chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, the unknown number of patients were inadvertently administered PROQUAD, that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). NO concomitant therapies were reported. No adverse effects reported. Follow up information received on 19-AUG-2014. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse refers to an unknown number of patients of unknown demographics. On unspecified dates after 12-AUG-2014, those patients were administered doses of PROQUAD and VARIVAX injections (dose, frequency, route of administration, lot# and therapy date unspecified for both), that were improperly stored on 14-AUG-2014 and 15-AUG-2014. No concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2014, the patient was vaccinated with doses of ZOSTAVAX (LOT# unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other cases 1409USA002420 and 1409USA002126(Same reporter link). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-AUG-2014 the patient was vaccinated with a ZOSTAVAX (dose: 0.65 ml, frequency: unknown, subcutaneously) which underwent a supported temperature excursion. No adverse experience was reported. No product quality complaint was involved. Additional information has been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2014, the patient was vaccinated with dose of ZOSTAVAX (LOT# unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other cases 1409USA002126 and 1409USA002419 (Same reporter link). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 02-SEP-2014, the patient was vaccinated with ZOSTAVAX (LOT # unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other case 1409USA002420 and 149USA002419 (Same reporter link). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding unspecified number of patients of unknown age. Concurrent conditions and medical history were not reported. On an unknown dates, the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, dosage regimen, strength, route, lot # and expiry date were not reported) that was stored improperly (inappropriate product storage). No adverse events were reported. No further information was provided. This case is one of the several reports from same reporter. Follow-up information has been received from a nurse on 13-AUG-2014. The nurse was able to provide lot numbers for (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015; lot # reported as J014152, expiration date not reported). The nurse was unable to provide patient identifiers or dates of vaccinations. Follow up information has been received. It was confirmed that lot number J013907 (expiration date: 30-OCTG-2015) was valid for (Oka/Merck) VARIVAX. This case is related to 1408USA005761 (with lot # J014152) (Same Reporter Link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to several patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (route, dose, lot# and expiration date were not reported). The reporter stated that the patients experienced severe pain and numbness after receiving the GARDASIL injection (date unspecified). No specific information was provided on whether it was at the injection site or the arm. The patients did not seek any medical attention. The outcome of "severe pain and numbness" was unknown. The relatedness between the event of "severe pain and numbness" and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patient(s) of unknown age. On an unknown date, 3 doses GARDASIL (lot#, expiration date, dose, route not reported) that had been improperly stored were administered to unspecified patient(s). No adverse effects reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Learning disorder
Clinical narrative: This spontaneous report as received from a consumer regarding her son refers to a 10 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that the patient had received his first dose of M-M-R II around 12-15 months on an unspecified date. The reporter also mentioned that after the patient received the first dose of M-M-R II and prior to the start of her son entering elementary school, titers were drawn and immunity to M-M-R II were present. It was also reported that patient had never received a second dose of M-M-R II and the patient is now 10 years old and was requested by the school to have titers for immunity drawn again or to have the patient received the second dose of M-M-R II. On an unspecified date titers were drawn and immunity for measles was not present. The reporter also stated that patient had an unspecified learning disorder since an unknown date. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Age: 0.84
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None to note. Hepatitis a vaccine given out of recommended age range.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site urticaria, Pain
Clinical narrative: Pt had large hive present at vaccine site. Pt c/o generalized achiness; seen in office 9/5/14. BENADRYL, cold compress advised for tx.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. No medical history reported. Past drug history was unknown. On 25-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (1 injection once in the right deltoid, lot # J009827, indication: heavy smoking) that expired on 10-AUG-2014. No concomitant medications reported. It was unknown if there was any relevant laboratory data. On 25-AUG-2014 it was unknown if the patient would receive PNEUMOVAX 23 again. The patient was fine after being administered an expired vaccine. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patients were vaccinated with an improperly stored dose of COMVAX (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patients were vaccinated with an improperly stored dose of GARDASIL (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a female consumer unknown age. The patient's medical history and current condition are not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (unknown strength, dosed and frequency). On an unknown date the patient experienced had side effect with PNEUMOVAX 23. The patient received treatment for the event. Product quality complaint was not involved. The outcome of the event is unknown. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 6 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 08-AUG-2014 the patient was vaccinated with a dose (unspecified in series) of ROTATEQ (lot number reported as K00145D, expiration date 18-NOV-2015), 2 ml, orally, that had been exposed to 1 deg. C for 4 hours. No adverse effects reported. This case is linked to cases MARRS # 1408USA015578 and MARRS # 1409USA002596 (same reporter link). Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye haemorrhage, Rash macular
Clinical narrative: This spontaneous report was received from approximately a 71 year old male patient, regarding himself. The patient had no pertinent medical history, drug reactions and allergies. On 29-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and other details unspecified). No concomitant therapy was reported. On 30-JUL-2014, the patient experienced big-red blotches on his legs, popped eye vessels and bleeding from his eyes after receiving ZOSTAVAX. The consumer also stated that he was seen and released, the same day (30-JUL-2014), from an unspecified emergency room, on an unspecified date. The consumer stated that, he received treatment for events with antibiotic (unspecified name, dose/frequency and manufacturer), allergy medication (unspecified name, dose/frequency and manufacturer) and steroids (unspecified name, dose/frequency and manufacturer). No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was reported as recovered on 13-AUG-2014. The causality was unspecified in the report. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye haemorrhage, Local swelling, Rash, Rash macular, Skin infection
Clinical narrative: This spontaneous report was received from approximately a 71 year old male patient, regarding himself. The patient had no pertinent medical history, drug reactions and allergies. On 29-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and other details unspecified). No concomitant therapy was reported. On 30-JUL-2014, the patient experienced big-red blotches on his legs, popped eye vessels and bleeding from his eyes after receiving ZOSTAVAX. The consumer also stated that he was seen and released, the same day (30-JUL-2014), from an unspecified emergency room, on an unspecified date. The consumer stated that, he received treatment for events with antibiotic (unspecified name, dose/frequency and manufacturer), allergy medication (unspecified name, dose/frequency and manufacturer) and steroids (unspecified name, dose/frequency and manufacturer). No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was reported as recovered on 13-AUG-2014. The causality was unspecified in the report. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 9 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 08-AUG-2014 the patient was vaccinated with a dose (unspecified in series) of RECOMBIVAX HB (lot # 0386AE; expiration date reported as 10-NOV-2014), 0.5 ml, intramuscularly, that had been exposed to 1 degree C for 4 hours. No adverse effects reported. This case is linked to cases MARRS # 1408UISA015578 and MARRS # 1409USA002597 (same reporter link0. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patient were vaccinated with an improperly stored dose of VAQTA (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 15-AUG-2014 the patient was vaccinated with a dose (unspecified in series) of VAQTA INJ (lot # J016216; expiration date 18-AUG-2014), 0.5 ml, once, intramuscularly, that had been exposed to 1 deg. C for 4 hours. The patient did not seek medical attention. No adverse effects reported. This case is linked to cases MARRS # 1409USA002596 and MARRS # 1409USA002597 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, dose number, lot/batch number, expiration date and route were not reported) for shingles prevention. On an unknown date, reported as about a week after the administration, the patient experienced shingles. No product quality complaint (PQC) was involved. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since 28-JUL-2014, the patients were vaccinated with MMR II (dose, frequency, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. On approximately 2014, the dose that the patients received MMR II was improperly stored. No adverse effects were reported (also reported as no adverse effects were not reported). Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 15 month old male patient. Medical history was not reported. The nurse informed that on 29-AUG-2014 the patient received a fourth dose of ROTATEQ oral, (dosage, lot number and expiration date were not reported). The patient had received the first dose of ROTATEQ approximately in July 2013 at 2 months of age, the second dose approximately in September 2013 at 4 months of age and the third dose approximately in November 2013 at 6 months of age. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 31-AUG-2014, the patient was vaccinated with PNEUMOVAX 23, injection, 1 standard package syringe of 1, (lot # J004747; Exp. Date: 20-JUL-2014), 0.5 ml, intramuscular (strength and route not provided). Co-suspect or concomitant therapies were not provided. The dose of PNEUMOVAX 23 that the patient received on 31-AUG-2014 expired on 20-JUL-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a three patients of unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection, lot # J013345, expiration date: 11-JAN-2015, intramuscular (dosage was not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date two of the patients came back to the facility and complained of soreness, redness and pain at the injection site. Because of this the facility called another patient who received the PNEUMOVAX 23 as well, and that patient also complained of soreness, redness and pain at the injection site. The pharmacist stated that these reactions were not treated in anyway. The patients sought medical attention by a facility's visit. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was vaccinated with a dose of expired PNEUMOVAX 23 (dose and route not reported), lot # J009827, expiration date: 10-AUG-2014. Additional information is not expected because there was no consent to contact the reporter.
Age: 0.22
Sex: M
Vaccine: HIBV
Symptoms: Screaming, Vomiting
Clinical narrative: Vomiting, inconsolable screaming.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Fever to 104, myalgias, cough, headache, weakness.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Dysstasia, Erythema, Local swelling, Pain in extremity
Clinical narrative: He had pain in his leg, it was slightly red and swollen. He would not bear weight on it for 3 days or would cry in pain if tried to stand on it. Mom thinks it was his right leg.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: He had pain in his leg, it was slightly red and swollen. He would not bear weight on it for 3 days or would cry in pain if tried to stand on it. Mom thinks it was his right leg.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Asthenia, Borrelia test negative, CSF test normal, Coordination abnormal
Clinical narrative: It began with funny sensations, paresthesias in the saddle area. They were occassional and brief, almost felt like muscle twitches or a buzzing electric shock (hit your funny bone) feeling. That progressed a bit. After several weeks I noticed that it occurred predictably with neck flexion. Also over the time period of late October 2013 to late November, the paresthesias worsened, and I also developed weakness and mild dyscoordination in my legs bilaterally. Overall the symptoms were very disturbing, but I could still walk.The symptoms gradually improved over the next 10 months. Currently I am about 80% better but still notice some dyscoordination and my gait is permanently altered. I can run, but have trouble playing sports as my agility is reduced. The subjective feeling of leg movement is noticeably altered and this is unpleasant. I received a full work up and my neurologist diagnosed me with "post-viral syndrome". He did not think the symptoms were related to the vaccine. I had also had a brief but bad viral infection in early September 2013, which was initially diagnosed as Lyme Disease, but retrospectively as a viral syndrome, probably aseptic menengitis or possibly a mild viral encephalitis. That viral episode resolved withing 1 week though, and there was about 6 weeks between recovery from that and the development of these neurologic symptoms, and I was feeling normal in between. In summary, I think there is a good chance my symptoms are from the vaccine. I am a board certified psychiatrist, and a full-time faculty member at a university.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Meningitis aseptic, Movement disorder, Muscle twitching, Muscular weakness
Clinical narrative: It began with funny sensations, paresthesias in the saddle area. They were occassional and brief, almost felt like muscle twitches or a buzzing electric shock (hit your funny bone) feeling. That progressed a bit. After several weeks I noticed that it occurred predictably with neck flexion. Also over the time period of late October 2013 to late November, the paresthesias worsened, and I also developed weakness and mild dyscoordination in my legs bilaterally. Overall the symptoms were very disturbing, but I could still walk.The symptoms gradually improved over the next 10 months. Currently I am about 80% better but still notice some dyscoordination and my gait is permanently altered. I can run, but have trouble playing sports as my agility is reduced. The subjective feeling of leg movement is noticeably altered and this is unpleasant. I received a full work up and my neurologist diagnosed me with "post-viral syndrome". He did not think the symptoms were related to the vaccine. I had also had a brief but bad viral infection in early September 2013, which was initially diagnosed as Lyme Disease, but retrospectively as a viral syndrome, probably aseptic menengitis or possibly a mild viral encephalitis. That viral episode resolved withing 1 week though, and there was about 6 weeks between recovery from that and the development of these neurologic symptoms, and I was feeling normal in between. In summary, I think there is a good chance my symptoms are from the vaccine. I am a board certified psychiatrist, and a full-time faculty member at a university.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Sensory disturbance
Clinical narrative: It began with funny sensations, paresthesias in the saddle area. They were occassional and brief, almost felt like muscle twitches or a buzzing electric shock (hit your funny bone) feeling. That progressed a bit. After several weeks I noticed that it occurred predictably with neck flexion. Also over the time period of late October 2013 to late November, the paresthesias worsened, and I also developed weakness and mild dyscoordination in my legs bilaterally. Overall the symptoms were very disturbing, but I could still walk.The symptoms gradually improved over the next 10 months. Currently I am about 80% better but still notice some dyscoordination and my gait is permanently altered. I can run, but have trouble playing sports as my agility is reduced. The subjective feeling of leg movement is noticeably altered and this is unpleasant. I received a full work up and my neurologist diagnosed me with "post-viral syndrome". He did not think the symptoms were related to the vaccine. I had also had a brief but bad viral infection in early September 2013, which was initially diagnosed as Lyme Disease, but retrospectively as a viral syndrome, probably aseptic menengitis or possibly a mild viral encephalitis. That viral episode resolved withing 1 week though, and there was about 6 weeks between recovery from that and the development of these neurologic symptoms, and I was feeling normal in between. In summary, I think there is a good chance my symptoms are from the vaccine. I am a board certified psychiatrist, and a full-time faculty member at a university.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Viral infection
Clinical narrative: It began with funny sensations, paresthesias in the saddle area. They were occassional and brief, almost felt like muscle twitches or a buzzing electric shock (hit your funny bone) feeling. That progressed a bit. After several weeks I noticed that it occurred predictably with neck flexion. Also over the time period of late October 2013 to late November, the paresthesias worsened, and I also developed weakness and mild dyscoordination in my legs bilaterally. Overall the symptoms were very disturbing, but I could still walk.The symptoms gradually improved over the next 10 months. Currently I am about 80% better but still notice some dyscoordination and my gait is permanently altered. I can run, but have trouble playing sports as my agility is reduced. The subjective feeling of leg movement is noticeably altered and this is unpleasant. I received a full work up and my neurologist diagnosed me with "post-viral syndrome". He did not think the symptoms were related to the vaccine. I had also had a brief but bad viral infection in early September 2013, which was initially diagnosed as Lyme Disease, but retrospectively as a viral syndrome, probably aseptic menengitis or possibly a mild viral encephalitis. That viral episode resolved withing 1 week though, and there was about 6 weeks between recovery from that and the development of these neurologic symptoms, and I was feeling normal in between. In summary, I think there is a good chance my symptoms are from the vaccine. I am a board certified psychiatrist, and a full-time faculty member at a university.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Pruritus
Clinical narrative: Localized redness and itching; tightness of the chest;
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Mother described warmth and redness, soreness to touch at the vaccine sight; Right arm, between the shoulder and elbow.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Headache, Pain, Respiratory tract congestion
Clinical narrative: Headache, aching, 3 or 4 days later cough, congestion.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, very hot to touch, the size of a tennis ball.  I used cold compress and ibuprofen 800mg.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Headache, Myalgia, Nausea
Clinical narrative: Fever, joint and muscle pain (entire body), nausea, headache, cough; all symptoms lasted about 12 hrs. Treated with Advil.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, joint and muscle pain (entire body), nausea, headache, cough; all symptoms lasted about 12 hrs. Treated with Advil.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient received Zostavax vaccine on 9/3/14 6:15 pm, had no adverse reaction on injection site, left and went home. On 9/5/14 pt returned to phcy around 4:41 pm to fill rx for other meds and noticed the rash while talking to pharmacy tech, she then reported the rash to RPH who assess the local rash and determined that it had occurred almost 2 days later. The rash wasn't raised and didn't feel warmth to touch. Pt doesn't feel faint or lightheaded, aside from the rash, she feels fine. Rph advised pt to take Benadryl to reduce the incidence of rash or injection site reaction. No ice pack needed as there is no swelling involved. MD notified by fax about local site rash at the injection site.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt received zostavax vaccine on 9/5/14 around 12 pm, didn't have any problem encountered. RPh advised pt to remain in store for 15 minutes to observe for adverse events. Pt returned to pharmacy and reported to rph after 20 minutes that she noticed a rash around injection site, no swelling or bruising or warmth at injection site.RPh assessed the rash and determined the rash was about the size of a quarter.  Pt doesn't feel faint or lightheaded. Pt feels fine otherwise. Rph advised pt to take benadryl upon returning home to reduce incidence of local site reaction and told pt to call RPH immediately if any serious reactions should occur.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt has localzed rashed on right arm where vaccine was administered.  States it is painful and warm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: REDNESS, SWELLING, AND RASH AT INJECTION SITE. RADIATING THROUGHOUT UPPER ARM. RASH/REDNESS AND SWELLING ALL OVER UPPER ARM STILL ON 09-06-2014. PAIN PERSISTS. FEELS SMALL BUMPS AROUND SITE. MD SAW PATIENT 9-6-2014. PRESCRIBED KEFLEX 500MG.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Paraesthesia oral, Throat irritation, Throat tightness
Clinical narrative: Lips tingling, chest tightness, coarse throat.  Patient self took 1000mg of Tylenol within an hour of getting the shot. Subsequently after lunch he returned to the clinic and notified staff of his symptoms.  He was given 50mg of Benadryl PO.  VS stable and monitored on site.  Seen by provider.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Dyskinesia, Musculoskeletal stiffness, Stereotypy
Clinical narrative: Repetitive behavior including hand-flapping, arm flapping, stiffing arms, hands & upper body, wiggling fingers in front of the eyes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 3 inch area of redness (dark red spot in the middle surrounded by light pink area), swelling, itching, warmth to touch.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Activities of daily living impaired, Asthenia, Balance disorder, Cardiac stress test abnormal, Dizziness
Clinical narrative: After running a half marathon one month prior, and within days of Gardasil dose #1 (Lot #0057AA) administered on 7/19/2011, patient could not finish her daily 3 mile run due to extreme lack of ability to catch breath, fatigue, and dizziness. Needed to be rescued. # months after the vaccination, because she was still struggling to walk up a flight of stairs by mid October (approx 3 months after Gardasil dose) she had no stamina and landed in the emergency room with severe head-ache, spiked fever and racing heart rate that could not be managed. Still severe symptoms when returned home for winter break. Primary Physician referred patient for a Pulmonary Stress test early January 2012. Heart rate did not return to rest and she was admitted to the Cardiac unit. In hospital 5 days. Diagnosed with POTS and put on a beta blocker. Could not return to college for spring semester. Ongoing and new and debilitating symptoms keep appearing, with no answers.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dyspnoea, Fatigue, Headache, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: After running a half marathon one month prior, and within days of Gardasil dose #1 (Lot #0057AA) administered on 7/19/2011, patient could not finish her daily 3 mile run due to extreme lack of ability to catch breath, fatigue, and dizziness. Needed to be rescued. # months after the vaccination, because she was still struggling to walk up a flight of stairs by mid October (approx 3 months after Gardasil dose) she had no stamina and landed in the emergency room with severe head-ache, spiked fever and racing heart rate that could not be managed. Still severe symptoms when returned home for winter break. Primary Physician referred patient for a Pulmonary Stress test early January 2012. Heart rate did not return to rest and she was admitted to the Cardiac unit. In hospital 5 days. Diagnosed with POTS and put on a beta blocker. Could not return to college for spring semester. Ongoing and new and debilitating symptoms keep appearing, with no answers.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Pyrexia, Vision blurred
Clinical narrative: After running a half marathon one month prior, and within days of Gardasil dose #1 (Lot #0057AA) administered on 7/19/2011, patient could not finish her daily 3 mile run due to extreme lack of ability to catch breath, fatigue, and dizziness. Needed to be rescued. # months after the vaccination, because she was still struggling to walk up a flight of stairs by mid October (approx 3 months after Gardasil dose) she had no stamina and landed in the emergency room with severe head-ache, spiked fever and racing heart rate that could not be managed. Still severe symptoms when returned home for winter break. Primary Physician referred patient for a Pulmonary Stress test early January 2012. Heart rate did not return to rest and she was admitted to the Cardiac unit. In hospital 5 days. Diagnosed with POTS and put on a beta blocker. Could not return to college for spring semester. Ongoing and new and debilitating symptoms keep appearing, with no answers.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Pruritus, Swelling
Clinical narrative: Itchy, and swollen and red for 3 days. Dizzy spell AM of 4th day.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Sensation of pressure
Clinical narrative: The patient came in to pharmacy to claim that he had soreness at injection site with a little redness and so had pressure at raising arm.  He said he will take Advil or Tylenol to see if it will relieve.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Oropharyngeal pain, Productive cough, Rhinorrhoea, Sinus headache
Clinical narrative: Sore throat for 24 hours, then runny nose and sneezing for following 7 days, also coughing due to mucus in throat. Pressure in sinuses around eyes.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Sneezing
Clinical narrative: Sore throat for 24 hours, then runny nose and sneezing for following 7 days, also coughing due to mucus in throat. Pressure in sinuses around eyes.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Dysphagia, Lymphadenopathy, Oral mucosal erythema, Oropharyngeal pain, Rash
Clinical narrative: Throat started hurting, by Saturday morning could hardly swallow, white spots inside mouth, bright red, when to walk in clinic, which prescribed an antibiotic, which I don't think will help. Jaw and right face lymph nodes involved.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bronchiolitis, Cough, Haematochezia, Mucous stools, Stool analysis
Clinical narrative: Coughing, wheezing, blood and mucus in stool.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Wheezing
Clinical narrative: Coughing, wheezing, blood and mucus in stool.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chest discomfort, Cough, Eye discharge, Fatigue, Foreign body sensation in eyes
Clinical narrative: Throat became sore, nasal congestion, eyes felt like there was serious sand/debris in them a then quickly became goopy, chest tightened with the constant need to clear my lungs, then the onset of the cough to try and clear my lungs. Ar about 4:30 AM I felt exhausted, worn out; however, I felt significantly better.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Throat became sore, nasal congestion, eyes felt like there was serious sand/debris in them a then quickly became goopy, chest tightened with the constant need to clear my lungs, then the onset of the cough to try and clear my lungs. Ar about 4:30 AM I felt exhausted, worn out; however, I felt significantly better.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Local swelling, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blood test normal, Drug administered at inappropriate site, Feeling hot, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Injection site swelling, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS, FLUX, VARZOS, FLU3, VARZOS
Symptoms: Blister, Cellulitis, Erythema, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old female patient. The patient's concurrent condition included hypertension, fibromyalgia and allergic to tape, sulfa drug, nortriptyline and morphine. Historic condition included shingles twice. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX 1 injection (dose and lot # not reported) subcutaneous. Other suspect therapies included flu shot/influenza virus vaccine (name and manufacturer unspecified) on the same day by a pharmacist in same arm. Concomitant therapies included CYMBALTA, LYRICA, ampicillin sodium (reported as AMPOLINE), amlodipine besylate (reported as VESYLATE), benazepril hydrochloride, acetaminophen, PERCOCET, simvastatin (manufacturer unknown), PROTONIX and XANAX. The patient felt the shot was given in a strange location, very near her underarm; on the underside of her arm. On 16-AUG-2014, the patient started experiencing headache and got really hot, red and swollen at the injection site. The patient reported that the injection site had swollen to the size of an egg by the next night (17-AUG-2014) and the swelling migrated down her arm. She went to emergency room she was treated and send home. Her symptoms started to clear up. On AUG-2014, Saturday morning (date unspecified) she woke up feeling paralyzed on the right side of her face. She went back to hospital and was hospitalized overnight. She was diagnosed with Bell's Palsy. Patient was treated with valacyclovir hydrochloride for adverse events. No product quality complaint (PQC) was involved. The lab diagnostics tests included blood work which was reported to be normal. The outcome of events was unknown. The causality of was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: After administration on 8-30-14 redness, swelling, rash and warm to touch. MD prescribed KEFLEX 500mg BID x 5 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye swelling, Headache, Insomnia, Local swelling
Clinical narrative: FLUZONE HD swelling - eyes. FLUZONE HD vaccination 9-5-14 at 3:10 pm. Next day at 10:20 am (9-6-14) pt called pharmacy had reported - swollen hands, headache overnight (bad), chills, fever, up most of night. No rash - now as of 9-6-14 at 10:20am. No reaction previously.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: FLUZONE HD swelling - eyes. FLUZONE HD vaccination 9-5-14 at 3:10 pm. Next day at 10:20 am (9-6-14) pt called pharmacy had reported - swollen hands, headache overnight (bad), chills, fever, up most of night. No rash - now as of 9-6-14 at 10:20am. No reaction previously.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Muscle tightness
Clinical narrative: Patient has visible bruising and complains of muscle tightness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Hives, rash and itching all over the body.