chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Muscle spasms
Clinical narrative: Patient began having muscle spasms in back and chest, became unable to walk.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Initially, erythema at injection site, then clear filled vesicles (blisters) that eventually broke open & healed. Advised to treat with OTC Claritin & Advil by physician.
Age: 55.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The patient was outside of the age range for this vaccine.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Body aches, soreness and stiffness.
Age: 1.07
Sex: F
Vaccine: DTAP, FLU3, HEP, HEPA, HIBV, MMR, VARCEL
Symptoms: Fatigue
Clinical narrative: No adverse event noted yet except tiredness. When I called to tell them that they administered the 3rd flu shot (I was not at the appt) they could not tell me what adverse effects she may experience from a 3rd dose of the vaccine.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea
Clinical narrative: Started to feel as if I were getting a little car sick (I was a passenger at the time.) Then the nausea kept getting worse and about 10 minutes after I felt it coming on, I felt so much worse. Laid down and after about 5 minutes I felt a lot better. Then an hour later I sat back up and almost immediately felt sick again. So I laid back down for the rest of the night and felt much better. Never had a reaction to flu shot before and I get them every year. Called pharmacists where it was given but they said nausea isn't a symptom. Then looked on CDC website where I saw that it is a possible reaction. It sucked.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Injection site warmth, Skin burning sensation
Clinical narrative: "Face, neck, chest, shoulders flushed and hot".  Pt took Zyrtec and Advil at home evening of 10/16/13 and used ice packs to sites. She states she "felt some better the next morning but after a hot shower the symptoms got worse extending bilat arms to wrists". Pt. states it felt like a "bad sunburn" and like her skin was "on fire".
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Nausea, Pain
Clinical narrative: Body ache and stomach ache. Nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site started sometime within 24 hours. Exact time not known. Symptoms still present after 80 hours.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: Last night, as our son was getting ready for a shower, we noticed red splotches (about the size of a coin) on his back and one on his neck. I wondered if they could be related to the vaccine. My husband thought more likely from playing outside. Today, as he got ready for a shower (after 9 PM), he had a huge raised welt, all across his lower back. It was itchy, he said. We gave him Benadryl (1.5 teaspoons), and we plan to call our doctor tomorrow morning. (Saturday.) We didn't call about the splotches yesterday.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Blood creatinine normal, Blood urine present, C-reactive protein increased, Duodenal ulcer
Clinical narrative: Acute diffuse abdominal pain and nausea/vomiting. These GI sx continued for 2 full weeks until she developed palpable purpura and petechiae to the lower extremities suggestive of HSP. Earlier in the illness (around illness day #8) she had several days of self-limited petechiae that did not recur until illness day #14. Presence of this skin lesions along with diffuse abdominal pain favors a dx of HSP.  Once HSP was diagnosed, she was treated with supportive care.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Endoscopy gastrointestinal abnormal, Gastrointestinal erosion, Haematocrit decreased, Haematuria, Haemoglobin decreased
Clinical narrative: Acute diffuse abdominal pain and nausea/vomiting. These GI sx continued for 2 full weeks until she developed palpable purpura and petechiae to the lower extremities suggestive of HSP. Earlier in the illness (around illness day #8) she had several days of self-limited petechiae that did not recur until illness day #14. Presence of this skin lesions along with diffuse abdominal pain favors a dx of HSP.  Once HSP was diagnosed, she was treated with supportive care.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Henoch-Schonlein purpura, Nausea, Oesophagogastroduodenoscopy abnormal, Palpable purpura, Petechiae
Clinical narrative: Acute diffuse abdominal pain and nausea/vomiting. These GI sx continued for 2 full weeks until she developed palpable purpura and petechiae to the lower extremities suggestive of HSP. Earlier in the illness (around illness day #8) she had several days of self-limited petechiae that did not recur until illness day #14. Presence of this skin lesions along with diffuse abdominal pain favors a dx of HSP.  Once HSP was diagnosed, she was treated with supportive care.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Platelet count increased, Protein urine present, Vomiting, White blood cell count increased
Clinical narrative: Acute diffuse abdominal pain and nausea/vomiting. These GI sx continued for 2 full weeks until she developed palpable purpura and petechiae to the lower extremities suggestive of HSP. Earlier in the illness (around illness day #8) she had several days of self-limited petechiae that did not recur until illness day #14. Presence of this skin lesions along with diffuse abdominal pain favors a dx of HSP.  Once HSP was diagnosed, she was treated with supportive care.
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash, Injection site erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: Red round rash at administration site, itchiness to site, get itchiness all over body but only rash at administration site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Cough, Dysphonia, Fatigue
Clinical narrative: Awoke w/ throat discomfort which quickly turned to several flu-type symptoms: muscle ache and weakness, tightness in chest, fever, fatigue, general weakness, brief headache and brief itchy rash.  Except for headache and rash, the symptoms were significant for 2 days, lessening on 3rd day, however then dry cough and hoarseness started and persisted for 10 days, accompanied by some nasal discharge.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia, Rash pruritic
Clinical narrative: Awoke w/ throat discomfort which quickly turned to several flu-type symptoms: muscle ache and weakness, tightness in chest, fever, fatigue, general weakness, brief headache and brief itchy rash.  Except for headache and rash, the symptoms were significant for 2 days, lessening on 3rd day, however then dry cough and hoarseness started and persisted for 10 days, accompanied by some nasal discharge.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: Awoke w/ throat discomfort which quickly turned to several flu-type symptoms: muscle ache and weakness, tightness in chest, fever, fatigue, general weakness, brief headache and brief itchy rash.  Except for headache and rash, the symptoms were significant for 2 days, lessening on 3rd day, however then dry cough and hoarseness started and persisted for 10 days, accompanied by some nasal discharge.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Severe hives, severe itching, swelling and redness at injection site. Joint pain. Ongoing progressive symptoms even after ten days.
Sex: U
Vaccine: PPV
Symptoms: Activities of daily living impaired, Erythema, Malaise, Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number patients of unknown age and gender. Medical assistant reported that an unspecified number patients received an unspecified pneumococcal vaccine (dose, route and lot number were not reported) about one to two weeks ago, in approximately September 2013. Medical assistant reported that about fifty percent of those who received the pneumococcal vaccine had been "coming down sick". Medical assistant reported that these patients had also experienced "slowing of the arm" with a "red streak" down the arm (in 2013). She also stated that these patients were in enough pain that they missed one day of work (in 2013). The outcome of coming down sick, patients were in enough pain that they missed one day of work, red streak down the arm and slowing of the arm was not reported. The relationship between the unspecified pneumococcal vaccine and the events was not reported. Upon internal review patients missed one day of work was considered to be a disabling event. This case is linked to case 1310USA008712 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Erythema, Malaise, Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to her husband, a male patient of unknown age. Medical assistant reported that her husband received an unspecified pneumococcal vaccine (dose, route and lot number were not reported) about one to two weeks ago, in approximately September 2013. Medical assistant reported that the patient "coming down sick", and he also experienced "slowing of the arm" with a "red streak" down the arm (in 2013). She also stated that the patient was in enough pain that he missed one day of work (in 2013). The outcome of coming down sick, patient was in enough pain that he missed one day of work, red streak down the arm and slowing of the arm was not reported. The relationship between the unspecified pneumococcal vaccine and the events was not reported. Upon internal review patient missed one day of work was considered to be a disabling event. This case is linked to case 1310USA004288 via same reporter link. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: International normalised ratio increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of international normalized ratio increased in a male subject of unspecified age who was vaccinated with FLULAVAL. Concurrent medications included Warfarin. The nurse documented that reactions experienced with previous flu shots as "last year was Sanofi." It was unclear from the report what this statement meant. On an unspecified date (s) the subject received a dose of FLULAVAL (.5 ml, unknown details). The nurse documented "about 5 men" received FLULAVAL and provided the following as dates of administration: 1 October 2013, 3 October 2013 and August 2013. It was unclear from the report which date the subject received his vaccination. See details for other subjects in case A1045974A. In 2013, at an unspecified time after vaccination with FLULAVAL, the subject experienced international normalized ratio increased. The healthcare professional considered the event was clinically significant (or requiring intervention). The nurse stated that this subject's "event may have been life-threatening if he did not get the proper treatment." Relevant test results included international normalized ratio level taken in 2013 and the result was 11. The subject was treated with vitamin K. At the time of reporting the event was unresolved. The nurse reported another case with FLULAVAL. See case A1045974A for details on the other case.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Immune system disorder, Lymphadenopathy, Pain, Rash erythematous
Clinical narrative: This case was reported by a healthcare professional (nurse, also subject) and described the occurrence of red rash on neck in a 32-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 8 October 2013 at 12:00 the subject received a dose of Influenza vaccine unspecified (unknown details). The subject knows that she received a prefilled syringe of GSK influenza vaccine but "could not confirm which formulation." On 8 October 2013, 9 hours after vaccination with Influenza vaccine unspecified, the subject experienced red rash on neck, skin pustules, swelling of rash areas. The subject described the reaction as "rash on neck in the form of pustules which are red and swollen" and "painful rash". On the same day as vaccination with influenza vaccine unspecified, the subject experienced weak immune system. On 9 October 2013 at 16:00, 1 day after vaccination with influenza vaccine unspecified, the subject experienced lymph node swelling. On the afternoon of 10 October 2013, the subject experienced shingles. The subject was diagnosed with shingles on 10 October 2013. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with hydrocortisone ointment and Valacyclovir. The subject stated that the "hydrocortisone ointment did not help and is now using valacyclovir." At the time of reporting the events of shingles, red rash on neck, skin pustules, swelling of rash areas (and painful rash) were worse. AT the time of reporting, the event of lymph node swelling was unresolved and the event of weak immune system was unknown. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine unspecified.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pustular, Swelling
Clinical narrative: This case was reported by a healthcare professional (nurse, also subject) and described the occurrence of red rash on neck in a 32-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 8 October 2013 at 12:00 the subject received a dose of Influenza vaccine unspecified (unknown details). The subject knows that she received a prefilled syringe of GSK influenza vaccine but "could not confirm which formulation." On 8 October 2013, 9 hours after vaccination with Influenza vaccine unspecified, the subject experienced red rash on neck, skin pustules, swelling of rash areas. The subject described the reaction as "rash on neck in the form of pustules which are red and swollen" and "painful rash". On the same day as vaccination with influenza vaccine unspecified, the subject experienced weak immune system. On 9 October 2013 at 16:00, 1 day after vaccination with influenza vaccine unspecified, the subject experienced lymph node swelling. On the afternoon of 10 October 2013, the subject experienced shingles. The subject was diagnosed with shingles on 10 October 2013. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with hydrocortisone ointment and Valacyclovir. The subject stated that the "hydrocortisone ointment did not help and is now using valacyclovir." At the time of reporting the events of shingles, red rash on neck, skin pustules, swelling of rash areas (and painful rash) were worse. AT the time of reporting, the event of lymph node swelling was unresolved and the event of weak immune system was unknown. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope, Tonic clonic movements
Clinical narrative: This case was reported by a physician and described the occurrence of syncope in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, approximately 2 weeks after vaccination with FLULAVAL, the subject experienced syncope and tonic-clonic activity. In 2013, within months of vaccination with FLULAVAL, the subject experienced loss of consciousness. The subject is currently hospitalized. No further details were reported. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The physician reported another case with FLULAVAL. See case A1045807A for details on the other case.
Sex: U
Vaccine: FLU3
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This case was reported by a physician and described the occurrence of tonic-clonic activity in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced tonic-clonic activity and syncope. No further details were reported. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The physician reported another case with FLULAVAL. See case A1045820A for details on the other case.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient called pharmacy on 10/17/13 stating that she couldn't move her arm at night after administration stated difficulty turning on bed. In the morning had severe pain shoulder to elbow. On 10/18/13 spoke w/t patient -> now a little better, but unable to move with ease. Also pain in injection site, no swelling.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling of body temperature change, Flushing
Clinical narrative: After 30 min of getting rhe vaccination patient reported  L arm/L sequela/L cheek/ L lower limb flushing and so far as alternating between hot and cold. No SOB. Went to ED left AMA. Took Benadryl at gh's and sx were subsided. No weakness.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills
Clinical narrative: Patient experienced chills and chest pain. Went to bed and slept from 4pm to 12:30am woke up feeling better. Patient contacted doctor, but did not go into clinic or hospital.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Disease prodromal stage, Papule, Rash, Skin lesion
Clinical narrative: Prodrome 1 week ago with a few scattered lesions. Multiple lesions today with varied papules at different stages of healing. P. course and rash discussed, RTC prn.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Severe pain in injected arm starting 5 hrs after pneumococcal vaccination in same arm, tingling fingers same extremity no localized redness.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported injection site reaction (pain, erythema, swelling). Swelling has since decreased.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, swelling, fever, pain at injection site. Diarrhea and vomiting.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Rash, swelling, fever, pain at injection site. Diarrhea and vomiting.
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Contusion, Pain
Clinical narrative: ZOSTAVAX was given on 10/10/13. She came back to the pharmacy today 10/18/13 complaining of bruising. I remember when I gave it to her, she claims to be painful. I advised her to take MOTRIN and apply cold compress.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Glassy eyes, Immediate post-injection reaction, Urticaria
Clinical narrative: Almost immediate "glazing" of eyes. Coughing attack within 40 minutes and hives noticed widespread by 1 1/2-2 hours later.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Chills, nausea and vomiting, painful, red, raised around injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Chills, nausea and vomiting, painful, red, raised around injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise, Oropharyngeal pain
Clinical narrative: No fever, heavy duty cough, sore throat, malaise. Had flu shot Wednesday. Pt saw MD on Saturday: MD prescribed antibiotic and MUCINEX.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Localized erythema/induration; suspected cellulitis 2d. after vaccine administration. Rx'd PO Abx and f/u arranged.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt came down with chicken pox.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Over body itchy rash, but mainly on thighs, legs and ankles. Taking BENADRYL. Now beginning to recede (10/19). Took many flu shots previously, but never the High Dose. Never had a reaction of any note.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dyspepsia, Nausea
Clinical narrative: Patient reported severe nausea 2 hours after vaccine was administered. She said it also felt like her stomach was burning. Pt said she has hx of IBS and acid reflux. She said she had no appetite. I called her 24 hours later and she said things had improved but still slightly nauseated.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Throat tightness
Clinical narrative: After administering the vaccine (Pneumovax) she turned red and started complaining of throat constriction and breathing problems. - Treatment - Epi pen.
Age: 51.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Headache, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Full body rash, itching (small red bumps). Headache all day (6 on scale of 10) still gets them. Started 1 week after vaccination. Note: vaccine given 9/17/13 at pharmacy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site rash
Clinical narrative: Pt developed big red rash around the vaccination site. Went to dr. Dr has give naproxen 500 mg 1 PO BID #10 and cephalexin 500 mg 1 PO Q8H x 7F #21.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 81 year old female patient with penicillin allergy. The patient had no pertinent medical history. On 08-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J004332, expiration date 26-SEP-2013) 0.5 ml, intramuscular for prevention of pneumonia. Concomitant therapies included CELEBREX and vitamin d (unspecified). On 09-OCT-2013, the patient experienced redness, warmth and puffiness just below the injection site, after received PNEUMOVAX 23. No treatment was received for the adverse events. The outcome of redness, warmth and puffiness just below the injection site was not reported. The relationship between PNEUMOVAX 23 and the events was not reported. Patient sought medical attention: Called pharmacist. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 01-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J006921, expiry date 09-AUG-2014. On an unknown date in 2013, the patient experienced injection site reaction that she described as soreness in her arm and warm to touch and soreness in her arm and warm to touch. No treatment was rendered for the events. The outcome of the events were reported as unknown. The patient was scheduled for a follow up appointment. This is one of the 3 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-SEP-2013 the patient was vaccinated with M-M-R II (lot# H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No know adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter link). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 62 year old female patient. On 27-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J006242, expiry date 03-AUG-2014. On an unknown date in SEP-2013, the patient experienced injection site reaction that she described as soreness in her arm and warm to touch and soreness in her arm and warm to touch. The outcome of the events were reported as recovering, the patient was scheduled for a follow up appointment. This is one of the 3 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) (total daily dose not specified). The patient stated she had pain at the site of insertion, after receiving the ZOSTAVAX vaccine. The patient did not seek medical attention. The outcome of pain at the site of insertion was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Injection site reaction, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report refers to a male patient of unknown age with heart issues/problems. Drug reactions/allergies included penicillin and "calflex". On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and dose not provided). Concomitant medication included unspecified treatment for heart problems. On an unspecified date 10 months ago (estimated as December 2012) patient experienced an injection-site reaction. It has spread and been consistent. The rash was mainly red, rough dry spots appearing all over his body from his neck to his toes. While the rash was very itchy, the patient had no pain. The spots came and go. Patient had used 4 unspecified creams prescribed by a dermatologist, however, they only got rid of the spots briefly before new ones showed. Yesterday (estimated as 06-OCT-2013) patient developed a rash all over the upper part of his body that was very red. Patient "just" (estimated as an unspecified date in 2013) got the flu shot. Other suspect therapies included influenza virus vaccine (Manufacturer unknown). The outcome of itchy, rash all over and injection site reaction was reported as not recovered/not resolved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 77 year old male patient. On 24-SEP-2013 (estimated date, reported as "about a week ago") the patient was vaccinated with ZOSTAVAX. Route, dose, dose number and lot number were not reported. Concomitant therapies included LIPITOR. The patient reported that he received an unspecified flu vaccine (manufacturer unspecified) about a few weeks prior to ZOSTAVAX vaccination. On 26-SEP-2013 (reported as "two days after the shot") the patient experienced injection site reaction of redness and swelling but no pain or itching. The patient to a pharmacist. No treatment was given. The outcome of injection site reaction of redness and swelling was reported as recovering/resolving. Reporter causality assessment was not reported. Additional information is expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. Approximately on an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number, expiry date and route were not reported), 0.5 ml (reported as standard dose) in the arm. The patient had prior vaccination with PNEUMOVAX23 on an unknown date in 2012. Approximately on an unknown date in 2013, on the same day the patient was also vaccinated with influenza virus vaccine (manufacturer unknown) (Lot number, expiry date, route and dose were not reported) in the same arm. On 03-OCT-2013(also reported as 04-OCT-2013), the patient developed cellulitis in the arm that received these vaccinations. The patient sought medical attention with the practice where the shot was administered. Unspecified treatment was provided. The outcome of developed cellulitis in the arm was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old male patient. The patient received first and second dose of GARDASIL on 08-JUL-2013 and 18-SEP-2013. Due to an error in his practice's transcription, the patient also received a dose 3 of GARDASIL on 08-OCT-2013. The patient was not currently exhibiting any adverse effects. The physician will report any adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse refers to a patient of unknown age and gender. On 02-OCT-2013, the patient was vaccinated with GARDASIL intramuscular (dose and indication were not reported) by the medical assistant, and while administering the GARDASIL, the medical assistant felt the GARDASIL leet out. The reporter stated that the "hub" was not on the needle of the GARDASIL "all the way" and that is the reason the GARDASIL leak out. The amount of GARDASIL the patient received was unknown to the nurse. No adverse effect reported. This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. There was no drug allergies. On an unknown date, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date was not reported). On an unknown date, the patient after vaccination within a minute developed erythema. Subsequently erythema cleared within a day. The outcome of the event was reported as recovered. The patient sought medical attention. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 40 year-old patient with a history of recurrent shingles, who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, route and dose were not reported) that was expected to temperatures as low as 28 Fahrenheit for an unspecified length of time since an unspecified date in January 2010. No adverse effects were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Herpes zoster
Clinical narrative: This spontaneous report as received from an 82 year old female patient with thyroid disorder, high blood pressure and penicillin allergy (anaphylactic shock) refers to herself. On 06-JUN-2012 the patient was vaccinated with ZOSTAVAX (route and dosage was unknown). Concomitant therapies included unspecified thyroid medication, hydrochlorothiazide (manufacturer unknown) and losartan potassium (manufacturer unknown). The patient reported that in October 2013 she was diagnosed with shingles after receiving ZOSTAVAX. The patient saw her physician to seek medical attention. No lab diagnostics studies were performed. The patient also reported that she was taking 1 gram/day of Valacyclovir which was causing her to have bad constipation. At the time of the report, the outcome of shingles was reproted as not recovered. The outcome of bad constipation was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient, who in April 2013, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). It was reported that the dose of ZOSTAVAX has been reconstituted and stored at unspecified refrigerator temperatures for over 12 hours before it was administered to the patient. No adverse effects were reported. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 8 year old female patient. On 06-AUG-2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry not reported) and second dose on 06-OCT-2009. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. About three years ago (in October 2010) the patient may was vaccinated with ZOSTAVAX (lot #, dose, anatomical location and indication not reported). The pharmacist reported that the patient might have received with ZOSTAVAX about three years ago, and he still got shingles on an unknown date. The outcome of the event was unknown. He was not sure that the patient had ever received ZOSTAVAX previously. The pharmacist stated that he would call the patient to see if that was correct, and then he would call back. It was unspecified if the patient sought medical attention.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient in her 50's. In July 2013 the patient ws vaccinated with single standard dose of ZOSTAVAX for prevention of shingles (route and lot # not reported). In July 2013 the patient developed a rash, swelling and hives after receiving  ZOSTAVAX. The patient talked to their doctor for medical attention. The outcome of hives, rash and swelling was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Ocular discomfort
Clinical narrative: This spontaneous report was received from a 50 year old pharmacist regarding herself, the patient has no pertinent medical history or drug allergies. On 03-OCT-2013, while preparing ZOSTAVAX (lot# J005848, expiry date 17-AUG-2014) injection, the pharmacist pressed on the syringe plunger in error and some ZOSTAVAX sprayed into her eyes. She rinsed her eyes with water. The patient experienced discomfort in her eyes. Concomitant medications were none. The outcome of discomfort in her eyes was reported as not recovered. There was no lab tests performed. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Information has been received from a male consumer with no allergies or drug reactions, reporting on himself, who on 15-OCT-2013, was vaccinated with a dose of ZOSTAVAX. The patient reported that, on 15-OCT-2013, he experienced "burning as the her received his injection of ZOSTAVAX". The patient did not seek medical attention, no lab tests were done and no treatment was given. The patient recovered from burning on 15-OCT-2013. Relatedness between burning and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a patient, who, in April 2013 (six months ago), was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # not provided). It was reported that, on an unspecified date in 2013, the patient developed redness at the injection site. It was localized issue, but then (2013) it spread. The outcome for redness at the injection site that spread was unknown. Relatedness between redness at the injection site that spread and ZOSTAVAX was not reported. This is one of two reports form the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Rash pruritic, Tenderness
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 63 year old female patient. The patient's medical history included trigeminal neuralgia. On 25-SEP-2013 the patient was vaccinated with ZOSTAVAX (transdermally in the under arm area", dose and lot number unknown) dose 1. No other suspect therapy was reported. The patient was using unspecified concomitant medication. The patient reported that the route of therapy by which ZOSTAVAX was administered to her was "transdermally in the under arm area". This is an other-than indicated route of administration for ZOSTAVAX. Since receiving ZOSTAVAX (onset date reported as 26-SEP-2013), the patient experienced that her arm is swollen around the injection site and she has developed "itchy spots" on the back of her arm. She stated that this area is red and tender and that new "itchy spots" seem to  appear each day. No treatment was given. The outcome of "itchy spots" on the back of her arm, arm swollen around injection site, area is tender and red was reported as recovering/resolving. The reporters relatedness of "itchy spots" on the back of her arm, arm swollen around injection site, area is tender and red to ZOSTAVAX is unknown. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a Nurse Practitioner who was referring to a infant patient (2 months old at the day of the first adverse event onset) of unknown gender. Information on medical history was not reported. It was reported that on an unknown date the patient received their first dose of RECOMBIVAX HB (# lot not reported) (dose, route not reported)"  at birth, their second dose at 2 months old and 3rd at 4 months old. Information on concomitant therapies was not reported. There was no adverse effect reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Information has been received from a physician concerning 2 patients, who, in April 2013 (six months ago), were vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # not provided). It was reported that, on an unspecified date in 2013, the patients developed redness at the injection site. They were localized issues. The outcome for redness at the injection site was unknown. Relatedness between redness at the injection site and ZOSTAVAX was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) when he was "65 or 66 years old". She reported that the patient was diagnosed and treated for pneumonia when he was 70 years old. The outcome of pneumonia was reproted as recovered/resolved. Causality 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 as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Pruritus, Rash, Swelling
Clinical narrative: Redness, swelling, itching, rash, knot.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 25 year old female patient regarding herself. On an unknown date in August 2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and route not reported). The patient reported that she was pregnant when she received VARIVAX (Merck). The patient discovered that she was pregnant on 01-OCT-2013. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) is not known. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr. and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, swollen, itchy, warm to touch. Lasted 10 days. Took Benadryl for 1 day.