chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Lower respiratory tract infection, Mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On 09-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, lot#, expiration date and route were not reported). On an unknown date in 2014 the patient experienced the inability to move her arm, chest cold and swelling arm after receiving PNEUMOVAX 23. The patient was treated with prednisone (unspecified dose, frequency and manufacturer). It was unknown if the patient sought medical attention. The outcome of the events was not recovered. Additional information is not expected because there is not reporter contact information.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid swelling, erythema and pain which occurred about 4 hours after injection. Pt was seen in clinic on 12/5/14 - Recommended BENADRYL 25 mg 4 hrs. Symptoms improved, and resolved when pt was seen again on 12/8/14.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 7 year old patient of unknown gender. On 05-DEC-2014 this 7 year old patient was vaccinated with a dose of GARDASIL (lot# not reported, 0.5 ml/once, intramuscularly). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant on 21-NOV-2014 concerning 3 female patient who between 15-OCT-2014 and 27-OCT-2014 were vaccinated with an improperly stored dose of MMR II (dose, route of administration were not reported). Lot number K005175, expiration date 10-APR-2016. No adverse effects were reported. No further information received. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received on 21-NOV-2014 from the primary reporter, a medical assistant. The medical assistant reproted that 2 unspecified patients (gender and age not reported) were administered VARIVAX (Merck) that was stored improperly. No dates of vaccinations provided. No adverse effects reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received on 21-NOV-2014 from a nurse regarding doses of PROQUAD (Merck) and VARIVAX (Merck) (Reference MARRS # 1411USA011230) that were exposed to a supported temperature excursion on 15-NOV-2014 have been administered to unspecified patients on unspecified dates since this excursion on 15-NOV-2014. No adverse effect has been observed or reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 02-DEC-2014 the patient was vaccinated with an expired dose of ZOSTAVAX vial (lot # J008436, expiration date 11-OCT-2014 subcutaneously. Strength, indication and dose not provided). There was no concomitant medication. No known adverse effects. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pallor, Rash erythematous, Rash generalised
Clinical narrative: First blanching red spots, then lacey red rash in same areas; Cheeks, back, wrist, ankles, still has rash today.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Headache, Loss of consciousness
Clinical narrative: About 2 wks after #2 GARDASIL patient began having short, severe headaches N5 min in length x1/wk. H/A progressed to frequency of dly and lasting a full day-pain progressively got more severe to where patient would pass out. Many Dr visits-put on meds-tried several types- ELAVIL, Topiramate. R/O other causes. Dr felt from her vaccination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Arm swelling, red spots on arms, stomach and face. Onset after shot. Went away - came back with nausea, fever. Pt received rx VALTREX 1 gm TID x 7d. 12/8/14. Prednisone 20 mg taper down.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain at site of injection progressed to redness, swelling, warmth extending down (L) arm. Treated with anti-histamine, antibiotic, and prednisone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red rash at site of injection. Lighter red rash surrounding it. Slightly swollen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: 9 days after vaccine, red area around injection site followed by slightly pruritic maculopapular rash neck, arms, legs but most prominent on trunk.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JUL-2014 tha patient was inadvertently vaccinated with a second dose of ZOSTAVAX (0.65 ml, subcutaneous, anatomical location, lot number was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified) and then received another dose of ZOSTAVAX (lot#, expiration date, dose and route unspecified) on 02-DEC-2014. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 59 year old female patient. On 04-DEC-2014 the patient was inadvertently vaccinated with a pediatric dose of VAQTA (0.5 ml, once, intramuscular, lot # K008252, expiry date:24-OCT-2015), In 2013 (exact date unspecified, reported as about a year ago) the patient was vaccinated with a first dose of VAQTA (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old male patient. No pertinent medical history or drug reactions/allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency and route of administration were not reported). No concomitant medications were reported. On an unknown date, one week after receiving ZOSTAVAX the patient experienced rash and was diagnosed with a mild case of shingles, by his unspecified physician. The outcome of a mild case of shingles was reported as recovered (date unknown). Relatedness between vaccination with ZOSTAVAX and the adverse event was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. On 08-OCT-2014 the patient was vaccinated with second dose of VAQTA lot # K007791, expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. The patient's current conditions and medical history was not reported. On 06-SEP-2001, the patient was vaccinated with first dose of an unknown hepatitis B vaccine (manufacturer unknown) (dose, frequency, lot # and route of administration were not reported). On 04-DEC-2014 (reported as now), was in the reporting physician's office to receive a second dose. No adverse symptoms were reported. No product quality complaint (PWC) was reported for hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received on 21-NOV-2014 from a nurse regarding doses of VARIVAX (Merck) and PROQUAD (Merck) (Reference MARRS # 1412USA004221) that were exposed to a supported temperature excursion on 15-NOV-2014 have been administered to unspecified patients on unspecified dates since this excursion on 15-NOV-2014. No adverse effect has been observed or reported. No additional information was provided. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 19NOV2014 from a pharmacist. The pharmacist reported that a patient was supposed to receive a dose of VARIVAX, but instead inadvertently received a dose of ZOSTAVAX. The pharmacist does not want to be contacted. She stated the ZOSTAVAX was administered by another pharmacist (unspecified name). No symptoms were reported. The pharmacist did not want to provided any further information. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a field representative refers to a 24 year old female patient. On an unknown date the patient was inadvertently administered a dose of PROQUAD (dose, lot# and route not reported). No adverse effects reported. Additional information is not expected because the physician is not allowed to contact.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Swelling, Urticaria
Clinical narrative: Patient called me on the morning of 12/4/14 with complaints of hives, swelling and visible edema. Told to go to urgent care and went that afternoon. Called me again on 12/9/14 and told me that the symptoms have resolved.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Lethargy, Peripheral swelling, Rash
Clinical narrative: Chills (3-4 days). Skin rash on area vaccinated 5" x 3 1/2" wide. Weak and lethargic (3-4 days). Swelling on the arm.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Diarrhoea, Injection site rash, Irritability, Rash, Rash maculo-papular
Clinical narrative: On 5/9/2014 - received 12 month vaccines. On 5/20/2014 - presented with 7 days fussiness, loose stool and 3 days diffuse maculopapular truncal eruption w/ some to face and extremities. Not fussy 5/20/14. Rash self resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Skin ulcer
Clinical narrative: Patient had the vaccine on 12-2-14 and on 12-4-14 she called and left a message that she had a sore on her behind and the injection site was warm and red. We called her doctor and she was calling her to come in for a visit.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to a female patient of unknown age. Past drug history included: ZOSTAVAX. The patient explained she had a shingles outbreak that started in her pubic area in a thin band-like rash with excruciating pain that extended along her body in 200 and she went to an unidentified clinic where she thinks she was given ZOSTAVAX as treatment for her diagnosed shingles. The clinic could not confirm or deny that she was given the ZOSTAVAX vaccine. The patient did not wish to participate in the AE survey and gave limited information because of this reason. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous. Concomitant medication was not reported. On an unknown date the patient experienced she had a shingles outbreak. The outcome of she had a shingles outbreak is unknown. Action taken with the vaccine ZOSTAVAX were not reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. Past medical history included: vaccinated with ZOSTAVAX and experienced soreness at injection site date unknown. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 DF, subcutaneous. Concomitant medication were reported. On an unknown date the patient experienced soreness at the injection site. The outcome of soreness at the injection site is unknown. Action taken with ZOSTAVAX were not reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm is swollen, itching, red, hot one day after the vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Hot red swollen arm. Water blistes. Fever. Achy. Dr 11/26/14 starting to clear but blister still there.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Hot red swollen arm. Water blistes. Fever. Achy. Dr 11/26/14 starting to clear but blister still there.
Age: 60.0
Sex: M
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Culture urine, Pyrexia, Urinary tract infection
Clinical narrative: 12-03-14 Vaccines administered. 12-04-14 Wife called stating pt has fever 103. I encouraged call to PMD immediately. 12-5-14 Spoke to wife, pt was dx with UTI and put on LEVAQUIN by his PMD.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Continuing soreness and throbbing.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Localized reaction less than 24 hours did not report until 12/3/14.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age, who is also a nurse, refers to herself via company representative. The patient pertinent medical history was not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided). I was also reported that, at the same time, the patient additionally received another unspecified vaccine. On an unknown date, the patient experienced itching and swelling at the injection site. The nurse reported that she did not receive treatment, but the symptoms resolved on their own on an unspecified date. The patient did not seek medical attention. The relatedness between the events and the ZOSTAVAX was not provided. Additional information is not expected because the reporter did not wish to be contacted.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient with high blood pressure and without any drug reactions and allergies. It was reported that the patient was also a nurse. On 15-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, lot number reported as K007769, expiration date 09-OCT-2015, dose and frequency were not reported). Concomitant therapies included metoprolol, lisinopril (manufacturer unknown) and lithium carbonate. On 15-NOV-2014, after receipt of ZOSTAVAX the patient experienced an injection site reaction described as swollen lump about the height of six quarters which was warm to the touch. On 17-NOV-2014 (also reported as Monday), the patient saw an unspecified physician assistant for this reaction and the physician assistant administered an injection of DEPO-MEDROL as treatment. No lab diagnostic studies were performed. On an unknown date (reported as now) approximately in November 2014, the injection site become red but the size of a mosquito bite. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. Lot number K007769 is an invalid not number for zoster vaccine live. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: A spontaneous report was received from a 72 year old male patient who on 19-DEC-2014, received ZOSTAVAX (route and lot number not provided). Concomitant medications included an unspecified heart medication and high blood pressure medication. Concurrent conditions included "heart condition", high blood pressure and allergy to sulfur medications. The patient reported that he had two previous cases of shingles (dates not reported). In the latter part of October 2014, he came down with a case of the shingles that was worse than his previous two cases. He visited the doctor and was treated with two types of antiviral medications. No labs or diagnostic studies were performed. The outcome of the shingles was recovering. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 73 year old female patient who is also physician. The patient was immunocompetent. On 07-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date: 04-MAR-2016, 0.5 ml, intramuscular in the right arm). The reason for vaccination was reported that she was age-appropriate and so that she won't carry anything to her elderly mother. On 08-NOV-2014, the patient experienced injection site swelling and redness which was the size of a quarter on 08-NOV-2014 and had progressed to be the size of a baseball by 10-NOV-2014. No treatment was given for the events. Action taken with PNEUMOVAX 23 was not reported. The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No additional information was provided. The reporter requested for lot check for PNEUMOVAX 23, lot # K008409, expiry date: 04-MAR-2016. She indicated that she is not comfortable using any more this lot # PNEUMOVAX 23, due to these two adverse events. This one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Impaired work ability, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Cellulitis in arm of the injection, red, hard, inflamed injection site appears to have had a blister that popped. Pt experienced migraine w/aura; extreme fever, myalgia that caused loss of work.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Migraine, Migraine with aura, Myalgia, Pyrexia
Clinical narrative: Cellulitis in arm of the injection, red, hard, inflamed injection site appears to have had a blister that popped. Pt experienced migraine w/aura; extreme fever, myalgia that caused loss of work.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a 54 year old female who reported itching at the injection site after being administered with ZOSTAVAX in the left tricep on 22-NOV-2014 around 6pm. She noticed itching late at night on Sunday (23-NOV-2014). On the morning of 24-NOV-2014, the patient said she woke up and looked into the mirror and noticed a large red welt at the injection site. She explained that it is swollen and it hurts to touch. Patient said that it still itches at the injection site as well. The patient said she is not having any other symptoms. Concomitant medication included SYNTHROID. Pertinent medical history included thyroid cancer. No additional adverse event information was provided. Additional information had been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 19NOV2014 via a telephone call from a registered nurse. The nurse reported that an unspecified number of patients were administered improperly stored doses of PROQUAD (Merck) and VARIVAX (Merck). No adverse events were reported. No further information was provided. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with attention deficit disorder. On 07-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K008409, expiry date: 04-APR-2014, 0.5 ml, intramuscular in the right arm) as she had started working in a hospital. Concomitant therapies included ADDERALL tablets for attention deficit disorder and she was also on an unspecified birth control medication. On 08-NOV-2014 the patient experienced injection site swelling and tenderness and she visited physician on 10-NOV-2014. No treatment had been prescribed. Action taken with PNEUMOVAX 23 was not reported. The outcome of the events was reported as not recovered/not resolved. No additional information was provided. The causality was unknown. The reporter requested for lot check for PNEUMOVAX 23, lot # K008409, expiry date: 04-APR-2014. She indicated that she was not comfortable using any more this lot of PNEUMOVAX 23, due to these two adverse events. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date (reported as Friday or Saturday), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were not reported). On an unknown date, the patient developed flu-like symptoms, headache, redness and swelling at the injection site. The outcome of flu-like symptoms, headache and redness and swelling at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not 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 nurse refers to unknown number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with improperly stored PEDVAX (strength, dosage, frequency and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: A spontaneous report was received on 25-NOV-2014 from a female physician, who was also the patient. On an unspecified date, the female received an injection of ZOSTAVAX (route and lot number not provided). Medical history and concomitant medications were not provided. In November 2014 (reported as "about a week ago") after receiving the injection, she developed redness, itchiness and "wheel" at the injection site. At the time of the report, the redness had migrated to the elbow. The physician/patient declined to provide any further information at the time of the report. The redness at the injection site was not recovered. The outcomes of the itchiness and "wheel" at injection site were unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient complained of pruritus and reddened bumps to extremities. Patient stated she took BENADRYL and the symptoms subsided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The concomitant medication included an unknown number of unspecified medications. On 01-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number: K008880, expiration date: 09-SEP-2015) (dose and frequency were unknown) subcutaneously. On an unknown date in 2014 after receiving ZOSTAVAX the patient experienced pain at the injection site. The current condition of the patient included allergies with penicillin and codeine. There was no treatment given for the adverse event. No lab diagnostic studies were performed. The patient had called the pharmacy for medical attention. The outcome of the event was reported as not recovered. The causal relationship of the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient had painful swelling at ZOSTAVAX injection site which was tender to touch.
Sex: F
Vaccine: MMR
Symptoms: Foetal disorder, Maternal exposure timing unspecified
Clinical narrative: Information has been received from a female who on 30-JUN-1988 was vaccinated with MMR (second generation). She was 4 and a half months pregnant at the time. She gave birth to a male who was blind in one eye, had a seizure disorder, experienced fevers "off and on", diarrhea, and had learning problems. The patient also developed a skin rash which "when it came it covered his body". She also indicated her son may be sterile. She indicated her son had other unspecified conditions as well. No further information is available. Follow up information has been received from a female consumer who on an unspecified date 26 years ago while pregnant (previously reported as four and a half months) was vaccinated with M-M-R II (previously reported as vaccinated on 30-JUN-1988 with MMR (second generation). No further information was provided. The adverse events of blind in one eye, retarded, seizure disorder, high fevers "off and on", diarrhea, skin rash, skin rash, sterility and unspecified condition have been removed and captured into the child's case (MARRS # 1412USA003684). Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain in extremity, Tenderness, Upper extremity mass
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with high blood pressure. On 21-AUG-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K004483 and expiration date was 16-AUG-2015) dose 0.5 ml, intramuscular. No concomitant therapy was reported. On an unknown date approximately in 2014, the patient experienced pain at the injection site immediately after receiving the PNEUMOVAX 23. The pharmacist stated that the patient reported that it feels like there was something there at the injection site, had a lot of discomfort at the injection site which developed on an unspecified date since receiving the PNEUMOVAX 23. The pharmacist reported that the patient also received an unspecified Flu vaccine on the same day as the PNEUMOVAX 23 but the Flu vaccine was administered in the opposite arm as the PNEUMOVAX 23. Patient sought medical attention as the patient went in to the pharmacy on 20-NOV-2014 to inform the pharmacist of the symptoms. The outcome of pain at the injection site immediately after receiving PNEUMOVAX 23 was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with high blood pressure. On 21-AUG-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K004483 and expiration date was 16-AUG-2015) dose 0.5 ml, intramuscular. No concomitant therapy was reported. On an unknown date approximately in 2014, the patient experienced pain at the injection site immediately after receiving the PNEUMOVAX 23. The pharmacist stated that the patient reported that it feels like there was something there at the injection site, had a lot of discomfort at the injection site which developed on an unspecified date since receiving the PNEUMOVAX 23. The pharmacist reported that the patient also received an unspecified Flu vaccine on the same day as the PNEUMOVAX 23 but the Flu vaccine was administered in the opposite arm as the PNEUMOVAX 23. Patient sought medical attention as the patient went in to the pharmacy on 20-NOV-2014 to inform the pharmacist of the symptoms. The outcome of pain at the injection site immediately after receiving PNEUMOVAX 23 was reported as not recovered/not resolved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site nodule, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: One inch needle - patient weight 125 pounds. Immediate sharp hairline pain shooting to elbow (medial upper arm) and radiating over shoulder down to left scapula. Unable to move arm next day lasting to 3 days (movement returned). Pain continues to upper arm; unable to lift arm against resistance. Unable to stretch arm over head or do lateral twisting of arm. Loss of range of motion approximately 25% so far is permanent.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: One inch needle - patient weight 125 pounds. Immediate sharp hairline pain shooting to elbow (medial upper arm) and radiating over shoulder down to left scapula. Unable to move arm next day lasting to 3 days (movement returned). Pain continues to upper arm; unable to lift arm against resistance. Unable to stretch arm over head or do lateral twisting of arm. Loss of range of motion approximately 25% so far is permanent.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: One inch needle - patient weight 125 pounds. Immediate sharp hairline pain shooting to elbow (medial upper arm) and radiating over shoulder down to left scapula. Unable to move arm next day lasting to 3 days (movement returned). Pain continues to upper arm; unable to lift arm against resistance. Unable to stretch arm over head or do lateral twisting of arm. Loss of range of motion approximately 25% so far is permanent.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Abnormal dreams, Activities of daily living impaired, Fatigue, Feeling abnormal
Clinical narrative: Within two minutes heart started to race.  Lasted approx 30-60 sec then stopped.  Sneezed all day long and was drowsy.   Awoke the next morning with sinuses severely congested and swollen. Had extreme exhaustion but no fever.  These symptoms lasted a little over a week and stayed home sick 1-1/2 days.  Symptoms subsided for a couple days and now feel like I have hard compacted sinuses, foggy brain, vivid dreams and mild hallucinations upon falling asleep and waking. My neck is tight but this may be normal for me as I have had whiplash multiple times.  It should be noted that each time I get the flu sinus or stomach related my neck hurts sometimes to extremes.  I feel that the first week is related to the LIAV nasal vaccination and feel that the virus may be stuck in my sinuses causing havoc.  I did not realize that the nasal vaccine had live viruses as I would not have tried this.  It has been approx 20 yrs since my last flu vaccine. I got sick with each shot. It should be noted that in 80s I had a RASP test that said I was allergic to eggs. I currently eat eggs 3-5 times a week with no symptoms.  Since the Laiv vaccine my stomach hurts each time I eat eggs.  Wanted to report all symptoms in case this is happening to anyone else. Thank you.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Hallucination, Muscle tightness, Palpitations, Sinus congestion, Sinus disorder
Clinical narrative: Within two minutes heart started to race.  Lasted approx 30-60 sec then stopped.  Sneezed all day long and was drowsy.   Awoke the next morning with sinuses severely congested and swollen. Had extreme exhaustion but no fever.  These symptoms lasted a little over a week and stayed home sick 1-1/2 days.  Symptoms subsided for a couple days and now feel like I have hard compacted sinuses, foggy brain, vivid dreams and mild hallucinations upon falling asleep and waking. My neck is tight but this may be normal for me as I have had whiplash multiple times.  It should be noted that each time I get the flu sinus or stomach related my neck hurts sometimes to extremes.  I feel that the first week is related to the LIAV nasal vaccination and feel that the virus may be stuck in my sinuses causing havoc.  I did not realize that the nasal vaccine had live viruses as I would not have tried this.  It has been approx 20 yrs since my last flu vaccine. I got sick with each shot. It should be noted that in 80s I had a RASP test that said I was allergic to eggs. I currently eat eggs 3-5 times a week with no symptoms.  Since the Laiv vaccine my stomach hurts each time I eat eggs.  Wanted to report all symptoms in case this is happening to anyone else. Thank you.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Sneezing, Somnolence
Clinical narrative: Within two minutes heart started to race.  Lasted approx 30-60 sec then stopped.  Sneezed all day long and was drowsy.   Awoke the next morning with sinuses severely congested and swollen. Had extreme exhaustion but no fever.  These symptoms lasted a little over a week and stayed home sick 1-1/2 days.  Symptoms subsided for a couple days and now feel like I have hard compacted sinuses, foggy brain, vivid dreams and mild hallucinations upon falling asleep and waking. My neck is tight but this may be normal for me as I have had whiplash multiple times.  It should be noted that each time I get the flu sinus or stomach related my neck hurts sometimes to extremes.  I feel that the first week is related to the LIAV nasal vaccination and feel that the virus may be stuck in my sinuses causing havoc.  I did not realize that the nasal vaccine had live viruses as I would not have tried this.  It has been approx 20 yrs since my last flu vaccine. I got sick with each shot. It should be noted that in 80s I had a RASP test that said I was allergic to eggs. I currently eat eggs 3-5 times a week with no symptoms.  Since the Laiv vaccine my stomach hurts each time I eat eggs.  Wanted to report all symptoms in case this is happening to anyone else. Thank you.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Feeling of body temperature change, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: Muscles hurt in legs and arms.  Became feeling cold and trembling. Took two aspirin at 2:00 AM 12/10/2014 and ate a banana. Went from cold to hot and got the sweats. Feel better now and I seem to be stable.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Muscles hurt in legs and arms.  Became feeling cold and trembling. Took two aspirin at 2:00 AM 12/10/2014 and ate a banana. Went from cold to hot and got the sweats. Feel better now and I seem to be stable.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain
Clinical narrative: Right arm felt sore, a bit of pain at site. Redness.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: This medically confirmed report (initial receipt 25-Nov-2014) concerns a 14 year old male patient. On the 07-Nov-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and the GARDASIL (batch number not reported) on the same day. On the 13-Nov-2014, the patient had a stroke. Outcome was not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Myalgia, Myositis, Neuralgia, Restlessness
Clinical narrative: This spontaneous report as received from a 71 year old female consumer refers to herself as a patient with asthma, borderline type 2 diabetic, ampicillin and CAFERGOT allergy. On 28-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot, dose and route were not reported). Concomitant medication included astatine and cataract medication. On an unknown date in 2014 (reported as a couple of days after receiving the vaccine), the patient experienced nerve pain and inflamed muscle pain all over her body. The patient was unable to walk and now had to use a walker. When the patient tried to lie down she was unable to rest because of the severity of the pain. The patient sought for medical attention (called physician). The patient received unspecified pain shot as treatment for the events. No lab diagnostics performed. The outcome of nerve pain and inflamed muscle pain all over her body, unable to walk and unable to rest were reported as not recovered. The events were considered serious due to disability by the reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: This spontaneous report as received from a 71 year old female consumer refers to herself as a patient with asthma, borderline type 2 diabetic, ampicillin and CAFERGOT allergy. On 28-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot, dose and route were not reported). Concomitant medication included astatine and cataract medication. On an unknown date in 2014 (reported as a couple of days after receiving the vaccine), the patient experienced nerve pain and inflamed muscle pain all over her body. The patient was unable to walk and now had to use a walker. When the patient tried to lie down she was unable to rest because of the severity of the pain. The patient sought for medical attention (called physician). The patient received unspecified pain shot as treatment for the events. No lab diagnostics performed. The outcome of nerve pain and inflamed muscle pain all over her body, unable to walk and unable to rest were reported as not recovered. The events were considered serious due to disability by the reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Blindness congenital, Convulsion, Diarrhoea, Learning disorder, Malaise
Clinical narrative: Information has been received from a female who on 30-JUN-1988 was vaccinated with MMR (second generation). She was 4 and a half months pregnant at the time. She gave birth to a male who blind in one eye, had a seizure disorder, experienced fevers "off and on", diarrhea, and had learning problems. The patient also developed a skin rash which "when it came it covered his body". She also indicated her son may be sterile. She indicated her son had other unspecified conditions as well. No further information is available. Follow up information has been received from a female consumer who refers to her now 26 year old son. The patient's mother stated, "on an unspecified date 26 years ago (previously reported as 30-JUN-1988), while she was pregnant (date not provided, previously reported as 4 and a half months), was given a dose of MMR" (also reported as M-M-R II INJ and previously reported was vaccinated with MMR, second generation). The patient's mother stated, "her son was born blind (previously reported as blind in one eye), extremely ill, has suffered physically and mentally all his life, mildly retarded and suffers from seizures." No further information was provided. Upon internal review born blind, mildly retarded and seizures were determined medically significant. The events of born blind and mildly retarded were considered both disabling and a congenital anomaly. The adverse events were previously reported within the maternal case (MARRS # 98032333). Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mild mental retardation, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a female who on 30-JUN-1988 was vaccinated with MMR (second generation). She was 4 and a half months pregnant at the time. She gave birth to a male who blind in one eye, had a seizure disorder, experienced fevers "off and on", diarrhea, and had learning problems. The patient also developed a skin rash which "when it came it covered his body". She also indicated her son may be sterile. She indicated her son had other unspecified conditions as well. No further information is available. Follow up information has been received from a female consumer who refers to her now 26 year old son. The patient's mother stated, "on an unspecified date 26 years ago (previously reported as 30-JUN-1988), while she was pregnant (date not provided, previously reported as 4 and a half months), was given a dose of MMR" (also reported as M-M-R II INJ and previously reported was vaccinated with MMR, second generation). The patient's mother stated, "her son was born blind (previously reported as blind in one eye), extremely ill, has suffered physically and mentally all his life, mildly retarded and suffers from seizures." No further information was provided. Upon internal review born blind, mildly retarded and seizures were determined medically significant. The events of born blind and mildly retarded were considered both disabling and a congenital anomaly. The adverse events were previously reported within the maternal case (MARRS # 98032333). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Atrioventricular block first degree, Blood glucose normal, Bundle branch block right, Cardiac stress test normal
Clinical narrative: Received 5 vaccines (Tdap, MCV4, Gardasil, HepA, flu) in office, returned to office after going across the hall to get brothers bloodwork done, (child did not actually have blood drawn), where child had an event where he turned pale, became sweaty, lightheaded, and nauseated. Was standing still when sx started. Never had syncopal events prior, and no exertional syncope, dizziness or chest pain. Hadn't had anything to eat that day. Oon arrival back to office c/o periumbilical abdominal pain. No loss of consciousness in lab, able to walk in to our office, but here with decreased arousability, not responding appropriately to commands, alert to name and day of week, not place. Stable glc (103). Irregular heart rate (c/w PVCs) strength 5/5, symmetric and full facial movements, perrl, eomi. Monitored in office for > 20 minutes, without return to normal consciousness, so called 911 and transported to ER.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
Clinical narrative: Received 5 vaccines (Tdap, MCV4, Gardasil, HepA, flu) in office, returned to office after going across the hall to get brothers bloodwork done, (child did not actually have blood drawn), where child had an event where he turned pale, became sweaty, lightheaded, and nauseated. Was standing still when sx started. Never had syncopal events prior, and no exertional syncope, dizziness or chest pain. Hadn't had anything to eat that day. Oon arrival back to office c/o periumbilical abdominal pain. No loss of consciousness in lab, able to walk in to our office, but here with decreased arousability, not responding appropriately to commands, alert to name and day of week, not place. Stable glc (103). Irregular heart rate (c/w PVCs) strength 5/5, symmetric and full facial movements, perrl, eomi. Monitored in office for > 20 minutes, without return to normal consciousness, so called 911 and transported to ER.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Heart rate irregular, Hyperhidrosis, Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: Received 5 vaccines (Tdap, MCV4, Gardasil, HepA, flu) in office, returned to office after going across the hall to get brothers bloodwork done, (child did not actually have blood drawn), where child had an event where he turned pale, became sweaty, lightheaded, and nauseated. Was standing still when sx started. Never had syncopal events prior, and no exertional syncope, dizziness or chest pain. Hadn't had anything to eat that day. Oon arrival back to office c/o periumbilical abdominal pain. No loss of consciousness in lab, able to walk in to our office, but here with decreased arousability, not responding appropriately to commands, alert to name and day of week, not place. Stable glc (103). Irregular heart rate (c/w PVCs) strength 5/5, symmetric and full facial movements, perrl, eomi. Monitored in office for > 20 minutes, without return to normal consciousness, so called 911 and transported to ER.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Ventricular extrasystoles
Clinical narrative: Received 5 vaccines (Tdap, MCV4, Gardasil, HepA, flu) in office, returned to office after going across the hall to get brothers bloodwork done, (child did not actually have blood drawn), where child had an event where he turned pale, became sweaty, lightheaded, and nauseated. Was standing still when sx started. Never had syncopal events prior, and no exertional syncope, dizziness or chest pain. Hadn't had anything to eat that day. Oon arrival back to office c/o periumbilical abdominal pain. No loss of consciousness in lab, able to walk in to our office, but here with decreased arousability, not responding appropriately to commands, alert to name and day of week, not place. Stable glc (103). Irregular heart rate (c/w PVCs) strength 5/5, symmetric and full facial movements, perrl, eomi. Monitored in office for > 20 minutes, without return to normal consciousness, so called 911 and transported to ER.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever (100.8F), severe chills (until 4:00 AM next day)), total body aches (ongoing), headache (resolved), fatigue (ongoing).  Patient took Nyquil.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diet refusal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth started at injection site (Left ant thigh)within 1 hour of injection. Radiated down left leg into foot during course of the day until about 2:00AM. Swelling & redness was significant. Child crying inconsolably. No fever. Wouldn't nurse. Dr. advised cool compresses to leg, bath and acetaminophen. Mother sent pictures of leg via cell phone.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Headache
Clinical narrative: Headache, body ache and chills, dizziness and light headed did not eat or drink for two days with fever of 99.8. Husband to me to Hospital. Was put on 24 hour quarters after eating small amounts of food I then had diarrhea for 2 days and returned to Health Care where they gave me a shot in the butt and meds to take for the diarrhea.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, body ache and chills, dizziness and light headed did not eat or drink for two days with fever of 99.8. Husband to me to Hospital. Was put on 24 hour quarters after eating small amounts of food I then had diarrhea for 2 days and returned to Health Care where they gave me a shot in the butt and meds to take for the diarrhea.