chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Drug dose omission, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. ON 03-JUN-2015 the two patients missed prescribed doses of unspecified  frozen vaccine which may have been (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication due to improper storage. NO concomitant medications were reported. No adverse events were reported. The action taken with the therapy with (Oka/Merck) VARIVAX was unknown. The outcome of the event was unknown. The relatedness of the events to the therapy with (Oka/Merck) VARIVAX was unknown. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Axillary pain, Erythema, Hyperhidrosis, Local swelling, Mobility decreased
Clinical narrative: Pt. given vaccine 9/1/15 - 24 hrs later woke up with pain and swelling (R > L) under both arms (golf ball sized). C/o nausea and sweats. Took ibuprofen and went in to get relief. Patient unable to lift arm until today. Decreased swelling under axilla 5" x 2 1/2" redness and warmth left deltoid.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Skin warm
Clinical narrative: Pt. given vaccine 9/1/15 - 24 hrs later woke up with pain and swelling (R > L) under both arms (golf ball sized). C/o nausea and sweats. Took ibuprofen and went in to get relief. Patient unable to lift arm until today. Decreased swelling under axilla 5" x 2 1/2" redness and warmth left deltoid.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # K016313, expiration date: 31-MAY-2016, (dose was not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Arthralgia, Burning sensation, Erythema, Joint swelling, Peripheral swelling
Clinical narrative: Began with burning, itching both forearms, developed large welts w/ redness and swelling, spreading to (R) hand and (R) upper arm and upper delt leg-applied cortisone 1% and took BENADRYL. 2 AM hives worsened. 6:45 AM hives receding. Additional (R) ankle and knee joint pain and swelling-took BENADRYL 3:05PM on 8/21/15.
Age: 53.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Began with burning, itching both forearms, developed large welts w/ redness and swelling, spreading to (R) hand and (R) upper arm and upper delt leg-applied cortisone 1% and took BENADRYL. 2 AM hives worsened. 6:45 AM hives receding. Additional (R) ankle and knee joint pain and swelling-took BENADRYL 3:05PM on 8/21/15.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Patients relevant medical history, concurrent conditions and drug reactions/allergies were unspecified. On 19-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot # and expiration date was unavailable). No concomitant medications were reported. Since an unspecified date in August 2015 (reported as 1-2 days later), the patient developed 3 inch by 2 inch blisters (injection site vesicles), redness (injection site erythema), tingling (injection site paraesthesia) and warmth at injection site. Reporting pharmacist stated that the patient required medical attention and went to the emergency department on an unspecified date. She was not hospitalized. The patient received treatment with Clobetasol and was 5released after an unspecified amount of time. Outcome of  the events were reported as resolved. Reporting pharmacist did not assessed the causality of the events with respect to vaccination with ZOSTAVAX. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: Patient became limp and unresponsive x 3 minutes, approx 20 minutes after administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: 3 inch x 3 inch Erythema and swelling. Vaccines given 9-2-2015. Today is 9-4-2015. Mother stated no medication or ice has been applied. RN informed the mother to apply ice 20 mins on 20 mins off.
Sex: U
Vaccine: HEP, RV5, HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L008660, expiration date 10-NOV-2016) and of an improperly stored dose of ROTATEQ (lot # and expiration date not reported). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA00142, 1509USA001921 and 1509USA001922). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L001327 and expiration date 13-JAN-2017) (dose and route were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. 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 concerning an unspecified number of patients of unknown ages and genders. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (Batch, lot # K013861, expiration date: 18-MAY-2016), oral. Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and genders. Pertinent Medical History and Drug Reactions/Allergies were not reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (batch, lot # K010216, expiration date: 17-SEP-2016)(route not reported). Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has  been requested (correspondence containing a request for additional information is scheduled).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and gender. Pertinent Medical History and Drug Reactions/Allergies were not reported. On an unknown dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL (Batch, lot # K0090202, expiration date: 17-DEC-2016) (route not reported). Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. ON 25-AUGF-2015, the patietn was vaccinated with expired (Oka/Merck) VARIVAX (lot # J009989) 0.5 ml once, subcutaneous. No adverse events were reproted. No further information available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L010596, expiration date 16-APR-2017). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA001921, 1509USA001922 and 1509USA001921). Additional information is not expected.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L010596, expiration date 16-APR-2017). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA001842, 1509USA001922 and 1509USA001923). Additional information is not expected.
Sex: U
Vaccine: HEP, RV5, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L008660, expiration date 10-NOV-2016) and of an improperly stored dose of ROTATEQ (lot # and expiration date not reported). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA00142, 1509USA001921 and 1509USA001923). Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On 19-AUG-2015, the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneous (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On 24-AUG-2015, the patient developed an itchy, bumpy rash on her back and abdomen. The patient was advised to use hydrocortisone cream as treatment, but at the time of this report no treatment was used for the event. The outcome of rash was reported as recovering. The reporter did not provide a causality relationship assessment between the event and therapy with M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and genders. Pertinent Medical History and Drug Reactions/Allergies were not reported. On unknown dates, the patients were vaccinated with unspecified dates of improperly stored (Oka/Merck) VARIVAX (batch; lot# K0088253, expiration date 19-JUNJ-2016) (route not reported). Concomitant therapies were reported. No adverse effect was reported. No further information was provided. This is one of four reports from the same spruce. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given only diluent; the vaccine was not added to syringe.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ, 2 ml, once, orally, lot # L000568, expiration date 10-JUL-2016. No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Impaired driving ability, Mobility decreased, Musculoskeletal disorder, Pain in extremity, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 25-year-old male patient who received BOOSTRIX (batch number 5MG55, expiry date 15th October 2016). Concomitant products included citalopram. On 20th July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In July 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to BOOSTRIX. Additional details provided are as follows: This case was not previously reported to anyone. In July 2015, less than a week after receiving BOOSTRIX, the patient's arm was initially sore as expected after receiving the vaccination. Two days after vaccination the pain in the arm increased. In July 2015, less than a month after vaccination, the patient was unable to raise their left arm to shoulder level and cannot use their left arm to turn the steering wheel of the car. Also the patient was unable to sleep on the left arm. The patient described that the pain was getting worse.
Age: 25.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 25-year-old male patient who received BOOSTRIX (batch number 5MG55, expiry date 15th October 2016). Concomitant products included citalopram. On 20th July 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In July 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to BOOSTRIX. Additional details provided are as follows: This case was not previously reported to anyone. In July 2015, less than a week after receiving BOOSTRIX, the patient's arm was initially sore as expected after receiving the vaccination. Two days after vaccination the pain in the arm increased. In July 2015, less than a month after vaccination, the patient was unable to raise their left arm to shoulder level and cannot use their left arm to turn the steering wheel of the car. Also the patient was unable to sleep on the left arm. The patient described that the pain was getting worse.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Erythema, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old male patient who received BOOSTRIX (batch number 55MT7, expiry date 14th February 2017). Co-suspect products included MENVEO (batch number M14094, expiry date 30th November 2015) and TYPHIM (batch number K1200-1, expiry date 15th April 2016). On 26th June 2015, the patient received the 1st dose of BOOSTRIX  (intramuscular) .5 ml, MENVEO and TYPHIM. On 26th June 2015, less than a day after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection limb mobility decreased was not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to BOOSTRIX. Additional details provided are as follows: This case was not previously reported to anyone. On 26th June 2015, at 11:00, the patient received a dose of BOOSTRIX (left deltoid). On the same day, after an unspecified time, the patient also received MENVEO (right deltoid) and TYPHIM vaccines (right deltoid). On 26th June 2015, within 24 hours of receiving the vaccines the patient experienced pain, swelling, redness that extended down one or two inches below his elbow. The patient was unable to extend his arm. At the time of reporting, the patient was seen by the reporter, and the patient stated that he still could not fully extend his arm. The reporter stated that there was a 15 to 20 degree lack of ability to extend arm. The reporter did not specify the arm which was involved in this adverse event. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to MENVEO and TYPHIM as well.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old male patient who received BOOSTRIX (batch number 55MT7, expiry date 14th February 2017). Co-suspect products included MENVEO (batch number M14094, expiry date 30th November 2015) and TYPHIM (batch number K1200-1, expiry date 15th April 2016). On 26th June 2015, the patient received the 1st dose of BOOSTRIX  (intramuscular) .5 ml, MENVEO and TYPHIM. On 26th June 2015, less than a day after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection limb mobility decreased was not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to BOOSTRIX. Additional details provided are as follows: This case was not previously reported to anyone. On 26th June 2015, at 11:00, the patient received a dose of BOOSTRIX (left deltoid). On the same day, after an unspecified time, the patient also received MENVEO (right deltoid) and TYPHIM vaccines (right deltoid). On 26th June 2015, within 24 hours of receiving the vaccines the patient experienced pain, swelling, redness that extended down one or two inches below his elbow. The patient was unable to extend his arm. At the time of reporting, the patient was seen by the reporter, and the patient stated that he still could not fully extend his arm. The reporter stated that there was a 15 to 20 degree lack of ability to extend arm. The reporter did not specify the arm which was involved in this adverse event. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to MENVEO and TYPHIM as well.
Age: 40.0
Sex: M
Vaccine: MNQ, TYP, MNQ, TDAP, TYP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 40-year-old male patient who received BOOSTRIX (batch number 55MT7, expiry date 14th February 2017). Co-suspect products included MENVEO (batch number M14094, expiry date 30th November 2015) and TYPHIM (batch number K1200-1, expiry date 15th April 2016). On 26th June 2015, the patient received the 1st dose of BOOSTRIX  (intramuscular) .5 ml, MENVEO and TYPHIM. On 26th June 2015, less than a day after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were recovered/resolved and the outcome of the injection limb mobility decreased was not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to BOOSTRIX. Additional details provided are as follows: This case was not previously reported to anyone. On 26th June 2015, at 11:00, the patient received a dose of BOOSTRIX (left deltoid). On the same day, after an unspecified time, the patient also received MENVEO (right deltoid) and TYPHIM vaccines (right deltoid). On 26th June 2015, within 24 hours of receiving the vaccines the patient experienced pain, swelling, redness that extended down one or two inches below his elbow. The patient was unable to extend his arm. At the time of reporting, the patient was seen by the reporter, and the patient stated that he still could not fully extend his arm. The reporter stated that there was a 15 to 20 degree lack of ability to extend arm. The reporter did not specify the arm which was involved in this adverse event. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injected limb mobility decreased and injection site pain to be related to MENVEO and TYPHIM as well.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 34-year-old female patient who received BOOSTRIX (batch number 5SR2L, expiry date 18th December 2016). Concomitant products included AFLURIA. On 24th August 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On 25th August 2015, 1 days after receiving BOOSTRIX, the patient experienced injection site pain, injection site swelling, injection site warmth, fever and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth, fever and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth, fever and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: On 24th August 2015, the patient received BOOSTRIX in left arm. On 25th August 2015, the patient presented with slight fever, sore arm, slightly swollen and pinkish arm. The arm was also warm to touch. The events were specific to left arm.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 34-year-old female patient who received BOOSTRIX (batch number 5SR2L, expiry date 18th December 2016). Concomitant products included AFLURIA. On 24th August 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On 25th August 2015, 1 days after receiving BOOSTRIX, the patient experienced injection site pain, injection site swelling, injection site warmth, fever and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site warmth, fever and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth, fever and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: On 24th August 2015, the patient received BOOSTRIX in left arm. On 25th August 2015, the patient presented with slight fever, sore arm, slightly swollen and pinkish arm. The arm was also warm to touch. The events were specific to left arm.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: A lot of swelling at site of injection; itching; headache.  Today is 09/04/2015 and still having swelling and itching using Benadryl pills and cream per Dr. directions.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site swelling, Pruritus
Clinical narrative: A lot of swelling at site of injection; itching; headache.  Today is 09/04/2015 and still having swelling and itching using Benadryl pills and cream per Dr. directions.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a nurse concerning a 22 year old female patient. Patient's concurrent conditions included unspecified environmental allergies. Medical history and drug reactions/allergies were not reported. On 26-AUG-2015 at 11:00 am, the patient was vaccinated with second dose of GARDASIL (strength, dose and frequency unspecified) intramuscularly in the left arm (reported as left deltoid). Concomitant therapies included CLARITIN. Reporting nurse stated that the patient noted a fine, superficial rash on both shoulders, the left deltoid (site of administration), as well as on her chest by 3:00 pm the same day. Patient sought medical attention and was seen at the health office on 28-AUG-2015. At that time, the rash was noted but not diagnosed. No treatment was provided for the adverse event. Patient reported that the rash began to fade since 31-AUG-2015. The outcome of rash was reported as recovering. Reporting nurse did not assessed the causality of the event with respect to vaccination with GARDASIL. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Multiple sclerosis, Paraesthesia
Clinical narrative: Numbness and tingling in feet and legs. This has continued since my flu shot symptoms began on 11/10/2014. I was diagnosed with MS on 08/6/2015.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging brain
Clinical narrative: Numbness and tingling in feet and legs. This has continued since my flu shot symptoms began on 11/10/2014. I was diagnosed with MS on 08/6/2015.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Numbness and tingling in feet and legs. This has continued since my flu shot symptoms began on 11/10/2014. I was diagnosed with MS on 08/6/2015.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Lethargy, Poor quality sleep, Somnolence, Vaccine positive rechallenge
Clinical narrative: Extreme fatigue and tiredness, sleeping fine but waking up and feeling like you had no sleep, drinking plenty of caffeine but cannot stay awake, lethargy, more tired than ever - this happened as well with the first dose 6 months prior.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised warm administration site reaction (red circle on arm).
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event noted at this time.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother called stating her son had shots in Center on Wednesday and now the area where he received one of his injections is red, slightly swollen, and itchy. Nurse asked what arm it is. Mother stated it is the left arm. Nurse informed mother that client received a Hep A and Varicella injection in that arm. Mother denied any pain, fever, or any other symptoms.
Age: 2.0
Sex: F
Vaccine: 6VAX-F, IPV
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Migraine, Pain
Clinical narrative: My daughter had severe Migraines, that would occur 2 to 3 days after vaccination.  Each Booster of the HPV Gardasil shot she was sent to the ER.  Stayed at hospital for a week. Second vaccine was 05/27/2013, 3rd vaccine was 09/30/2013. Each time was debilitating, Severe pain.
Age: 1.03
Sex: F
Vaccine: MMR
Symptoms: Blood test, Culture urine, Pyrexia, Rheumatoid arthritis, X-ray
Clinical narrative: Fever started out at 102. One month later 105 fever that would not go down. Continued with daily fevers of 100-102 for the next 7 months. Fevers a currently gone. RA type symptoms the entire time.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Patient started experiencing fever, chills, body aches. Was not feeling well.
Age: 49.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Arthralgia, Asthenia, Borrelia test negative, Computerised tomogram normal, Fatigue
Clinical narrative: Case Narrative: Information received from a 49 year old male consumer on 27AUG2015 who inquired whether BioThrax was known to cause low hemoglobin. On approximately 02AUG2015, in preparation for deployment, the male received vaccination with BioThrax, dose two (lot unknown); at the same time he received both MMR and typhoid vaccines. Medical history: Non-Hodgkin's lymphoma stage I (JUL2012) - treated with chemotherapy x 3, and radiation. In JUL2013 he was deemed to be in remission. Approximately one week later, he began to experience joint pain and weakness. He was tested for Lyme disease - result negative. The symptoms continued with the addition of headaches and fatigue. On or around 18AUG2015 laboratory testing revealed hemoglobin of 5.5 and white blood cell count of 1.5. He was hospitalized at that time. During the hospitalization he received 5 units of blood. He noted that in July, at a check-up, all of his "numbers were good", hemoglobin was 14, and a CT scan was negative. He denied any blood in his stool. On 22AUG2015, his hemoglobin reached 9.5, and he was discharged. The reporter indicated the hospital staff felt that the incident may have been a "virus". At the time of report, his symptoms (fatigue, headache, joint pain and weakness) had resolved, and he was scheduled for additional testing and follow up. On 01SEP2015 a follow up attempt revealed the consumer's hemoglobin and white blood cell count were improving, but his liver enzymes were "up". Further information was requested. Concomitant medications: occasional NSAIDs. Sender's Comments: This report was received from a consumer without medical records. The complicated past medical history and the limited anemia evaluation provided do not rule out other causes. The WBC count is also noted to be low and we are not provided a differential. Lastly, he received live virus vaccines concomitantly (MMR) that confound the case further. Therefore, in this instance there is insufficient information available to provide a causality assessment.
Age: 49.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Haemoglobin decreased, Headache, Hepatic enzyme increased, Transfusion, White blood cell count decreased
Clinical narrative: Case Narrative: Information received from a 49 year old male consumer on 27AUG2015 who inquired whether BioThrax was known to cause low hemoglobin. On approximately 02AUG2015, in preparation for deployment, the male received vaccination with BioThrax, dose two (lot unknown); at the same time he received both MMR and typhoid vaccines. Medical history: Non-Hodgkin's lymphoma stage I (JUL2012) - treated with chemotherapy x 3, and radiation. In JUL2013 he was deemed to be in remission. Approximately one week later, he began to experience joint pain and weakness. He was tested for Lyme disease - result negative. The symptoms continued with the addition of headaches and fatigue. On or around 18AUG2015 laboratory testing revealed hemoglobin of 5.5 and white blood cell count of 1.5. He was hospitalized at that time. During the hospitalization he received 5 units of blood. He noted that in July, at a check-up, all of his "numbers were good", hemoglobin was 14, and a CT scan was negative. He denied any blood in his stool. On 22AUG2015, his hemoglobin reached 9.5, and he was discharged. The reporter indicated the hospital staff felt that the incident may have been a "virus". At the time of report, his symptoms (fatigue, headache, joint pain and weakness) had resolved, and he was scheduled for additional testing and follow up. On 01SEP2015 a follow up attempt revealed the consumer's hemoglobin and white blood cell count were improving, but his liver enzymes were "up". Further information was requested. Concomitant medications: occasional NSAIDs. Sender's Comments: This report was received from a consumer without medical records. The complicated past medical history and the limited anemia evaluation provided do not rule out other causes. The WBC count is also noted to be low and we are not provided a differential. Lastly, he received live virus vaccines concomitantly (MMR) that confound the case further. Therefore, in this instance there is insufficient information available to provide a causality assessment.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT ARM REDNESS AROUND THE INJECTION SITE AND SWELLING.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Eye swelling, Rash macular, Swelling face, Vomiting
Clinical narrative: Child vomited and then late developed red blotches all over body. The next morning the red blotches are still present and a little more along with swollen face and eye. Child was given Benadryl.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Seizure, Skull fracture, Syncope
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via a company representative concerning a 11 year old female patient. Pertinent Medical History and Drug Reactions/Allergies were not reported. On an unknown date, in approximately 2013, the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). Concomitant vaccinations included meningococcal vaccine (unspecified) and Tdap (Lot #, doses and routes not reported). On an unspecified date in 2013 after receiving therapy with GARDASIL, the patient fainted (she refused to sit down) in the office, hit the wall, had a seizure and then fractured her skull. Subsequently, she was admitted to hospital where had a full recovery without further complications (dates unknown). There were no Lab Diagnostics Studies specified by the reporter. No further adverse event information was provided. Upon internal review seizure and skull fracture were considered to be medically significant. Additional information is not expected as reporter refused additional contact.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hyperhidrosis, Loss of consciousness, Pulse abnormal, Syncope
Clinical narrative: Patient had an episode of syncope following immunizations (Fluzone HD, and Prevnar 13). Patient went unconscious, and EMS was dispatched. Patient did have a weakened pulse and was sweating. Patient was put in supine position with feet eleveated and ice pack placed behing neck. Patient was still breathing and had a strong pulse after elevating feet. Within 5 minutes EMS took over and patient sent to hospital. Patient called the following day saying she was okay.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itching to the Left deltoid.
Age: 71.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of the left inside arm below the injection site, patient took a couple Tylenol and by 5pm on the 9/3/15 the swelling was going down.  The patient was told to take some Benadryl and let us know if it worsened.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, White blood cell count increased
Clinical narrative: 16cm x 17 cm indurated, hot, red, painful patch on left upper arm.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Computerised tomogram normal, Erythema, Laboratory test normal, Pain in extremity
Clinical narrative: Patient reported eyes are sensitive to light, rt arm very sore, reddened and warm. Temperature 103.1. In no acute distress. RN Supervisor notified Dr., Director of International Center and district ARNP. Decision was made to transport to Emergency Department.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Skin warm
Clinical narrative: Patient reported eyes are sensitive to light, rt arm very sore, reddened and warm. Temperature 103.1. In no acute distress. RN Supervisor notified Dr., Director of International Center and district ARNP. Decision was made to transport to Emergency Department.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Mild, local erythema.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting- patient received water, cool towel to back of neck.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Reports noted swelling and redness on left arm but has subsided.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Unknown time of onset, this is when patient sought treatment in Immediate Care setting; clinician notes from that encounter: "Mom says pt had flu shot 2 days ago, then that night mom noticed his right deltoid was a bit red and a bit swelling. Swelling and redness increased since yesterday. Mom gave him Benadryl last night and maybe this am (she was not sure loratadine or Benadryl this am). His arm is a bit tender but not much pain. He still played soccer. He is still active as usual. He appeared well at home to mom besides the right arm problem. He has not had fever, swelling throat, lips, tongue, face or anywhere else besides the right upper arm. No rashes in body, abd pain, diarrhea, chest pain, SOB. He used to have mild allergies with egg and peanut at age 1 after the allergy tests. He had flu shot every year the last several years without reactions. He has been eating eggs and peanuts without reactions the last several years. Mom noted he grew out of his allergies.  He is not taking any regular medication besides vitamin. He is a healthy kid in general." Pt prescribed OTC analgesics and antibiotic in case infection present.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site haematoma
Clinical narrative: PT presents to IMMS clinic on 03SEP15 complaining of a hematoma to the left deltoid at the injection site. PT hematoma is the size of a baseball with no pain or drainage with appearance of healing bruising. PT has no hx of bruising due to vaccinations and denies any other symptoms at this time. PT states hematoma is "getting better" since vaccine was administered on 26AUG2015. PT instructed to return to IMMS clinic if it gets worse or any other symptoms occur.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Urticaria
Clinical narrative: Hives around eyes, nose, upper lip-->Benadryl given.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Cough, Dizziness, Headache, Malaise
Clinical narrative: Patient complained of feeling "sick as a dog" with symptoms of headache, runny nose, worsening of asthma symptoms, cough, mucus in chest, feeling dizzy.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: Patient complained of feeling "sick as a dog" with symptoms of headache, runny nose, worsening of asthma symptoms, cough, mucus in chest, feeling dizzy.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: BRIGHT RED CIRCULAR SPOT AT SITE OF INJECTION. APPROXIMATELY 2 INCHES IN DIAMETER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site nodule, Myalgia, Pain
Clinical narrative: Knot at injection site, next morning had red circle about 1 1/2" in diameter around injection site, woke with muscle and joint pains, hurt all over.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Phlebitis
Clinical narrative: Phlebitis symptoms in the ventral wrist ipsalateral to the shoulder that the Tdap and HPV vaccines were administered earlier in the day.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test, Computerised tomogram head, Epilepsy, Irritability, Laboratory test
Clinical narrative: Static Epileptic Seizure for 5-6 hours, irritability, lethargy, and neurologic regression shortly thereafter for several months.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Lethargy, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: Static Epileptic Seizure for 5-6 hours, irritability, lethargy, and neurologic regression shortly thereafter for several months.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Balance disorder, Blood pressure increased, Blood test normal, Carbon dioxide decreased, Chest X-ray normal
Clinical narrative: I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Computerised tomogram head normal, Dizziness, Dyspnoea, Dysstasia, Electrocardiogram normal
Clinical narrative: I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Influenza like illness, Malaise, Memory impairment, Panic attack, Speech disorder
Clinical narrative: I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Blood test, Chest X-ray, Computerised tomogram head normal, Dizziness, Dyspnoea
Clinical narrative: I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Electrocardiogram, Influenza like illness
Clinical narrative: I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Balance disorder, Blood pressure increased, Blood test normal, Carbon dioxide decreased, Chest X-ray normal
Clinical narrative: Patient received the Flu vaccine on 9/2/2015. She developed severe flu like symptoms, dizziness, shortness of breath, evaluated in ER.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Computerised tomogram head normal, Dizziness, Dyspnoea, Dysstasia, Electrocardiogram normal
Clinical narrative: Patient received the Flu vaccine on 9/2/2015. She developed severe flu like symptoms, dizziness, shortness of breath, evaluated in ER.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Influenza like illness, Malaise, Memory impairment, Panic attack, Speech disorder
Clinical narrative: Patient received the Flu vaccine on 9/2/2015. She developed severe flu like symptoms, dizziness, shortness of breath, evaluated in ER.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Blood test, Chest X-ray, Computerised tomogram head normal, Dizziness, Dyspnoea
Clinical narrative: Patient received the Flu vaccine on 9/2/2015. She developed severe flu like symptoms, dizziness, shortness of breath, evaluated in ER.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Electrocardiogram, Influenza like illness
Clinical narrative: Patient received the Flu vaccine on 9/2/2015. She developed severe flu like symptoms, dizziness, shortness of breath, evaluated in ER.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Feeling hot, Nasal congestion, Pain
Clinical narrative: Same day as vaccine, developed redness and warmth, followed by ache.  That night, pain worsened and awoke with chills.  +nasal congestion.  Continued pain, redness, warmth with blanching erythema approx 56 hours after injection.