chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported. I, LPN was given several vaccines by another LPN to give to said patient. Upon charting said vaccines, after they were given, I realized patient had been previously given the same injections the month before. Upon further investigation I found where patient had titer performed for MMR; 9 days prior to first injection and was reactive.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 15-JUN-2015 with a dose of ROTATEQ lot # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 14 year old patient (gender unknown) who on an unknown date was vaccinated with an adult dose of VAQTA (route, dose, lot # and expiration date were not provided) instead of the pediatric dose which was considered as an overdose. No adverse effects 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 medical assistant refers to a patient of an unknown age and gender who on 31-MAR-2015 was vaccinated with a dose of ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site pain, Sensation of foreign body, Wheezing
Clinical narrative: Patient states pain at injection site immediately after injection. Sometime later maybe next day (unsure) she felt short of breath, wheezing and feeling lump on throat. Patient states symptoms gradually resolved without intervention.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Site noticed by mom on 7/14.  Red about 10 cm.  Not painful, no treatment.  Noted to the side of the injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Rash
Clinical narrative: Patient presented to the office with a case of shingles in the area just superior and lateral of the left orbit.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender who on 31-MAR-2015 was vaccinated with a dose of, oral, ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 23-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 for prophylaxis that were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On an unspecified date in 2015 (reported as either 30-JUN-2014 or 01-JUL-2015), the patient was administered (Oka/Merck) VARIVAX, 1 vaccine lot # L002214 expiration date 21-JAN-2017 (dose, frequency and route of administration were not provided), after it had a temperature excursion (incorrect product storage). Concomitant medication was not reported. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient ever received (Oka/Merck) VARIVAX again and the outcome of the event, incorrect product storage was unknown. This is one of the six reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: After shot 5-6cm indurated red (R) thigh. Redness almost all (R) thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed swelling, redness and warmth to injection site. Was given Kinrix.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood test, Chills, Fatigue, Headache
Clinical narrative: Weakness, nausea, arm pain, headache, body aches, chills, tiredness, fever.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Weakness, nausea, arm pain, headache, body aches, chills, tiredness, fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Disorientation, Heart rate increased
Clinical narrative: Acute vomiting, disorientation.  After he had vomited a few times at around 5:30 am,  he laid back down. He began vomiting again, and I picked him up and he continued to vomit with his eyes closed limp in my arms.  I tried to talk to him but he would not answer.  He eventually answered me after a few minutes, but seemed very out of it.  I took him to the ER where he was treated with Zofran. This stopped the vomiting.  At the ER he was alert and had become more alert to not he 25 minutes drive to the ER.  His appetite was noticeably decreased for first 48 hours.  Crying more easily than normal.  Swelling and redness at injection site.  Ran low grade fever of 99.5 or so within about 6 hours of vaccines which continues to today.  On the morning of 7/15/15 he woke up and complained that his heart was beating very fast.  He told me "mommy I'm not nervous or scared but my heart is beating so fast" and proceeded to cry.  This was right as he woke up.  His heart rate was 150 bps.  He was trembling.  He hadn't eaten much the day before so I got him orange juice and crackers.  He had slept for approx 15 hours.  He drank the orange juice and ate the crackers.  Within 20 minutes he seemed better.  I am an emergency veterinarian so I tried to tell myself maybe he just had a low blood sugar, but these events post-vaccine are concerning, and this is from a mother and vet who believes in vaccines.  I now think 8 vaccines at once is too much.  I would advise anyone else to break them up.  I wish I would have known that the MMR and Chicken pox vaccines could have been given sooner.  I would have given them when he was 4.  However, one month before kindergarten starts there was little time to make vaccine decisions.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypotonia, Injection site erythema, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Acute vomiting, disorientation.  After he had vomited a few times at around 5:30 am,  he laid back down. He began vomiting again, and I picked him up and he continued to vomit with his eyes closed limp in my arms.  I tried to talk to him but he would not answer.  He eventually answered me after a few minutes, but seemed very out of it.  I took him to the ER where he was treated with Zofran. This stopped the vomiting.  At the ER he was alert and had become more alert to not he 25 minutes drive to the ER.  His appetite was noticeably decreased for first 48 hours.  Crying more easily than normal.  Swelling and redness at injection site.  Ran low grade fever of 99.5 or so within about 6 hours of vaccines which continues to today.  On the morning of 7/15/15 he woke up and complained that his heart was beating very fast.  He told me "mommy I'm not nervous or scared but my heart is beating so fast" and proceeded to cry.  This was right as he woke up.  His heart rate was 150 bps.  He was trembling.  He hadn't eaten much the day before so I got him orange juice and crackers.  He had slept for approx 15 hours.  He drank the orange juice and ate the crackers.  Within 20 minutes he seemed better.  I am an emergency veterinarian so I tried to tell myself maybe he just had a low blood sugar, but these events post-vaccine are concerning, and this is from a mother and vet who believes in vaccines.  I now think 8 vaccines at once is too much.  I would advise anyone else to break them up.  I wish I would have known that the MMR and Chicken pox vaccines could have been given sooner.  I would have given them when he was 4.  However, one month before kindergarten starts there was little time to make vaccine decisions.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Acute vomiting, disorientation.  After he had vomited a few times at around 5:30 am,  he laid back down. He began vomiting again, and I picked him up and he continued to vomit with his eyes closed limp in my arms.  I tried to talk to him but he would not answer.  He eventually answered me after a few minutes, but seemed very out of it.  I took him to the ER where he was treated with Zofran. This stopped the vomiting.  At the ER he was alert and had become more alert to not he 25 minutes drive to the ER.  His appetite was noticeably decreased for first 48 hours.  Crying more easily than normal.  Swelling and redness at injection site.  Ran low grade fever of 99.5 or so within about 6 hours of vaccines which continues to today.  On the morning of 7/15/15 he woke up and complained that his heart was beating very fast.  He told me "mommy I'm not nervous or scared but my heart is beating so fast" and proceeded to cry.  This was right as he woke up.  His heart rate was 150 bps.  He was trembling.  He hadn't eaten much the day before so I got him orange juice and crackers.  He had slept for approx 15 hours.  He drank the orange juice and ate the crackers.  Within 20 minutes he seemed better.  I am an emergency veterinarian so I tried to tell myself maybe he just had a low blood sugar, but these events post-vaccine are concerning, and this is from a mother and vet who believes in vaccines.  I now think 8 vaccines at once is too much.  I would advise anyone else to break them up.  I wish I would have known that the MMR and Chicken pox vaccines could have been given sooner.  I would have given them when he was 4.  However, one month before kindergarten starts there was little time to make vaccine decisions.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Has had headache since receiving vaccine and has stiff neck for the last couple days.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Tenderness
Clinical narrative: Localized swelling and redness, about 4-5 cm in diameter over the injection site. Swelling in the ipsilateral axilla, about 6-7 cm in diameter and mildly tender. The reaction appeared 4 days after receiving the Prevnar and improved on its own after 4 days. Required no treatment for the adverse event.
Age: 18.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Disturbance in attention, Headache, Muscle spasms, Presyncope, Pruritus
Clinical narrative: Sensation of throat spasm, headache, mild pruritus of neck and trouble focusing following Tdap, IPV and MCV4 immunizations and PPD.   Suspect this is related to a vasovagal reaction and not likely IgE-mediated.  We would not expect these symptoms to recur or, but if she develops other symptoms following an immunization she should return to Allergy/Immunology Clinic for further evaluation.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt. mother reports that the child has swelling, pain, redness, and warmth on the left upper arm where the vaccines were administered.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very bright redness to area to majority of L shoulder, swelling, heat, and pain to sight. Also complained of general pain, nausea and headache and body pains.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Very bright redness to area to majority of L shoulder, swelling, heat, and pain to sight. Also complained of general pain, nausea and headache and body pains.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, rasied and warm to the touch. Treatment provided was ice packs.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Chromaturia, Decreased appetite, Dizziness, Headache
Clinical narrative: Headache, dizziness, poor appetite, arm pain and swelling, fever, back and neck pain, tea color urine.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Headache, dizziness, poor appetite, arm pain and swelling, fever, back and neck pain, tea color urine.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Incoherent, Laboratory test normal, Loss of consciousness, Vision blurred
Clinical narrative: Throwing up, Blurred vision, Passing out, Lack of Appetite, incoherent.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Throwing up, Blurred vision, Passing out, Lack of Appetite, incoherent.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Severe erythema edema pain.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash
Clinical narrative: Rash on face, swelling of lips. BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Arm redness/swelling at injection site immediately after administration of the MMRV. Iced area for 10-15 min. then sent home. Phoned mother of child then on 7/17/15 at 1:15 pm and was told swelling/redness was gone after about one hour.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender who on 03-APR-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a female patient of unknown age who on 12-JUL-2015 was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). On 13-JUL-2015, the patient developed a red, round, warm, itchy area with a ring around it at the injection site. At the time of the report, the outcome of injection site erythema, infusion site warmth and injection site pruritus was reported as not recovered. Additional information is not expected as the reporter did not provided contact details.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Reddness rash blister at injection site. Recommended mo.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Area near injection site swelled up to size of small bean. Red and inflamed on that area. Time given at 6:30pm. No fevers. Patient been informed to seek physician to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: Area near injection site swelled up to size of small bean. Red and inflamed on that area. Time given at 6:30pm. No fevers. Patient been informed to seek physician to follow up.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Dyspnoea, Injection site reaction, Product sterility lacking
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 61 year old female patient with no drug reactions or allergies. On 07-JUL-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L003227, expiration date 13-OCT-2016), 0.5 ml, intramuscular. There was no concomitant medication provided. On an unspecified date in July 2015, the patient experienced difficulty breathing and an unspecified local injection site reaction. On 10-JUL-2015, the patient was admitted to an unspecified hospital critical care unit for the treatment of the reactions. The unspecified threatening physician at the hospital stated that the symptoms were either due to an allergic reaction to PNEUMOVAX 23 or the vaccine was unsterile. The reporter stated that they have 22 remaining doses of PNEUMOVAX 23 lot L003227, that they did not want to use anymore, therefore they requested that a lot check be completed. At the reporting time, the outcome of dyspnoea, injection site reaction and allergy to vaccine was unknown. The reporter considered the dyspnoea to be a life threatening condition. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site urticaria, Myalgia, Oropharyngeal pain, Pruritus
Clinical narrative: Large hive at injection site; muscle ache axillary area and muscles of chest. Shot was given at 2:00pm - reaction at 6:00pm (red, swollen, welt (hive)); 9:00pm itchy - next day, sore throat x3 days. Took BENADRYL - lasted 5+ days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Large hive at injection site; muscle ache axillary area and muscles of chest. Shot was given at 2:00pm - reaction at 6:00pm (red, swollen, welt (hive)); 9:00pm itchy - next day, sore throat x3 days. Took BENADRYL - lasted 5+ days.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 16 hours after vaccine, then possible staring episode last few seconds, but respond to name. Tmax 104.
Age: 70.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site pain
Clinical narrative: Sore am at injection site for extended period (about 2 months and ongoing).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site - treatment: AUGMENTIN x10 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, swelling and warmth upper arm.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and warmth upper arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 31-MAR-2015, the patient was vaccinated with a dose of ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports 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 as received from a medical assistant refers to a patient of an unknown age and gender who on 29-MAY-2015 was vaccinated with a dose of GARDASIL (lot # K006960) expiration date, dose and route not reported) that was 63 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Follow-up information has been received from the healthcare professional on 02-JUL-2015. This report concerned to a patient of unspecified age and gender, who on 23-APR-2015 received a 0.5 ml dose of GARDASIL lot # K006960 (expiration date not reported). This vaccine was exposed to 15 hours of temperature excursion. Additional information is not expected, as all follow-ups to complete the case have already been received. Products and narrative was updated.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 15-APR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 "25/0.5" injection, lot # J005071 and expiration date 19-JAN-2015 (dose and route of administration were not provided). No adverse effect was reported. The concomitant medication was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 31-MAR-2015, the patient was vaccinated with a dose oral, ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 30-MAR-2015, the patient was vaccinated with a dose ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 30-MAR-2015, the patient was vaccinated with a dose of ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for his vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to two patients of unknown age and gender. Concurrent conditions and medical history were not provided. On 16-FEB-2015, two patients were vaccinated with two expired doses of PNEUMOVAX 23 "25/0.5" injection, lot # J005071 and expiration date 19-JAN-2015 (dose and route of administration were not provided). No adverse effect was reported. The concomitant medication was not provided. This is one of two 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 as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, dose, route and site of administrations were not provided) that was exposed to temperatures outside the recommended range for 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 15-MAY-2015, the patient was vaccinated with a dose oral, ROTATEQ (lot # K015816) (expiration date, dose and route of administration were not provided). There was a 63 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports 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 as received from a medical assistant refers to an adult patient of an unknown age and gender who on 01-JUN-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (expiration date, dose and route not reported) that was exposed to only one temperature excursion of 63 hours. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adult patient of an unknown age and gender who on 29-MAY-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (expiration date, dose and route not reported) that was exposed to only one temperature excursion of 63 hours. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date the patient stated to the physician that she had read an article on GARDASIL and neurological events. The name and source of the article was unspecified. The company representative could not confirm if specific patients were involved. The outcome of the neurologic events was unknown. The reporter did not assess the causality of the event with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, route and site of administrations were not provided) that was exposed to temperatures outside of the recommended range for 24 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I started to develop a rash on my wrist. It started to get worse and then it spread to the other arm. Really itchy, bumpy, welts.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Decreased appetite, Lethargy, Pyrexia, Vomiting
Clinical narrative: Recurrent fever of up to 103.5 throughout the 48 hour period following the vaccine administration, along with lethargy and decreased appetite. One incident of vomiting (without fever) approximately 36 hours after vaccine administration. Fever was treated with acetaminophen & ibuprofen, which brought the fever down on all but one occasion.
Age: 22.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Dizziness, headache, fever (started on 7/17/2015).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Consciousness fluctuating, Crying, Eye movement disorder, Pyrexia
Clinical narrative: Fever 100.3 circa; crying; in and out of consciousness; eyes rolling back (showing the white of the eyes); called the pediatrician hotline and following their advice gave the child acetaminophen 125 ml.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Affect lability, Crying, Frustration, Irritability
Clinical narrative: SUDDEN CHANGE IN MOOD/BEHAVIOR; VERY LABILE. IRRITABLE, CRYING FOR NO REASON, SOME EPISODES OF INCONSOLABILITY.  NOT ABLE OR NOT WANTING TO VOICE WHY SHE IS CRYING OR TELL US WHAT SHE WANTS.  APPEARS VERY FRUSTRATED.  THESE ARE ALL NEW/DIFFERENT BEHAVIORS.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Mood altered
Clinical narrative: SUDDEN CHANGE IN MOOD/BEHAVIOR; VERY LABILE. IRRITABLE, CRYING FOR NO REASON, SOME EPISODES OF INCONSOLABILITY.  NOT ABLE OR NOT WANTING TO VOICE WHY SHE IS CRYING OR TELL US WHAT SHE WANTS.  APPEARS VERY FRUSTRATED.  THESE ARE ALL NEW/DIFFERENT BEHAVIORS.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Profuse watery diarrhea and vomiting lasting for 6 hours which did resolve on it's own.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Erythema, Herpes zoster, Pain
Clinical narrative: Had burning pain and broke out with red areas which later became blisters.  Later diagnosed as shingles.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Dystonia, Eye movement disorder, Flushing, Syncope
Clinical narrative: Upon administration of vaccine, Havrix, the patient's eye's rolled back in his head and began getting very flushed. His then began producing dystonias and then developed syncope. Patient recovered in about 3 minutes.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Injection site swelling
Clinical narrative: Employee called in to advise that her both her eyes were swollen along with her upper arm was swollen where the injection was given. Employee went to an urgent care to be checked and they could not provide a definitive answer that her symptoms were due to the Hepatitis B vaccination she received or due to something else. Employee was prescribed Benadryl.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Disorientation, Dizziness
Clinical narrative: Each day that the pill was taken (at around 7:45 AM -8:15 AM) illness has set in around 12:45 PM. Pills were taken as prescribed, with 8 oz of water without eating or drinking coffee for at least one hour before/after. Symptoms include Moderate to Severe Stomach Cramps, Diarrhea, General Gut/Abdominal Ache, Nausea, Gas, Dizziness, some Disorientation (unable to figure out homework assignments, when on the non-pill day I completed the same problem easily). Symptoms lasted anywhere from 8:00 PM to 11:00 PM. Non-pill days I generally feel fine. Have one last pill in the series.]
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Flatulence, Gastrointestinal pain, Nausea
Clinical narrative: Each day that the pill was taken (at around 7:45 AM -8:15 AM) illness has set in around 12:45 PM. Pills were taken as prescribed, with 8 oz of water without eating or drinking coffee for at least one hour before/after. Symptoms include Moderate to Severe Stomach Cramps, Diarrhea, General Gut/Abdominal Ache, Nausea, Gas, Dizziness, some Disorientation (unable to figure out homework assignments, when on the non-pill day I completed the same problem easily). Symptoms lasted anywhere from 8:00 PM to 11:00 PM. Non-pill days I generally feel fine. Have one last pill in the series.]
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Headache, Myalgia, Pyrexia
Clinical narrative: Mild fever, chills, mild headache, loss of appetite, muscle pain all over body.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Right upper arm (vaccine site) very sore, progressed to extreme pain (8-9 out of 10) by 7 PM, severely limited ROM at shoulder, ie 40 degrees abduction and flexion. Any amount of movement at shoulder/elbow produced extreme pain, unrelieved by Ibuprofen and Acetaminophen. Pain and limited ROM continued through 7/16/2015; by 7/17, pain decreased and ROM began to return; by 7/18, near full ROM, although some pain persists. Call was made to nurse on 7/15, who advised contacting clinic, which I did also on 7/15. Clinic nurse advised use of cold compress, then heat.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Fatigue, Malaise, Pain, Pyrexia, Rash
Clinical narrative: High fever, rash, fatigue, generally acting/feeling sick.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Neck pain, VIIth nerve paralysis
Clinical narrative: Neck pain started on 7/17/15 in the evening. On 7/18/15 the patient woke up w/left face paralysis which was continued to be Bell's Palsy. The patient is pregnant and has ITP.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: S/sx unconscious, stop breathing. Tx EPIPEN (0.3mg) inj x1.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Rash generalised, Rash macular
Clinical narrative: Erythematous macular blanching rash over entire body. No hives. No petechial.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Rash, Swelling
Clinical narrative: Skin rash, rash, erythema multiforme and swelling. Prednisone 40 mg every day, prednisone 20 mg every day.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Swelling, Tenderness
Clinical narrative: Patient received vaccine on 7/24/14. He noted tenderness and swelling on 7/25/14. He presented to clinic on 7/28/14 for evaluation to rule of infection. Redness, warmth at injection site.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Injection site movement impairment, Joint range of motion decreased, Localised oedema
Clinical narrative: Information has been received from a registered nurse referring to 3 or 4 patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection (dose, route, frequency and lot # unspecified). Concomitant therapy was not reported. On an unknown date, patient experienced extreme pain that was debilitating and "achiness" described as "she had decrease range of motion in the shoulder joint of the upper arm area". Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated the pain as a "10 out of 10". Nurse reported patients also had localized edema in an unspecified location. Nurse also reported that these 3 or 4 other patients who experienced the same symptoms as the patient in related case (MARRS#1506USA003505) after taking pneumococcal vaccine. The patient had sought medical attention and spoke to nurse. The outcome of joint range of motion decreased, asthenia, localised oedema and musculoskeletal pain was unknown. Causality assessment was not reported. This is one of several reports that received from the same reporter. Follow-up information has been received from the same reporter. Follow-up information has been received on 07-JUL-2015: All telephone attempts to obtain follow-up information have been unsuccessful. Follow up has been received from the registered nurse on 07-JUL-2015, refers to an adult female patient of unknown age (reported as greater than 60 years old). Reporting nurse stated that the patient received PNEUMOVAX 23 injection at his office. The patient experienced acute pain with limited range of motion at the injection site within hours of injection. Symptoms persisted for a duration of a couple of days. The patient was treated with ice, ibuprofen and slow range of motion on an unspecified date. She did not experienced any long term disability and recovered completely on an unspecified date. This is one of the two reports received from the same source (MARRS # 1506USA009447). Additional information has been requested. Event and narrative were updated.
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse referring to 3 or 4 patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection (dose, route, frequency and lot # unspecified). Concomitant therapy was not reported. On an unknown date, patient experienced extreme pain that was debilitating and "achiness" described as "she had decrease range of motion in the shoulder joint of the upper arm area". Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated the pain as a "10 out of 10". Nurse reported patients also had localized edema in an unspecified location. Nurse also reported that these 3 or 4 other patients who experienced the same symptoms as the patient in related case (MARRS#1506USA003505) after taking pneumococcal vaccine. The patient had sought medical attention and spoke to nurse. The outcome of joint range of motion decreased, asthenia, localised oedema and musculoskeletal pain was unknown. Causality assessment was not reported. This is one of several reports that received from the same reporter. Follow-up information has been received from the same reporter. Follow-up information has been received on 07-JUL-2015: All telephone attempts to obtain follow-up information have been unsuccessful. Follow up has been received from the registered nurse on 07-JUL-2015, refers to an adult female patient of unknown age (reported as greater than 60 years old). Reporting nurse stated that the patient received PNEUMOVAX 23 injection at his office. The patient experienced acute pain with limited range of motion at the injection site within hours of injection. Symptoms persisted for a duration of a couple of days. The patient was treated with ice, ibuprofen and slow range of motion on an unspecified date. She did not experienced any long term disability and recovered completely on an unspecified date. This is one of the two reports received from the same source (MARRS # 1506USA009447). Additional information has been requested. Event and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug allergies were unspecified. On an unknown dates, the patient was vaccinated with M-M-R II (dose, frequency, route and lot# were not reported). Concomitant medications were unspecified. On an unknown date, the patient's blood test results showed that the patient "low or negative titers" for mumps. The nurse did not know if it showed "low or negative" as she had limited information. The outcome and causality of the event were not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was inadvertently administered a dose of PNEUMOVAX 23 (strength, dose, route, lot# and expiration date unknown), which had been improperly stored. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected since the reporter would not like to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since 24-FEB-2015, the unspecified patients were vaccinated with GARDASIL 0.5 ml, once intramuscularly that were improperly stored. No adverse effects were reported. The healthcare worker stated that the patient, lot and actual dates of administration were not available. The dates of administration range from 24-FEB-2015 to present 15-JUL-2015. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and unknown gender. On 15-JUL-2015, the patient was vaccinated with M-M-R II (lot#, dose and route were not reported) which was expired on 20-JUN-2015. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Since 24-FEB-2015, the unspecified patients were vaccinated with VAQTA that were improperly stored. No adverse effects were reported. The healthcare worker stated that the patient, lot and actual dates of administration were not available. The dates of administration range from 24-FEB-2015 to present 15-JUL-2015. No product quality complaint (PQC) was reported for VAQTA. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Muscle spasms, Muscular weakness
Clinical narrative: For 6 years now, I have been suffering from the following: tingling in hands/feet; seizure-like symptoms; legs giving out randomly; muscle spasms all over body.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Seizure like phenomena
Clinical narrative: For 6 years now, I have been suffering from the following: tingling in hands/feet; seizure-like symptoms; legs giving out randomly; muscle spasms all over body.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Asthenia, Blood culture, Haemorrhage, Intussusception, Pyrexia
Clinical narrative: Bloody diaper, vomiting, weakness, fever, etc. Diagnosed with intussusception. Rotateq was determined to be the cause. Was initially treated at one hospital, then transferred by ambulance to another hospital.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound scan, Vomiting, X-ray
Clinical narrative: Bloody diaper, vomiting, weakness, fever, etc. Diagnosed with intussusception. Rotateq was determined to be the cause. Was initially treated at one hospital, then transferred by ambulance to another hospital.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Arthralgia, Back pain, Crying, Fatigue
Clinical narrative: Pain at injection site first 5 hours following injection but no redness. Really bad headache and body aches developed first during later afternoon (4pm). By 5pm terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply, low grade fever. Nurse was called and ibuprofen given. Symptoms worsened over course of the night. Progressed to higher fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen) horrible joint pain and dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (and she never cries). Better by morning but still had headache and body aches. Today, third day out, better but exhausted and has body aches and headache still. Symptoms worsen when she is fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches return). Not sure if I'm remembering all of them, but this is as accurate as I can remember.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Headache, Hyperaesthesia, Injection site pain, Nausea, Pain
Clinical narrative: Pain at injection site first 5 hours following injection but no redness. Really bad headache and body aches developed first during later afternoon (4pm). By 5pm terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply, low grade fever. Nurse was called and ibuprofen given. Symptoms worsened over course of the night. Progressed to higher fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen) horrible joint pain and dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (and she never cries). Better by morning but still had headache and body aches. Today, third day out, better but exhausted and has body aches and headache still. Symptoms worsen when she is fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches return). Not sure if I'm remembering all of them, but this is as accurate as I can remember.