up crying and continued to cry during the night, waking up frequently and feeling uncomfortable. High fever started on 6/3/2017, she broke out in rash on 6/4/2017, continued to cry inconsolably on and off.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling and redness. Area hot to touch.
Age: 23.0
Sex: M
Vaccine: 6VAX-F, FLUX
Symptoms: Angiotensin converting enzyme, Asthenia, Blood chloride, Blood creatine, Blood potassium
Clinical narrative: Tremors, Weakness, Dizziness, overall feeling sick. Symptoms continued to worsen each day, until body could not do any of the daily living functions.
Age: 23.0
Sex: M
Vaccine: 6VAX-F, FLUX
Symptoms: Blood sodium, Blood urea, Carbon dioxide, Computerised tomogram, Dizziness
Clinical narrative: Tremors, Weakness, Dizziness, overall feeling sick. Symptoms continued to worsen each day, until body could not do any of the daily living functions.
Age: 23.0
Sex: M
Vaccine: 6VAX-F, FLUX
Symptoms: Electrocardiogram, Electroencephalogram, Full blood count, Glomerular filtration rate, Loss of personal independence in daily activities
Clinical narrative: Tremors, Weakness, Dizziness, overall feeling sick. Symptoms continued to worsen each day, until body could not do any of the daily living functions.
Age: 23.0
Sex: M
Vaccine: 6VAX-F, FLUX
Symptoms: Lumbar puncture, Malaise, Platelet count, Positron emission tomogram, Tremor
Clinical narrative: Tremors, Weakness, Dizziness, overall feeling sick. Symptoms continued to worsen each day, until body could not do any of the daily living functions.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site nodule, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to herself 52 year old female with fibromyalgia, asthma, chronic obstructive pulmonary disease (COPD), emphysema, sleep disorder and back disorder. The patient's medical history included cerebrovascular accident (2007) and transient ischaemic attack (reported as mini strokes from 2007 to 2009). On 17-JAN-2017 the patient was vaccinated with PNEUMOVAX23 via right arm (lot number, expiration date not reported) for prophylaxis. Concomitant therapies included clopidogrel bisulfate(PLAVIX), clonazepam(KLONOPIN), hydrocodone, baclofen, zolpidem tartrate(AMBIEN), calcium carbonate, cholecalciferol, albuterol, unspecified natural laxatives and melatonin. On 19-JAN-2017, the patient experienced a huge welt in her right armpit. On an unspecified date, the patient also experienced stinging, pain and burning from her right shoulder down to her hip and toes. The patient reported similar symptoms on her left side. On an unspecified date the patient experienced drooling and slurred speech. The patients primary physician ordered brain and back magnetic resonance imaging ( MRI), and it was noted the physician advised the patient that she did not have a stoke. The patient was treated with depo and diphenhydramine (BENADRYL) (dosage and frequency not reported). On an unknown date, the patient had seen her neurologist  and was prescribed gabapentin for pain. The outcome of urticaria, dysarthria, drooling, arthralgia, burning sensation, musculoskeletal pain and pain was reported as not recovered. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Burning sensation, Drooling, Dysarthria, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself 52 year old female with fibromyalgia, asthma, chronic obstructive pulmonary disease (COPD), emphysema, sleep disorder and back disorder. The patient's medical history included cerebrovascular accident (2007) and transient ischaemic attack (reported as mini strokes from 2007 to 2009). On 17-JAN-2017 the patient was vaccinated with PNEUMOVAX23 via right arm (lot number, expiration date not reported) for prophylaxis. Concomitant therapies included clopidogrel bisulfate(PLAVIX), clonazepam(KLONOPIN), hydrocodone, baclofen, zolpidem tartrate(AMBIEN), calcium carbonate, cholecalciferol, albuterol, unspecified natural laxatives and melatonin. On 19-JAN-2017, the patient experienced a huge welt in her right armpit. On an unspecified date, the patient also experienced stinging, pain and burning from her right shoulder down to her hip and toes. The patient reported similar symptoms on her left side. On an unspecified date the patient experienced drooling and slurred speech. The patients primary physician ordered brain and back magnetic resonance imaging ( MRI), and it was noted the physician advised the patient that she did not have a stoke. The patient was treated with depo and diphenhydramine (BENADRYL) (dosage and frequency not reported). On an unknown date, the patient had seen her neurologist  and was prescribed gabapentin for pain. The outcome of urticaria, dysarthria, drooling, arthralgia, burning sensation, musculoskeletal pain and pain was reported as not recovered. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to herself 52 year old female with fibromyalgia, asthma, chronic obstructive pulmonary disease (COPD), emphysema, sleep disorder and back disorder. The patient's medical history included cerebrovascular accident (2007) and transient ischaemic attack (reported as mini strokes from 2007 to 2009). On 17-JAN-2017 the patient was vaccinated with PNEUMOVAX23 via right arm (lot number, expiration date not reported) for prophylaxis. Concomitant therapies included clopidogrel bisulfate(PLAVIX), clonazepam(KLONOPIN), hydrocodone, baclofen, zolpidem tartrate(AMBIEN), calcium carbonate, cholecalciferol, albuterol, unspecified natural laxatives and melatonin. On 19-JAN-2017, the patient experienced a huge welt in her right armpit. On an unspecified date, the patient also experienced stinging, pain and burning from her right shoulder down to her hip and toes. The patient reported similar symptoms on her left side. On an unspecified date the patient experienced drooling and slurred speech. The patients primary physician ordered brain and back magnetic resonance imaging ( MRI), and it was noted the physician advised the patient that she did not have a stoke. The patient was treated with depo and diphenhydramine (BENADRYL) (dosage and frequency not reported). On an unknown date, the patient had seen her neurologist  and was prescribed gabapentin for pain. The outcome of urticaria, dysarthria, drooling, arthralgia, burning sensation, musculoskeletal pain and pain was reported as not recovered. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Herpes zoster, Sunburn
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old male patient with blood pressure abnormal as concurrent condition. The patient's medical history, drug and allergy history were not reported. On 22-MAY-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous route (strength, dose, lot number and expiration date were not reported) for prophylaxis, using sterile diluent (manufacturer unknown), (lot number, expiration date were not reported). The patient's concomitant medication include an unspecified blood pressure medication treatment. It was reported that on 23-MAY-2017, the patient experienced a funny feeling like sunburn on his stomach. On the same date, the patient visited an urgent care clinic, and he was diagnosed with shingles (Herpes zoster). The patient was prescribed with Acyclovir, 800mg, orally, five times per day as treatment for Herpes zoster. It was reported that the patient also sought medical attention and consulted a pharmacist. The outcome of herpes zoster was reported as not recovered/not resolved. The causality between ZOSTAVAX and shingles was not reported.      Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Malaise, Mental impairment
Clinical narrative: Started having fatigue and unrestful sleep/chronic fatigue. Trouble concentrating/thinking/brain fog. Never feels well and rested again.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Poor quality sleep, Restlessness
Clinical narrative: Started having fatigue and unrestful sleep/chronic fatigue. Trouble concentrating/thinking/brain fog. Never feels well and rested again.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Poor quality sleep
Clinical narrative: Started having fatigue and unrestful sleep/chronic fatigue. Trouble concentrating/thinking/brain fog. Never feels well and rested again.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Acne cystic, Alopecia, Anxiety, Apoptosis
Clinical narrative: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cervicectomy, Cervix carcinoma, Constipation, Cow's milk intolerance, Depression
Clinical narrative: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Food intolerance, Fungal infection, Gallbladder pain, Hypoaesthesia, Menstrual disorder
Clinical narrative: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Raynaud's phenomenon, Skin discolouration, Streptococcal infection, Temperature intolerance
Clinical narrative: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Urinary tract infection, Vitamin B12 decreased, Weight increased
Clinical narrative: Severe, sudden weight gain, all over hair loss, cystic acne, menstrual cycle disruption, Raynaud's Syndrome, cervical cancer, 1/4" of cervix taken out due to cervical cancer cells, food intolerance of-wheat, corn, soy, dairy, eggs, canola, cold intolerance, numbness in arms, hands, and feet, chronic UTI's, chronic yeast infections, chronic, severe stomach aches, severe constipation, random, unexplainable aches and pains, gallbladder pains, hands and feet turning purple/blue/black, arms and hands shaking (nervous system damage), anxiety and depression, chronically low B12, DNA damage, strep virus all over body (internally).
Age: 0.42
Sex: F
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a clinic unit clerk and refers to a 4-month-old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 11-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # M034187, expiration date 17-MAY-2019; dose, route of administration, and frequency were not reported) and ROTATEQ orally (lot # M018958, expiration date 03-MAR-2018; dose and frequency were not reported) both for prophylaxis. The vaccine data logger measured a temperature range from 32°F to 35°F for a total time frame of 25 minutes. There was no previous temperature excursion. No adverse effects were reported, and no product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning to a 9 year old female patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant therapies. On an unspecified date in 2008, the patient completed the vaccine schedule with VARIVAX, subcutaneously for "prevention from varicella" (the lot #, expiration date, dose, strength and frequency were not provided). On 22-MAY-2017, the patient went to the doctor's office, and the physician stated that the patient had shingles. The patient was treated with acyclovir. At the reporting time, the patient had not recovered from the event of shingles. No laboratory tests were performed. The causal relationship between the event and the therapy was not provided. Additional information is not expected because there was no consent to contact physician.