chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Rash generalised
Clinical narrative: Patient developed a rash Saturday evening. The rash is not localized to the site of injection. It is all over his body. Patient stated that he went to see his doctor today 08/21/17 and the physician felt that the rash was due to an allergy to the vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever and rash on face started on 08/16/17, still having intermittent fevers and rash is still has flat red rash on face. No other symptoms.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: There was no adverse event!!! Administration error as patient was supposed to get a KINRIX instead of PEDIARIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Furuncle
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient's concurrent condition was hypertension and allergy to penicillin. The patient's medical history included breast cancer (the patient was currently in remission). The patient had no concomitant medications. On 19-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N012492, expiration date 17-MAR-2018 for prophylaxis. Other suspect therapies included sterile diluent lot # N015632, expiration date 18-FEB-2019. On 29-JUL-2017, the patient experienced boil on her chin and fatigue. The patient sought medical attention by visiting a physician, yet no lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The relatedness between the event and suspect therapies was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex test positive, Vaginal lesion, Vulvovaginal pain
Clinical narrative: This spontaneous report as received from a other health professional refers to a 71 year old female patient. On 07-JUN-2017 the patient was vaccinated with ZOSTAVAX lot # M032141, .65 ml, subcutaneous for prophylaxis. On JUN-2017 the patient experienced vaginal lesion, herpes simplex test positive, herpes simplex and vulvovaginal pain. The outcome of vaginal lesion, herpes simplex test positive, herpes simplex and vulvovaginal pain was reported as recovered/resolved. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 11-AUG-2017, the patient was vaccinated with two separate doses of GARDASIL 9 lot # N012093 (one in the left arm, and the other one in the right arm) for prophylaxis (inappropriate schedule of drug administration and overdose). No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 06-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M034586 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effects reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008906: US-009507513-1708USA008905: US-009507513-1708USA008904: US-009507513-1708USA008907:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored VAQTA (lot N016805 expiry date 04-SEP-2018) or (lot M033611 expiry date 02-MAR-2018) or (lot N005796 expiry date 26-MAY-2018) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 6 hours 7 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1708USA008709: US-009507513-1708USA008708: US-009507513-1708USA008710: US-009507513-1708USA008711: US-009507513-1708USA008711.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored GARDASIL 9 (lot N003703 expiry date 29-OCT-2019) or (lot M041212 expiry date 21-JUN-2019) (incorrect product storage) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 35 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA008709: US-009507513-1708USA008409:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored  PNEUMOVAX 23 from lot # M042324 expiry date 10-JUN-2018 (incorrect product storage) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 2 hours and 6 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA008409: US-009507513-1708USA008409:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M034586 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. There was no product quality complaint involved. Sender's Comments: US-009507513-1708USA008906: US-009507513-1708USA008905: US-009507513-1708USA008907: US-009507513-1708USA008368.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M042496, for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008906: US-009507513-1708USA008368: US-009507513-1708USA008907: US-009507513-1708USA008904:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M042496 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008368: US-009507513-1708USA008905: US-009507513-1708USA008907: US-009507513-1708USA008904:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Strength, dose, frequency, route and anatomical location were not reported) of lot # M004116 with an expiry date of 12-OCT-2017, for prophylaxis. No adverse effect reported. The vaccines were exposed to 47 degree Fahrenheit to 77 degree Fahrenheit for 257 hours and 15 minutes. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved. Sender's Comments: US-009507513-1708USA008906: US-009507513-1708USA008905: US-009507513-1708USA008368: US-009507513-1708USA008904.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: See attached page.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Adverse drug reaction, Asthenia, Colitis, Condition aggravated, Constipation
Clinical narrative: Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Dry eye, Erythema, Faeces hard, Gastrointestinal pain
Clinical narrative: Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Malaise, Peptic ulcer
Clinical narrative: Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Quality of life decreased, Rosacea, Skin lesion, Somnolence
Clinical narrative: Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Stupor, Vascular injury, X-ray limb
Clinical narrative: Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Injection site vesicles, Vaccination complication
Clinical narrative: Four days after immunization patient presented to the pharmacy with a swollen injection site reaction on the back of her arm. There were also skin blisters at the injection site. Patient went to the ER where they determined it was an allergic RXN to the vaccine. She was told to cover blisters with a BANDAID and follow up w/her PCP.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS 15 days hosp.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt. got ZOSTAVAX on Friday 8-11-17 and develops shingles-like rash on abdomen.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Exposure during pregnancy, Local reaction, Pain, Pyrexia
Clinical narrative: Patient received smallpox and anthrax vaccine on 29 July 2017 for upcoming job. Pregnancy test at date of vaccination was negative. Patient reported to me on 18 August 2017 that a subsequent pregnancy test done at home approximately 10 days later was positive. Pregnancy testing completed on 18 August 2018 in the clinic was positive. Patient estimated date of conception to be 19 July 2017 and was pending evaluation by OB-GYN. Patient denied adverse symptoms beyond local reaction, mild aches, pain, low grade temp expected with smallpox and anthrax reaction and was doing well during our initial follow up beyond concerns for developing fetus. Patient reported that she started prenatal vitamins, stopped smoking and stopped con.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Antibody test negative, Antinuclear antibody negative, Asthenia, Decreased appetite, Diarrhoea
Clinical narrative: Patient presented to the ED with full body rash beginning 5 days post receiving zostavax/influenza immunizations. The rash began on back and progressively over all four extremities and abdomen. The rash consists of vesicles on erythematous base in various stages of resolution. Rash is not in dermatomal distribution. The rash is pruritic and not painful. Has been scratching at them causing them to break open and scab. Patient admits to night sweats for the past week, difficulty urinating, nausea, vomiting, generalized weakness, and SOB. Also admits to episode of non bloody diarrhea 2 days ago, and loss of appetite for the past 3 days. Patient denies dysuria, abdominal pain, fever, and chest pain.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dyspnoea, Dysuria, HIV test negative, Hypotension, Nausea
Clinical narrative: Patient presented to the ED with full body rash beginning 5 days post receiving zostavax/influenza immunizations. The rash began on back and progressively over all four extremities and abdomen. The rash consists of vesicles on erythematous base in various stages of resolution. Rash is not in dermatomal distribution. The rash is pruritic and not painful. Has been scratching at them causing them to break open and scab. Patient admits to night sweats for the past week, difficulty urinating, nausea, vomiting, generalized weakness, and SOB. Also admits to episode of non bloody diarrhea 2 days ago, and loss of appetite for the past 3 days. Patient denies dysuria, abdominal pain, fever, and chest pain.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Night sweats, Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Patient presented to the ED with full body rash beginning 5 days post receiving zostavax/influenza immunizations. The rash began on back and progressively over all four extremities and abdomen. The rash consists of vesicles on erythematous base in various stages of resolution. Rash is not in dermatomal distribution. The rash is pruritic and not painful. Has been scratching at them causing them to break open and scab. Patient admits to night sweats for the past week, difficulty urinating, nausea, vomiting, generalized weakness, and SOB. Also admits to episode of non bloody diarrhea 2 days ago, and loss of appetite for the past 3 days. Patient denies dysuria, abdominal pain, fever, and chest pain.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rectal haemorrhage, Scab, Tachycardia, Vomiting
Clinical narrative: Patient presented to the ED with full body rash beginning 5 days post receiving zostavax/influenza immunizations. The rash began on back and progressively over all four extremities and abdomen. The rash consists of vesicles on erythematous base in various stages of resolution. Rash is not in dermatomal distribution. The rash is pruritic and not painful. Has been scratching at them causing them to break open and scab. Patient admits to night sweats for the past week, difficulty urinating, nausea, vomiting, generalized weakness, and SOB. Also admits to episode of non bloody diarrhea 2 days ago, and loss of appetite for the past 3 days. Patient denies dysuria, abdominal pain, fever, and chest pain.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Full blood count normal, Petechiae, Platelet count normal, Pruritus, Rash erythematous
Clinical narrative: Small, red pinpoint dots rash all over body on hands, feet, body. Petechiae present on body developed Saturday morning after vaccine given Friday afternoon. Itchiness started Friday night, no prior h/o itchiness in child and then Saturday morning rash appeared and spread to rest of body. Seen in office on Monday rash not spreading anymore. No swelling, no difficulty breathing, no facial swelling, no SOB, no itchy throat, no other sxs. Pt is eating, peeing, pooping normally.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: Small, red pinpoint dots rash all over body on hands, feet, body. Petechiae present on body developed Saturday morning after vaccine given Friday afternoon. Itchiness started Friday night, no prior h/o itchiness in child and then Saturday morning rash appeared and spread to rest of body. Seen in office on Monday rash not spreading anymore. No swelling, no difficulty breathing, no facial swelling, no SOB, no itchy throat, no other sxs. Pt is eating, peeing, pooping normally.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on upper thigh of both legs, hives on inner arm near injection site.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram head, Fall, Head injury, Seizure, Syncope
Clinical narrative: Patient fainted in office post vaccine admin. Fell hitting her head, appeared to have seizure lasting just under one minute. Pt. recovered in less than 30 min.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient became pale, light headed and diaphoretic after vaccine. Stable in less than 20 min.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Within 4 to 5 hours, she had a fever of 103.8 degrees. The next morning, her arm at the injection site was very red, swollen, and red. She also started throwing up that next morning and continued for about 48 hours. The fever remained high for about 48 hours, as well.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Constipation, Vomiting
Clinical narrative: 2 days of vomiting 2x a day on 8/2 and 8/3 then once a day went to ER on 8/8 got ZOFRAN and MIRALAX for constipation. First used that night.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: After receiving a shingles vaccine from pharmacy, on 14 August 2017, I am noticing a reddening of my arm extending in a 6 inch radius from the injection location. It was suggested by a clinical pharmacologist (MD) I work with to report this.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: Patient experienced severe pain at INJ. site nausea and dizziness - 4 hrs after INJ. Symptoms resolved (Right arm).
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Hyperhidrosis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: On day 1 of injection around lunch time, the patient was okay. On day 2 morning, she had a pea sized bump and she had reported that she suffered diarrhea, sweat, fever and body pain. On day 3, patient stated the bumps around injection site has spread to a size of an orange. On day 4, patient visited store and shown me her orange size bumps. These bumps are fairly big in size and reddish in color.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: On day 1 of injection around lunch time, the patient was okay. On day 2 morning, she had a pea sized bump and she had reported that she suffered diarrhea, sweat, fever and body pain. On day 3, patient stated the bumps around injection site has spread to a size of an orange. On day 4, patient visited store and shown me her orange size bumps. These bumps are fairly big in size and reddish in color.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Asthenia, Nausea, Urticaria
Clinical narrative: Wheals globally all over started about 2 hours after vaccines. They disappear with BENADRYL but come back when BENADRYL wears off. Treated with Prednisone 20mg BID x 5 days and Triamcinolone cream q8 hr.
Age: 67.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Abnormal dreams, Feeding disorder, Influenza like illness, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Started with flu-like symptoms. Then at night started having vivid dreams, where he could/felt himself talking - like out-of-body conversations. This lasted three nights. He could not sleep, eat, or do anything except lay in bed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Swelling face, Throat tightness, Vomiting
Clinical narrative: Patient had anaphylactic reaction to flu vaccine. Pt. was vomiting, had facial swelling tightened airway.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Area red, swollen, and hot to touch. She can't pick up her arm due to pain, also felt dizzy.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Area red, swollen, and hot to touch. She can't pick up her arm due to pain, also felt dizzy.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8-9-17, Patient received PREVNAR 13. On 8-14-17 patient called and stated injection site red, warm, and swollen. Patient instructed to use cool compress to area. I called patient on 8-16-17 to follow up. Patient stated the redness and swelling has spread. Got patient an apt for 8-16-17 too see physician. Physician Dx adverse reaction to PREVNAR 13 vaccine.
Age: 41.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of pain (not soreness) the night the vaccinations were given (given 8/19/2017) in her left arm and the following morning noticed it was a bit swollen and slight redness. That evening she was rubbing it and noticed it was warm to the touch. Today Monday August 21, 2017 she stopped by the pharmacy and arm is more swollen and redness has spread all over upper left arm and is now hot to the touch. She was advised to go to a clinic to follow up with a doctor.
Age: 41.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Skin warm
Clinical narrative: Patient complained of pain (not soreness) the night the vaccinations were given (given 8/19/2017) in her left arm and the following morning noticed it was a bit swollen and slight redness. That evening she was rubbing it and noticed it was warm to the touch. Today Monday August 21, 2017 she stopped by the pharmacy and arm is more swollen and redness has spread all over upper left arm and is now hot to the touch. She was advised to go to a clinic to follow up with a doctor.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest pain, Fatigue, Injection site erythema, Malaise, Pain
Clinical narrative: Patient vaccinated with PNEUMOVAX and FLUARIX on 8/16, 1 day after vaccination patient felt tired, terrible. 2 days after pt's arm red from shoulder to elbow, and painful. radiating to chest. 8/18 patient went to emergency room with fever 101 to 102--admitted overnight on IV antibiotics--discharged on 8/19 on oral Keflex.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient vaccinated with PNEUMOVAX and FLUARIX on 8/16, 1 day after vaccination patient felt tired, terrible. 2 days after pt's arm red from shoulder to elbow, and painful. radiating to chest. 8/18 patient went to emergency room with fever 101 to 102--admitted overnight on IV antibiotics--discharged on 8/19 on oral Keflex.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Induration, Vaccination complication
Clinical narrative: Vaccine administered on 7/28 (ZOSTAVAX). 2 to 3 inch diameter red area appeared 7/30 (R arm); per nurse - reaction to ZOSTAVAX. Area also hard...(erythema, induration).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of VAQTA lot # M038572 with expiration date of 11-MAR-2018 or lot #M047658 with expiration date of 28-OCT-2017. No adverse effects were reported. The digital data logger was involved in recording the excursion. The vaccines were exposed to temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 30 minutes. This is one of six reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005170:  US-009507513-1708USA005168: US-009507513-1708USA005169: US-009507513-1708USA005166: US-009507513-1708USA001493:
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Blood test, Gait disturbance, Headache, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient's mother) via a sales representative. A male patient of an unspecified age (age: 16; unit: Unknown) and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation, MENACTRA, via an unspecified route of administration on unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) at same visit in same arm. The next day patient had fever over 102, abdominal pain, headache worse than a migraine, muscle weakness so bad that the mom had to help him walk. Urgent care sent him to the ER where he got IV fluids and blood work. They said it was either viral or from the vaccines. He felt better the next day. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient's mother) via a sales representative. A male patient of an unspecified age (age: 16; unit: Unknown) and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation, MENACTRA, via an unspecified route of administration on unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) at same visit in same arm. The next day patient had fever over 102, abdominal pain, headache worse than a migraine, muscle weakness so bad that the mom had to help him walk. Urgent care sent him to the ER where he got IV fluids and blood work. They said it was either viral or from the vaccines. He felt better the next day. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse and pharmacist (patient's mother) via Pfizer sales representative. This nurse and pharmacist (mother) reported for a 16 year old male patient. A 16-years-old male patient of an unspecified ethnicity received first dose of TRUMENBA (Lot# R5077, exp. 31Jul2018), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site, arm pain, overall body malaise/fatigue, chills and nausea 3-4 hours later on an unspecified date after injection, and lasting at least 12 hours. Mother gave him TYLENOL and said symptoms appeared to improve after 12 hours. The outcome was recovering.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse and pharmacist (patient's mother) via Pfizer sales representative. This nurse and pharmacist (mother) reported for a 16 year old male patient. A 16-years-old male patient of an unspecified ethnicity received first dose of TRUMENBA (Lot# R5077, exp. 31Jul2018), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at injection site, arm pain, overall body malaise/fatigue, chills and nausea 3-4 hours later on an unspecified date after injection, and lasting at least 12 hours. Mother gave him TYLENOL and said symptoms appeared to improve after 12 hours. The outcome was recovering.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Dysgeusia, Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 68-year-old female patient of unknown race/ethnicity received a single dose of PREVNAR 13 on an unknown date (reported as Friday) for immunization and cortisone (manufacturer unknown) injection in knee on an unknown date (reported as Thursday) for an unspecified indication. Concomitant medications and medical history were not reported. The patient after a glass of wine experienced bright red face for 36 hours. The patient took BENADRYL and symptoms resolved. No nausea and food did not taste the same since. Action taken with cortisone was unknown.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Laboratory test normal
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of the physician. This is a spontaneous report from a contactable other hcp. An 80-year-old male patient received PREVNAR 13 lot R19477 exp date 31Jan2018, via an unspecified route of administration in right deltoid on 08Feb2017 10:30 at 0.5 ml, single for immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced severe fatigue two days after vaccination in Feb2017 with outcome of unknown. He had a complete work up and everything came back normal and the physician feels that it must relate to the vaccination.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some swelling and itching at the injection site on an unspecified date. The outcome of the events was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited case received from an other healthcare professional on 11-AUG-2017. This case involves two patients (age and gender not reported) who was vaccination with a dose of FLU VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unknown date, following the flu vaccination, the patients developed Guillain-Barre syndrome (GBS). The reporter did not know the names of the 2 employees, did not know dates of vaccination, did not know what brand of flu vaccine the 2 employees had received, and did not know how long after vaccination the 2 employees experienced GBS. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: Guillain Barre syndrome. List of documents held by sender: none. Sender's Comments: In this case, the symptoms and evolution of GBS (Guillain Barre Syndrome) has not been reported. The time to event onset post vaccination was unknown. The manufacturer of the influenza vaccine was not reported. Further information regarding GBS diagnosis confirmation (cerebrospinal fluid and electrophysiological analyses, absence of tendon reflexes, information on limbs weakness, information on the development of the disease i.e. monophasic pattern or not), vaccine details and infectious work up to confirm the absence of concurrent infection are needed for complete assessment of the case.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Inflammation, Myalgia, Pyrexia, Rash, Tenderness
Clinical narrative: Next morning muscle soreness, pt ran fever and tenderness. Rash to the inside of the arm. Patient reported inflammation has been subsiding and almost fully resolved.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Rash on the left thigh. EPIPEN was administered (injection).
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain and swelling in left arm and shoulder up to the neck every since 7/25/17.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Pulmonary function test
Clinical narrative: Severe pain and swelling in left arm and shoulder up to the neck every since 7/25/17.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Tinnitus
Clinical narrative: Post vaccine patient C/O wanting to pass out. Also C/O ringing in her ears.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: No treatment. Vomited right after administering ROTATEQ within 1 minute.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema, swelling one day of injections on both arms lasting at least 5 days. Mom neglected to tell us this has happened with previous injections.
Age: 13.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Basophil percentage, Body temperature increased, Chest discomfort, Chills, Eosinophil percentage
Clinical narrative: Patient developed chills, T: 40 degree C, stiffed body, chest discomfort, nausea. Approximately 3 hrs after administration of BEXSERO and GARDASIL seen at ER. Treated with dexamethasone, TORADOL, ZANADOL.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Haemoglobin decreased, Lymphocyte percentage, Musculoskeletal stiffness, Nausea, Neutrophil percentage increased
Clinical narrative: Patient developed chills, T: 40 degree C, stiffed body, chest discomfort, nausea. Approximately 3 hrs after administration of BEXSERO and GARDASIL seen at ER. Treated with dexamethasone, TORADOL, ZANADOL.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Platelet count normal, White blood cell count increased
Clinical narrative: Patient developed chills, T: 40 degree C, stiffed body, chest discomfort, nausea. Approximately 3 hrs after administration of BEXSERO and GARDASIL seen at ER. Treated with dexamethasone, TORADOL, ZANADOL.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Pt phoned 8/11/17 AM to report he'd noticed tenderness at his Imm. injection site yesterday, but his arm became red, hot and swollen today. Pt was scheduled for an apt and was seen for evaluation on 8/11/17.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Left arm swelling and erythema at deltoid. 13.5 inch circumference vs 12.5 inch circumference on right deltoid.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Bradycardia, Syncope
Clinical narrative: Patient fainted approximately 5 min after receiving 4 vaccines. Paramedics were at the vaccination clinic and immediately provided care. Pt. remained bradycardic and fainted again in the chair. Pt. was brought to the ER at Hospital at 1:40 PM.
Age: 18.0
Sex: U
Vaccine: YF
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient called 5/30 (3 days after receiving shot - After spending 15min in sun booth that are and only shot area got extremely warm and burnt.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness near injection site w/warmth.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Loss of personal independence in daily activities
Clinical narrative: Chills, malaise, loss of appetite, muscle aches, joint pain, red painful arm began approximate 18-24 hrs after vaccine and continued for 4 days. Missed 1 1/2 days work. Also vomiting.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Myalgia, Pain in extremity, Vomiting
Clinical narrative: Chills, malaise, loss of appetite, muscle aches, joint pain, red painful arm began approximate 18-24 hrs after vaccine and continued for 4 days. Missed 1 1/2 days work. Also vomiting.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4.5-5 in cellulitis to L upper arm plus warmth. Maybe mild swelling to one area plus erythema marked with pen. Able to freely move extremity. Mildly TTP. No puncture site visualized.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Rash
Clinical narrative: Patient had the shots around 4pm, did not report the symptoms to his mother until the next day, but they believe they started late that same night. A rash appeared circling both armpits which also ran down the back of his arms. It felt like "a rug burn." Today his arms still have redness, but it hurts less. Mom has not used any new detergents, child was not wearing anything new. Recovering, but not completely recovered yet.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Confusional state, Emotional distress, Fatigue, Loss of consciousness, Pallor
Clinical narrative: Pt looked pale. She moved to chair next to chair that she was sitting in for vaccine. She was talking to RN and then slumped in chair. RN supported her weight while she was out. Pt then had a quick seizure and came to. She was confused and upset. The event happened less than 5 minutes after vaccines were given. She sat on her mom's lap and was tearful and breathing fast. RN ENC her to take slow deep breaths. Pt then walked to room next door and laid on exam table with legs elevated. RN put cool cloth on her head. RN gave her apple juice to sip on and fruit snacks. RN observed pt for about a half hr before pt left. Child reported that before she fainted she had blurry vision and felt really tired. Mom stated that child has never had a seizure before. RN ENC mom to take child to walk in or to her PCP today to be evaluated. Mom stopped at PCP's office and nurse there stated that if she had symptoms again to bring her in to be seen. She was not seen by nurse or PCP. RN called mom to CK in this afternoon. She reports that child threw up on the way home and reported feeling much better afterward.