chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Impaired driving ability, Local swelling, Neurological symptom, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of left arm was swollen in a 83-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7239G, expiry date June 2015). The patient's past medical history included blood clot in left leg (Patient takes warfarin because of the blood clot in his leg a few years ago). Concurrent medical conditions included no known drug allergy. Concomitant products included amlodipine, lisinopril, lovastatin, Pneumonia vaccine and warfarin. On 6th October 2014 13:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 7th October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced left arm was swollen, concentration difficulty, cannot drive, severe drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm, and difficultyto stand up. On an unknown date, the outcome of the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain and difficulty to stand up were not recovered/not resolved and the outcome of the redness in arm was recovering/resolving. It was unknown if the reporter considered the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm and difficulty to stand up to be related to FLUARIX QUADRIVALENT. Additional information: Patient reports that around 1:00pm Monday, October 6, 2014, he was administered a FLUARIX QUADRIVALENT vaccine and a pneumonia vaccine in his left arm. He reports that he was fine on Monday, but when he woke up on Tuesday October 6, 2014, he had symptoms of arm pain, redness, and swelling. He also had difficulty concentrating, and could not drive or get out of his chair. On Wednesday, October 8, 2014, the patient consulted with his pharmacist who advised if the reaction worsened that he should go to the ER. The patient went to his doctor on Thursday, October 8, 2014, and the doctor told him that he had a severe allergic reaction that was also neurological in nature to the FLUARIX QUADRIVALENT vaccine. The doctor told him that the reaction would not be from the pneumonia vaccine, and the he would not have gotten the reaction had he got the trivalent flu vaccine. The doctor told him that the reaction could persist for up to two weeks, and he told him to report the experience to the manufacturer. The patient has received flu vaccines yearly for the past 20 years, and he has never had symptoms before.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of left arm was swollen in a 83-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7239G, expiry date June 2015). The patient's past medical history included blood clot in left leg (Patient takes warfarin because of the blood clot in his leg a few years ago). Concurrent medical conditions included no known drug allergy. Concomitant products included amlodipine, lisinopril, lovastatin, Pneumonia vaccine and warfarin. On 6th October 2014 13:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 7th October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced left arm was swollen, concentration difficulty, cannot drive, severe drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm, and difficultyto stand up. On an unknown date, the outcome of the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain and difficulty to stand up were not recovered/not resolved and the outcome of the redness in arm was recovering/resolving. It was unknown if the reporter considered the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm and difficulty to stand up to be related to FLUARIX QUADRIVALENT. Additional information: Patient reports that around 1:00pm Monday, October 6, 2014, he was administered a FLUARIX QUADRIVALENT vaccine and a pneumonia vaccine in his left arm. He reports that he was fine on Monday, but when he woke up on Tuesday October 6, 2014, he had symptoms of arm pain, redness, and swelling. He also had difficulty concentrating, and could not drive or get out of his chair. On Wednesday, October 8, 2014, the patient consulted with his pharmacist who advised if the reaction worsened that he should go to the ER. The patient went to his doctor on Thursday, October 8, 2014, and the doctor told him that he had a severe allergic reaction that was also neurological in nature to the FLUARIX QUADRIVALENT vaccine. The doctor told him that the reaction would not be from the pneumonia vaccine, and the he would not have gotten the reaction had he got the trivalent flu vaccine. The doctor told him that the reaction could persist for up to two weeks, and he told him to report the experience to the manufacturer. The patient has received flu vaccines yearly for the past 20 years, and he has never had symptoms before.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt broke out in a rash on both R/L upper arms. Pt was prescribed meds by provider and released. Advised to return if any more outbreaks.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Anxiety, Asthenia, Contusion, Fatigue
Clinical narrative: She developed a "normally" sore left arm after receiving the vaccination, but this progressed to an extremely painful left arm, approximately one week after receiving the vaccination. It was severe enough that she could barely lift the arm for 3 weeks due to pain and could not exercise. There was no erythema or swelling. The patient clearly remembers that the vaccine was not given high near the shoulder. She also developed rib pain that extended around the edge of the left rib cage. In mid Apr '12, approximately 4 weeks after vaccination, she developed weakness and "muscle atrophy" in the entire body and lost 20 lbs in the next 4 months. She continued with exquisite left arm pain especially on palpation. She also had debilitating fatigue necessitating frequent rest periods. She still was unable to use her left arm fully, and also states she "bruised" a lot. She sought medical evaluation and was diagnosed with anxiety and was prescribed sertraline. The arm pain, fatigue and energy level gradually began to improve about 8 months later, but the pain in the left rib cage has never resolved.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscle atrophy, Pain in extremity, Weight decreased
Clinical narrative: She developed a "normally" sore left arm after receiving the vaccination, but this progressed to an extremely painful left arm, approximately one week after receiving the vaccination. It was severe enough that she could barely lift the arm for 3 weeks due to pain and could not exercise. There was no erythema or swelling. The patient clearly remembers that the vaccine was not given high near the shoulder. She also developed rib pain that extended around the edge of the left rib cage. In mid Apr '12, approximately 4 weeks after vaccination, she developed weakness and "muscle atrophy" in the entire body and lost 20 lbs in the next 4 months. She continued with exquisite left arm pain especially on palpation. She also had debilitating fatigue necessitating frequent rest periods. She still was unable to use her left arm fully, and also states she "bruised" a lot. She sought medical evaluation and was diagnosed with anxiety and was prescribed sertraline. The arm pain, fatigue and energy level gradually began to improve about 8 months later, but the pain in the left rib cage has never resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Tenderness to palpation site 2 wks after administration. Small area of erythema and firmness at injection site. No evidence of infection. "Dizziness" starting 1 week after injection.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Approx. 4 wks after receiving vaccines (MMR, varicella, Hep A, Hib and flu), patient developed fever (Tmax 101.3 F) and rash on anterior trunk (lower half) and right upper thigh. Rash may be a modified varicella rash.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye pain, Nasal congestion, Oropharyngeal pain, Sensation of pressure
Clinical narrative: 11/24/14 345 throat pressure, pain, hoarse voice, painful red eyes, nasal congestion, cracking ears. 445 increased above sx; 830 PM seen by urgicare MD. Sx; decreased.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: 11/24/14 345 throat pressure, pain, hoarse voice, painful red eyes, nasal congestion, cracking ears. 445 increased above sx; 830 PM seen by urgicare MD. Sx; decreased.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: 10 x 7 cm indurated, hyperpigmented noticed on (R) thigh on 11/7/14. Mom noticed it 1 day after vaccine given (10/17/14).
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia
Clinical narrative: Pt received PNEUMOVAX inj into right arm. A few hours later arm went numb. Pt was sent to ER where he was prescribed NSAID.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Red area at injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Patient reported red area and small bump under injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Vomiting, chills, headache
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Arm got severely swollen, redness, hot to touch. Painful in left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events - No treatment needed. *Child was given "ZOSTAVAX" instead of "PROQUAD".
Age: 62.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Anxiety, Dyspnoea, Erythema, Inflammation, Swelling
Clinical narrative: Pt came in the pharmacy on 11/26/14 complaining of redness, swelling, inflammation, difficulty breathing and anxiety (which he felt yesterday afternoon on 11/25/14).
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site swelling, Vaccination complication
Clinical narrative: Patient states had allergic reaction to vaccine the next day with swelling in the arm at site of injection.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Lymphadenitis
Clinical narrative: Mesenteric adentiis dx 10/28/14.
Age: 1.01
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose MMR II (lot H020255, expiration date not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter stated that as of 29-AUG-2014 they had 6 doses of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with a dose MMR II (lot H020255, expiration date not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter stated that as of 29-AUG-2014 they had 6 doses of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 month old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2105)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 month old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2105)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Injection site discomfort
Clinical narrative: This spontaneous report as received from a male patient who was also a physician of 65 years ago regarding himself. Current conditions and medical history was reported as none. On an unknown date in 2010(reported as 4 years ago), the patient had received PNEUMOVAX 23 vial, 0.5 milliliters (ml), intramuscular in the left arm. On 08-NOV-2014, the patient was received with PNEUMOVAX 23. Concomitant medications were reported as none. On an unknown date approximately in November 2014, the patient reported that he had developed injection site reaction which was described as injection site discomfort. Patient stated that he was using TYLENOL for the discomfort. No lab diagnostics studies performed. The outcome was reported as not recovered. Causality assessment was not reported. Product quality complaint was not reported. This is one of the 2 reports reported by same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old female patient (wife) who was smoker. The physician stated that in the past, his wife had redness and swelling at the injection site after receiving an unspecified tetanus vaccine (manufacturer unspecified). On an unknown date in 2010(reported as 4 years ago), the patient had received PNEUMOVAX 23 vial, 0.5 milliliter (ml), intramuscular in the left arm. On 08-NOV-2014, the patient was revaccinated with PNEUMOVAX 23 in the left arm. Concomitant medications were reported as none. On an unknown date approximately in November 2014, the patient had developed injection site reaction which was described as injection site swelling and redness of her left arm at the injection site and up into the axilla area. Patient was using BENADRYL. No lab diagnostics studies performed. The outcome was reported as not recovered. Causality assessment was not reported. Product quality complaint was not reported. This is one of the 2 reports reported by same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Flushing, Pyrexia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a 65 year old female patient. No current condition was reported. No historical medication was reported. On 01-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose strength was not reported). No concomitant medication was reported. On an unknown date approximately in November 2014, the patient experienced flush, weak, dizzy and developed a fever. Treatment given to the patient was METAZINE (manufacturer unknown) (dosage and frequency was unknown). Sought medical attention was reported as yes. The outcome of flush, weak, dizzy and developed a fever was unknown. No PQC was involved. The causality between PNEUMOVAX 23 and event was not reported. No further adverse event information was provided. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 57 year old patient with no pertinent medical history or drug reactions/allergies. Approximately on 17-NOV-2014 "one day last week" the patient was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (lot # K010523, expire date 25-FEB-2016). There was no concomitant medication. Healthcare worker stated patient returned couple days later. Healthcare worker stated according to nurse practitioner that patient was experiencing cellulitis from injection site on left arm around arm to back the back of her elbow. Healthcare worker stated patient was treated yet treatment unspecified at this time. No lab diagnostics studies were performed. The patient was now "doing better". The patient sought medical attention via office visit. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Ecchymosis, Erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 66 year old female consumer regarding herself. The historical drugs included DEMEROL, CIPRO and NOVOCAIN. She had a current condition of fibromyalgia. The patient was allergic to following drugs DEMEROL, CIPRO and NOVOCAIN and also allergic to adhesive tape. On 22-OCT-2014, the patient received pneumonia vaccination (manufacturer unknown) (strength, dose, frequency, product lot#, expiry date, route not reported). It was also reported that adverse event was reported for PNEUMOVAX 23 as the product because PNEUMOVAX 23 could not be ruled out as the vaccine the patient received. Concomitant therapy included NORALOX. The patient reported that on 22-OCT-2014, after receiving vaccine, she experienced the following injection site reactions: soreness, swelling and itchiness and also reported the following systemic adverse reactions: chills, myalgia, pain, ecchymosis, and erythema. She stated that both the injection site reactions and systemic reactions began immediately after receiving the vaccination. The patient applied ice to the injection site to treat her injection site reactions. No laboratory diagnostics studies were performed. The patient sought medical attention. On an unknown date in 2014, the patient recovered from all the injection site reactions, but had not recovered from any of the systemic adverse reactions. The causality of the events was unknown. Additional information is not expected as patient would not answer any more questions.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pain
Clinical narrative: This spontaneous report was received from a 66 year old female consumer regarding herself. The historical drugs included DEMEROL, CIPRO and NOVOCAIN. She had a current condition of fibromyalgia. The patient was allergic to following drugs DEMEROL, CIPRO and NOVOCAIN and also allergic to adhesive tape. On 22-OCT-2014, the patient received pneumonia vaccination (manufacturer unknown) (strength, dose, frequency, product lot#, expiry date, route not reported). It was also reported that adverse event was reported for PNEUMOVAX 23 as the product because PNEUMOVAX 23 could not be ruled out as the vaccine the patient received. Concomitant therapy included NORALOX. The patient reported that on 22-OCT-2014, after receiving vaccine, she experienced the following injection site reactions: soreness, swelling and itchiness and also reported the following systemic adverse reactions: chills, myalgia, pain, ecchymosis, and erythema. She stated that both the injection site reactions and systemic reactions began immediately after receiving the vaccination. The patient applied ice to the injection site to treat her injection site reactions. No laboratory diagnostics studies were performed. The patient sought medical attention. On an unknown date in 2014, the patient recovered from all the injection site reactions, but had not recovered from any of the systemic adverse reactions. The causality of the events was unknown. Additional information is not expected as patient would not answer any more questions.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 50 year old female patient, as part of a marketing research program. No medical history and current conditions were reported. On an unknown date in 2008 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number was unspecified). It was reported that the patient had received a PNEUMOVAX 23 vaccination one year prior in her physician's office. On an unknown date in 2008 the patient experienced large, local reaction on her arm. It was reported that the patient recovered without incident and physician reported the event at the time. The outcome of large, local reaction on her arm was reported as recovered on an unknown date in 2008. The reporter considered large, local reaction on her arm to be related to PNEUMOVAX 23. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age. On 12-NOV-2014 the patient was vaccinated with 4th dose of GARDASIL 0.5 ml, intramuscular. No adverse effects were reported. Product quality complaint was reported. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information on medical history and drug reactions or allergies. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 dose .5 ml (milliliter), strength, route not reported, product lot # J004080 that expired on 22-AUG-2014 inadvertently. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old patient of unknown gender. On 16-JAN-2014 the patient was vaccinated with PNEUMOVAX 23, (0.5 ml dose). Concomitant medications were not reported. On 07-NOV-2014, the patient again received PNEUMOVAX 23. No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K007826, (route, dose and expiration date not reported). On an unknown date, 24 to 48 hours after being administered PNEUMOVAX 23, the patient experienced hot and painful injection site reaction. The patient sought medical attention and was diagnosed with cellulitis at the injection site. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration
Clinical narrative: 5 x 3cm faint erythema, firm. Non-tender. May apply warm compress and Flu 2 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored doses of (Merck) VARIVAX. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's medical history included chickenpox. On 10-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# were not reported). Concomitant therapy was not reported. On an unknown date approximately in November 2014 (reported as within 2 to 3 days) the patient over 30 spots. The patient was seen by the physician who diagnosed him with chicken pox. The patient had been quarantined for the next week. Patient sought medical attention by visiting physician. No Product Quality Complaint (PQC) was involved. The outcome of chicken pox was reported as not recovered/not resolved. Causality assessment was not provided by the reporter. This is one of the two reports from the same reporter. This case was linked to MARRS # 1411USA012528 (patient wife case). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included chickenpox. On 10-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# were not reported). Concomitant therapy was not reported. Within one day, approximately in 11-NOV-2014, the patient developed itchy generalized rash. That was progressed to over 300 spots all over her body. On an unknown date approximately in November 2014, the patient was seen by the physician who diagnosed her with chicken pox. The patient had been quarantined for the next week. Patient sought medical attention by visiting physician. No Product Quality Complaint (PQC) was involved. The outcome of chicken pox was reported as not recovered/not resolved. Causality assessment was not provided by the reporter. This is one of the two reports from the same reporter. This case was linked to MARRS # 1411USA007397 (patient husband case). Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: Few days after receiving PREVNAR, pt stated he started itching starting from midline and shoulder blades to lower back and front trunk and back of lower left leg. He also noticed some bumps on his body.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Tinnitus
Clinical narrative: Dizziness, ringing of ears, pallor, feel of faint/poss faint.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 21 month old child with unknown gender. No pertinent medical history was reported. On 12-NOV-2014, the patient was vaccinated with an expired dose of pediatric VAQTA (lot # was 1697AA and expiration date was 22-Sep-2014) (strength, dose, route, were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Papule, Pyrexia
Clinical narrative: Pt rec'd 11 yr vaccinations on 11/24/14; S/s began 11/25/14. Seen 11/26/14 with s/s: 3"x6" area erythema with 1cm circular erythema with central papual (Lt) shoulder; (+) induration; no tender or warm to touch afebrile. Tx supportive care -> if fever dev. = start KEFLEX.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K010016, expiration date 05-AUG-2015 (route and dose not reported). On an unknown date, 24 to 48 hour after being administered PNEUMOVAX 23, the patient experienced hot and painful injection site reaction. The patient sought medical attention and was diagnosed with cellulitis at the injection site. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Post vaccine, patient's right thigh became red and swollen. Patient's mother treated with cold packs and NSAIDS. Remained extremely swollen for 3 days. This rxn has happened with every DTAP shot but this was the most extreme.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Dyspnoea, Gait disturbance, Musculoskeletal stiffness, Palpitations
Clinical narrative: Patient returned to school after vaccines given. School contacted mom and she had a friend pick him up. Reports stiff all over, hear racing with some difficulty breathing and walking. Mom gave him 2 ALEVE and he rested, when he awoke he was fine.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Pt. was vaccinated with Dtap on 11-10-14. 3 days after vaccination developed face swelling, lips and tongue - problem resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child received a dose of PCV13, Pfizer Inc., H45099. IM/Right deltoid on 8/13/2014 at which time the child was 67 months old (and had no risk factors).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-NOV-2014, reported as "yesterday", the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number and expiration date were not reported) at the reporter's pharmacy. On 25-NOV-2014, reported as "today" the patient went to another unspecified pharmacy and inadvertently received another dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 24-NOV-2014 the 4 patients were vaccinated with doses of improperly stored PEDVAX HIB (lot#, dose, route and frequency were not provided). No adverse effect was reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 1 year old child. No current or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (dosing regimen, route of administration and indication not provided). No concomitant therapies were reported. On an unknown date, the patient developed a complicated case of shingles after administration of (Merck) VARIVAX at the back and leg. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Approximately on 24-NOV-2014 (reported as "probably yesterday"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route were not reported) that expired on 29-AUG-2014). Additional information is not expected due to no consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K004542 and expiration date 19-AUG-2015 (route and dose not reported). On an unknown date, 24 to 48 hours after being administered PNEUMOVAX 23, the patient experienced hot and painful injection site reaction. The patient sought medical attention and was diagnosed with cellulitis at the injection site. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 50 year old female patient. The patient's medical history included fibromyalgia. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and indication were not provided) (Dose/Frequency also reported as 1 injection) and PREVNAR 13. The following day after vaccine injection, the patient experienced dizziness and felt nauseated. The patient went to the Emergency Room because of her symptoms. The outcome of events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. Information regarding drug reactions or allergies and medical history was not reported. In 2009 (exact dates not reported) the patient was vaccinated with ZOSTAVAX (dose, anatomical location, route of administration, lot#, expiration date were not reported). Concomitant medications were not reported. The patient reported that, on unknown date, she thought she might have had an outbreak of a mild case of shingles after being vaccinated with ZOSTAVAX. The only thing the patient mentioned was a possible rash. The outcome of the events was not reported. The relatedness between the therapy with ZOSTAVAX and the events was not reported. No other information was provided before the patient disconnected the call. Additional information is not expected because there was no patient's and physician's contact details provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (dose strength and route was unknown). No adverse effects were reported. No concomitant medication was reported. The outcome of improperly stored PEDVAXHIB administered to unspecified number of patients was unknown. No PQC was involved. This is one of the several reports related via same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient's pertinent medical history and drug allergies/reactions were unspecified by reporter. On 20-NOV-2014 the patient was vaccinated with 0.5ml dose of PNEUMOVAX 23 (lot # K009874, expiration date 19-MAR-2016), intramuscular in the left arm. The patient called in to the pharmacy on 21-NOV-2014, stated that at 11 pm last night (on 20-NOV-2014) his left arm went numb and he had pain from his left shoulder all the way down to the tips of his fingers. The patient went to an unspecified Emergency Room (on 20-NOV-2014) and "they didn't do anything for him, just discharged him at 6 am this morning (on 21-NOV-2014)". No treatment was given for the event. The pharmacist stated "the patient told me today (on 21-NOV-2014) that he can't move his left arm over his head". The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, route, product lot#, expiry date not reported). The reporter stated that one dose of ZOSTAVAX was administered to patient after being improperly stored. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with PNEUMOVAX 23 (dose number, route, lot # and expiration date were not provided). In 2014, doses of PNEUMOVAX 23 that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified dates, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Blister, Coxsackie viral infection, Coxsackie virus test positive, Herpes simplex
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 60 year old male patient with coronary arterial sclerosis, depressive disorder, gastrooesophageal reflux disease (GERD), hypertension, obstructive sleep apnea, disorder of the prostate and hyperlipidemia. The patient had allergic to SELDANE and VALIUM. On 30-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K003595, exp. date: 07-FEB-2015, 0.65 ml, subcutaneously (dose number not reported). Concomitant therapies included alfuzosin hydrochloride, alprazolam, aspirin, citalopram hydrobromide, CRESTOR, DILTAIZEM CD, furosemide, hydroxychloroquine sulfate, lidocaine hydrochloride (manufacturer unknown), LYRICA, NEXIUM, acetaminophen, oxycodone hydrochloride, PLAVIX, prednisone (manufacturer unknown), RANEXA, vitamin D and zolpidem tartrate (manufacturer unknown). In October 2014, after the vaccination, patient was seen by his physician on 3 separate occasions on unspecified dates due to developing unspecified viral symptoms. The reporter stated that the patient was started on amoxicillin on 17-OCT-2014 for 10 days due to developing ulcers and blisters on his tongue and the roof of his mouth (diagnosed with aphthous ulcers) and a fever. She also states that the patient was started on MACROBID (started on 29-OCT-2014 and discontinued on 08-NOV-2014) for what she "thinks" was prescribed for a urinary tract infection which developed on an unspecified date. The nurse reported that the patient had unspecified labs drawn on 30-OCT-2014 and the results of the labs showed that the patient was positive for herpes simplex and positive for Coxsackie B types 1 through 6. Patient sought medical attention by visiting his physician. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex serology positive, Pyrexia, Urinary tract infection, Viral infection
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 60 year old male patient with coronary arterial sclerosis, depressive disorder, gastrooesophageal reflux disease (GERD), hypertension, obstructive sleep apnea, disorder of the prostate and hyperlipidemia. The patient had allergic to SELDANE and VALIUM. On 30-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # K003595, exp. date: 07-FEB-2015, 0.65 ml, subcutaneously (dose number not reported). Concomitant therapies included alfuzosin hydrochloride, alprazolam, aspirin, citalopram hydrobromide, CRESTOR, DILTAIZEM CD, furosemide, hydroxychloroquine sulfate, lidocaine hydrochloride (manufacturer unknown), LYRICA, NEXIUM, acetaminophen, oxycodone hydrochloride, PLAVIX, prednisone (manufacturer unknown), RANEXA, vitamin D and zolpidem tartrate (manufacturer unknown). In October 2014, after the vaccination, patient was seen by his physician on 3 separate occasions on unspecified dates due to developing unspecified viral symptoms. The reporter stated that the patient was started on amoxicillin on 17-OCT-2014 for 10 days due to developing ulcers and blisters on his tongue and the roof of his mouth (diagnosed with aphthous ulcers) and a fever. She also states that the patient was started on MACROBID (started on 29-OCT-2014 and discontinued on 08-NOV-2014) for what she "thinks" was prescribed for a urinary tract infection which developed on an unspecified date. The nurse reported that the patient had unspecified labs drawn on 30-OCT-2014 and the results of the labs showed that the patient was positive for herpes simplex and positive for Coxsackie B types 1 through 6. Patient sought medical attention by visiting his physician. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date unspecified number of patients were vaccinated with improperly stored GARDASIL (dose strength and route was unknown). No adverse effects were reported. No concomitant medication was reported. The outcome of improperly stored GARDASIL administered to unspecified number of patients was unknown. No PQC was involved. This is one of the several reports related via some reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with (Merck) VARIVAX injection (lot number and expiry date unknown) (Dose 0.5 ml, frequency unknown) subcutaneously which on an unknown date had undergone a temperature excursion (details unspecified). No adverse events were reported. No product quality issue was reported. The action taken with the (Merck) VARIVAX therapy and the outcome of the events was unknown. The relatedness of the events to the therapy with (Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified  number of patients of unknown age and gender. On unspecified dates, since 23-OCT-2014, the patients were vaccinated with GARDASIL (dose number,, route, lot # and expiration date were not provided). In 2014, doses of GARDASIL that were exposed to a supported temperature excursion (0.2 C for 55 hours) had been administered to unspecified patients on unspecified dates, since 23-OCT-2014. No adverse effects had been observed or reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot number and route were not reported. No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 17, units not reported) of unknown gender. On 10-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.