chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route of administration were not provided). No information regarding concomitant medications were reported. The second day after injection of ZOSTAVAX, the patient experienced a localized injection site reaction. The patient recovered from this event on an unknown date. Causality between the event and ZOSTAVAX was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 11-MAY-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004148, expire date 10-MAY-2015, 0.5 ml, once) intramuscularly. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer regarding himself a male patient of unknown age. No concurrent condition and historical medication was reported. On an unknown date 11 years ago approximately in 2004, the patient was vaccinated with ZOSTAVAX (dose strength was unknown). No concomitant medication was reported. On an unknown date in November 2014, the patient got the shingles for an unspecified length of time. The patient stated that he did get better, but did not give any specific information about this. No product quality complaint was involved. The outcome of shingles was reported as resolved. Causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 62 year old female patient. The patient's pertinent medical history included hypertension, hyperlipidaemia and Barrett's Oesophagus and had no reported allergies. On an unknown date in 2001, the patient was vaccinated with pa dose of PNEUMOVAX 23 (dose, frequency and route were not reported) for pneumonia prevention by an unspecified allergist. Concomitant therapies included Simvastatin (manufacturer unknown), Omeprazole (manufacturer unknown), Lisinopril (manufacturer unknown) and hydrochlorothiazide. On an unknown date in 2001, the patient's arm blew up, the patient experienced large swollen area locally at the injection. Medical assistant stated that it was unknown if any treatmentt was administered at the time of reaction and also stated at unspecified time in the past, a flu (manufacturer unspecified) vaccines were given to patients in smaller, split doses but that was a while ago. The outcome of the event was unknown. The relatedness of the event with the PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. In January 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). In January 2015, the patient experienced a red mark and itching at the injection site where ZOSTAVAX was administered. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired healing, Injection site pruritus, Injection site reaction, Rash vesicular, Scab
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. In January 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). In January 2015, the patient experienced a red mark and itching at the injection site where ZOSTAVAX was administered. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. In January 2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). In January 2015, the patient experienced a red mark and itching at the injection site where ZOSTAVAX was administered. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and pain on left upper arm vaccine site.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 5 year old patient of unknown gender. There was no information on pertinent medical history and drug reactions or allergies. On 22-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, product lot#, expiry date not reported) instead of a dose of (Merck) VARIVAX. No adverse effects was reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No current condition or medical history was reported. On 05-MAY-2015, the patient was mistakenly vaccinated with an expired dose of ZOSTAVAX (lot # J013449, expired date 24-JAN-2015; dose, strength and route were not reported). No adverse event was reported. No concomitant therapy was reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unknown number of patients of unknown age and gender. Since 26-APR-2015, the patients were vaccinated with (Merck) VARIVAX (subcutaneous; dosage, lot# not provided) which had undergone supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chest pain, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. Pertinent medical history was unspecified by reporter. The patient had none known drug reactions or allergies. On 10-APR-2015 the patient was vaccinated with 1 dose of ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included gemfibrozil, metformin (manufacturer unknown), NEXIUM, gabapentin and clonazepam (duration and schedule were not reported). On an unspecified date in April 2015, after receiving the vaccine, the patient experienced erythema, swelling and pain at the injection site. Then, on an unspecified date in April 2015, the injection site pain spread to the patient's shoulder, axilla and chest. The pharmacist also reported that the patient had a difficulty moving her shoulder (hypokinesia). The patient sought medical attention by calling the pharmacist on 23-APR-2015. No treatment was given for the adverse events. The outcome of the injection site erythema and injection site swelling was reported as recovered on an unspecified date in April 2015. The outcome of injection site pain, shoulder pain, hypokinesia, chest pain and axillary pain was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. Pertinent medical history was unspecified by reporter. The patient had none known drug reactions or allergies. On 10-APR-2015 the patient was vaccinated with 1 dose of ZOSTAVAX, 0.65 ml, subcutaneous (dose number, anatomical location, lot number and expiration date were unspecified). Concomitant therapies included gemfibrozil, metformin (manufacturer unknown), NEXIUM, gabapentin and clonazepam (duration and schedule were not reported). On an unspecified date in April 2015, after receiving the vaccine, the patient experienced erythema, swelling and pain at the injection site. Then, on an unspecified date in April 2015, the injection site pain spread to the patient's shoulder, axilla and chest. The pharmacist also reported that the patient had a difficulty moving her shoulder (hypokinesia). The patient sought medical attention by calling the pharmacist on 23-APR-2015. No treatment was given for the adverse events. The outcome of the injection site erythema and injection site swelling was reported as recovered on an unspecified date in April 2015. The outcome of injection site pain, shoulder pain, hypokinesia, chest pain and axillary pain was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an other health professional referring to unspecified number of unspecified patients. No concurrent condition or medical history was reported. On unspecified dates since 09-MAR-2015, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (dose and route were unknown), Lot# was reported as J014406 exp 13-NOV-2015, K026386 exp 15-DEC-2016, K001390 exp 29-JAN-2016, K010338 exp 22-JUL-2016). No adverse effects reported. This is one of several reports from the same reporter (1505USA005156, 1505USA003305). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: 4/29/15 (10:00pm)- Pt mom called on-call triage nurse, reported leg edema, leg twice the size of the other leg, redness, warm to touch, rash on leg reported to be bigger than the size of a softball. Per patient's father, Sx's occurred 4/29/15 after a bath.
Age: 71.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient came in for ZOSTAVAX and VARIVAX was administered. No adverse reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Began 5-13-15 10 am w/(L) arm sore/red itch. Observed (L) arm 120 mm/65 mm red, warm, rasied, 1+tender, R arm 40x20 mm warm with red and pain-both at site of injection. Rx KEFLEX 250 mg/5 ml, 5 ml TID, BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Began 5-13-15 10 am w/(L) arm sore/red itch. Observed (L) arm 120 mm/65 mm red, warm, rasied, 1+tender, R arm 40x20 mm warm with red and pain-both at site of injection. Rx KEFLEX 250 mg/5 ml, 5 ml TID, BENADRYL.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Discomfort, Injection site pain
Clinical narrative: 7-10 days after PNEUMOVAX 23 administration, pt. complained of nagging ache/pain at injection site. Discomfort comes and goes. Denies redneess or swelling. Area is painful when pressure applied.
Age: 39.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Fatigue, Full blood count, Headache, Hyperhidrosis
Clinical narrative: Typhoid given on 4/21/2015 via (L) deltoid. Symptoms of fatigue, sweating, light headed, lethargy, headache.
Age: 39.0
Sex: M
Vaccine: TYP
Symptoms: Lethargy
Clinical narrative: Typhoid given on 4/21/2015 via (L) deltoid. Symptoms of fatigue, sweating, light headed, lethargy, headache.
Age: 30.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Arthropathy, Full blood count normal, Red blood cell sedimentation rate normal, X-ray limb normal
Clinical narrative: Persistent right shoulder since receiving flu vaccine in January 2015. Has been seen twice times for follow up. Had right shoulder X-ray and blood work which was normal. Later received a steroid injection and sent to physical therapy.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: After receiving the vaccine the patient stood up and fainted hitting the floor, observed in the office by MD and was then released to go home. Vitals taken all normal.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Antinuclear antibody positive, C-reactive protein increased, Cognitive disorder, Headache, Lumbar puncture
Clinical narrative: Shaking spells, development of tremor, headache, cognitive difficulty. Complaints of daily HA, frequent seizures, development of head and hand tremor and memory problems.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Memory impairment, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Seizure, Tremor
Clinical narrative: Shaking spells, development of tremor, headache, cognitive difficulty. Complaints of daily HA, frequent seizures, development of head and hand tremor and memory problems.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at injection site (lft upper arm).
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered at inappropriate site, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: 4/1/15, Day of vaccine administered to day 3 states aware had sot. Severe pain started 4/4/15 upper arm, states above elbow to shoulder. States injection given top, proximal part of deltoid, not middle. Unable to use arm or sleep unless takes MOTRIN 4 tabs 2 x day. MOTRIN relieves pain. Heating pad. States had full R.O.M. denies numbness, swelling, redness. Refer to doctor. Denies lifting or injury to arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area at injection site, entire back upper and lower aching x 48 hrs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: At 12 noon 4/10/15 she examined back of right arm where ZOSTAVAX administered. Large size (larger than a fist), color deep red, hard, hot to touch area. Since time of vaccine administer reports arm was sore, has not felt herself, and no energy today. Advise warm compress, consult her physician.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after 4th injection for 5 sec. then patient was alert and awake. Patient then stated that she has history of family with any needle injections.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nausea, Oral administration complication, Vomiting
Clinical narrative: Pt took 1st oral typhoid capsule 4-30-15 with slight nausea. Took 2nd capsule 5-2-15 with nausea, vomited about 1 hr after and saw capsule in emesis. Phoned me 5-4-15 to ask what she should do. States had phoned Crucell and they told her to call med prescriber. Pt advice from Crucell advised pt if takes 3 more every other day capsules starting tday would still have 5 yr protection. Pt will pick up replacement capsule today. Advised to take on empty stomach eat 1 hr after taking should be well hydrated on days takes capsules.
Age: 0.58
Sex: F
Vaccine: HEP, HEPA, MMRV, RV1
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Post vaccine cellulitis left shoulder mid center of top of shoulder. PREVNAR 13 received by pt on 4/27/15. Pt seen on 5/16/15 with 4.5 x 3 cm circular area of warmth and slight tenderness over left deltoid, tender to palp.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain only at injection site mild tenderness. No redness. No warmth. No swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Headache, Vomiting
Clinical narrative: Vomiting 4-5 times around 6-7 hrs after immunizations. Also complained of headache and abdominal pain. No fever.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 18-APR-2012, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose, route and site of administration, lot # and expiry date unspecified). No concomitant medications were reported. The nurse reported that the patient came to the office and would like to receive the second dose of GARDASIL on 30-APR-2015 (reported as "now"). No adverse symptoms were reported. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Erythema, Papule, Pruritus
Clinical narrative: Child had both Varicella and MMR II on right thigh on 4/19/15. Mom noticed a few papules over the area where the vaccines were given on 5/8/15. Initially they were scanty non-erythematous papules and were very itchy and pt. was scratching them. Later papules spread to face and extremities but not the trunk. Since then most have disappeared.
Age: 62.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Very sore arm-muscle weakness painful to raise arm for 5 or 6 weeks muscular not painful to touch.
Age: 0.44
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Irritability
Clinical narrative: Mother reports excessive fussiness for several nights and redness around injection site of right leg. Mother never called office with questions and infant was never seen in office for the issue.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site nodule, Injection site pain, Injection site warmth, Rash
Clinical narrative: Pt reports 6cm knot on left deltoid, area warm and tender to touch. Rash and redness lower left area developed a few days later. Ice, BENADRYL.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Skin rash. Treatment was fluocinonide .05% cream to apply to area twice daily for 14 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Emotional disorder, Fear, Insomnia
Clinical narrative: Received Fu shot 1-2 months prior. Next day pain on right hip started. Felt like it was going through the bone. Pain was intense. 2nd day became very fearful, emotional, fears took over mind like night terrors. Couldn't sleep for 10 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep terror
Clinical narrative: Received Fu shot 1-2 months prior. Next day pain on right hip started. Felt like it was going through the bone. Pain was intense. 2nd day became very fearful, emotional, fears took over mind like night terrors. Couldn't sleep for 10 days.
Sex: F
Vaccine: FLU3
Symptoms: Blood immunoglobulin G normal, Malaise, No therapeutic response, Sinusitis
Clinical narrative: This case was reported by a consumer and described the occurrence of therapy non-responder in a female patient who received Flu vaccine. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced therapy non-responder, sinus infection and sickness. The patient was treated with Z-PAK. On an unknown date, the outcome of the therapy non-responder, sinus infection and sickness were unknown. It was unknown if the reporter considered the therapy non-responder, sinus infection and sickness to be related to Flu vaccine. Additional information received: A patient reported that her IgG level have increased, and that she has been sick all winter because of the flu vaccine lack of efficacy. She currently has a sinus infection. Her IgG level was in the mid-500's. Patient declined consent to be contacted. No additional information was provided.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Vomiting
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 17 year old female patient. No concurrent conditions or medical history were reported. On 05-MAY-2015, the patient was vaccinated with the first dose of GARDASIL (lot # and expiration date were not provided) intramuscular. Concomitant therapies included NORTREL. On 05-MAY-2015, the patient experienced vomiting and asthenia reported as "felt very weak" after receiving the first dose of GARDASIL. On an unspecified date, the patient received ZOFRAN for treatment of vomiting and asthenia. The patient did not seek medical attention. No laboratories diagnostic studies were performed. It was not confirmed if the subsequent doses of GARDASIL would be administered, although the reporter stated that she requested for the GARDASIL, to be discontinued. The outcome of vomiting and asthenia was reported as not recovered at the time of the report. The reported did not assess the relatedness of GARDASIL to vomiting and asthenia. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age/gender. The patient's concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored of ROTATEQ orally (dose, lot number and expiration date were not provided). No symptoms were reported with regard to the medication error. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with (Merck) PROQUAD lot # K023365/expiry date 20-MAY-2016. The nurse reported that the unspecified patient received a dose of improperly stored (Merck) PROQUAD. No adverse effect was reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Immunology test abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of immunology nos abdominal in a 68-year-old male patient who received ENGERIX B (batch number 9H2H2, expiry date 30th January 2016). On 13th March 2015, the patient received ENGERIX B. On 16th March 2015, 3 days after receiving ENGERIX B, the patient experienced immunology nos abnormal. On an unknown date, the outcome of the immunology nos abnormal was unchanged. It was unknown if the reporter considered the immunology nos abnormal to be related to ENGERIX B. Additional information received: A patient was given a booster dose of ENGERIX-B on 13 March 2014, and on 16 March 2015, the patient had positive blood work for hepatitis B surface antigen (antigenemia).
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrene of allergic reaction in a female patient who received DTPa. On an unknown date, the patient received DTPa. On an unkown date, unknown after receiving DTPa, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to DTPa. Additional information received: The patient reported that she had an allergic reaction to tetanus when she was a child.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 23-APR-2015 the patient was vaccinated with (Merck) VARIVAX of unknown dose via subcutaneous route which underwent a supported temperature excursion. No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-APR-2015, the patient was vaccinated with an improperly stored ROTATEQ, 1 dose 2 ml orally, (lot number were not reported). The patient's concomitant therapies were not reported. Adverse effects were not reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 55 year old male patient, reporting on himself. It was reported that the patient was a survivor of HPV cancer. "About 6 months ago" in approximately November 2014 the patient was vaccinated with the third dose of GARDASIL (route and lot# not provided). It was reported that the patient completed the 3 dose regimen (dates of doses 1 and 2 were not reported). The patient reported that he received GARDASIL after being "cancer free" for two years, which is other than indicated in the prescribing information. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS, FLUX, TTOX, VARZOS
Symptoms: Back pain, Pain
Clinical narrative: Felt burning, itching sensation on back that progressed into severe stabbing pain.  Similar to pain I experienced when I had a previous case of shingles.
Age: 61.0
Sex: F
Vaccine: FLUX, TTOX, VARZOS, FLUX, TTOX, VARZOS
Symptoms: Burning sensation, Pain, Pruritus
Clinical narrative: Felt burning, itching sensation on back that progressed into severe stabbing pain.  Similar to pain I experienced when I had a previous case of shingles.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a consumer reporting on himself: to a 60-year-old male patient. The patient's medical history included allergy ro simvastatin (manufacturer unknown). On 08-APR-2015, the patient was vaccinated dose of with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration date were not reported). Concomitant therapies included naproxen. On 06-APR-2015, the patient experienced various symptoms including: an injection site reaction which included swelling and redness. The patient stated that the injection site was also hot to the touch and "palpable". The patient stated that he had gone to an unspecified urgent care facility (date unspecified). On an unknown date in approximately April 2015, while in the urgent care office the patient was also diagnosed with prostatis and an infected prostate. The patient also mentioned that he has had severe joint pain in the knees, elbows and shoulders since vaccination (08-APR-2015). The patient sought medical attention via urgent care office and received unspecified treatment. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Prostate infection
Clinical narrative: This spontaneous report was received from a consumer reporting on himself: to a 60-year-old male patient. The patient's medical history included allergy ro simvastatin (manufacturer unknown). On 08-APR-2015, the patient was vaccinated dose of with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration date were not reported). Concomitant therapies included naproxen. On 06-APR-2015, the patient experienced various symptoms including: an injection site reaction which included swelling and redness. The patient stated that the injection site was also hot to the touch and "palpable". The patient stated that he had gone to an unspecified urgent care facility (date unspecified). On an unknown date in approximately April 2015, while in the urgent care office the patient was also diagnosed with prostatis and an infected prostate. The patient also mentioned that he has had severe joint pain in the knees, elbows and shoulders since vaccination (08-APR-2015). The patient sought medical attention via urgent care office and received unspecified treatment. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Prostatitis
Clinical narrative: This spontaneous report was received from a consumer reporting on himself: to a 60-year-old male patient. The patient's medical history included allergy ro simvastatin (manufacturer unknown). On 08-APR-2015, the patient was vaccinated dose of with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration date were not reported). Concomitant therapies included naproxen. On 06-APR-2015, the patient experienced various symptoms including: an injection site reaction which included swelling and redness. The patient stated that the injection site was also hot to the touch and "palpable". The patient stated that he had gone to an unspecified urgent care facility (date unspecified). On an unknown date in approximately April 2015, while in the urgent care office the patient was also diagnosed with prostatis and an infected prostate. The patient also mentioned that he has had severe joint pain in the knees, elbows and shoulders since vaccination (08-APR-2015). The patient sought medical attention via urgent care office and received unspecified treatment. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Autoinflammatory disease, Influenza like illness, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer reporting on himself: to a 60-year-old male patient. The patient's medical history included allergy ro simvastatin (manufacturer unknown). On 08-APR-2015, the patient was vaccinated dose of with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration date were not reported). Concomitant therapies included naproxen. On 06-APR-2015, the patient experienced various symptoms including: an injection site reaction which included swelling and redness. The patient stated that the injection site was also hot to the touch and "palpable". The patient stated that he had gone to an unspecified urgent care facility (date unspecified). On an unknown date in approximately April 2015, while in the urgent care office the patient was also diagnosed with prostatis and an infected prostate. The patient also mentioned that he has had severe joint pain in the knees, elbows and shoulders since vaccination (08-APR-2015). The patient sought medical attention via urgent care office and received unspecified treatment. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Prostatitis
Clinical narrative: This spontaneous report was received from a consumer reporting on himself: to a 60-year-old male patient. The patient's medical history included allergy ro simvastatin (manufacturer unknown). On 08-APR-2015, the patient was vaccinated dose of with ZOSTAVAX subcutaneous (strength, dose, frequency, lot number, expiration date were not reported). Concomitant therapies included naproxen. On 06-APR-2015, the patient experienced various symptoms including: an injection site reaction which included swelling and redness. The patient stated that the injection site was also hot to the touch and "palpable". The patient stated that he had gone to an unspecified urgent care facility (date unspecified). On an unknown date in approximately April 2015, while in the urgent care office the patient was also diagnosed with prostatis and an infected prostate. The patient also mentioned that he has had severe joint pain in the knees, elbows and shoulders since vaccination (08-APR-2015). The patient sought medical attention via urgent care office and received unspecified treatment. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Diarrhoea, Intussusception, Nuclear magnetic resonance imaging, Surgery, Vomiting
Clinical narrative: My grandson was vaccinated with the ROTATEQ vaccine when shortly after became very ill and had to have surgery. The diagnosis is intussusception. This vaccine should not be on the market. This is I feel extremely unsafe for our children.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: X-ray
Clinical narrative: My grandson was vaccinated with the ROTATEQ vaccine when shortly after became very ill and had to have surgery. The diagnosis is intussusception. This vaccine should not be on the market. This is I feel extremely unsafe for our children.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5
Symptoms: Intussusception, Malaise, Surgery
Clinical narrative: My grandson was vaccinated with the ROTATEQ vaccine when shortly after became very ill and had to have surgery. The diagnosis is intussusception. This vaccine should not be on the market. This is I feel extremely unsafe for our children.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had allergy to sulfa drugs and to ciprofloxacin (unspecified). The patient medical history included chicken pox and measles in the childhood. Concomitant therapies included atenolol, meloxicam, ROBAXIN, BENTYL, PRILOSEC and red yeast rice. On 20-APR-2015 (at 19:15), the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65 ml, route subcutaneous in the left arm, lot # K018175, expiration date 10-JAN-2016). On 26-APR-2015, the patient began to experience nuasea and diarrhea which have resolved by the time of reporting. 01-MAY-2015, the patient developed also shingles rash (described as lesion, rashes on forehead and arms). The patient was seen by a physician and was diagnosed with herpes zoster.On the same day, a sample from vesicle/lesion was collected. The rash did not occur at the site of vaccination. The patient did not have recent varicella zoster virus (VZV) exposure to chicken pox and shingles. The patient was prescribed an unspecified antiviral medication. The outcome of herpes zoster was not recovered/not resolved. The relatedness between the events and therapy with ZOSTAVAX was not provided. This is one of the two reports received from the same reporter. Additional infomation has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Diarrhoea, Herpes zoster, Nausea, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had allergy to sulfa drugs and to ciprofloxacin (unspecified). The patient medical history included chicken pox and measles in the childhood. Concomitant therapies included atenolol, meloxicam, ROBAXIN, BENTYL, PRILOSEC and red yeast rice. On 20-APR-2015 (at 19:15), the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65 ml, route subcutaneous in the left arm, lot # K018175, expiration date 10-JAN-2016). On 26-APR-2015, the patient began to experience nuasea and diarrhea which have resolved by the time of reporting. 01-MAY-2015, the patient developed also shingles rash (described as lesion, rashes on forehead and arms). The patient was seen by a physician and was diagnosed with herpes zoster.On the same day, a sample from vesicle/lesion was collected. The rash did not occur at the site of vaccination. The patient did not have recent varicella zoster virus (VZV) exposure to chicken pox and shingles. The patient was prescribed an unspecified antiviral medication. The outcome of herpes zoster was not recovered/not resolved. The relatedness between the events and therapy with ZOSTAVAX was not provided. This is one of the two reports received from the same reporter. Additional infomation has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Breath holding, Decreased appetite, Emotional distress, Hypersomnia, Loss of consciousness
Clinical narrative: Woke up screaming and was inconsolable for a while. Unusual increased lack of appetite and slept longer than usual. Also started having breath holding spells at about 10 months old. Very textbook: triggered by getting very worked up, passing out and then coming "to" again after about 20 seconds. Onset of these followed her 9 mo. shots. Not sure if there is a coorelation, but it is worth mentioning. It is also worth mentioning that her older sister Adisen had a reaction to her shots. Both shots were given on the same day at the same time by the same provider and within 12 hours, both girls developed a reaction that lasted for approximately 20 hours post vaccination.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Screaming
Clinical narrative: Woke up screaming and was inconsolable for a while. Unusual increased lack of appetite and slept longer than usual. Also started having breath holding spells at about 10 months old. Very textbook: triggered by getting very worked up, passing out and then coming "to" again after about 20 seconds. Onset of these followed her 9 mo. shots. Not sure if there is a coorelation, but it is worth mentioning. It is also worth mentioning that her older sister Adisen had a reaction to her shots. Both shots were given on the same day at the same time by the same provider and within 12 hours, both girls developed a reaction that lasted for approximately 20 hours post vaccination.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching. Spread for four days to 6inch by inches. Still itching.
Age: 1.53
Sex: M
Vaccine: HEPA
Symptoms: Antisocial behaviour, Developmental delay, Injection site erythema, Pyrexia, Speech disorder developmental
Clinical narrative: Patient developed a fever that night and it continued until the next day. Redness at injection site. I gave ibuprofen and acetaminophen staggered until normal temp. I was told he was getting a different type of immunization on 7/24/14 so it would not be the same reaction, but it was worse.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted, checked out by physician, given ibuprofen by RN. Sat for another 10min and left okay.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pain
Clinical narrative: Afebrile, 3x3 area around site, warm to touch, body aches.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed hives approximately 10 minutes after vaccine administration; hives were all over body, administered 13 mg of Benadryl, patient did not have any difficulty breathing, no wheezing on auscultation, per MD, pt discharged home and advised to continue Benadryl.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Mother contacted school clinic on the morning of 05/13/2015 stating that student was fine yesterday afternoon, but in the evening she started feeling tired and aching and high fever of 102.  Mother states of the morning of 05/13/2015 student still did not feel well and continued to run temp. Took to care center and temp was per mother 104.8 and was taken to ER for further testing. When I spoke with mother she stated the only s/sx were temp and aching and fatigue.
Age: 1.15
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: 104.7 temperature came out of no where accompanied by a episode of him zoning out for 3-4 minutes.   The on call Dr was called and I was advised to give a fever reducer and watch him closely.   Between 5/6 and 5/9 his fever never got below 102 with or without a fever reducer.   The on call was called a second time on 5/7 and I was advised to increase the amount of Tylenol and motion.   5/8 a third call to the on call was made due to another 3-4 minute episode of zoning out and again I was told to watch him and take to urgent care of we were too concerned.   His fever finally broke on 5/9 and has only been up to 101 since then.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance
Clinical narrative: My son woke up not walking properly. He looks like he is limping or walking sideways. Like if he had one leg shorter then the other one. No pain and no lumps where the vaccine was administrated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of unspecified patients. On an unspecified day in May 2015 (reported as 07-MAY-2015 or 08-MAY-2015), the patients were administered unspecified number of doses of improperly stored ROTATEQ, (lot# not reported, orally). No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. From 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored ROTATEQ rote defaulted to oral (dose, lot # and expiration date were not reported). The reporting nurse stated she had no research the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of several reports from the same reporter's source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Redness, itching, hot.
Age: 1.0
Sex: F
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient presented to the clinic with symptoms of chickenpox on limbs only. Per mother patient has received varicella vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. From 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored VAQTA (dose, route, lot # and expiration date were not provided). The reporting nurse stated she had no research the medical records, that is why it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is a one of the several reports from the same reporters source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient presented to clinic on 4.30.2015 with lesions on limbs-arms and legs. Lab test done on 5.6.15 confirming patient had the chickenpox-zoster virus despite 2 doses of varicella vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Hyperhidrosis, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Had vacc on 5/11/15, reaction occurred later that day. Fever 103 degrees, leg pain, swelling, redness around site. Dr saw pt. on 5/13/15, fever 103 degrees, sweating-inj area red/swollen 6.5 inches vertically x 8 inches horizontally, splotchy red raised patches. Tx with KEFLEX: Dexamethasone.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Had vacc on 5/11/15, reaction occurred later that day. Fever 103 degrees, leg pain, swelling, redness around site. Dr saw pt. on 5/13/15, fever 103 degrees, sweating-inj area red/swollen 6.5 inches vertically x 8 inches horizontally, splotchy red raised patches. Tx with KEFLEX: Dexamethasone.
Age: 21.0
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Pt. answered no to pregnancy, received VAR 5-6-15. Pt. states had (+) HCG a few days later. She is not having reaction.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Irritability, Pyrexia, White blood cell count increased
Clinical narrative: Fever. Patient seen for well child physical on 4/28/15 and received routine 2 mos vaccinations. Pt developed fever 100.6 and fussiness that eve. Went to ER - WBC elevated. ROCEPHIN given IV. BC and UC done. F/U in office on 4/29/15 - temp 98.4 TA in office. ROCEPHIN given in office on 4/29/15. BC neg. UC neg.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain in extremity, Sinus disorder, Upper respiratory tract infection
Clinical narrative: Based on additional information received on 01 May 2015, this case initially considered as non-serious was upgraded to serious due to important medical event: upper respiratory infection and now the case became medically confirmed. Initial unsolicited report received from a non-healthcare professional (office manager) on 06 March 2015. A 53-year-old female patient, had received an intramuscular dose FLUZONE QIV (batch number- UI205AE, expire date - 30 June 2015) dose, dose in series, site of administration was not reported on 16 February 2015. The patient had no illness at time of vaccination. The patient had medical history of obesity and concomitant medications were not reported. On an unspecified date, the patient has been seen twice in the office for pain at the injection site that radiates up into her neck. The patient had required ER/doctor visit. Laboratory investigations were not provided and VICODIN was prescribed. At the time of this report the patient was not recovered from the event. Documents held by sender: none. Follow-up report received from a physician on 01 May 2015. It was reported that the patient was seen on 13 March 2015 for upper respiratory infection that started on an unspecified date and still complained of some arm pain. Patient was again seen on 13 April 2015 for sinus issue and it was reported that arm pain was completely recovered on an unspecified date. No other additional information was provided. At the time of report, the outcome of the events upper respiratory infection and sinus issue was unknown. Upon internal review, the company decided to consider the event serious because of important medical event (upper respiratory infection). Documents held by sender: none.