chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 months old patient. The patient was vaccinated with VAQTA (route, dose and lot # were unknown) rather than RECOMBIVAX HB on 07-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No product confusion, just an administration error. The outcome of event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 69 years old female patient who on 09-NOV-2012 was vaccinated with a first dose of PNEUMOVAX23 intramuscular (IM) (lot number reported as H013399, expiration date: 07-MAR-2014) (dose and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that the patient developed on injection site after receiving her first vaccination with PNEUMOVAX23. She had swelling from the injection site to her elbow including her entire forearm on 11-NOV-2012. The patient was treated with BENADRYL and ice for the adverse event. The patient sought medical attention, she was seen by health care professional (HCP). At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site reaction, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 85 years old female patient who in 2006 was vaccinated with the first dose of PNEUMOVAX23 (lot number, dose, route and indication were not reported). On 08-NOV-2012, the patient was vaccinated with a second dose of PNEUMOVAX23 intramuscular (IM) (lot number reported as H013399, expiration date: 07-MAR-2014) (dose and indication were not reported). No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). The physician assistant reported that the patient developed a localized injection site reaction which was beginning on day 2 (on 10-NOV-2012) after vaccination with his second dose of PNEUMOVAX23. It started at the injection site and "drifted" down to the elbow. The patient entire forearm was red, hot, swollen and painful. The patient was treated with BENADRYL and ice for the adverse event. The patient sought medical attention, she was seen in the office. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 85 years old female patient who in 2006 was vaccinated with the first dose of PNEUMOVAX23 (lot number, dose, route and indication were not reported). On 08-NOV-2012, the patient was vaccinated with a second dose of PNEUMOVAX23 intramuscular (IM) (lot number reported as H013399, expiration date: 07-MAR-2014) (dose and indication were not reported). No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). The physician assistant reported that the patient developed a localized injection site reaction which was beginning on day 2 (on 10-NOV-2012) after vaccination with his second dose of PNEUMOVAX23. It started at the injection site and "drifted" down to the elbow. The patient entire forearm was red, hot, swollen and painful. The patient was treated with BENADRYL and ice for the adverse event. The patient sought medical attention, she was seen in the office. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a female patient with no pertinent medical history, who on 02-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Other suspect therapies included TDAP, mfr unknown (vaccinated on the same day, 02-AUG-2012). No concomitant medications were reported. it was reported that, after receiving ZOSTAVAX (in 2012), the patient developed bilateral hives on her neck, on face, legs and trunk. It was also reported that, in 2012, the patient developed bilateral arm swelling and stiffness. The patient sought a medical attention. The patient's symptoms were treated with unspecified antihistamine and steroids. At the time of the report, the patient's outcome was not recovered. The relatedness for stiffness, bilateral arm swelling and hives was unknown for ZOSTAVAX and TDAP. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of RECOMBIVAX HB (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA006714, 1211USA006715, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 13-NOV-2012, the patient was vaccinated with a single 0.65 mL subcutaneous injection of ZOSTAVAX (lot # not provided) and experienced on the same day a tightening of the throat and difficulty breathing. Unspecified treatment was given to the patient. The patient seek medical attention. The outcome of the events was unknown. The relatedness of the events with ZOSTAVAX was not provided. Additional information is not expected.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old patient of unknown gender who on 06-NOV-2012, was vaccinated with a dose of ZOSTAVAX, lot # 671074/1199AA, that expired on 25-OCT-2012 (dose and route not reported). No adverse reactions reported. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with MMR II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to MMR II. Lot # 1250Z Exp 09/29/2012. No adverse effects reported. No other information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to some patients of unknown age. The patients were vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that possibly some patients might have been vaccinated with improperly stored PNEUMOVAX 23. The vaccines were exposed to -0.5C for 2 hours. No adverse effect was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a some patients of unknown age. The patients were vaccinated with a dose of RECOMBIVAX HB (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that possibly some patients might been vaccinated with improperly stored RECOMBIVAX HB. The vaccines were exposed to -0.5C for 2 hours. No adverse effect was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with penicillin. No pertinent medical history reported. It was reported that the patient was given on 25-OCT-2012, the patient was vaccinated subcutaneously with a 0.65 mL dose ZOSTAVAX (lot # 0168AE; exp. date: 06-MAR-2013) and went to the pharmacy 1 week later (November 2012 approximately) because the injection site was red and inflamed. The patient went to the pharmacy on 14-NOV-2012 and the area was the size of a tennis ball circumference and black and bruised. No treatment was given. At the time of the report there were not any issues from it such as pain but it was still there. The patient seek medical attention, he visited the pharmacy. Concomitant therapy included 7-8 unspecified maintenance medications. The outcome of the events was unknown. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from 73 years old male patient concerning on himself with no drug reactions or allergies. On October 2012, reported as "1-2 weeks ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number, route and expiration date not provided). No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown), omeprazole, hydrochlorothiazide (manufacturer unknown), sertraline hydrochloride, finasteride (manufacturer unknown) and metoprolol. Past drug therapy included a flu shot vaccine one week before he received the ZOSTAVAX vaccine. On approximately 05-NOV-2012, "reported as noticed within the last 3 days", the patient developed pink spot with red dots in the area at his ZOSTAVAX injection site. The patient stated that as the injection site reaction began to heal, the patient noticed that he had larger spots developed on his back that were large somewhat itchy and scattered. No treatment information was given. Laboratory was performed through yearly check up. The patient did not seek medical attention. At the time of the report, the outcome of the events of pink spot with red dots in the area at his ZOSTAVAX injection site and larger spots developed on his back that are large somewhat itchy and scattered was reported as not recovered. The relatedness for pink spot with red dots in the area at his ZOSTAVAX injection site and larger spots developed on his back that are large somewhat itchy and scattered were unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: Tongue felt strange. Couldn't taste anything.  On 10/19/2012 woke up with left side of my face paralyzed.  Diagnosed with Bell's Palsy at Hospital.
Age: 1.8
Sex: F
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Baseball size welt/hive 1/4 inch away from vaccine site, getting larger as the day goes on.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Agitation, Balance disorder, Chills, Communication disorder, Disorientation
Clinical narrative: Severe itch in area, when touched upper arm hot & tender, pink blistery area surrounding shot site. All shift other RN's concerned if I was ok as halting speech & losing train of thought, increased DIFFICULTY WITH VISION, HEARING & BALANCE. We all thought I was just exhausted, forgot about shot. Became increasingly agitated & disoriented after work. Severve occipital headache WHICH INCREASED WHEN TRIED TO LIE DOWN. TIGHT MUSCLE IN ABDOMEN, RIB CAGE & COLLAR BONE, NECK & LOWER FACE. I LIVE ALONE SO NO FAMILY TO HELP & SEE WHAT WAS HAPPENING. GOT BAD CHILLS ABOUT 5AM- TEMP 95.8 FOR 2+HR. CALLED md OFFICE WHEN OPENED. UNABLE TO COMMUNICATE clearly as this point so staff thought I was crazy. I just moved to area last year & had few contacts only while going thru my infection & recovery. My PAST physician group before I relocated, knew me for years & knew I had multiple allergic reactions & reactions to vaccines throughout my life. when tried to ask 11/12 if reacting to vaccine was told- "that doesn't happen to people."
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Hearing impaired, Infection, Injection site erythema
Clinical narrative: Severe itch in area, when touched upper arm hot & tender, pink blistery area surrounding shot site. All shift other RN's concerned if I was ok as halting speech & losing train of thought, increased DIFFICULTY WITH VISION, HEARING & BALANCE. We all thought I was just exhausted, forgot about shot. Became increasingly agitated & disoriented after work. Severve occipital headache WHICH INCREASED WHEN TRIED TO LIE DOWN. TIGHT MUSCLE IN ABDOMEN, RIB CAGE & COLLAR BONE, NECK & LOWER FACE. I LIVE ALONE SO NO FAMILY TO HELP & SEE WHAT WAS HAPPENING. GOT BAD CHILLS ABOUT 5AM- TEMP 95.8 FOR 2+HR. CALLED md OFFICE WHEN OPENED. UNABLE TO COMMUNICATE clearly as this point so staff thought I was crazy. I just moved to area last year & had few contacts only while going thru my infection & recovery. My PAST physician group before I relocated, knew me for years & knew I had multiple allergic reactions & reactions to vaccines throughout my life. when tried to ask 11/12 if reacting to vaccine was told- "that doesn't happen to people."
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site pruritus, Injection site vesicles, Injection site warmth, Muscle tightness
Clinical narrative: Severe itch in area, when touched upper arm hot & tender, pink blistery area surrounding shot site. All shift other RN's concerned if I was ok as halting speech & losing train of thought, increased DIFFICULTY WITH VISION, HEARING & BALANCE. We all thought I was just exhausted, forgot about shot. Became increasingly agitated & disoriented after work. Severve occipital headache WHICH INCREASED WHEN TRIED TO LIE DOWN. TIGHT MUSCLE IN ABDOMEN, RIB CAGE & COLLAR BONE, NECK & LOWER FACE. I LIVE ALONE SO NO FAMILY TO HELP & SEE WHAT WAS HAPPENING. GOT BAD CHILLS ABOUT 5AM- TEMP 95.8 FOR 2+HR. CALLED md OFFICE WHEN OPENED. UNABLE TO COMMUNICATE clearly as this point so staff thought I was crazy. I just moved to area last year & had few contacts only while going thru my infection & recovery. My PAST physician group before I relocated, knew me for years & knew I had multiple allergic reactions & reactions to vaccines throughout my life. when tried to ask 11/12 if reacting to vaccine was told- "that doesn't happen to people."
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Speech disorder, Thinking abnormal, Visual impairment
Clinical narrative: Severe itch in area, when touched upper arm hot & tender, pink blistery area surrounding shot site. All shift other RN's concerned if I was ok as halting speech & losing train of thought, increased DIFFICULTY WITH VISION, HEARING & BALANCE. We all thought I was just exhausted, forgot about shot. Became increasingly agitated & disoriented after work. Severve occipital headache WHICH INCREASED WHEN TRIED TO LIE DOWN. TIGHT MUSCLE IN ABDOMEN, RIB CAGE & COLLAR BONE, NECK & LOWER FACE. I LIVE ALONE SO NO FAMILY TO HELP & SEE WHAT WAS HAPPENING. GOT BAD CHILLS ABOUT 5AM- TEMP 95.8 FOR 2+HR. CALLED md OFFICE WHEN OPENED. UNABLE TO COMMUNICATE clearly as this point so staff thought I was crazy. I just moved to area last year & had few contacts only while going thru my infection & recovery. My PAST physician group before I relocated, knew me for years & knew I had multiple allergic reactions & reactions to vaccines throughout my life. when tried to ask 11/12 if reacting to vaccine was told- "that doesn't happen to people."
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria...started around site of vaccine, then spread to trunk and other areas of body...Started the following morning after vaccines.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Laboratory test abnormal, Pyrexia, Typhoid fever, Vomiting
Clinical narrative: Daughter has been diagnosed with Typhoid. She has been hospitalized and is on antibiotics and fluids. Fever of 104.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain at injection site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Pt said immunization didn't hurt when administered but seemed to be given higher up on the shoulder than she normally gets shots.  Within a few hours her shoulder began hurting and is still painful to use.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypokinesia, Musculoskeletal stiffness, Pain, Sensation of heaviness
Clinical narrative: Heaviness in right side. Reduced movement in fingers on right hand. Muscular stiffness in right side. Feeling numb on side of injection. Getting sore after very little physical activity. It's been 17 days since injection of Gardasil. Movements getting harder each day.
Age: 1.28
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Activated partial thromboplastin time normal, Band neutrophil percentage increased, Blood culture negative, C-reactive protein increased, Erythema multiforme
Clinical narrative: Child developed a serum-sickness like reaction on 10/22/2012. Started as hives, then rapidly progressed to swollen knees, refusal to walk. Hands and feet swollen the following day. Child miserable. Rash progressed to erythema multiforme with classic coalescing target lesions covering 50% of her body surface area. See by ER and Rheumatology. Labs drawn with CRP 69. Started on prednisone, 1mg/kg x 10 days, then tapered. Rash worse on 10/23/2012, with dusky centers of the lesions. Seen by burn/plastics. Concerned that she could progress to Stevens-Johnson and need skin grafting, but marked improvement by 10/25 on steroids. OF NOTE, child first noticed to have a "sentinel hive" on her left thigh, the site of two immunizations given on 10/8/2012 (influenza and Hep A). Serum sickness, when caused by an injectable protein based drug, is known to produce this sentinel hive prior to the full body rash. (She also received a varicella vaccine the same day, but in the opposite leg). Seen by allergy in follow-up, believes influenza vaccine potentially to blame. Please note, mother of child is a physician (hence the vocabulary used in this report).
Age: 1.28
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Feeling abnormal, Gait disturbance, Injection site joint swelling, Injection site urticaria, Liver function test normal
Clinical narrative: Child developed a serum-sickness like reaction on 10/22/2012. Started as hives, then rapidly progressed to swollen knees, refusal to walk. Hands and feet swollen the following day. Child miserable. Rash progressed to erythema multiforme with classic coalescing target lesions covering 50% of her body surface area. See by ER and Rheumatology. Labs drawn with CRP 69. Started on prednisone, 1mg/kg x 10 days, then tapered. Rash worse on 10/23/2012, with dusky centers of the lesions. Seen by burn/plastics. Concerned that she could progress to Stevens-Johnson and need skin grafting, but marked improvement by 10/25 on steroids. OF NOTE, child first noticed to have a "sentinel hive" on her left thigh, the site of two immunizations given on 10/8/2012 (influenza and Hep A). Serum sickness, when caused by an injectable protein based drug, is known to produce this sentinel hive prior to the full body rash. (She also received a varicella vaccine the same day, but in the opposite leg). Seen by allergy in follow-up, believes influenza vaccine potentially to blame. Please note, mother of child is a physician (hence the vocabulary used in this report).
Age: 1.28
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Metabolic function test normal, Oedema peripheral, Prothrombin time normal, Rash generalised, Red blood cell sedimentation rate increased
Clinical narrative: Child developed a serum-sickness like reaction on 10/22/2012. Started as hives, then rapidly progressed to swollen knees, refusal to walk. Hands and feet swollen the following day. Child miserable. Rash progressed to erythema multiforme with classic coalescing target lesions covering 50% of her body surface area. See by ER and Rheumatology. Labs drawn with CRP 69. Started on prednisone, 1mg/kg x 10 days, then tapered. Rash worse on 10/23/2012, with dusky centers of the lesions. Seen by burn/plastics. Concerned that she could progress to Stevens-Johnson and need skin grafting, but marked improvement by 10/25 on steroids. OF NOTE, child first noticed to have a "sentinel hive" on her left thigh, the site of two immunizations given on 10/8/2012 (influenza and Hep A). Serum sickness, when caused by an injectable protein based drug, is known to produce this sentinel hive prior to the full body rash. (She also received a varicella vaccine the same day, but in the opposite leg). Seen by allergy in follow-up, believes influenza vaccine potentially to blame. Please note, mother of child is a physician (hence the vocabulary used in this report).
Age: 1.28
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Serum sickness-like reaction, Skin lesion, Urticaria, White blood cell count increased
Clinical narrative: Child developed a serum-sickness like reaction on 10/22/2012. Started as hives, then rapidly progressed to swollen knees, refusal to walk. Hands and feet swollen the following day. Child miserable. Rash progressed to erythema multiforme with classic coalescing target lesions covering 50% of her body surface area. See by ER and Rheumatology. Labs drawn with CRP 69. Started on prednisone, 1mg/kg x 10 days, then tapered. Rash worse on 10/23/2012, with dusky centers of the lesions. Seen by burn/plastics. Concerned that she could progress to Stevens-Johnson and need skin grafting, but marked improvement by 10/25 on steroids. OF NOTE, child first noticed to have a "sentinel hive" on her left thigh, the site of two immunizations given on 10/8/2012 (influenza and Hep A). Serum sickness, when caused by an injectable protein based drug, is known to produce this sentinel hive prior to the full body rash. (She also received a varicella vaccine the same day, but in the opposite leg). Seen by allergy in follow-up, believes influenza vaccine potentially to blame. Please note, mother of child is a physician (hence the vocabulary used in this report).
Age: 1.61
Sex: M
Vaccine: DTAP, FLUX, IPV, PPV, VARCEL
Symptoms: Irritability, Pruritus, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: The rash started just around his neck as little bumps and with in 45 minutes the rash went from just his neck to all around his chest, arms and back. From there it got worse and became almost like little donuts. He was itching and very irritable and started running a fever. We called the on call doctor and they said take Benadryl. The next morning we took him to the Doctors office where the Rash was even more red and spread even more around his body. They said take Zyrtec. We got home and by 3:00 we took him back to the Doctor because he was getting worse and starting to swell. They sent us home and said just watch him. By that night he was running a fever of 102 and the rash was making his body swollen, his feet were purple and swollen and his face was swollen. The rash at this point had taken over his legs, chest, arms and back along with his face and in his hair. We went to the ER around 9:30 and he got a steroid shot and we came home around 1 am. Went to the Doctor again today around 12pm and they gave us Ranitidine and Prednisolone. He is still a little swollen but the rash is slowly calming down.
Age: 1.61
Sex: M
Vaccine: DTAP, FLUX, IPV, PPV, VARCEL
Symptoms: Skin discolouration, Swelling, Swelling face
Clinical narrative: The rash started just around his neck as little bumps and with in 45 minutes the rash went from just his neck to all around his chest, arms and back. From there it got worse and became almost like little donuts. He was itching and very irritable and started running a fever. We called the on call doctor and they said take Benadryl. The next morning we took him to the Doctors office where the Rash was even more red and spread even more around his body. They said take Zyrtec. We got home and by 3:00 we took him back to the Doctor because he was getting worse and starting to swell. They sent us home and said just watch him. By that night he was running a fever of 102 and the rash was making his body swollen, his feet were purple and swollen and his face was swollen. The rash at this point had taken over his legs, chest, arms and back along with his face and in his hair. We went to the ER around 9:30 and he got a steroid shot and we came home around 1 am. Went to the Doctor again today around 12pm and they gave us Ranitidine and Prednisolone. He is still a little swollen but the rash is slowly calming down.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot to the touch area around injection site.  Large part of upper arm affected.  Sore and tender.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately following administration, patient's eyes rolled backward, slumped in chair, and began convulsing. About 20 seconds later, she regained consciousness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: He had a bad fever upon waking on 11/16/2012 AND his arm where he was injected was VERY hot to the touch. I assumed it would go away, but its still hot, minus the fever now. I believe he ALSO had a seizure and fever after one of his other shots he got when he was 2 yrs old & took an ambulance ride to the E.R..although I never reported THAT incident. I will be taking him to the E.R today to have his arm looked at for the shot he got 2 days ago.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Throat irritation
Clinical narrative: Patient had trouble swallowing and itchy throat but was fine after 2 hours.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Convulsion, Laboratory test normal, Nuclear magnetic resonance imaging normal, Unresponsive to stimuli, X-ray normal
Clinical narrative: Patient went into seizures, following a typical toddler stumble and then became completely unresponsive. Emergency services were then called. Paramedics to him to nearest hospital where they performed test and administered drugs before being flown to another Hospital to provide proper care for the patient.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Blood pressure increased, Dyspnoea, Headache
Clinical narrative: 1:45 PM Headache, 3:00 burning skin, redness at injection site, headache much worse, 3:30 Skin on fire, back beginning to ache, right shoulder, right arm, neck and back burning tingling, 3:40 seen by RN who states "you're having a reaction" elevated BP and temp. 4:30 taken to ER. Fever, rash, elevated BP 154/81, temp 99.1 (normal 96.5-97) red-irritated blotches on legs, knees, arms, back, chest, neck and face. Headache, shaky, weak. Itching, burning. 6 PM nausea, headache worse, severe pain and burning like I am on fire. 9 PM trouble breathing, throat closing up, swelling, itching all over my body, temp 99.7. Scared!
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Nervousness, Paraesthesia, Pruritus generalised, Pyrexia
Clinical narrative: 1:45 PM Headache, 3:00 burning skin, redness at injection site, headache much worse, 3:30 Skin on fire, back beginning to ache, right shoulder, right arm, neck and back burning tingling, 3:40 seen by RN who states "you're having a reaction" elevated BP and temp. 4:30 taken to ER. Fever, rash, elevated BP 154/81, temp 99.1 (normal 96.5-97) red-irritated blotches on legs, knees, arms, back, chest, neck and face. Headache, shaky, weak. Itching, burning. 6 PM nausea, headache worse, severe pain and burning like I am on fire. 9 PM trouble breathing, throat closing up, swelling, itching all over my body, temp 99.7. Scared!
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular, Skin burning sensation, Swelling, Throat tightness
Clinical narrative: 1:45 PM Headache, 3:00 burning skin, redness at injection site, headache much worse, 3:30 Skin on fire, back beginning to ache, right shoulder, right arm, neck and back burning tingling, 3:40 seen by RN who states "you're having a reaction" elevated BP and temp. 4:30 taken to ER. Fever, rash, elevated BP 154/81, temp 99.1 (normal 96.5-97) red-irritated blotches on legs, knees, arms, back, chest, neck and face. Headache, shaky, weak. Itching, burning. 6 PM nausea, headache worse, severe pain and burning like I am on fire. 9 PM trouble breathing, throat closing up, swelling, itching all over my body, temp 99.7. Scared!
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
Clinical narrative: Miscarriage, fetus stopped developing at time of immunization. No previous history of miscarriage. At the time, 1 living child; 15 mos.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Joint crepitation, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme pain in shoulder more than arm increasing over next few days. Cracking and clicking of shoulder with pain over following weeks with some tingling and numbness in my hand and finger. Overall: significant pain and limited range of motion from day 1 until now.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Extreme pain in shoulder more than arm increasing over next few days. Cracking and clicking of shoulder with pain over following weeks with some tingling and numbness in my hand and finger. Overall: significant pain and limited range of motion from day 1 until now.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Muscular weakness, Pyrexia, Tremor
Clinical narrative: Three hours after vaccination, pt reported pain on upper right arm especially when she tried to move it, and small fever the day after. Followup a week later: pain bearable, hand shakes (right arm) when trying to move, no swelling, muscle weakness - Guillain-Barre like syndrome; was given pain medication & muscle relaxant in urgent care.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, itchiness and very warm at injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 65 year old female consumer reporting on herself with drug reaction or allergies to MOTRIN, allergies (unspecified) and high blood pressure. On 05-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, 1 time vaccine, subcutaneously (dose, lot number not reported). No other co-suspects were reported. Concomitant medications included metoprolol tartrate 25 (unit not reported) 2 times daily, CRESTOR, PROTONIX, "Virtec" for allergy and fluticasone propionate. On 05-NOV-2012, since the vaccination was given the patient experienced following side effects: headaches, redness at the injection site on her left arm, swelling, a lump and pain at the injection site. No treatment was given for the adverse events. The patient had not seen a physician. At the time of the report the patient's outcome was unknown. The relatedness for the adverse events was not reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was inadvertently vaccinated with an expired lot (669379/0453AA, exp 03-AUG-2012), 0.5 ml PNEUMOVAX on 11-NOV-2012 (site of administration not reported). No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unknown number of patients of unknown age and gender. On an unknown date, the patients received improperly stored VAQTA (lot#, dose and route not reported). No concomitant medications were reported. The vaccines were exposed at 11 degree centigrade(C) for 96 hours. No adverse effects were reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal X-ray, Arthralgia, Asthenia, Blood test abnormal, Exocrine pancreatic function test abnormal
Clinical narrative: STARTED FEELING WEAK AND WITH JOINT SORENESS IN BOTH ARMS GOT STOMACH FLU SYMPTOMS AND THEN FLU SYMPTOMS.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Gastroenteritis viral, Influenza, Ultrasound abdomen
Clinical narrative: STARTED FEELING WEAK AND WITH JOINT SORENESS IN BOTH ARMS GOT STOMACH FLU SYMPTOMS AND THEN FLU SYMPTOMS.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Began noticing extreme soreness first. Then below the injections redness started first in a couple spots, then enlarged. Afternoon progressed to chills and fever and aches throughout my body. I ended up in bed for most of the next 48 hours. Finally now the evening of 11/17/12 I'm feeling better, though my arm is still very sore. I've taken Theraflu, Nyquil, Aleve, Aspirin, Flexeril...
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Began noticing extreme soreness first. Then below the injections redness started first in a couple spots, then enlarged. Afternoon progressed to chills and fever and aches throughout my body. I ended up in bed for most of the next 48 hours. Finally now the evening of 11/17/12 I'm feeling better, though my arm is still very sore. I've taken Theraflu, Nyquil, Aleve, Aspirin, Flexeril...
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Low grade fever turning into sore throat lasted until 11/11/2012. Chest congestion, cough, nasal drainage 11/12/2012 through current.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Condition aggravated, Malaise, Migraine, Myalgia
Clinical narrative: Migraine headache, neck muscles sore, upset stomach, malaise lasting through night into next day.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever (102 by 10:30 AM up to 104 by 11:30 AM).  Patient vomited at 3:00 PM.  Administered Tylenol and was able to reduce fever.  Fever returns to as high as 104 when medicine wears off and he has vomited 3 times between 11/15/2012 and this morning 11/18/2012. He has not fully recovered yet.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site nodule, Injection site pruritus
Clinical narrative: Patient states she has had a nodule at the injection site accompanied by itching that stretches all the way down into her fingertips since a few hours after injection. She first notified the pharmacy of the continuing irritation on 11/17/12.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Woke up in AM with sore/red spot at injection site, throughout the day pain escalated, along with headache. Took Ibuprofen. Following morning (11/16/2012) whole upper arm was very painful and sore, redness had spread to whole upper arm. Also experienced low grade fever, and nausea, and headache.  Visit to Doctor to rule out infection. Redness continued to spread down arm for a few days, as pain diminished.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Non specific skin rash appeared on lower back then spread to arms over the course of the day. No other signs or symptoms were reported. Pt went to an urgent care facility where she recieved a prescription for a Medrol dose pack.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Dyspnoea, Eyelid oedema, Hypersensitivity, Rash generalised
Clinical narrative: I am a 51 yr old healthy female who on Aug 22 went in for a checkup. Dr suggested getting the Pneumococcal Vaccine. Because I had received many vaccine's while in the military and never had any reaction, I agreed. Later that morning I developed a rash on my wrists and back of neck. By that evening the rash had spread up my arms, neck, chest, back and face. All rash areas were hot and swollen; my eyes nearly shut. Aug 23 went back to Dr who put me on steroid pack, Benadryl and triamcinolone acetonide cream. Aug 25 the rash and swelling had not gotten any better and I was having breathing problems which landed me in the E.R. (transferred from Urgent Care due to the severity). E.R. administered three breathing treatments and two doses of epinephrine. Back to the Dr on Sept. 1 due to continued breathing issues, so he prescribed and inhaler and steroids. Two weeks to clear up, as well as two weeks of missed work. Nov.13 rash returned on my wrists, back of hands and neck. Next morning the rash was up my arms, neck, and face with swelling  same as the August experience, just not as severe and no breathing problems. There has been no change in meds or eating habits. Now it's been 4 days, I'm back on a steroids pack, Benadryl, cream but not getting better (but not worse so that's a positive). Wondering if since this vaccine is in my system, is this something that is going to happen to me again and if so, for how long.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: I am a 51 yr old healthy female who on Aug 22 went in for a checkup. Dr suggested getting the Pneumococcal Vaccine. Because I had received many vaccine's while in the military and never had any reaction, I agreed. Later that morning I developed a rash on my wrists and back of neck. By that evening the rash had spread up my arms, neck, chest, back and face. All rash areas were hot and swollen; my eyes nearly shut. Aug 23 went back to Dr who put me on steroid pack, Benadryl and triamcinolone acetonide cream. Aug 25 the rash and swelling had not gotten any better and I was having breathing problems which landed me in the E.R. (transferred from Urgent Care due to the severity). E.R. administered three breathing treatments and two doses of epinephrine. Back to the Dr on Sept. 1 due to continued breathing issues, so he prescribed and inhaler and steroids. Two weeks to clear up, as well as two weeks of missed work. Nov.13 rash returned on my wrists, back of hands and neck. Next morning the rash was up my arms, neck, and face with swelling  same as the August experience, just not as severe and no breathing problems. There has been no change in meds or eating habits. Now it's been 4 days, I'm back on a steroids pack, Benadryl, cream but not getting better (but not worse so that's a positive). Wondering if since this vaccine is in my system, is this something that is going to happen to me again and if so, for how long.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Decreased appetite, Erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: Fluzone ID given in right arm; Zostavax given in Left arm; 11/16/12, both arms hurt and left arm appeared red and left arm is still currently red; 11/17/12 pt had whole body aches and ate very little; 11/18/12 patient has been on couch all day with whole body aches and been sleepy and not eating; patient's wife says he feels warm but fever is unknown; patient wife said she has given him aleve (all per wife on 11/18/12 at 3:25pm); told wife that if she felt this was an emergency to take him to the ER and then to follow up with primary MD.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Somnolence
Clinical narrative: Fluzone ID given in right arm; Zostavax given in Left arm; 11/16/12, both arms hurt and left arm appeared red and left arm is still currently red; 11/17/12 pt had whole body aches and ate very little; 11/18/12 patient has been on couch all day with whole body aches and been sleepy and not eating; patient's wife says he feels warm but fever is unknown; patient wife said she has given him aleve (all per wife on 11/18/12 at 3:25pm); told wife that if she felt this was an emergency to take him to the ER and then to follow up with primary MD.
Age: 27.0
Sex: M
Vaccine: TTOX
Symptoms: Diarrhoea
Clinical narrative: Donor c/o diarrhea for two days, stating the day after he received immunization.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Ankle fracture, Fibula fracture, Flushing, Influenza like illness, Nausea
Clinical narrative: No sickness prior. At 6 PM chest congestion. At 9 PM felt like I had the flu. Got up at 3 AM to get med to help, felt very nauseated and flushed. I fainted resulting in a broken ankle needing surgery with plate and 6 screws.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Surgery, Syncope, Upper respiratory tract congestion, X-ray limb abnormal
Clinical narrative: No sickness prior. At 6 PM chest congestion. At 9 PM felt like I had the flu. Got up at 3 AM to get med to help, felt very nauseated and flushed. I fainted resulting in a broken ankle needing surgery with plate and 6 screws.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Chills, Pallor, Pyrexia, Vomiting
Clinical narrative: Chest Pain, Paleness, Fever Chills, Vomiting.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Muscle aches in chest, some difficulty breathing, progressed next day to fatigue, fever, weakness, diarrhea, loss of appetite for 48 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches in chest, some difficulty breathing, progressed next day to fatigue, fever, weakness, diarrhea, loss of appetite for 48 hours.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pruritus
Clinical narrative: I received the new interdermal flu shot 2 days ago and tonight my stomach and back felt a little bit itchy, then my arm where the vaccine was started itching fiercely and hurting. It has been 2 full days since I received my shot, so I thought this seemed unusual and unpleasant. My body still feels itchy.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Flatulence, Pruritus generalised, Vomiting
Clinical narrative: Itching all over body.  Increased abdominal pain. Increased gas/loose stool/emesis. Lasted 5 days.  Unable to keep any food down for five days. Itching continues to occur.
Age: 0.44
Sex: M
Vaccine: FLUX
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red rash developed mid-morning.  Spread from chest to neck, face and back by evening.  No treatment needed, no fever or other symptoms found.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pruritus
Clinical narrative: Feel nauseous, sick to my stomach, chills, feverish, headache, itchiness.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Feel nauseous, sick to my stomach, chills, feverish, headache, itchiness.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Swelling of Lt. upper arm with redness moving from injection site down arm, several inches below elbow. Painful, hot, red, shiny, fever and malaise. Required antibiotics (KEFLEX).
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pyrexia
Clinical narrative: Swelling of Lt. upper arm with redness moving from injection site down arm, several inches below elbow. Painful, hot, red, shiny, fever and malaise. Required antibiotics (KEFLEX).
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Headache, Musculoskeletal pain, Syncope
Clinical narrative: Patient was given vaccination & about 5 mins later she fainted. She fell backwards & hit her bottom & her head on the ground. She came to in a few seconds, but left the pharmacy 20 mins later & her head hurt. The next day she complained of a sore rear & intermittent headaches.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Nausea, Oedema peripheral
Clinical narrative: Developed cellulitis in left upper arm from site of injection to below elbow. Required antibiotics. Arm swollen, red moving down arm, hot, painful, fever, nausea, achiness.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Developed cellulitis in left upper arm from site of injection to below elbow. Required antibiotics. Arm swollen, red moving down arm, hot, painful, fever, nausea, achiness.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Severe vomiting all night after receiving immunization (FLUZONE HD) on 11-16-12.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Joint effusion, Nuclear magnetic resonance imaging abnormal, Pain in extremity, X-ray abnormal
Clinical narrative: Soreness in arm after 1 week. Saw MD and was given MEDROL DOSE PAK (8/30/120. Didn't help. Got MRI and X-ray within the course of 2 months. Found "pockets of fluid" in the joint. He had a procedure called "antibiotic flush" on 10/11/12 and given oral antibiotics for 1 week. Pt. to follow up w/ MD.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, tenderness, swelling at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 71 years old female patient. On 08-NOV-2012 the patient was vaccinated subcutaneously with a single 0.65 dose of ZOSTAVAX (lot # reported as 0366AE, exp. Date: 23-MAR-2013) for prevention of shingles. Concomitant medications included eye drops, famotidine, CELEXA, hydralazine, clonidine, SETAZINE, NOVOLOG, furosemide and VENTOLIN INHALER. On 12-NOV-2012 the patient experienced fever and redness at the injection site. The outcome of the events were unknown. Additional information is not expected.