chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient left with no s/sx after receiving Pneumovax at 5:30pm and called pharmacy the next morning at 8:30am with injection site redness/swelling.  This is a known side effect but patient was advised to take Benadryl and we would let his physician know about the reaction.  Otherwise patient said he is fine and wanted to let us know about the reaction he had.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Several swollen and painful lymph nodes in neck, began within a week after receiving the Pneumovax vaccine and has still not resolved.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Wheezing
Clinical narrative: WHEEZING, COUGH.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Pt noted blister + red streak on (R) arm 48 hours after immunization given no fevers.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Redness and swelling at injection site with streaking towards clavicle, swollen, tender lymph nodes on same side. Patient treated with Doxycycline and Benadryl by PCP.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Death, Dizziness, Headache, Pyrexia
Clinical narrative: Unknown if attributed to vaccine.  Patient had vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day.  Patient demise time unclear may not be related however per process noting that vaccination had occurred in the previous 36 hours.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: Sore throat, malaise, fatigue.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness postural, Tremor, Vomiting
Clinical narrative: Pt was shaky and light headed when she attempted to stand up after receiving vaccinations. Pt vomited. Took pt blood pressure and set with her until she felt better. Felt well enough to continue shopping after 10 - 15 mins.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: WITHIN 6 TO 7 HOURS OF VACCINE, PT EXPERIENCED FEVER, CHILLS, PAIN AT INJECTION SITE ON ARM AND ARM SO PAINFUL SHE COULD NOT LIFT SAID ARM.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness around injection site, gotten redder since shot. Pain when touched, itchy, and hardened area around shot site.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: Redness around injection site, gotten redder since shot. Pain when touched, itchy, and hardened area around shot site.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: LOCAL REDNESS AT SITE OF INJECTION. WARM TO TOUCH. OVER 48 HOURS REDNESS SPREAD DOWN TO ELBOW. STEROIDS AND BENADRYL TAKEN AND TOTAL IMPROVEMENT BY 72 HOURS AFTER INJECTION.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: Slight rash on face and neck with itchiness and soreness to touch. Took Benedryl and Tylenol to relieve symptoms. At 2 a.m. 11/16, awoke to severe pain throughout body (including just touching skin) and fever/chills. Took hot bath, Vicodin and Benadryl for relief of pain. 11/17 at approximately 5 p.m., onset of pain began to occur again. Took Vicodin and Benadryl to relieve symptoms.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Slight rash on face and neck with itchiness and soreness to touch. Took Benedryl and Tylenol to relieve symptoms. At 2 a.m. 11/16, awoke to severe pain throughout body (including just touching skin) and fever/chills. Took hot bath, Vicodin and Benadryl for relief of pain. 11/17 at approximately 5 p.m., onset of pain began to occur again. Took Vicodin and Benadryl to relieve symptoms.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: 11/7/14 Pt reported sore arm at injection site with tolerable, periodic pain with movement. No redness, swelling, or inflammation. Pt was advised to use apap or ibu for pain if neccessary. 11/20 Pt states pain has stopped and has experienced no other complications.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Eyelid oedema, Ocular hyperaemia, Swelling face, Wheezing
Clinical narrative: RED PAINFUL PUFFY EYES, PUFFY FACE, WHEEZING.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PATIENT REPORTS MODERATE TO SEVERE PAIN AND SOARNESS IN LEFT ARM. DECREASED RANGE OF MOTION.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Paraplegia
Clinical narrative: Patient given Pneumovax and Fluvirin, said could not move her arm, and was paralyzed waist down. She saw her Dr and given ibuprofen and methocarbamol.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Chills, Decreased appetite, Dizziness, Nausea
Clinical narrative: Patient experienced extreme fever, chills, nausea, loss of appetite, extreme dizziness and not able to walk.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient experienced extreme fever, chills, nausea, loss of appetite, extreme dizziness and not able to walk.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Bruising and hurting arm lasting for few weeks.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Diarrhoea, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient describes, soreness in arm where Fluzone HD was given; achy hot to touch, daily fever just over 100 F late in the day for 8 days, diarrhea for 8 days; uncomfortable feeling in arm that received the Zostavax.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Pyrexia, Sneezing
Clinical narrative: Flu like simptoms with fever, cough, sneezing for more than 1 week. I was taking Dayquil and Nyquil, Robatussin etc.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Convulsion, Fall, Haemorrhage, Head injury
Clinical narrative: Seizure while in store, fell backward & gashed head on shelving; transported by ambulance to Medical Center since he was on warfarin for the positive HIT dx & was actively bleeding from his head wound...he was also nonresponsive to questioning by EMT personnel.  Has some sort of red rash all over his face going down toward top of his shoulders, but dr had no idea what caused it (perhaps allergy to bindings they used to tie him down to gurney in ambulance (trying to protect his neck & keep him still as he was very combative in ambulance we were told).
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Rash erythematous, Rash generalised, Unresponsive to stimuli
Clinical narrative: Seizure while in store, fell backward & gashed head on shelving; transported by ambulance to Medical Center since he was on warfarin for the positive HIT dx & was actively bleeding from his head wound...he was also nonresponsive to questioning by EMT personnel.  Has some sort of red rash all over his face going down toward top of his shoulders, but dr had no idea what caused it (perhaps allergy to bindings they used to tie him down to gurney in ambulance (trying to protect his neck & keep him still as he was very combative in ambulance we were told).
Age: 67.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Chills, Erythema, Local swelling, Malaise, Pyrexia
Clinical narrative: Arm swollen and red, not at injection site, but rest of arm.  Fever, chills, and generalized malaise.
Age: 47.0
Sex: F
Vaccine: FLUN4
Symptoms: Cardiac function test, Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Pounding palpitations with chest discomfort.  Continued despite no caffeine.  Developed shortness of breath Saturday morning and did go to local ED to ensure all was well.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Physical examination abnormal
Clinical narrative: 1 3/4" x 2" pink skin marking non tender/not indurated] rt LUT deltoud immunization site.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Influenza quadrivalent 3 yrs IM injection placed 11/10/14 developed red, swollen area from shoulder to elbow. No fever. Mom called office 11/19. Appt given. Dx cellulitis 5 cm x 5 cm erythema, DURICEF started.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Eyelid oedema, Hyponatraemia, Weight increased
Clinical narrative: Sx: puffy eyes, weight gain. Dx: hyponatremia. Tx: furosemide, IV fluids. Note: influenza vaccine administered (outpatient) prior to hospital admission.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Decreased appetite, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: Sx: anorexia, low grade fever, HA, weakness sx of paresthesias in upper and lower extremities. Dx: Guillain-Barre Tx: NIG, non-responsive to tx, transferred to tertiary hospital. Note: Vaccine administered (outpatient) prior to hospital admission.
Age: 54.0
Sex: M
Vaccine: FLUC3
Symptoms: Paraesthesia, Pyrexia, Unresponsive to stimuli
Clinical narrative: Sx: anorexia, low grade fever, HA, weakness sx of paresthesias in upper and lower extremities. Dx: Guillain-Barre Tx: NIG, non-responsive to tx, transferred to tertiary hospital. Note: Vaccine administered (outpatient) prior to hospital admission.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Pain in extremity, Sensory disturbance
Clinical narrative: 10/10/14 call from patient to MD to report pain and decreased RDM left arm. Pt stated her arm has felt this way since receiving Flu vaccine 9/30/14. MD advised office visit. 10/13/14 Pt saw MD states cont pain, little relief with ADVIL, cannot raise arm over head. Pt describes "weird sensation from Left shoulder to hand. 11/13/14 - MD visit by patient complains of cont. Left arm pain." Weakness. Pain decreased. Physical Tx ordered.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscular weakness, Myalgia, Rotator cuff syndrome
Clinical narrative: Patient reported muscle pain at the left arm, where immunization was administered, after few months. Arm feels very weak, and something wrong w/ rotating cuff, pt claimed, told pt to have MD check.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Hypoaesthesia, Paraesthesia, Pruritus generalised, Swelling face
Clinical narrative: Pt was given MMR SQ in Rt arm and Tdap in Rt deltoid at 10:30 am. Minutes later pt complained of skin prickly all over. Then minutes later complained of itching all over, hands numb and tingly. Breathing felt tight. Dr came in and examined pt and observed facial swelling and hives. Nurse gave 25 mg BENADRYL IM and epi 0.3 mg and 911 was called. Pt was sent to ER.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Urticaria
Clinical narrative: Pt was given MMR SQ in Rt arm and Tdap in Rt deltoid at 10:30 am. Minutes later pt complained of skin prickly all over. Then minutes later complained of itching all over, hands numb and tingly. Breathing felt tight. Dr came in and examined pt and observed facial swelling and hives. Nurse gave 25 mg BENADRYL IM and epi 0.3 mg and 911 was called. Pt was sent to ER.
Age: 1.61
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: PENTACEL vaccine given on Left Thigh on 11/17/2014. Child developed extensive redness and bruising with 24 hours child was seen at office on 11/19 redness measure 16cm x 8cm extending from injection site with 7cm x 3cm bruising no induration treatment 1 dose of steroid and resolution of redness within 24 hrs seen again on 11/21 with mild bruising no redness on induration child well.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Shaking 20 min after vaccination. She tool EXCEDRIN 2 hrs later and felt a little better.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis, Nasopharyngitis, Sneezing
Clinical narrative: Bloody nose once after vaccine. Sneezing and cold sx.
Age: 1.0
Sex: F
Vaccine: FLUN4
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: 11 month old pt received FLUMIST when should have received injectiable flu. 2 days after administered developed a fever and diarrhea. Fever actually occurred several day received MIST.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pain and numbness in left arm since the vaccination (was just informed 11/21/14). Also lost feeling in left hand day after shot. Went to see Dr twice. Referred to another Dr. waiting to go for appointment.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Pruritus
Clinical narrative: Right arm swelling et itching-started 11/19/14. Tx-BENADRYL et warm compress.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Tenderness
Clinical narrative: (R) deltoid noted with redness and swelling approx 4 1/2" T x 5" wide hot to the touch. (L) deltoid 2" T x 1 1/2" wide. Warm to the touch. Pt c/o soreness and tenderness to the touch.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Localized rash w/ pruritis and erythema 3 days after injection. Seen in office 11/21/14.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ, 2 ml, oral. No co-suspect and concomitant therapies were reported. On an unknown date the patients were administered doses of ROTATEQ after 32 weeks of age. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA004296, 1411USA009916, 1411USA009918) with the same reporter link. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: This spontaneous report was received from a physician via regulatory authority. As from the beginning of the current school year (2014-2015) during the last month (October 2014), they have received to the Division of Epidemiology 4 reports of dizziness and pallor after vaccine administration in patients between the ages of 13-14 years. On an unknown date, the 4 patients were vaccinated with GARDASIL (lot # J016198 and expiration date was 30-MAY-2016, or lot# K007693, expiration date unspecified) (dose and route were not reported). On unknown dates the patients experienced dizziness and pallor. The outcome of events was unknown. Causality was not provided by agency. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-OCT-2014 the patient was vaccinated with a dose of PROQUAD (Merc) (lot#, strength, frequency unknown), 0.5 ml, subcutaneous, which was exposed to light, when stored outside of the box, in the freezer. No adverse effect was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test normal
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's medical history and current conditions were not reported. On 11-SEP-2014 the patient was vaccinated with GARDASIL (lot # K006117 and expiry date 14-JAN-2017), 0.5 ml, intramuscular in the left arm. Other co-suspects were not reported. Concomitant therapies included ABILIFY and WELLBUTRIN. Approximately on OCT-2014 (reported as, in the first week of October) the patient experienced unspecified joint pain after she received her first dose of GARDASIL. The patient consulted her pediatrician, who was unspecified by the nurse. Unspecified laboratory blood tests were ordered by the pediatrician, and the results were within normal limits. The patient has been referred to an unspecified rheumatologist for further evaluation. The unspecified joint pain has persisted since the onset of the symptoms. Cancer was not reported. The outcome of joint pain was reported as not recovered/not resolved. Causality was unspecified by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Exposure via direct contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous prospective pregnancy report as received from a female pharmacist of unknown age refers to herself with non known drug allergies. The patient was 7 months pregnant. The estimated Last Menstrual Period (LMP) was in April 2014. The Expected Delivery of Date (EDD) was not known. No concomitant medication and pertinent medical history were reported. Pharmacist stated that she was administering ZOSTAVAX (lot # K010648, expiration date 30-OCT-2015) on 19-NOV-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's eyes". The pharmacist immediately flushed her eyes with water however her eyes felt like they were "on fire". In the afternoon of 19-NOV-2014, the patient called back and stated that her eyes were fine "now". The outcome of "her eyes felt like they were on fire" was recovered in the afternoon of 19-NOV-2014. The pregnancy outcome was outcome pending. The patient didn't seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the events were unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA009916, 1411USA009915, 1411USA009918) with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009918, 1411USA004296, 1411USA009915, 1411USA009916) with the same reporter link. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative refers to a female patient who under 18 months old. On an unknown date the patient was vaccinated with PROQUAD (Merck) (1 dose, route was also reported as injection, lot# and expiration date were unknown) (also reported as vaccine). Concomitant therapies included ibuprofen. On an unknown date the patient had hives on face, arms, and back after receiving PROQUAD (Merck). Patient was seen in the emergency room. The patient had sought for medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA004296, 1411USA009915, 1411USA009918) with the same reporter link. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. Patient current condition included sulfa allergy and historical drug included sulfa drug. Dose 1 was administered 03-MAR-2014 (lot # H020848 exp: 03-APR-2015), Dose 2 was administered 29-MAY-2014 (lot# J011960 exp 06-AUG-2015) and Dose 3 was administered 05-NOV-2014 (lot # J006850 exp: 31-MAR-2016), dose: 5ml, intramuscular, right deltoid. After Dose 3 was administered it was discovered the patient was pregnant. Concomitant medications included multivitamin and unspecified oral contraceptive pill. It was reported that the patient was taking an oral contraceptive pill which has been discontinued now that it has been found the patient is pregnant. The patient became pregnant with last menstrual period (LMP) of 26-AUG-2014 and estimated delivery dare (EDD) of 02-JUN-2015. Lab test included urine pregnancy test. The patient sought medical attention. The pregnancy outcome was pending. Date of birth was confirmed. No other details was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose and lot number were unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA004296, 1411USA009915, 1411USA009916) with the same reporter link. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 12 year old male patient. On 06-JUN-2002 the patient was vaccinated with his first dose of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On 20-AUG-2013, patient received a "varicella IGG test to test titers" and the result of this test was 0.91 (unspecified unit of measurement). On 13-SEP-2013 the patient was vaccinated with his second dose of VARIVAX (Merck) lot # J003711, expiry date: 27-MAR-2015, (strength dose and injection site not reported). On 11-JUL-2014 the patient received a second "varicella IGG test titers" and the result of the second titer test was "less than 135". Therefore, the patient had two lower than normal titer results after the administration of VARIVAX (Merck). No treatment was given for events. The outcome of events was reported as not recovered/not resolved. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Patient's daughter called the pharmacy on 11/15/14 and stated that her father's arm was very inflamed and very painful and that he had fallen in the floor but since he had fallen a few times lately before getting the vaccine, this is likely unrelated.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Full blood count normal
Clinical narrative: Temp - 105 (rectal).
Sex: U
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients of unknown age and gender. On unknown dates, each of the patients were vaccinated with 2 separate doses of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On an unknown date the patients was found to have lower than normal titers after the 2 doses of VARIVAX (Merck). The outcome of event was unknown. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 22 year old male patient. On unknown dates the patient was vaccinated with 2 separate doses of VARIVAX (Merck) (strength, dose, injection site and lot # not reported). On an unknown date the patient was found to have lower than normal titers after the 2 doses of VARIVAX (Merck). The outcome of event was unknown. The causal relationship was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes simplex
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 55 year old female patient with herpes simplex virus genitals. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose, route were not reported) because the patient believed that ZOSTAVAX would prevent outbreaks of Herpes Simplex Virus (HSV) genitals. No concomitant medications were reported. On an unknown dates, the patient had more outbreaks of HSV genitals since vaccination with ZOSTAVAX. The outcome of more outbreaks of HSV genitals was not reported. The relatedness between the event "more outbreaks of HSV genitals" and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to an approximately 66 year old male patient. No information about medical history, concurrent conditions was reported. On 20-NOV-2009 the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency, route, indication not reported). No concomitant medications were reported. On 14-NOV-2014, he came into the doctors office with shingles on his right shoulder. The patient did not have any burning or pain, but the physician thought it was shingles. He also did not have any other symptoms. The patient sought medical attention (went to doctor). There was no product quality complaint. The event was treated with SAMVIR. No intervention was done to the event. The outcome of the event is unknown. Causality of the event was not specified. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a 60 year old nurse female consumer reporting on herself with allergy to itraconazole, bees and cats. On 08-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX intramuscular (dose, lot # and expiration date not reported). Concomitant therapy included levothyroxine sodium (manufacturer unknown). In November 2014 the area of injection had a small, had nodule at injection site and her arm was achy the way up the tricep and into her neck. No treatment was given for the adverse events. The patient did not seek attention. At the time of the report the outcome of small, hard nodule at injection site and her arm was achy up the tricep and into her neck was not tricep. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 21 year old female patient with pregnancy and food allergies but no drug allergies. The patient's medical history included chickenpox twice and shingles once. On 06-FEB-2013 the patient was inadvertently vaccinated with a dose of 0.5 ml VARIVAX (Merck) (lot # H018015, expired date 10-JAN-2014) subcutaneously. Concomitant medication included prenatal vitamins. The physician noted that an unspecified medical assistant at the office had given the VARIVAX (Merck) to this pregnant patient without medical orders. The patient was pregnant with LMP of 12-JAN-2013 (reported as 12 weeks and 2 days) and EDD of 19-OCT-2013. Initial exposure to VARIVAX (Merck) was at 3 week(s). There was no lab diagnostics studies performed. At the time of reporting, the pregnancy and outcome were unknown. The patient sought medical attention at physician's office. Follow-up information was received on 10-NOV-2014. The reporter stated that the patient changed providers during her pregnancy, and they did not follow-up on the pregnancy and they knew nothing about the outcome. The patient left their practice due to receiving VARIVAX (Merck) while pregnant. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Received pneumonia shot (PCV23) on 11/10/14. Swollen, painful (L) arm 2 days post injection (L) arm 12 in. in diameter (R) arm 11 inch in diameter.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Dyskinesia, Fall, Pyrexia, Skin discolouration
Clinical narrative: Child's mother states child started crying, her color changed to "green" and child started vomiting then fell down to floor and started jerking for about "3 minutes". Mother states child then went to sleep for approximately 5 hours and when she got up she acted fine. Mother states a "little fever" did not measure.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Child's mother states child started crying, her color changed to "green" and child started vomiting then fell down to floor and started jerking for about "3 minutes". Mother states child then went to sleep for approximately 5 hours and when she got up she acted fine. Mother states a "little fever" did not measure.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Balance disorder, Hypoaesthesia
Clinical narrative: Numbness Rt hand along ulnar nerve distribution. Some numbness Lt hand also. Dorsiflexion of bilateral toes. Increased problem with balance. Sx similar to when he had Guillain Barre as a child. Pt is feeling better sx have lasted longer than 6 months.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a female registered nurse reporting on herself. No medical history or concurrent conditions were reported. On 18-NOV-2014, the reporter because of a PQC (product quality complaint) PNEUMOVAX 23, had leaked onto both of her hands (topical route). She experienced no adverse effects. Additional information had been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with M-M-R II injection (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The nurse informed that on an unknown date the patient had titers drawn because she was starting a new job and M-M-R II titers resulted showed that patient did not have immunity to measles. The patient did not seek medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Nausea, vomiting, body aches, chest pain, large red area at injection site with swelling, fever of 103, went to urgent care 15 November TYLENOL w/codeine given antibiotics. Also prescribed steroid on 18Nov14. Redness and swelling only at site of pneumonia vaccine.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, body aches, chest pain, large red area at injection site with swelling, fever of 103, went to urgent care 15 November TYLENOL w/codeine given antibiotics. Also prescribed steroid on 18Nov14. Redness and swelling only at site of pneumonia vaccine.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Erythema, Myalgia, Vaccination complication
Clinical narrative: Patient is a 44 yo female who presents today for adverse reaction to pneumococcal vaccine, she is followed by another doctor for Crohn's disease. Patient states noticed some redness after receiving the pneumococcal vaccine that has radiated down her right upper extremity, this was her first pneumonia vaccine. She is managing pain with TYLENOL and seems to doing ok. She reports having a history of muscle aches and since the pneumonia vaccine her aches have worsened.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Laboratory test normal, Myalgia, Night sweats, Pyrexia
Clinical narrative: Feverish feeling night sweats, starting day after vaccine. Day 3 got myalgias and headache. Myalgias passed and headache, severe, coming in waves, has persisted x last 2 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a healthcare worker (medical assistant) and refers to a 12 year old female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 20-OCT-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscularly (lot#, exp.date and anatomical location were not provided). It was later learned that the patient was approximately 12 weeks pregnant at the time of vaccination (the estimated last menstrual date 28-JUL-2014, estimated due date: 04-MAY-2015). No adverse experience was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain, Cellulitis, Diarrhoea, Frequent bowel movements, Injection site erythema
Clinical narrative: Patient, age 32, is seen today in regards to (R) arm cellulitis. By patient report, he was seen on 11/07/2014, U.C. after a long absence (previously followed by dr, no maintenance medication in two years). He has abdominal pain and diarrhea, typically having 2-4 bowel movements daily, usually diarrhea with visible mucus, no blood. He was prescribed both UCERIS and LIALDA, both of which were started yesterday. He received both influenza and pneumonia vaccines on 11/07/2014 and has had erythematous, warm skin (R) upper arm, injection site. he is taking oral KEFLEX; however, redness has worsened. He had a fever; however, claims fever since resolved.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Mucous stools, Pyrexia
Clinical narrative: Patient, age 32, is seen today in regards to (R) arm cellulitis. By patient report, he was seen on 11/07/2014, U.C. after a long absence (previously followed by dr, no maintenance medication in two years). He has abdominal pain and diarrhea, typically having 2-4 bowel movements daily, usually diarrhea with visible mucus, no blood. He was prescribed both UCERIS and LIALDA, both of which were started yesterday. He received both influenza and pneumonia vaccines on 11/07/2014 and has had erythematous, warm skin (R) upper arm, injection site. he is taking oral KEFLEX; however, redness has worsened. He had a fever; however, claims fever since resolved.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. In October 2014 (exact date unspecified, reported as between 08-OCT-2014 and 22-OCT-2041) those patients were intramuscularly vaccinated with an improperly stored at 31F for 10 hours GARDASIL once (0.5 ml, lot number was not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old patient with mentally challenged. Medical history was not reported. Physician reported patient, who was 19 years of age, received a dose of VAQTA, 0.5 ml, intramuscular (lot number and expiry date were not provided) on 23-OCT-2014. No adverse effects were reported. Concomitant medication was not reported. The outcome of patient, who was 19 years of age, received VAQTA 0.5ml dose was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eyelid oedema, Injection site erythema, Injection site induration, Injection site swelling, Ocular hyperaemia
Clinical narrative: Left arm at injection site was red, swollen and hard. Site was 2 1/2 in by 2 1/2 in and roughly 1/2 inch deep. Also same side eye was red and puffy.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical nurse regarding a patient of unknown age and gender. On unknown date the patient received a dose of VARIVAX (Merck), lot # K007784 and expiration date on 28-MAY-2016, that were exposed to temperatures outside of the proper storage. No adverse effect reported. It was unknown in the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 73 year old female patient. On 06-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K010628, expiration date: 30-OCT-2015 (dose and route of administration was not reported). On 07-NOV-2014 the patient experienced redness and warmth at the injection site following administration of ZOSTAVAX. The reporter mentioned the area of redness was approximately 5 inches in diameter. Patient sought medical attention (she contacted her pharmacist). She did not receive any treatment for the adverse events. There were no laboratory diagnostics studies performed. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician and a registered nurse refers to a 69 year old male patient with none pertinent medical history. On 10-OCT-2014 the patient was vaccinated with ZOSTAVAX (Lot number, dose and route not reported). Concomitant vaccinations included Influenza virus vaccine (unspecified) administered on 08-OCT-2014, two days prior to the administration of the ZOSTAVAX (also reported as none concomitant medications). On 15-OCT-2014, 5 days after onset of therapy the patient developed a rash from the groin to the knee. None lab diagnosis studies were performed. The patient received cortisone cream and antihistamine. The physician report that the event improved within 24 hours and the patient was recovered. There was no reintroduction due to this being a vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red rash on chin, neck and chest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Hypersensitivity, Injection site swelling
Clinical narrative: Bump at injection site, tingling, minor pain, fatigue, redness, raised welt, itching, warm to hot, blisters, oozing. Present to urgent care 11/19/2014 with worsening symptoms,  Diagnosed by MD with severe allergic reaction.  Given prednisone 20mg tabs, 2 tabs daily for 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Secretion discharge, Skin warm
Clinical narrative: Bump at injection site, tingling, minor pain, fatigue, redness, raised welt, itching, warm to hot, blisters, oozing. Present to urgent care 11/19/2014 with worsening symptoms,  Diagnosed by MD with severe allergic reaction.  Given prednisone 20mg tabs, 2 tabs daily for 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Bump at injection site, tingling, minor pain, fatigue, redness, raised welt, itching, warm to hot, blisters, oozing. Present to urgent care 11/19/2014 with worsening symptoms,  Diagnosed by MD with severe allergic reaction.  Given prednisone 20mg tabs, 2 tabs daily for 5 days.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Induration, Mass, Oedema, Pain
Clinical narrative: Swelling, pain, edema, redness, hard lump, hot to touch, itching.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, pain, edema, redness, hard lump, hot to touch, itching.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Middle insomnia, Mobility decreased
Clinical narrative: TDAP vaccine administered in right deltoid. Symptoms began with the shoulder/clavicle aching and hurting. Deltoid muscle has ached since vaccine was given. First night was awakened by right had numb, tingling and burning, and was unable to close hand. After massaging area of injection and moving arm with circular motions, the sensations would go away but not completely, they would return after short periods of time. Sunday morning after another night of the same symptoms attempted to call DR who administrated vaccine, but they were closed. Sunday throughout the day had the same symptoms and was awakened several times by entire arm being asleep, fingers numb and burning sensation, right clavicle slightly burning and aching, and needing to get up to massage and exercise area. Called Monday morning to DR and explained all symptoms. Symptoms each day have been the same and some days strength of arm and fingers has declined. Tuesday around 1245pm was when I was contacted by Dr and said I was having a reaction to the vaccine and to take Tylenol, which I did take 1 tablet of 500 mg acetaminophen immediately. Symptoms have not since changed and every night I'm awakened and even now (5am Saturday morning) the symptoms are the same.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Paraesthesia, Vaccination complication
Clinical narrative: TDAP vaccine administered in right deltoid. Symptoms began with the shoulder/clavicle aching and hurting. Deltoid muscle has ached since vaccine was given. First night was awakened by right had numb, tingling and burning, and was unable to close hand. After massaging area of injection and moving arm with circular motions, the sensations would go away but not completely, they would return after short periods of time. Sunday morning after another night of the same symptoms attempted to call DR who administrated vaccine, but they were closed. Sunday throughout the day had the same symptoms and was awakened several times by entire arm being asleep, fingers numb and burning sensation, right clavicle slightly burning and aching, and needing to get up to massage and exercise area. Called Monday morning to DR and explained all symptoms. Symptoms each day have been the same and some days strength of arm and fingers has declined. Tuesday around 1245pm was when I was contacted by Dr and said I was having a reaction to the vaccine and to take Tylenol, which I did take 1 tablet of 500 mg acetaminophen immediately. Symptoms have not since changed and every night I'm awakened and even now (5am Saturday morning) the symptoms are the same.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Middle insomnia, Pain, Pain in extremity
Clinical narrative: Constant pain at injection site, pain with movement of arm, wakes up at night with arm pain, no relief with Tylenol, Aleve or Bengay.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Constant pain at injection site, pain with movement of arm, pain causing him to wake up at night.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Gait disturbance, Injected limb mobility decreased, Myalgia, Neck pain
Clinical narrative: Muscle began to ache terrible could hardly use my vacinated arm spread thoughout evening to neck across back down other arm.  Next day was in leg muscles, could hardly walk without pain.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Muscle began to ache terrible could hardly use my vacinated arm spread thoughout evening to neck across back down other arm.  Next day was in leg muscles, could hardly walk without pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Erythema, Pain, Swelling face
Clinical narrative: Achy body particularly my legs, redness on my stomach and face (looks like a sunburn, swelling of face, dizziness and weakness.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Malaise, Muscle spasms, Paralysis
Clinical narrative: I take FLU shots each year without incident.  I've had MS since 1998.  I just got the flu shot and pneumonia shot yesterday (dead virus)  I became ill within the hour and went to bed.  I woke up about 2 hours later with no voluntary movement except my head.  That's right.  Total body paralysis below my neck.  I slowly began to achieve some movement.  But, this was accompanied by violent total body spasms for about 2 hours.  It took me 6 hours until I was finally able to sit up in bed.  Still very weak.  Obviously, I will consult my Dr.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Headache, Inflammation, Mobility decreased, Myalgia
Clinical narrative: Left arm was extremely sore with limited motion.  Most of entire left arm was inflamed and red in color.  Experienced overall body muscle and aches as well as a headache.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm was extremely sore with limited motion.  Most of entire left arm was inflamed and red in color.  Experienced overall body muscle and aches as well as a headache.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal pain upper, Blood test, Crying, Dehydration, Diarrhoea
Clinical narrative: Fever 99.2 on 11/18/14 in the morning. Vomiting began at 10:00 pm after bottle. Vomiting continued into next day with bottles. Diarrhea as well along with stomach cramping and pain and crying. Treated in ER for deyhydration and possible intussusception.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pain, Pyrexia, Ultrasound abdomen, Urine analysis, Vomiting
Clinical narrative: Fever 99.2 on 11/18/14 in the morning. Vomiting began at 10:00 pm after bottle. Vomiting continued into next day with bottles. Diarrhea as well along with stomach cramping and pain and crying. Treated in ER for deyhydration and possible intussusception.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site.  Swelling has increased over time.  Patient taking acetaminophen and diphenhydramine.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flucelvax not approved by FDA for patients under 18. Flucelvax was inadvertently administered to this 15 year old patient. NO ADVERSE EFFECTS. Just reporting.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Lip pain
Clinical narrative: Fever of 102.5, body aches, stomach ache, headache, lips hurting, joints hurting, shaking in the evening. Fever through the night until 4am 11/22/2014 when Tylenol given, then tiredness.