chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Headache, Malaise, Disoriented, Swelling and Rash on administered arm "Look like Australia".  Itchiness, and swollen.
Age: 18.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Anxiety, Disturbance in attention, Fall, Hypoaesthesia
Clinical narrative: Seizures which are worst before, during or after her menstrual cycle, arms and legs numbness, anxiety, memory loss, no being able to focus and concentrate, can't deal with any level of stress, just a little of stress causes seizures (her entire body shakes like she is being hit with electricity, when this happen she is dropping things, she falls and she is hurting herself).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Seizure, Stress, Tremor
Clinical narrative: Seizures which are worst before, during or after her menstrual cycle, arms and legs numbness, anxiety, memory loss, no being able to focus and concentrate, can't deal with any level of stress, just a little of stress causes seizures (her entire body shakes like she is being hit with electricity, when this happen she is dropping things, she falls and she is hurting herself).
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Flat warm red rash on bicep area of arm that received vaccine. Patient went to emergency department. Patient reports he was given an injection of Bactrim. Patient also reports that staff in emergency department told him they have seen several patients with infections after receiving Prevnar 13 vaccine.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Pallor, Vomiting
Clinical narrative: PALLOR AND EMESIS.
Age: 37.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Facial urticarial and lower lip swelling, lasted 5 hours, resolved with Benadryl was not seen in clinic until 12/14/2015. At that time sx had fully resolved.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient presented to the ER 5 hours after receiving the vaccine in the pharmacy with swelling of lips and face.
Age: 72.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Rash
Clinical narrative: Rash covering top part of the arm.
Age: 52.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pruritus, Myalgia, Swelling
Clinical narrative: The swelling was noticed at 5:00 PM.  It may have started earlier.  The puffiness is evident.  It was red and itchy in the area where the needle was used. Some muscle pain felt. It became even more puffy the next 5 days.  It is still puffy by 12/14/2015 -- although less so than earlier.
Sex: F
Vaccine: MEN
Symptoms: Croup infectious, Ear infection
Clinical narrative: Initial unsolicited report received from a consumer on 04 December 2015. This case was linked to 2015SA206294 and 2015SA206305 (same vaccine, different patients). This case involves a female patient (age not reported) who was vaccinated with a dose of Meningococcal vaccine (manufacturer: unknown, batch number, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed croup and severe ear infection. The patient had several health issues and had many medications. The patient had required emergency room visit. Laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: croup and severe ear infection. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: I have waited to send this in case I had further complications. After taking shot one day I had a stroke the next, I spent 3 days in hospital after all the tests they could give me they said it was definitely a stroke a small one on the right side of brain no large damage. For several weeks after experiencing the stroke I had numbness on the right side of my face and continual headache. The top of my left arm and hand up to my elbow was numb and tingling to the touch. I have had headaches off and on for at least a month or more. I need to know what the ingredients of the shot are, there is something in the shot that obviously affected me.
Sex: U
Vaccine: DTP, FLUX
Symptoms: Pain, Tendonitis
Clinical narrative: Case number PHEH2015US025172, is an initial spontaneous report received from a consumer on 01 Dec 2015. This report refers to a patient of unknown demographics. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly and DTP vaccine (manufacturer and batch number: not reported) on an unknown date. On 3 Nov 2015, the patient experienced extreme pain and right shoulder tendinitis. Final outcome of the events was unknown. Seriousness and causality of the events was not reported. Seriousness of the events was upgraded based on information available in the source document.
Sex: M
Vaccine: FLUX
Symptoms: General physical health deterioration, Myelitis transverse
Clinical narrative: Case number PHEH2015US025897, is an initial spontaneous report received from a consumer (also patient) on 09 Dec 2015. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced transverse myelitis. The outcome of the event was reported as condition deteriorated. Seriousness and causality was not reported. Seriousness of the event was upgraded based on Novartis Important Medical Events list. No follow up contact information was provided and there was no consent to contact the reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hot flush, Palpitations
Clinical narrative: Dizzy, lightheaded, weak, hot flashes, heart racing. Dizzy heart racing lasted 3 week. Other symptoms lasted 4 days.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt given Rota vaccine at 4 month visit. Initial dose is out of recommended guidelines.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Received shot in (R) arm. Arm has been sore event sent shot. Taken 2 steroid pack. Now taking indomethacin going to specialist December. As well as using eat.
Sex: F
Vaccine: FLU3
Symptoms: Pulmonary pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pulmonary pain in a female patient who received Influenza vaccine. In November 2015, the patient received Influenza vaccine. In 2015, 14 days after receiving Influenza vaccine, the patient experienced pulmonary pain. On an unknown date, the outcome of the pulmonary pain was unknown. It was unknown if the reporter considered the pulmonary pain to be related to Influenza vaccine. Additional details were received as follows: The patient stated that, 2 weeks ago from reporting date, the patient received a dose of Flu vaccine and now (approximately 2 weeks after vaccination) the patient experienced very soreness in right lung. The patient was curious about the ingredients in this years Flu vaccine.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: The patient reported chills, fever, and malaise - the next couple of days.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: Approx 30 min following administration of both FLULAVAL 0.5 ml IM and TUBERSOL pt developed a papular rash on his back. It has not spread in 24 hrs. It does get worse with heat and painful at times. So far managed adequately with Ibupofen and BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after her vaccine, her (R) arm got swollen and warm and painful; it was worse the next day and better today.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: 11/30/15 - 12/3/15: Nausea, vomiting, low grade fever.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness and swelling noted at injection site, RD extending to elbow. C/O H/A and nausea advised to take BENADRYL, TYLENOL, ADVIL as directed and if no allergies as needed and to follow-up with MD.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Hypophagia, Pruritus, Rash vesicular, Varicella post vaccine
Clinical narrative: Chicken pox-vesicular rash (itchy), decreased intake. Had vaccine on 12/9/15.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired vaccine (Td) given to patient. Td (TENIVAC) has expiration date 10/3/15.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was a new employee of the hospital. Her varicella titer was negative - requiring vaccination. she received it on 10/30/15. LMP was 10/10/15. She did not know she was pregnant at the time of the vaccination.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Above named employee reported: nausea, vomiting, diarrhea, headache, chills, body aches 10 1/2 hrs after receiving Flu vaccine - lasted x 24 hrs, then fully recovered. Flu Vac manufacturer: Sanofi Pasteur Lot # UI482AA Exp. 6-30-2016.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Above named employee reported: nausea, vomiting, diarrhea, headache, chills, body aches 10 1/2 hrs after receiving Flu vaccine - lasted x 24 hrs, then fully recovered. Flu Vac manufacturer: Sanofi Pasteur Lot # UI482AA Exp. 6-30-2016.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Received ZOSTAVAX vaccine Friday 12/11/15 AM SQ (L) arm. Friday night started red swelling, itch, pain at site of vaccine. Has continued to increase in size, headache, nausea and loose stools and fatigue. Today in office size of erythema 10 cm x 10 cm with central 3 x 3 cm induration and brighter erythema and tender.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Received ZOSTAVAX vaccine Friday 12/11/15 AM SQ (L) arm. Friday night started red swelling, itch, pain at site of vaccine. Has continued to increase in size, headache, nausea and loose stools and fatigue. Today in office size of erythema 10 cm x 10 cm with central 3 x 3 cm induration and brighter erythema and tender.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Red, raised rash around injection site.
Age: 60.0
Sex: M
Vaccine: FLUC3
Symptoms: Eye swelling, Mouth swelling, Urticaria
Clinical narrative: Patient woke up following day with hives from head to toe, swelling of the eyes and mouth. Visited doctor and received prednisone.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash generalised
Clinical narrative: Local injection site reaction. Redness, swelling, warm to touch.  About 3" in diameter.  Full body rash developed 12 hours after injection and spread over entire body.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Raised knot at injection site, warmth, and redness. Patient instructed to use warm compresses and use Ibuprofen or Tylenol for pain.  Patient recovered.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hangover, Injection site pain, Injection site rash, Lethargy
Clinical narrative: No reaction on day of immunization (12/11/15) except standard muscle soreness at sight. Patient woke up Saturday AM feeling lethargic, "hung over" and with a rash on arm at site.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: High Fever (103F), chills, muscle aches, joint pain, nausea, vomiting, headaches, extreme soreness at injection site. High fever resolved 12/11. Low-grade fever, muscle aches, joint pain, headaches and nausea continued for three days.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: High Fever (103F), chills, muscle aches, joint pain, nausea, vomiting, headaches, extreme soreness at injection site. High fever resolved 12/11. Low-grade fever, muscle aches, joint pain, headaches and nausea continued for three days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Patient received influenza and started getting an itchy throat. She walked into an urgent care center and received a Benadryl shot.  No relief so went to hospital to receive steroids.  On 5 days of steroid treatment.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis, Vaccination site reaction
Clinical narrative: Tendonitis in arm where vaccine was administered.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling cold, Feeling hot, Headache, Injection site pain, Nausea
Clinical narrative: Nauseous, hot, cold, and headaches.  Site tender, but no rash or anything.
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Rash, Skin disorder, Swelling
Clinical narrative: Rash, blisters, red, swollen, leathery on left arm.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complained of soreness on arm since flu shot given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, C-reactive protein, Culture wound, Erythema, Full blood count
Clinical narrative: Pt received DTaP (R) arm Varicella (R) arm on 12/1 then 12/4 pt developed large bullae, required PO clindamycin, BENADRYL. That resolved but then on 12/10 developed similar red/warm region on (L) thigh (no vaccine given there) and 12/13 bullae also formed so admitted to hospital.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Metabolic function test, Red blood cell sedimentation rate, Skin warm
Clinical narrative: Pt received DTaP (R) arm Varicella (R) arm on 12/1 then 12/4 pt developed large bullae, required PO clindamycin, BENADRYL. That resolved but then on 12/10 developed similar red/warm region on (L) thigh (no vaccine given there) and 12/13 bullae also formed so admitted to hospital.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, trouble lifting arm.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: Patient said she was nauseated.  Her doctor was contacted, and doctor recommended that she goes to the ER.  However, after 10-15 minutes, patient felt better and went home.  Patient was encouraged to contact doctor.  There was another patient (patient's sister) who got the same shot at the same time and also claimed she had similar symptoms (nausea and couldn't see well).
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Ear discomfort, Ear swelling, Ear, nose and throat examination normal, Laryngoscopy normal
Clinical narrative: Patient reported that the day after vaccination he developed feeling of bilateral internal ear swelling, pressure and discomfort.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Patient complianed of severe bruising approx 4' diameter as well as soreness.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Lethargy, Malaise
Clinical narrative: Lethargy malaise mental confusion.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Apathy, Asocial behaviour, Depressed mood, Eyelid oedema
Clinical narrative: Swollen eyelid until today 12/14/2015. Rapid shallow breathing (first 3 days after vaccinate), behavior changes: isolation, irritation, sadness, apathy. Legs weakness (walking difficulties). Until now 12/14/2015.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Hypopnoea, Irritability, Muscular weakness, Respiratory rate increased
Clinical narrative: Swollen eyelid until today 12/14/2015. Rapid shallow breathing (first 3 days after vaccinate), behavior changes: isolation, irritation, sadness, apathy. Legs weakness (walking difficulties). Until now 12/14/2015.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dysphonia, Fatigue, Headache, Pain
Clinical narrative: Pt received vaccine Tues 12/8/15. Pt states at 130am on Thurs had diarrhea/ vomiting, aches fatigue, vocal cord hoarseness, headache,  and a fever >100F. As of Friday after noon pt states residual diarrhea, no fever, and minimal aches.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt received vaccine Tues 12/8/15. Pt states at 130am on Thurs had diarrhea/ vomiting, aches fatigue, vocal cord hoarseness, headache,  and a fever >100F. As of Friday after noon pt states residual diarrhea, no fever, and minimal aches.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness from site of injection to elbow on L arm; treatment: applied cool compress.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Pruritus, Rash, Rhinorrhoea
Clinical narrative: Rash and itching, more runny nose.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV
Symptoms: Chest pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extremely painful and tender swelling and redness at site of shot and beyond down to wrist and across to chest. Pain and swelling lasted for 5 days. This was worse than the reaction the previous year, which was similar but not quite as extensive or long lasting.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Extremely painful and tender swelling and redness at site of shot and beyond down to wrist and across to chest. Pain and swelling lasted for 5 days. This was worse than the reaction the previous year, which was similar but not quite as extensive or long lasting.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid localized reaction with redness, swelling, hot to the touch. Size is 8x14. No red streaks noted.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: I don't have an exact onset time so the one above reflects when the shot was given.  The patient's report was actually quite vague and I have difficulty attributing his shoulder pain to the vaccination. Patient came in to pharmacy today (12/14/2015) and complained that his shoulder has been hurting since he got the flu shot back in October.  His wife was not aware that it was bothering him until recently.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu like symptoms like Fatigue, chills body ache, headache.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, painful, raised area - warm to the touch for 3 days - went to walkin clinic on 12/14/15 - diagnosis was cellulitis secondary to injection - prescribed Keflex 500mg 1tid x10d.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Nausea, Throw up, Fever, swollen throat.  Severe headache in early morning of 12/13/2015 abated late on 12/14/2015.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Polymyalgia rheumatica
Clinical narrative: Muscle pain progressively increased during the two days after vaccination.  I used ibuprofen, normal dosage, for the following 4 months.  Then I got to see the rheumatologist who diagnosed Polymyalgia Rheumatica and diagnosed 15mg prednisone daily.  Pain declined to zero within 2 days after stopping ibuprofen and starting prednisone.  After 4 months now tapering off prednisone.  That will take 8 more months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient came back to the pharmacy at 5:40pm saying that she had a rash at the injection site. She stated that she the site was itchy and red.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient reports fever up to 102 degrees F since receiving vaccination. Patient advised to consult their PCP for follow up.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Injection site bruising, Injection site induration, Injection site nodule
Clinical narrative: At first 2 red places which later merged into a large red area. Hard knot beneath skin at injection site. Warm to the touch, swelling in same area. Pain to the touch similar to bruise. Headache on day 2. Red area became 8" before antibiotic started working.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At first 2 red places which later merged into a large red area. Hard knot beneath skin at injection site. Warm to the touch, swelling in same area. Pain to the touch similar to bruise. Headache on day 2. Red area became 8" before antibiotic started working.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: Red rash at onset, has grown in diameter to approximately 8 inches- elevated from skin with erythema. Darker red center with upraised white center at injection site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Shot administered 11/20, 12/14 patient came in and said arm still hurts. According to her due to Flu shot. Stated its getting better and performed push ups at the store show she's strong.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Scab
Clinical narrative: Administered shingles shot, patient developed rash and blister. Informed her the next day to apply ice, BENADRYL cream and pills. Saw her 10 days later looks like it healing. Scab where blister was.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patients of an unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored RECOMBIVAX HB (dose, route of administration, lot#, expiration date were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with five doses of GARDASIL 9 (strength, dose, frequency and route were not reported) lot # K006960 with an expiry date of 19-FEB-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a physician as part of a marketing research program refers to few patients of unknown age and gender. Patients' concurrent conditions and medical history was not provided. On an unknown date the patients were vaccinated with ZOSTAVAX, (dose#, route, lot# not reported). Concomitant therapy was not mentioned. A few patients who received the ZOSTAVAX, still had shingles (vaccination failure) and some of them 'would get a site reaction' (injection site reaction). The outcome of the events was not reported. Causality assessment was not provided. Additional information is not expected since the physician wanted to remain anonymous.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a "baby" female patient of unknown age. Patient's medical history and concurrent condition were not provided. On 28-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Food allergy, Respiratory distress, Tongue pruritus
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, a couple of months ago, the patient was vaccinated with M-M-R II (dose, route, lot # and expiration date were not reported). Concomitant drug was not reported. On an unknown date after receiving M-M-R II, the patient developed an "itchy" tongue and went into acuter respiratory distress that required epinephrine. The patient was sent to an allergist due to the event and it was noted that the patient was highly allergic to gelatin. Outcome of the event acute respiratory distress was not reported. The causality between the events and M-M-R II was not reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB lot# K019701, expiration date: 17-JUL-2015 or lot# K008874, expiration date: 23-FEB-2017 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of improperly stored VARIVAX (Merck) (dose and route were not provided) lot # L023594, expiration date 26-JUN-2017. No adverse effects has been reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L001316, expiration date: 10-NOV-2016; lot # reported as L013192, expiration date: 19-JAN-2017, dose, frequency were not reported). default to orally. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report a received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple patients' of an unknown age and gender. No information regarding the patient's concurrent conditions and medical history was provided. On an unknown dates, the patient were vaccinated with an unspecified number of doses of improperly stored VARIVAX (Merck) lot # K021484, expiration date: 03-NOV-2016 (dose, route of administration were not reported). The patient's concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medication and pertinent medical history reported. On 23-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. 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: This spontaneous report was received form a medical assistant and refers to multiple patients of an unknown gender and age. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates (reported as multiple unspecified dates), multiple patients were vaccinated with improperly stored GARDASIL lot # K011325, expiration date: 08-APR-2017 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored dose of M-M-R II lot # K022284 expiration date 12-NOV-2016 (indication and dose number were not reported) was given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of the several reports of the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 21 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-SEP-2015 at 11:11 AM, the patient was intramuscularly vaccinated with a dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose was not reported) in the right deltoid which was under temperature excursion (reported as "too cold"). No adverse experience was reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017)(dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse referring to a 10 year old female patient. There was no concurrent condition or medical history reported. On 06-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L007560, expiration date unspecified) (dosage and strength not reported) intramuscularly. There was no concomitant medication reported. On 07-OCT-2015 (on the following day), the patient developed hives at the injection site after receiving the GARDASIL 9 which lasted for 9 days. On 11-OCT-2015, the patient also developed swelling and pain at the injection site 6 days after receiving GARDASIL 9 which lasted for 2 weeks. The patient called the physician and treatment with BENADRYL was given. No lab diagnostics studies was performed. The outcome of the events was reported as recovered. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot # K011317, expiration date: 13-AUG-2016; lot # K022285, expiration date: 12-NOV-2016; lot # K004948, expiration date: 04-APR-2016; lot # L001336, expiration date: 13-JAN-2017; lot # L012479, expiration date: 10-APR-2017; dose, frequency and route of administration were not reported). No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 30-NOV-2015, the patient was vaccinated with an insufficient dose of VARIVAX (Merck), because the vaccine leaked out of the needle during the administration. Administration route, lot number and expiration date were not provided. No concomitant therapies were reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Rash, Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's medical history and concurrent condition included rheumatoid arthritis (chronic condition). On an unspecified date in July-2013, the patient was vaccinated with ZOSTAVAX vial dry SD (dosage, frequency, lot number not provided). Concomitant therapies included methotrexate. About 10 days later approximately on an unspecified date in July-2013, the patient was diagnosed with chicken pox. The patient experienced disseminated rash on her thighs, waists, breasts and forehead. The physician stated that the patient had came in for an office visit last week (approximately in 2015) and complained that since taking ZOSTAVAX, she noticed that she has been persistently getting cold sore on her lips. The patient sought medical attention, had visited office and the patient was treated with acyclovir and LYRICA. The outcome of events and causality assessment were unknown. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. No medical history or concomitant conditions were reported. On 07-OCT-2015, the patient was vaccinated with a second dose of improperly stored oral, ROTATEQ, administered orally (dose unspecified), with lot # L004466 and expiry date 02-AUG-2016. No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a "baby" female patient of unknown age. Patient's medical history and concurrent condition were not provided. On 29-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-NOV-2015, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lot was administered)(dose, route of administration and location were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lost was administered)(dose, route of administration and location were not reported0. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 25 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided. On 25-SEP-2015 at 10:00 AM, the patient was intramuscularly vaccinated with a dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose was not reported) in the right deltoid which was under temperature excursion (reported as "too cold"). No adverse experience was reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence was received.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: This spontaneous report as received from a registered nurse, via a company representative, refers to a 15 year old male patient. Information about the patient's medical included Attention deficit/hyperactivity disorder (ADHD) and Acne. Information about the patient's concurrent conditions was not provided. According to the reporter, the patient was vaccinated on 03-DEC-2015, with a dose of GARASIL 9 lot number L014415, expiration date: 25-JUL-2017 (administration route was not reported). The reporting nurse stated that this dose corresponded to the 3rd one in the series, but that the previous two doses were GARDASIL doses. Concomitant therapies included VYVANSE 50 mg and amphetamine 5mg daily. On -4-DEC-3025, "about midnight", the patient developed a severe headache, for which he took 2 tablets of MOTRIN at about 7:00 AM, and his headache "decreased a bit." According to the nurse, the patient went later to the clinic at 8:00 am, and when she saw him he was "sitting on the clinic floor writhing in pain". The reporter stated that the pain being felt by the patient, was in his frontal lobe. The patient's body temperature was elevated to 100.3 F. The patient was then administered a TORADOL injection for treatment and was sent home. The outcome of headache and body temperature increased was unknown at the time of this report. The reporter did not provide a causality relationship assessment between the events and therapy with GARDASIL 9 and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Clonus, Headache, Hyperreflexia, Interchange of vaccine products, Muscular weakness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitant medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyper reflexive and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Neurological examination abnormal, Optic neuritis, Somnolence, Tremor
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitant medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyper reflexive and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Additional information has been requested.