chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 14 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: PEDIARIX, ACTHIB and PREVNAR administered and child developed hives on both feet diminished within 5 minutes.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 year old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014.  There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J006358, expiry 23-MAy-2015 ("VFC" stock) 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 13 month old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unreported date. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date after two weeks after administration of ZOSTAVAX, the patient experienced itching at the injection site. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 years old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 years old child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling around injection site, 4.5 cm x 7.5 cm. Ibuprofen given at 1300 today, Benadryl given in clinic today.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Facial paresis, Hypogeusia, VIIth nerve paralysis
Clinical narrative: Facial weakness, facial droop, decreased taste sensation.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a consumer via company representative refers to a 16 year old patient. On an unknown date, the 16 year old patient was vaccinated inadvertently an adult dose of VAQTA (50/1.0 U/ML) (dose, route and frequency were not reported). No further details were provided. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old patient. On 23-APR-2014, the patient was vaccinated with second dose of expired ROTATEQ suspension 2, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved. The outcome of events was unknown. No other information was reported. This report is linked to 1405USA001639 and 1405USA006754 by the same reporter link. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular, Scab, Skin lesion
Clinical narrative: Varicella vaccine given on 4/22/14. On 5/10/14 patient presented to office with "rash". Rash started around 5/8/14. First on face around mouth/nose, then spread almost everywhere. On exam - scattered papulovesicular rash - some in clusters - nose, mouth, torso, extremities, lesions in different stages of disease. Some scabbed.
Age: 51.0
Sex: F
Vaccine: HEPAB, IPV, MMR, TDAP, TYP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Client phoned 2 weeks after receiving vaccine c/o pain in both arms. No fever no swelling no redness just pain. Client will contact us if persists. Client returns from trip and reports pain continues left arm is worse than right arm. Unable to life anything or cross arm over her chest client is going to ER for evaluation.
Age: 0.4
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: See attached report.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, strength, route and lot# not reported) that was stored improperly. The nurse did not have the temperature and the time period the RECOMBIVAX HB was out of range. No adverse effects were reported. No PQC involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 patients of unknown age and gender. On an unknown date the patients were inadvertently vaccinated with an unspecified doses of VARIVAX (Merck) (route, lot number and expiration date not reported) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Age: 1.24
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5ml, intramuscular (lot # J006695, expiry 30-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 years child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on a unspecified date. No adverse effect was reported. This is one of several reports form the same source. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 11 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006695, expiry 30-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Redness and swelling, pain at injection site.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX 0.5ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.98
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX 0.5ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated that was a power outage on 12-APR-2014 and (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Infant received first set of shots, developed fever and had seizure. 911 called and transported to ER. Treated with MOTRIN, observed and released. All events reported to me by mother via phone call.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported). Other suspect therapies included PROQUAD (Merck) (Lot #, dose and route not reported). It was reported that VARIVAX (Merck) and PROQUAD (Merck) were stored improperly. No adverse effects reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report as received from a medical assistant refers to a 11-month-old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, intramuscular (lot # J006358, expiry 23-MAY-2015) that was stored inappropriately. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 78 year old female patient reporting on herself. No pertinent medical history, drug reactions or allergies reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) lot # J014404, expiry date: 22-JAN-2015. Concomitant therapies included lisinopril (manufacturer unknown) (5mg, once daily). On an unknown date, the same day she received the vaccine, the patient experienced "severe adverse reactions" that included, pain and swelling in her arm that hurt so bad she could not move it. The patient stated that the pain and swelling increased the next day. No treatment was given for the adverse events. No lab studies were performed. The patient did not seek medical attention. On an unknown date, after the third day, the patient was recovered. Causality was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Rash, Skin discolouration
Clinical narrative: This spontaneous report was received from a consumer refers to a 60 year old female patient. No pertinent medical history. No drug reactions or allergies. On 07-NOV-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous injection for prevention of shingles (lot number, strength and dose number not provided). Concomitant therapy reported as COUMADIN (unspecified dose, frequency and manufacturer). On 10-NOV-2013, the patient initially experienced redness and aches at the injection site where she received ZOSTAVAX injection. Since the initial injection, her symptoms have progressed into weakness, discoloration of skin, indentations, white spots and pain in and around the injection site. No treatment was given for the event. Lab diagnostics studies were not performed. Patient sought medical attention through an office visit (unspecified date). At the time of the report, the outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: This spontaneous report was received from a consumer refers to a 60 year old female patient. No pertinent medical history. No drug reactions or allergies. On 07-NOV-2013, the patient was vaccinated with ZOSTAVAX, subcutaneous injection for prevention of shingles (lot number, strength and dose number not provided). Concomitant therapy reported as COUMADIN (unspecified dose, frequency and manufacturer). On 10-NOV-2013, the patient initially experienced redness and aches at the injection site where she received ZOSTAVAX injection. Since the initial injection, her symptoms have progressed into weakness, discoloration of skin, indentations, white spots and pain in and around the injection site. No treatment was given for the event. Lab diagnostics studies were not performed. Patient sought medical attention through an office visit (unspecified date). At the time of the report, the outcome of the events was reported as not recovered/not resolved. The causal relationship between the events and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site. Swelling at injection site. Warm to touch.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. On 25-APR-2014 the patient was vaccinated with ZOSTAVAX (route, lot number and expiration date not reported). On 25-APR-2014, the patient received less than a full dose of ZOSTAVAX. Pharmacist stated that the syringe leaked upon administration of the ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients of unspecified demographics. On an unknown date, doses of VARIVAX (Merck) were exposed to 36 Fahrenheit (F) for 20 hours. On an unknown date, unspecified patients might have vaccinated with VARIVAX (Merck) (doses unspecified) doses which were exposed to 36 Fahrenheit (F) for 20 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of doses of VARIVAX (Merck) exposed to 36 F for 20 hours was unknown. No further information reported. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema, Skin warm, Swelling
Clinical narrative: Redness, edema, warmth/hot to touch area also w/lump per pt.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Swelling, tenderness and erythema to about 5-6 cm.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hypoacusis, Muscle spasms
Clinical narrative: After administration of HAVRIX, pt felt faint, light headedness and hard of hearing and fingers cramping within 5 mins of receiving vaccine. Prior to administration, pt felt nervous but reported no adverse rxns to any other vaccines. Pt does report that similar feelings have occurred due to menstruation. Pt did not report hives or shortness of breath. Possible anxiety attack or due to vaccine unknown. Pt later recovered and was able to leave pharmacy when symptoms resolved.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swelling surrounding injection site (R) thigh x 2 days (diluent J015691 06/2016 - for both MMR/VZV).
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Cerebral haemorrhage, Hemiplegia
Clinical narrative: Cerebral bleed causing left hemiplegia.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Pain from this flu shot much worse than any other shots I have received since I was a child. As days progressed, pain in left arm at sight of injection went from 3 to 6 (pain scale), sharp pain from shoulder to elbow, limiting mobility. For 6 months pain went from 6 to 3, dull ache, increased mobility. Now at 8 months noticed pain increasing to 4-5, decreasing mobility. OTC pain meds don't help, exercise makes pain worse. Don't think doctor would/could help. I do not believe pain was from vaccine but from inept administration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Herpes zoster, Lethargy, Nasopharyngitis
Clinical narrative: I had shingles years ago. Approximately two weeks after vaccine, I began having burning sensations in same area as shingles rash appeared previously. No rash, but some sensation to varying degrees every day on/off. Also mild on/off cold symptoms, low fever, lethargy. Continues to present.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had shingles years ago. Approximately two weeks after vaccine, I began having burning sensations in same area as shingles rash appeared previously. No rash, but some sensation to varying degrees every day on/off. Also mild on/off cold symptoms, low fever, lethargy. Continues to present.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: I got a Shingles vaccine to keep from getting Shingles and immediately got Shingles after getting the vaccine. I have been receiving treatment for Shingles since May 07.
Age: 82.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pruritus
Clinical narrative: My right arm was itching near the injection site and when, I looked at it, there was a large area from just below the shoulder down to the elbow and the width of the arm that was red and swollen with the hives.  Hydrocortisone was applied to the area and Benadryl taken to relieve the itching.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Excruciating joint pain that started in the left wrist and then moved to the right.  The pain lasted about 2-3 days each side. Excessive pain was caused by turning and putting any pressure on the writs lasted for about 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Noticed red area around vaccination site on (L) upper leg/thigh yesterday. No fever. A little warm to touch. Area about 20cm wide.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash vesicular
Clinical narrative: Severe swelling of injection site zoster outbreak on face, under eyes. Physician chose not to treat as if appears to be resolving.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: 19 cm x 19 cm area of redness on (R) thigh, warm, non tender. Cellulitis,
Age: 1.09
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain
Clinical narrative: Within a minute of administration child developed local allergic reaction. Large red area with mild swelling, pain. BENADRYL po given and soreness dissipated within 1/2 hr left clinic with mild erythema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on (L) upper arm, stomach, and (R) leg the next day after vaccine. Received one dose BENADRYL. Rash cleared right away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Patient reports sore arm, warm to touch patient on doxycycline for another infection told patient to ice and take MOTRIN if worsens contact primary care provider.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised circular area noted at injection site (R) deltoid measures 4 cm (L) x 2 cm W. Red raised warm to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAY-2014, the unspecified number of patients were vaccinated with ZOSTAVAX, subcutaneous (lot number, dose number and dose not provided). The pharmacist reported that ZOSTAVAX vaccine reached a -9C. No adverse effects were reported. At the time of the report, the outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old daughter. On 15-APR-2014, the patient was vaccinated with a fourth dose of GARDASIL (dose, route and lot # not reported). The consumer stated that the patient received her third dose at a previous doctor's visit within the same office. The physician stated to the mother that her daughter was in their computer system twice under two names and that was why he administered her the fourth shot of GARDASIL. There were no Lab diagnostics or studies performed. Follow up information was received stated that: On 15-APR-2014 at 4:00 pm, the patient was vaccinated with a fourth dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016), intramuscular in the left arm for prevention of HPV. The patient received a fourth dose of GARDASIL, but they were not aware that the patient received a previous dose at another physician's office. The patient never had any effects. They had a verbal consent from the parent. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 22-APR-2014, the patient was vaccinated with the first dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# unknown). On 05-MAY-2014 the patient was vaccinated with the second dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# unknown). Pharmacist stated patient might have received 2 doses of ZOSTAVAX. Pharmacist stated upon entry into "MICR" (Immunization records) in the last few days, an entry was noted for patient that ZOSTAVAX was administered at an unspecified location on 22-APR-2014 by an unspecified clinician. Pharmacist stated patient received ZOSTAVAX on 05-MAY-2014 at a store from a pharmacist. No adverse effects reported. Pharmacist stated there might have been a language barrier when patient communicated she needed as "shot for shingles". The patient did not seek for medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. No Medical history or concurrent conditions were reported. On 09-MAY-2014, the unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot number, dose number and dose not provided). The pharmacist reported that the (Oka/Merck) VARIVAX vaccine reached a -9C. No adverse effects were reported. At the time of the report, the outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer, reporting to his 16 month old female daughter. Medical history was not reported. On 08-MAY-2014 the patient was vaccinated with GARDASIL lot number, route, strength, dosage, frequency, were not reported, on her thigh. Concomitant therapy was not reported. The consumer informed that on 08-MAY-2014, her daughter received GARDASIL, all 3 doses at the same time. The consumer stated that the doctor accidentally gave her daughter the vaccine. No adverse effects have been reported. The outcome of the events were unknown. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, reporting to his 16 month old female daughter. Medical history was not reported. On 08-MAY-2014 the patient was vaccinated with GARDASIL lot number, route, strength, dosage, frequency, were not reported, on her thigh. Concomitant therapy was not reported. The consumer informed that on 08-MAY-2014, her daughter received GARDASIL, all 3 doses at the same time. The consumer stated that the doctor accidentally gave her daughter the vaccine. No adverse effects have been reported. The outcome of the events were unknown. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, reporting to his 16 month old female daughter. Medical history was not reported. On 08-MAY-2014 the patient was vaccinated with GARDASIL lot number, route, strength, dosage, frequency, were not reported, on her thigh. Concomitant therapy was not reported. The consumer informed that on 08-MAY-2014, her daughter received GARDASIL, all 3 doses at the same time. The consumer stated that the doctor accidentally gave her daughter the vaccine. No adverse effects have been reported. The outcome of the events were unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Later that night was not able to sleep all night rest less and site of injection was very painful.   Next day 5/13/14 ran a fever school nurse took temp and it was at 102.00 in addition headache, nausea with stomach ache, very tired/weak and dizzy.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Insomnia, Nausea, Pyrexia, Restlessness
Clinical narrative: Later that night was not able to sleep all night rest less and site of injection was very painful.   Next day 5/13/14 ran a fever school nurse took temp and it was at 102.00 in addition headache, nausea with stomach ache, very tired/weak and dizzy.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Local swelling, Tenderness
Clinical narrative: Significant swelling with firm area of induration measuring 6cmX4cm, no erythema, no discharge. Mild TTP, no radicular component, no gross motor weakness.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Barium swallow, Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram
Clinical narrative: Pain across shoulders, numbness and tingling in feet, hands, throat.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Lumbar puncture, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain across shoulders, numbness and tingling in feet, hands, throat.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pharyngeal hypoaesthesia, Scan, Throat irritation
Clinical narrative: Pain across shoulders, numbness and tingling in feet, hands, throat.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose 3; route, dosage and lot number unknown). The pharmacist reported that the patient received the third dose of GARDASIL on an unspecified date approximately 1.5 years after the second dose. The pharmacist did not know the dates the patient received any of the previous doses. No adverse symptoms were reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Headache, Local swelling, Musculoskeletal stiffness
Clinical narrative: Day 5 - Aching in knee joints, dull headache, more tired than usual; Day 6 - Aching in elbows, wrists and fingers; Day 7 - Aching in hips, stiff and slightly swollen fingers.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Severe total body tremors/trembling; inability to get warm or to stop trembling for 4-5 hours followed by 104 degree fever and sweating. The fever began shortly after the trembling stopped and lasted for 4-5 hours. With the fever came redness and swelling of the face, joint pain and body aches. 3 doses of Naproxen Sodium relieved the fever, but the joint pain and fatigue remain.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling face, Tremor
Clinical narrative: Severe total body tremors/trembling; inability to get warm or to stop trembling for 4-5 hours followed by 104 degree fever and sweating. The fever began shortly after the trembling stopped and lasted for 4-5 hours. With the fever came redness and swelling of the face, joint pain and body aches. 3 doses of Naproxen Sodium relieved the fever, but the joint pain and fatigue remain.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA, IPV, TYP
Symptoms: Arthralgia
Clinical narrative: Onset of pain and soreness of hip joints. Patient returned today to get Hep B accel. He inquired if any of the vaccines he received 4/25 could make for soreness in hip joints. States he noticed yesterday a soreness in both hip joints (very isolated areas), but particularly in left hip. States he has not done any sports or anything that would make him sore like this, but only traveled on airplane for work etc. I inquired if he would rather wait and not do 2nd Hep B today and he said "no, he was fine to proceed, that he wasn't even sure it was the vaccines". We reviewed common side effects of each of the vaccines he received 4/25, and none appear to cause joint soreness. I encouraged him to let me know if symptoms worsened and informed him I would report to VAERS.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a 61 year old female registered dental hygienist (R.D.H) refers to herself. The patient had no pertinent medical history and no drug reactions/allergies. On 19-FEB-2014 the patient was vaccinated with ZOSTAVAX vial (dose, route and lot# unspecified). No concomitant medication. On approximately 02-APR-2014 (reported as "6 weeks" after receiving ZOSTAVAX), the patient experienced neuropathy mainly in her toes that was very painful. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given for the event. The registered dental hygienist stated the neuropathy came and went and if it affected her walking she would consider it a significant disability. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a consumer as part of a marketing research program refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (unknown dose, frequency and route). Respondent mentioned when he asked MD about shingles, the doctor mentioned there was a vaccine for it, but he said that he doesn't recommend it because it can cause paralysis. Respondent did not receive vaccine personally). The outcome of the event was unknown. Causality assessment was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TYP, YF
Symptoms: Acne, Eye swelling, Hyperhidrosis, Increased upper airway secretion, Influenza like illness
Clinical narrative: Described flu-like symptoms very sore throat which feels "coated". Very sweaty, but denied any fever. Initially had swelling and 'bump like' pimples under each eye, but resolved within a day. On next day she had improvement "gargling" helped throat (had yellow phlegm). Was going to take cold and allergy medicine.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TYP, YF
Symptoms: Oropharyngeal pain
Clinical narrative: Described flu-like symptoms very sore throat which feels "coated". Very sweaty, but denied any fever. Initially had swelling and 'bump like' pimples under each eye, but resolved within a day. On next day she had improvement "gargling" helped throat (had yellow phlegm). Was going to take cold and allergy medicine.
Age: 1.29
Sex: F
Vaccine: HBHEPB, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Given a Tdap instead of a DTaP.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Pain
Clinical narrative: Patient noted on 5/13/14 arm soreness with movement - (L) upper arm. Then noted red and tender nodule under the skin. Punctuate at (L) deltoid noted. Exam on 5/15/14 revealed sl red, tender, well circumscribed nodule. Recommended warm compresses and treated with AUGMENTIN 875 twice a day for 10 days.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Temp 97.8 axillary. Hives - within 24 hr of receiving vaccination and on her bottom, thigh and arms. Given BENADRYL 2.5 ml on Tuesday.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Chills, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: FEVER, STIFF NECK, LACK OF ENERGY UPON WAKING UP. WORSENED THROUGH OUT THE DAY. FEVER SET IN AT 104.5 - 105 DEG. NAUSEA, AND CHILLS UNEFFECTED BY MEDICATION TO REDUCE TEMPERATURE. USED COLD COMPRESS TO HELP REDUCE FEVER. 24 HOURS AFTER ONSET OF TEMPERATURE FEVER REMAINS. STILL NAUSEATED AND VOMITING. TEMPERATURE 30 HOURS AFTER ADMINISTRATION OF VACCINE STILL 104 DEG. WE ARE TAKING HIM BACK TO PROVIDER FOR FOLLOW UP.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: FEVER, STIFF NECK, LACK OF ENERGY UPON WAKING UP. WORSENED THROUGH OUT THE DAY. FEVER SET IN AT 104.5 - 105 DEG. NAUSEA, AND CHILLS UNEFFECTED BY MEDICATION TO REDUCE TEMPERATURE. USED COLD COMPRESS TO HELP REDUCE FEVER. 24 HOURS AFTER ONSET OF TEMPERATURE FEVER REMAINS. STILL NAUSEATED AND VOMITING. TEMPERATURE 30 HOURS AFTER ADMINISTRATION OF VACCINE STILL 104 DEG. WE ARE TAKING HIM BACK TO PROVIDER FOR FOLLOW UP.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Had typical arm soreness after injection but arm has been sore ever since. I have had flu shots before and never had this happen. My arm has been sore everyday since the shot especially when I move it to reach something.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old female patient. The patient had history of shingles and her current conditions included penicillin allergy. On 07-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot # reported as J0011829, expiration date 26-DEC-2014; anatomical site of injection and dose not reported. Concomitant therapies included levofloxacin. On 08-MAY-2014, the patient called the pharmacy and stated that the injection site was sore, her forehead was red and she was feeling as if she was getting the shingles again. It was reported that the patient has had no lesions at the time of the report. The patient had no lab diagnostic studies performed. The outcome of all adverse events was reported as not recovered/not resolved. Relatedness between vaccination with ZOSTAVAX and reported adverse events was unknown. Lot number J0011829 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown demographics. On an unknown date (also reported as a couple of weeks ago), the patient was vaccinated with ZOSTAVAX injection, 1 shot (dosing regimen unspecified). Patient's concomitant medication was not reported. On an unknown date the physician stated that a patient had a rash along leg after ZOSTAVAX. Patient sought medical attention. There was no product quality complaint (PQC) involved. The outcome of had a rash along leg was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 year old female patient with asthma and with no drug reactions/allergies. On 06-MAY-2014 the patient and her twin sister were vaccinated with PNEUMOVAX 23 (batch #: H018440, lot #: 0718AE, expiration date: 29-MAR-2014, dose, route of administration, anatomical location not reported) due to "high risk for asthma". Concomitant therapies included albuterol sulfate (manufacturer unknown) and FLOVENT. On 06-MAY-2014 the patient received expired dose of PNEUMOVAX 23. It was also reported that PNEUMOVAX 23 did not have any previous temperature excursions. On 07-MAY-2014, the patient experienced localized swelling and redness at the injection site. There was no laboratory tests performed. There was treatment with MOTRIN and KEFLEX given for the reported events. The outcome of localized swelling at the injection site and redness at the injection site was reported as recovering/resolving. The patient sought medical attention by visit in emergency room and then by follow-up office visit. The relatedness between the therapy with PNEUMOVAX 23 and the events of localized swelling and redness at the injection site were not reported. This is one of several reports from the same source. Additional information has been requested.