chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse via Poison and Drug Center refers to an unknown number of patients of unknown age and gender. The patients' history and concurrent conditions were unknown. On an unknown date, the patients were vaccinated with unknown doses of (Oka/Merck) VARIVAX (route was not reported, lot #L005298, expiry date 17-FEB-2017), that underwent temperature excursions as follows: 8.9 degrees Celsius for 1 hour and 28 minutes on 07-JUL-2015 and 0.4  degrees Celsius for 1 hour and 25 minutes on 28-JUL-2015. Concomitant medications were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored GARDASIL (dose, frequency and route of administration not reported (lot 3 J011272, expiration date 21-APR-2015; lot # K005881, expiration date 14-JAN-2017) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored RECOMBIVAX HB (dose, frequency and route of administration not reported) lot # J006511, expiration date 28-JAN-2016 (also reported as 28-FEB-2016) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a patient who received HAVRIX (batch number D23LP, expiry date 28th APRIL 2016). On 29th JUNE 2015, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to HAVRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. On 29th or 30th JUNE 2015, the patient was vaccinated with HAVRIX. After vaccination with HAVRIX the patient experienced an unspecified adverse event. No further details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored VAQTA (dose, frequency and route of administration not reported) (lot # H021243, expiration date 25-SEP-2015) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
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. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015 the patient was inadvertently vaccinated with a dose of expired RECOMBIVAX HB (lot # H017304, exp. date: 11-JUL-2015) (strength was not reported) 1 ml, intramuscularly. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L006386 with expiration date 25-FEB-2017; dose and route of administration were not reported). No adverse effects were reported. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy was not reported. On 23-JAN-2013, the patient was vaccinated with a first dose of (recombinant) (manufacturer unknown) (lot number, dose and route were not reported). On 10-AUG-2015, the patient visited the office to receive a second dose of RECOMBIVAX lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse  and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with   an improperly stored dose of ZOSTAVAX (lot # L013546 with expiration date 17-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L013546 with expiration date 17-JUL-2016; dose and route of administration were not reported). No adverse effects were reported. 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 as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided), which were exposed to temperatures outside of the recommended range incorrect product storage). No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Presyncope, Speech disorder
Clinical narrative: This spontaneous report as received from an office manager refers to an adolescent male patient of unknown age. On an unknown date in 2015 (reported as within the last couple weeks) the patient was vaccinated with a dose of GARDASIL 9 (lot #, strength and dose were not reported), intramuscularly. Other suspect therapies included MENVEO which the patient received on the same day. On an unknown date in 2015, the patient experienced a loss of blood pressure with reported result: 60/30 (units not specified) and almost fainted after receiving GARDASIL 9. He could barely speak and came close to needing an ambulance. He recovered after lying down for an unspecified period of time at the physician's office. The outcome of the patient's events was reported as recovered (date unspecified, 2015). The relatedness between vaccination with GARDASIL 9 and MENVEO and the patient's events was not reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an 18 year old patient of unknown gender. On 26-JUN-2015, the patient started series and was vaccinated with a dose of GARDASIL 9 (lot # K026246., exp. date: 28-JAN-2017) 0.5 ml injection, intramuscularly. On 17-AUG-2015, the patient was vaccinated with the second dose of series, with GARDASIL (lot # K016966, exp. date reported as 10-MAY-201) 0.5 ml injection, intramuscularly. No adverse reaction were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date in November 2015, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported) and the second dose was vaccinated on an unknown date in June 2015 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Instillation site vesicles
Clinical narrative: Pt. seen in clinic on 8/13/15 with scattered vesicles and one bulla at injection site. She received zoster vaccine at her primary care doctor's office on 8/11/15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a patient of unkonwn age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (Lot # L006386 with expiration date 25-FEB-2017; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None at this time.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tongue discolouration, Urticaria
Clinical narrative: Started with a red tongue few hours after the vaccine, and approx. 6 hours after vaccine, began with hives. Family called our physician on call, who recommended BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Area became swollen, red, warm to touch, very hard, very itchy. Also had low grade fever.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin warm
Clinical narrative: Area became swollen, red, warm to touch, very hard, very itchy. Also had low grade fever.
Sex: U
Vaccine: DTAPIPVHIB, MMR, VARCEL, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt received injection in rt leg (thigh). Next day mother noticed redness and swelling. Went to ER Dx with cellulitis given antibiotics. Recovered 8/12/2015.
Sex: U
Vaccine: DTAPIPVHIB, MMR, VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: Pt received injection in rt leg (thigh). Next day mother noticed redness and swelling. Went to ER Dx with cellulitis given antibiotics. Recovered 8/12/2015.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein normal, Pain in extremity, Rheumatoid factor negative
Clinical narrative: Three days after her second HPV she noticed pain in knees, thighs and hips. Pain stopped over Spring break. Started again in May.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Decreased appetite, Fatigue, Irritability, Pyrexia, Vomiting
Clinical narrative: Fever 102 for 24 hr. Irritable, decreased appetite, vom for 24 hours, tired, inconsolable.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Musculoskeletal stiffness
Clinical narrative: Body aches, cold, stiff, shivering (sometime violently) coughing, shortness of breath, extreme weakness. (Started AM of 5/13 and got progressively worse until emergency room visit 5/16/15.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Nasopharyngitis, Pain, X-ray
Clinical narrative: Body aches, cold, stiff, shivering (sometime violently) coughing, shortness of breath, extreme weakness. (Started AM of 5/13 and got progressively worse until emergency room visit 5/16/15.
Age: 0.24
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Culture stool, Escherichia test, Full blood count, Haematochezia
Clinical narrative: Developed bloody/mucousy stools 6 days after Rotavirus vaccine. Lasted for approximately 12 hrs has labs, AXR and stool studies, trial of hypoallergenic formula - symptoms resolved.
Age: 0.24
Sex: M
Vaccine: RV5
Symptoms: Metabolic function test, Mucous stools
Clinical narrative: Developed bloody/mucousy stools 6 days after Rotavirus vaccine. Lasted for approximately 12 hrs has labs, AXR and stool studies, trial of hypoallergenic formula - symptoms resolved.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Eyelid oedema, Pruritus, Rash
Clinical narrative: Puffy eyes, rash on neck, itch 1/2 days later persistent - took BENADRYL beginning 1 wk after shot.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Fell and hit head from fainting. Sat for 20 minutes afterward. Alert, oriented. Drank some water. Follow up next day-unable to reach.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: See attached.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with his first dose of GARDASIL 9, (lot number #L001312, expiration date 24-FEB-2017, dose and route not reported) and then, on 11-AUG-2015, received his second dose of GARDASIL 4) (lot no., dose, route and anatomical location of administration were not reported) (interchange of vaccine products). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown gender and aged around 6 to 12 years old. The patient's relevant medical history and past drug history were unknown. On 28-JUL-2105 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAS (lot # K026386, expiration date: 15-DEC-2016, dose, route, frequency and dose number unknown). This vial of (Oka/Merck) VARIVAX underwent temperature excursions as follows: On 07-JUL-2015, 8.9 degrees Celsius for 1 hour and 28 minutes; on 28-JUL-2015, 0.4 degrees Celsius for 1 hour and 25 minutes. Concomitant medications were unknown. The nurse reported the patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continued on (Oka/Merck) VARIVAX and the patient had not experienced any adverse events. This is one of several reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker referring to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # K025761, expiration date 06-JUN-2016, route not provided). No adverse experiences were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 8-10-15 patient called to report severe soreness, swelling, and tender to touch since the evening of injection - has used ice and Ibuprofen all weekend (3 days).
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Numbness tingling (4-5x's); severe pain - feels like she was punched in back of arm and side. She can't even lift a glass of water. Pain radiated past elbow into forearm. She was cold all night and she's never cold. Pain feels 10x's worse than tetanus shot. Seeking tx from primary PCP at 1 PM today, 8-17-15.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling cold, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Numbness tingling (4-5x's); severe pain - feels like she was punched in back of arm and side. She can't even lift a glass of water. Pain radiated past elbow into forearm. She was cold all night and she's never cold. Pain feels 10x's worse than tetanus shot. Seeking tx from primary PCP at 1 PM today, 8-17-15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to eleven unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored VARIVAX (Merck) (lot# reported as K015972; expiration date: 23-SEP-2016, lot# L010148; expiration date: 24-MAR-2017, route and dose were unknown). No adverse effect were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: (L) arm swelling with 5th dose of DTaP - discussed normal mild reaction. Mom still asked that it be reported.
Age: 37.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash to trunk, BUE and BLE. No fever, pharyngitis, testicular pain. Severe itching.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 11-AUG-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L005293 and expiry date: 17-AUG-2016). No adverse effects were reported. Additional information has been requested.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: 8/7/15 at well child visit received MMR, VARIVAX and Hep A, after shots small amount of redness and swelling at (R) thigh injection site. 2 days ago (8/15/15) developed new redness (R) thigh, pink dots, papules. 8/16/15 hives off and on arms and legs. Went to ER for eval, fever to 102. Hives resolved. Question virus vs. vaccine reaction.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication, Viral infection
Clinical narrative: 8/7/15 at well child visit received MMR, VARIVAX and Hep A, after shots small amount of redness and swelling at (R) thigh injection site. 2 days ago (8/15/15) developed new redness (R) thigh, pink dots, papules. 8/16/15 hives off and on arms and legs. Went to ER for eval, fever to 102. Hives resolved. Question virus vs. vaccine reaction.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient started having pain starting on arm (site of injection) radiating to neck, back, lower back and buttocks. Patient has had X-rays done, which did not show anything. MRI pending.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Patient started having pain starting on arm (site of injection) radiating to neck, back, lower back and buttocks. Patient has had X-rays done, which did not show anything. MRI pending.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Swelling at site of immunization.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patients right arm (upper deltoid area) was swollen and hard, also developed redness, hot to touch on 8/12/15. Patient seen on 8/14/15 symptoms subsided. Dx local reaction.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling on LD injection site. No fever, area is hot to touch. Symptoms developed on 08/14/15.
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: At 48 hrs, 3cm circular area of redness and erythema (L) deltoid.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of left arm.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Big red patch on left arm. Patient described that female was itchy, hot & little painful. Patient tried taking TYLENOL, BENADRYL and Hydrocortisone cream but not a significant difference. Going to see MD next.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood test, Injection site erythema, Injection site inflammation, Injection site swelling, Pruritus
Clinical narrative: Red, swollen, inflamed at injection site. Arm also itchy.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pain, Swelling
Clinical narrative: Swelling, redness at site, chills, pain. Was prescribed triamcinolone acetonide 0.025% external cream and BENADRYL allergy 25mg oral tablet.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Heart rate increased, Pallor, Pyrexia, Sluggishness
Clinical narrative: Patient was pale, heart rate increased, fever, sluggish was taken to the ER and diagnosed with cellulitis in the arm.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 37 y/o male, admitted to medicine for suspected cellulitis, potential DVT. Pt. administered IM influenza and pneumococcal vaccines in right arm following admission. 24hr after administration, pt. febrile to 102.9 degrees, right arm tender, warm, erythematous around injection site. Fever abated over following day.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site reaction, Rash erythematous, Rash macular
Clinical narrative: Red macular rash approx. 14 by 5 cm diameter on (L) thigh.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash papular
Clinical narrative: Erythematous papular rash 4 cm in diameter. (L) deltoid appearing within 4 hours of GARDASIL injection.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with unknown doses of ZOSTAVAX (strength, route unspecified). The pharmacist reported that on unspecified dates after receipt of ZOSTAVAX, two patients were diagnosed with shingles and this happened years ago (dates unspecified). The outcome of event reported was unknown. Varicella zoster virus (VZV) packet was sent. No product quality complaint was involved. Intervention to prevent seriousness criteria was not done. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had a tragic incident and under all the stress I broke out with shingles. Same location. They were not as severe as before. Still having the sensation from the nerves periodically.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursitis, Exostosis, Mobility decreased, Pain in extremity, Tendon injury
Clinical narrative: Patient complains of continued arm pain and decreased arm mobility since September of 2014.  She reports pain after the injection.  She reports that she thought it was a continuation of rheumatoid arthritis.  She reports that she now attributes pain to vaccine after reading reports of similar reactions on the internet.  She reports that she has seen her doctor (she did not report their diagnosis) and she is receiving acupuncture therapy.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Acupuncture, Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of continued arm pain and decreased arm mobility since September of 2014.  She reports pain after the injection.  She reports that she thought it was a continuation of rheumatoid arthritis.  She reports that she now attributes pain to vaccine after reading reports of similar reactions on the internet.  She reports that she has seen her doctor (she did not report their diagnosis) and she is receiving acupuncture therapy.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with dose of ZOSTAVAX in the arm (dose and route of vaccination were not reported). On an unknown date, the arm, which received the injection, developed an adverse reaction. There was "severe" swelling at the injection site. The affected arm was "difficult to move" because of the severe swelling. The patient sought medical attention and was treated with BENADRYL and recovered on an unknown date. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with dose of ZOSTAVAX in the arm (dose and route of vaccination were not reported). On an unknown date, the arm, which received the injection, developed an adverse reaction. There was "severe" swelling at the injection site. The affected arm was "difficult to move" because of the severe swelling. The patient sought medical attention and was treated with BENADRYL and recovered on an unknown date. Causality assessment was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Laceration, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 17 year old male patient. The patient had no pertinent medical history. The patient had allergy to amoxicillin (no dates, manufacturer or reaction specified). On 07-AUG-2015 the patient was vaccinated with a dose of GARDASIL 9 (Lot# L014198; expiration date: 05-SEP-2017), intramuscular. On 07-AUG-2015, the patient was also vaccinated with a dose of MENACTRA. Concomitant medication included an unspecified topical steroid. The pharmacist reported that "shortly after vaccination" (exact timeframe unspecified), the patient developed syncope and fell and received a laceration on an unspecified area of the face from falling. It was reported that the laceration bled, but the bleeding stopped "quickly" on 07-AUG-2015 and did not require stitches. No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. It was reported that the patient recovered "quickly" from the syncope after falling. It was unspecified the date the laceration completely healed. The patient fully recovered on an unspecified date. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Fall, Haemorrhage, Laceration, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 17 year old male patient. The patient had no pertinent medical history. The patient had allergy to amoxicillin (no dates, manufacturer or reaction specified). On 07-AUG-2015 the patient was vaccinated with a dose of GARDASIL 9 (Lot# L014198; expiration date: 05-SEP-2017), intramuscular. On 07-AUG-2015, the patient was also vaccinated with a dose of MENACTRA. Concomitant medication included an unspecified topical steroid. The pharmacist reported that "shortly after vaccination" (exact timeframe unspecified), the patient developed syncope and fell and received a laceration on an unspecified area of the face from falling. It was reported that the laceration bled, but the bleeding stopped "quickly" on 07-AUG-2015 and did not require stitches. No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. It was reported that the patient recovered "quickly" from the syncope after falling. It was unspecified the date the laceration completely healed. The patient fully recovered on an unspecified date. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Crying, Headache, Tremor, Vomiting
Clinical narrative: Severe headache, crying, vomiting, trembling 3 days after MMR vaccine.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Abnormal behaviour, Decreased appetite, Gait disturbance, Headache
Clinical narrative: Severe headache, crying, vomiting, trembling 3 days after MMR vaccine.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Irritability, Neurological examination normal, Pain in extremity, Pharyngeal erythema, Social avoidant behaviour
Clinical narrative: Severe headache, crying, vomiting, trembling 3 days after MMR vaccine.
Age: 6.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Severe headache, crying, vomiting, trembling 3 days after MMR vaccine.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Pt and mother walked out of office without incident, he became dizzy and fainted in the parking lot.  Mom helped him up and escorted him back inside the clinic where he was assessed.  He was monitored for 15 minutes and recovered without incident.  He was discharged home with his mother.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Day 1 (8/12) afternoon, fever of 99.9, baby acted as if he didn't feel well; evening fever of 101.1, gave ibuprofen, and fever went away. Day 2 (8/13) baby woke with fever of 99.9, gave ibuprofen, fever went away; afternoon baby woke with a fever of 101, gave ibuprofen and the fever went away, that evening fever of 102, have ibuprofen, fever went away. Saturday (8/15), baby woke with a mild raised rash over head, face, neck, chest, stomach, back, and diaper area. Rash got worse over the course of the day. No itching or fever was associated with the rash. Baby didn't seem to notice it, and he played, ate, eliminated, and slept normally. Sunday (8/16) Rash lightened over the course of the day, with no other symptoms. Monday (8/17) rash was barely visible on stomach and back, not visible on face, head or neck. (8/18) no symptoms. Symptoms reported to the doctor's office. No additional visit was deemed necessary.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Pt Father noticied rash around injection site on left leg / father stated " rash was raised with a few hives" one day after injection. 4-7 days after injection father stated rash was all over body, trunk, arms, legs. The same rash was concentrated around the injection site. pt was brought to Urgent Care on 14 Aug 2015 by parents.  Pt was given hydroxyzine and rash cleared up, no other symptoms reported.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic kidney disease, Tuberculosis
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 34 years old female patient. The patient's pertinent medical history and drug reaction/allergies were unspecified. On an unknown date, the patient was vaccinated with GARDASIL (dose/frequency, route and lot number not reported). The physician reported to the field representative that the patient was on therapy with unspecified steroids and was in end stage renal failure because of her therapy with GARDASIL. The patient was also diagnosed with tuberculosis on unspecified date after receiving GARDASIL. The patient's present status and outcome of the events were unknown. The reporting physician considered the event of end stage renal failure related to therapy with GARDASIL and causality of tuberculosis was unknown. Upon internal review the event of End stage renal failure was determined to be medically significant. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a pharmacist refers to a 22 year old female patient who was participated in a Market research program. Concurrent condition and medical history were not reported. On an unknown date in August 2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose and route were unknown), and the patient discovered her pregnancy 1 week later after the vaccination. The patient's last menstrual period (LMP), estimated date of delivery and pregnancy outcome were unknown. The outcome of exposure during pregnancy was reported as recovered/resolved on an unknown date. The reporter considered the event was serious. Additional information is not expected as the reporter was not willing to be contacted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Pyrexia, Rash, Skin warm, Swelling
Clinical narrative: Fever, rash (blister appearance), swelling, hot to touch.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional dose administered; no adverse reaction.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Fatigue, Hyperhidrosis, Vomiting
Clinical narrative: Dizzy, short breath, sweating, vomiting, tired.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Tooth fracture
Clinical narrative: After receiving the HPV vaccine the Patient fell and tooth/teeth cracked.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Pain in extremity, Pruritus
Clinical narrative: Patient recieved the Prevnar 13 shot on 8/13/15. She returned to the pharmacy on 8/15/15 complaining of redness/rash at injection site. Pt said her arm was very sore the day after the shot and the morning of 8/15/15, she had a rash/redness around the injection site and some itching, but the soreness was better. Told pt she could use a cold compress on the site for 15 minutes, take acetaminophen for soreness, and an antihistamine for the itching if needed. Pt was fine, just wanting to make sure she didn't need to seek medical treatment. Told pt the redness/rash and pain were both possible side effects of the shot. Followed up with the patient on 8/16/15 and she reported she was doing fine and the redness was gone now.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Injection site pain, Paraesthesia, Syncope
Clinical narrative: FAINT, PAIN AT THE INJECTION SITE, TINGLING IN BOTH ARMS.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness with small bump with slight warmth to the left arm injection site.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Body temperature increased, Skin warm
Clinical narrative: 8/12/2015 child felt warm to mother but she did not take temp.  Second day after child did not feel well and took a nap.  When he woke T 104.5 ax, withing a half hour down to 103.5  She was willing to give antipyretics, and was going to call doctor for the recommended dosing. Using alternative therapies, soaking vinegar water in feet.  Writer recommended cool rags, but not so cold to induce shivering.  Follow up call 8/18/2015 Mom reports child ran fevers until Friday evening, but has been fine since then.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Redness is round and even, no streaking. Redness extends 2.5 inches vertical, and 3 inches lateral. Area is swollen, red, very itchy, and hot to the touch.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from contactable nurse. This nurse reported for five patients with the same lot number of PREVNAR 13 given on the same date. This is the 5th of 5 reports. A 83-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot # L62074, exp. date Nov2016) intramuscular at 0.5 ml, single in left deltoid on 09Jun2015. The patient did not receive other vaccines. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, the patient experienced cellulitis and redness. The patient called the office and returned for an office visit to see the doctor for the occurred events 4 days after the vaccination. The patient was not hospitalized for the event. The patient received KEFLEX for the events. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness began on day of injection.  Has gotten worse since.  Began swelling and getting red. Today swelling and redness is approx. Baseball size.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Injection site pain, Local swelling, Oropharyngeal pain
Clinical narrative: FEVER 102F, SEVERE PAIN AT SIGHT (RT DELTOID) SWOLLEN AROUND NECK, DIZZINESS, WEAKNESS AND SORE THROAT. SHE SAID SHE WAS TOO WEAK TO EVEN GO TO THE HOSPITAL...
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: FEVER 102F, SEVERE PAIN AT SIGHT (RT DELTOID) SWOLLEN AROUND NECK, DIZZINESS, WEAKNESS AND SORE THROAT. SHE SAID SHE WAS TOO WEAK TO EVEN GO TO THE HOSPITAL...
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site movement impairment, Injection site swelling, Injection site warmth
Clinical narrative: Are too sore to move right after shot.  24 hours later small white dots, red rash with itching under chin, cheeks, started covering entire face and neck.  The location of the shots is red, firm, hot, swollen from shoulder to elbow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Are too sore to move right after shot.  24 hours later small white dots, red rash with itching under chin, cheeks, started covering entire face and neck.  The location of the shots is red, firm, hot, swollen from shoulder to elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue that has lasted over a week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Vaccine was given subcutaneously and not IM.  Pain at injection site - redness at injection site.
Age: 1.06
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: Fever, no appetite, and diarrhea that started on Saturday August 15 and Monday, August 17 she has rashes all over her body.
Age: 79.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Central nervous system lesion, Intensive care, Leukocytosis, Paralysis flaccid, Pyrexia
Clinical narrative: Patient developed bilateral flaccid paralysis both lower extremities on 8/7/15 and subsequently admitted to hospital with transfer to another hospital ICU on subsequent day.
Age: 79.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Patient developed bilateral flaccid paralysis both lower extremities on 8/7/15 and subsequently admitted to hospital with transfer to another hospital ICU on subsequent day.
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction to drug in a adult female patient who received BOOSTRIX. Concurrent medical conditions included latex allergy. On 1st April 2015, the patient received BOOSTRIX. On 1st April 2015, immediately after receiving BOOSTRIX, the patient experienced anaphylactic reaction to drug (serious criteria hospitalization and GSK medically significant). BOOSTRIX was discontinued. On an unknown date, the outcome of the anaphylactic reaction to drug was unknown. It was unknown if the reporter considered the anaphylactic reaction to drug to be related to BOOSTRIX. Additional details were provided as follows: Nurse is the manager of the occupational health at a clinic. Nurse told GSK representative that one of their nurses received a BOOSTRIX prefilled syringe and had an anaphylactic reaction to the latex on the prefilled syringe. Anaphylactic reaction happened about 5 minutes after being exposed to the syringe. It was on the nurse's medical records that she was allergic to latex. The clinic called 911 to administer care. Patient did not receive any other vaccines on that same day.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pruritus generalised
Clinical narrative: Itching sensation on opposite arm; followed by generalized itching  particularly both hands. Loratadine and diphenhydramine administered.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Crying, Decreased appetite, Hypersomnia, Somnolence, Vomiting projectile
Clinical narrative: Excessive hard crying. Drowsiness. Long periods of sleeping. Loss of appetite. Vomiting (projectile vomiting through mouth and nose).
Age: 34.0
Sex: F
Vaccine: HEPAB
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever 100.6, lethargy, no other symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Cold urticaria
Clinical narrative: Developed cold urticaria approximately 4 weeks after flu vaccine. I have no allergies and all blood work was negative. No other underlining disease or cause was found. I had never had the flu vaccine and that was the only thing different prior to onset of symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema, Pain
Clinical narrative: Twenty four hours after receiving the injection, patient presented with red skin at injection site. Patient only stated the area was red and denied fever, pain, or heat at the injection site.  After three days, patient reported that the redness spread and was hurting her, but still denied a fever. Patient saw MD who diagnosed her with cellulitis.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Swelling of the face, Pt. was to ER at 1:45 PM By.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site pustule
Clinical narrative: Pustules popped up around vaccination sight.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Contusion, Fall, Laceration, Loss of consciousness
Clinical narrative: Client received vaccines and upon leaving the clinic lost consciousness and fell. Sustained lacerations and contusions to face and extremities, also lost a tooth. Client regained consciousness and wound care was provided, vital signs were monitored, and 911 was called. Client was transported to emergency room for further evaluation by EMS.
Age: 22.0
Sex: F
Vaccine: ANTH, JEV, SMALL
Symptoms: Abdominal pain, Dry skin, Rash, Skin exfoliation, Vaginal haemorrhage
Clinical narrative: On day 2 or 3 she woke up with a rash that wrapped around her neck down the non smallpoxed arm. She had bad abdominal cramps, started with heavy vaginal bleeding outside of her expected menstruation time. She still has cramping. Both arms are very dry and flaky.The emergency dept gave her Benadryl and dx with Vaccinia.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Erythema, warmth, swelling. On day two, erythema significantly increased. Treated for presumptive cellulitis.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms.  Fever, severe fatigue and aches.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: As of 8/16/15, patient's left upper arm, about 5 inches between deltoid and elbow area, was red and warm to the touch and she was complaining of itchiness. No pain. Her symptoms started on 8/12 and 8/13. Advised to use a cold compress and watch if the redness spreads. As of 8/18/15, itchiness has subsided but redness has spread. She feels weaker than usual.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Immediate post-injection reaction, Injection site joint pain, Pruritus, Urticaria
Clinical narrative: Immediate urticarial with itching, spreading and generalized.  Followed by headache and mild joint pain of the elbow and shoulder in the arm which was vaccinated.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blood creatinine increased, Blood lactate dehydrogenase, Blood urea increased, C-reactive protein increased, Differential white blood cell count
Clinical narrative: Low-grade fever onset on 08/13/2015 (100-101 F). Fever increased to 103 F by early afternoon of 08/15/2015, spiked to 105-106 F that evening, and stayed in range of 103-105 into evening of 08/17/2015.  Fever meds (oral ibuprofen and acetominophen suppositories) were used to bring fever down during this time.  Child was taken to pediatrician on 08/17/2015.  Doctor did urine analysis and ordered stat bloodwork (comprehensive metabolic panel, LD, CBC panel with differential, and Sed Rate).  Bloodwork revealed high BUN/Creatinine (36.8), high CRP (15.4), slightly elevated monocytes (1080) and high Westergren Sed Rate (39).  All other results were normal.  Patient fever was 104 that night, ibuprofen was used to reduce to about normal.  As of PM on 08/18/2015, no signs of fever.  Child saw doctor on 08/18/2015 and doctor said to monitor for fever return or other unusual signs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Full blood count, Metabolic function test, Monocyte count increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Low-grade fever onset on 08/13/2015 (100-101 F). Fever increased to 103 F by early afternoon of 08/15/2015, spiked to 105-106 F that evening, and stayed in range of 103-105 into evening of 08/17/2015.  Fever meds (oral ibuprofen and acetominophen suppositories) were used to bring fever down during this time.  Child was taken to pediatrician on 08/17/2015.  Doctor did urine analysis and ordered stat bloodwork (comprehensive metabolic panel, LD, CBC panel with differential, and Sed Rate).  Bloodwork revealed high BUN/Creatinine (36.8), high CRP (15.4), slightly elevated monocytes (1080) and high Westergren Sed Rate (39).  All other results were normal.  Patient fever was 104 that night, ibuprofen was used to reduce to about normal.  As of PM on 08/18/2015, no signs of fever.  Child saw doctor on 08/18/2015 and doctor said to monitor for fever return or other unusual signs.