chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt states that her arm was sore the day of the vaccination. She went to the ED later that day. The soreness subsided and when she went to the MD yesterday, the soreness was discussed and noted but this was not the reason for her MD visit. Today she states the soreness has returned. This was reported to MD.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: ERYTHEMA, REDNESS, SWELLING, WARM. CONTINUE CEPHALEXIN 500MG FOR ANOTHER 5 MORE DAYS (TOTAL 10 DAYS FROM SWELLING DAY). PATIENT IS CURRENTLY TAKING CEPHALEXIN DUE TO TOE INFECTION AND IS 5 DAYS OUT OF 10 DAY THERAPY CURRENTLY.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient came to pick up medication on Sunday 8/20/17 and when we asked how he was doing, he showed up the location that his flu shot was given and there was a light bluish-black circular bruise. Patient said there was no pain.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who was referring to a patient of unknown age gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 20-JUL-2017, the patient was vaccinated with improperly stored ROTATEQ lot # M017558, expiration date: 27-FEB-2017 and with improperly stored PEDVAXHIB lot #L051122, expiration date: 12-OCT-2017 or lot# M045206, expiration date: 27-JUN-2017 (lot number was not specified) both for prophylaxis. The vaccines were stored in temperature 67.5 F for 9 hours and 6 minutes. There was a previous temperature excursion when the vaccines were stored in 72.1F for 3 hours and 58 minutes. The call was because of digital data logger. No adverse effects were reported. Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX for prophylaxis. On an unknown date the patient experienced drug administered to patient of inappropriate age and no adverse event. This is one of two reports from the same source.; Sender's Comments: US-009507513-1708USA009469:
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A female adolescent patient received TRUMENBA (lot S26962) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and patient's concomitant medications were not reported. The patient fainted and sent to the ER for fluids on an unspecified date. The outcome of the event was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Spoke with the patient on 8/19/2017 in the afternoon when she reported that she had been given pneumococcal vaccine and had redness, soreness at the injection site with fever. The fever had been up to 102 F. She had called on Friday when she was recommended to take TYLENOL but she reported that the fever has continued but had started to get better on TYLENOL. Since, she is immunocompromised, I asked her to go to nearest ER to get evaluated and if she did not want to go to ER which seemed the case to me (as she was somewhat better), she should continue TYLENOL and keep herself hydrated. She denied any localizing symptoms of URTI/LRTI/UTI. Denied any chills, night sweats. I recommended her to keep a low threshold to go to ER which she understood.
Age: 20.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Serum sickness
Clinical narrative: Patient potentially had serum sickness and a large injection injection site reaction.
Age: 20.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Skin reaction
Clinical narrative: Patient potentially had serum sickness and a large injection injection site reaction.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Woke up in the night vomiting, one-time episode. No treatment.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Swelling
Clinical narrative: SWELLING, RASH, PAIN.
Age: 54.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Cold sweat, Decreased appetite, Dizziness, Feeling abnormal, Vomiting
Clinical narrative: PATIENT CALLED PHARMACY REGARDIND ADVERSE REACTION. HE STARTED FEELING "ODD" AFTER ABOUT 1 and 1/2 HOURS OF VACCINATIONS. HE WAS AT WORK AND FELT DIZZY AND "CLAMMY" AT AROUND 2 PM, ASKED BOSS FOR DAY OFF. PATIENT WENT HOME AND LAID ON BATHROOM FLOOR ABOUT 4 HRS AFTER VACCINATIONS, VOMITED AT AROUND 3:30 PM, STILL FEELING DIZZY BUT SYMPTOMS WERE NOT GETTING WORSE. FELT BETTER AND AT 9 PM WENT OUT TO BUY GATORADE FOR FLUIDS AND A COUPLE OF COOKIES, COULDN'T EAT OR DIDN'T FEEL LIKE EATING ANYTHING. PATIENT ALSO VOMITED AT AROUND 10:30 PM (LAST VOMIT). PATIENT IS FEELING A LOT BETTER TODAY (DAY AFTER VACCINES), ABOUT 80% BETTER PER PATIENT. NO PHYSICAL REACTION ON SKIN WHERE SHOTS WERE GIVEN. THE DIZZINESS ALSO WENT AWAY THIS MORNING. (PER PATIENT LAST TETANUS SHOT WAS ABOUT IN 1987)
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient claims her arm started getting very red, swollen and warm and somewhat painful. It has been 7 days and her arm continues to be red and swollen.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Laboratory test normal, Loss of consciousness, Muscle rigidity, Urinary incontinence
Clinical narrative: Less than 5 min post vaccination pt became unconscious, rigid and incontinent of urine. Assisted to floor, regained consciousness, felt weak and no memory of event, transported to hospital for eval by paramedics. Mom reports was fine with no further events, tests negative and sent home. 6 days post vaccination child appears to have recovered without issues.
Sex: U
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Migraine, Pyrexia, Vomiting
Clinical narrative: Patient suffered a 4 day migraine with vomiting and mild fever.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Chills, Dysstasia, Electrocardiogram, Fall
Clinical narrative: Pt. left exam room with parents after receiving vaccines. He was standing by checkout desk, he fell to floor and hit his forehead (per father). Pt was near unconsciousness. Mom stood him up, he was unable to stand. At this point a code blue was called by reception. EMT called. Staff had tended to this child and laid him down and elevated his legs. O2 was applied via FM. He was very pale, shivering. SpO2 100% with O2. VS stable. Pulses palpable but weak. EMT arrived and CT collar placed. He was still conscious but unable to speak appropriately. He was transferred to Hospital ED.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Head injury, Pallor, Pulse abnormal
Clinical narrative: Pt. left exam room with parents after receiving vaccines. He was standing by checkout desk, he fell to floor and hit his forehead (per father). Pt was near unconsciousness. Mom stood him up, he was unable to stand. At this point a code blue was called by reception. EMT called. Staff had tended to this child and laid him down and elevated his legs. O2 was applied via FM. He was very pale, shivering. SpO2 100% with O2. VS stable. Pulses palpable but weak. EMT arrived and CT collar placed. He was still conscious but unable to speak appropriately. He was transferred to Hospital ED.
Age: 50.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: Pt. experienced numbness in left leg.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Fatigue, Injection site rash, Pyrexia, Rash
Clinical narrative: Low grade fever, rash at injection site which then spread to both legs, fatigue.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: Patient developed a bruise at the injection site that started the day after her vaccine. It was about 1-2" in diameter, and a purple/brown color. She said it was sore. She also said it had improved since it originated.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain in extremity, Swelling
Clinical narrative: Copied from patient self report that was submitted in writing to clinic on 8/21/17:  "Following my pneumonia booster last Thursday a.m. I experienced severe arm soreness, some swelling & redness, and a flu like illness very bad Fri. and Sat. And not yet well. Just reporting as I have not had any significant reactions in the past."
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Erythema nodosum
Clinical narrative: 10 days following hep B injection developed erythema nodosum on both shins.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Painful lump at the injection site starting 8/6/17 until present (8/22/17).
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Patient called into clinic on 7/14/17 at 1024 complaining of right arm pain with 2 quarter size bumps at injection site that are red, hot and hard to the touch. Patient given homecare instructions. On 7/14/17 patient went to local Emergency Department where she was discharged common vaccination response to PNEUMOVAX without evidence for serious complications such as skin infection or abscess formation. She returned to another ED on 7/15/17 where she had a US done that was positive for cellulitis and was given abx. She went back to ED again on 7/16/17 had another US that was WNL no sign of abscess or cellulitis.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Patient called into clinic on 7/14/17 at 1024 complaining of right arm pain with 2 quarter size bumps at injection site that are red, hot and hard to the touch. Patient given homecare instructions. On 7/14/17 patient went to local Emergency Department where she was discharged common vaccination response to PNEUMOVAX without evidence for serious complications such as skin infection or abscess formation. She returned to another ED on 7/15/17 where she had a US done that was positive for cellulitis and was given abx. She went back to ED again on 7/16/17 had another US that was WNL no sign of abscess or cellulitis.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Eye movement disorder, Fall, Feeling abnormal, Hypotonia, Loss of consciousness
Clinical narrative: PATIENT WAS SITTING IN CHAIR AND EYES ROLLED, WENT LIMP AND FELL TO THE GROUND. A FEW SECONDS LATER HE REGAINED CONSCIOUSNESS BUT FELT "SLOW" LIKE HE JUST WOKE UP. AFTER 20 MINUTES OBSERVATION HE WAS ABLE TO GO BACK TO WORK.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Severe neck/arm/hand pain; unable to move arm; chills and fever of 102. Chills and fever throughout the evening of the shot administration; pain lasted about 3 days, gradually lessening.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache
Clinical narrative: Patient complains of Headache after receiving vaccine that night that has lasted few days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Skin exfoliation
Clinical narrative: SWOLLEN, RASH, AND SKIN PEELING ON LEFT BICEP - SHE STATED IT HAS GOTTEN BETTER AS DAYS PROGRESS.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Paraesthesia, Paraesthesia oral
Clinical narrative: PAINFUL, RED, HOT INJECTION SITE. PT REPORTS TONGUE AND CHEST TINGLING.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Muscle spasms, Muscle twitching, Pain
Clinical narrative: Pt reports that after getting the FLUAD vaccine she began having muscle spasms and twitching from her shoulder down to her elbow particularly when lifting or extending her arm. Pt states that the current pain was a 9 out of 10 (08/21/2017). On 8/21/2017, pt went to urgent Care and received a prescription for MEDROL DOSE PACK.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Patient came back to pharmacy approximately 10-15 minutes after receiving the vaccination to report that she experienced a stinging/tingling feeling at the injection site. She said it comes and goes but hurts. Not a dull pain but sharper in feel.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Gait inability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: My 3 year old son began complaining of right knee pain at around 5:30pm. He began limping and about 20 minutes later, was completely unable to walk. He was fussy, irritable, and continued to complain of right knee pain and injection site pain. At around 7:30PM, I noticed that the right knee was significantly swollen and red. He continued to complain of knee pain, injection site pain, and was unable to walk. He went to sleep at around 8:30PM. I researched possible reasons for his sudden knee pain, and the most logical reason is Extensive Limb Swelling (ELS) due to the DTAP vaccination.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Irritability
Clinical narrative: My 3 year old son began complaining of right knee pain at around 5:30pm. He began limping and about 20 minutes later, was completely unable to walk. He was fussy, irritable, and continued to complain of right knee pain and injection site pain. At around 7:30PM, I noticed that the right knee was significantly swollen and red. He continued to complain of knee pain, injection site pain, and was unable to walk. He went to sleep at around 8:30PM. I researched possible reasons for his sudden knee pain, and the most logical reason is Extensive Limb Swelling (ELS) due to the DTAP vaccination.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Symptoms started around 7:30am and included pain where shot was given, redness and swelling where shot was given, mild fever, headache, tiredness, nausea, chills, sore joints, body aches.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Symptoms started around 7:30am and included pain where shot was given, redness and swelling where shot was given, mild fever, headache, tiredness, nausea, chills, sore joints, body aches.
Sex: U
Vaccine: RAB
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 4 days after receiving RABAVERT, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to RABAVERT. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that they experienced general body ache after receiving a dose of RABAVERT. The patient refused to provide all other details.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chills, Dizziness postural, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Sore stiff muscles, joints and had chills. Pt. also gets dizziness when standing at times. Treatment: Ibuprofen, Ice pack to the area and increase fluids. Call I fever greater than 101 or worse S/S. Spoke with mom again 8/21/17 - she is all better.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Sore stiff muscles, joints and had chills. Pt. also gets dizziness when standing at times. Treatment: Ibuprofen, Ice pack to the area and increase fluids. Call I fever greater than 101 or worse S/S. Spoke with mom again 8/21/17 - she is all better.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Syncope, Vomiting
Clinical narrative: Immediately after, patient stood up and fainted. He vomited twice. Gave juice and water, laid down, doctor called and checked BP. Patient discharged by doctor in stable condition.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red swollen and itchy surface 6 inches up and down thigh 3 inches side to side.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Chromaturia, Diarrhoea, Injection site pain, Malaise
Clinical narrative: Stomach pain, severe injection site soreness, orange urine, constant diarrhea, general malaise x12 days.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Swelling, redness, warmth to area evening of vaccination; itching next day. Treated with CLARITIN, BENADRYL, cortisone cream.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Diplopia, Headache, Idiopathic intracranial hypertension, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt. rec'd 11 yr imm. at WCE in office on 8/07/17. On 8/10/17 s/s=HA/blurry vision; 8/12=(+) diplopia. 8/13=O.D. turned inward. Pt. to ER and admitted x 2 days. Dx with "idiopathic intracranial hypertension". Tx'd with DIAMOX 250mg PO BID x3d; then 500mg.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Papilloedema, Strabismus, Vision blurred
Clinical narrative: Pt. rec'd 11 yr imm. at WCE in office on 8/07/17. On 8/10/17 s/s=HA/blurry vision; 8/12=(+) diplopia. 8/13=O.D. turned inward. Pt. to ER and admitted x 2 days. Dx with "idiopathic intracranial hypertension". Tx'd with DIAMOX 250mg PO BID x3d; then 500mg.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Parent notified - Tdap valid according to book. Child will come get polio.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered 8/9, pt. seen next day with left upper arm swollen, red, hot, painful at injection site, no fever noted, no SOB, no difficulty swallowing. Pt. advise to treat with Ibuprofen and hot/cold compresses.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Limb discomfort
Clinical narrative: Injection too high in the arm. Could not move arm in any direction. Limited mobility and lots of discomfort. Treated at urgent care with steroid and NSAID prescription.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: After immunization, patient presented with "egg-sized" bump on arm. No other S/S of allergy. Site: (L) Deltoid - PNEUMOVAX site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed swelling and redness in left thigh at injection site day after injection. Since then, increased redness and pruritus.
Age: 62.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Contusion, Insomnia, Paraesthesia
Clinical narrative: Patient was given shot (ADACEL) on 8-14-17 (Mon) developed bruise at night, 2 days later (elbows, knees (joint pain)), by Thursday terrible back pain (can't sleep). Took TYLENOL, pain becomes manageable. Still experiencing tingling.
Age: 62.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Back pain, Paraesthesia
Clinical narrative: Patient was given shot (ADACEL) on 8-14-17 (Mon) developed bruise at night, 2 days later (elbows, knees (joint pain)), by Thursday terrible back pain (can't sleep). Took TYLENOL, pain becomes manageable. Still experiencing tingling.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Blood pressure increased, Heart rate increased
Clinical narrative: Patient experienced several episodes of anxiety with feelings of doom. Patient had elevated BP and heart rate during these episodes. The episodes persisted for approx. 1 1/2 - 2 hours. 50 mg of BENADRYL given PO to alleviate symptoms (assuming allergic response).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site mass
Clinical narrative: Golf ball sized lump where vaccine administered day after given. No pain but itches. Recommended cold pack and BENADRYL cream. Was reported to me on 8/21/17 at 8pm and by 8/22/17 swelling was reduced and itching was gone.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Feeling hot, Mobility decreased, Pain
Clinical narrative: After vaccine 3 days of chills, redness and heat. 8/22/17 seen in UC throbbing pain full extension of arm limited due to pain, no redness or swelling. Pt. sent to Hospital ER for further evaluation.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: After vaccine 3 days of chills, redness and heat. 8/22/17 seen in UC throbbing pain full extension of arm limited due to pain, no redness or swelling. Pt. sent to Hospital ER for further evaluation.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Mother called c/o soreness in shoulder, upper body achy, more significant on rt side. Noted headache at 4 AM on Aug 17th. Rt. shoulder, deltoid area red/swollen. No fever or itching. No breathing problems. 5-22 spoke to pt. today, has recovered from vaccines.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Dysstasia, Pallor, Pulse abnormal
Clinical narrative: Shortly after receiving vaccines while waiting at checkout, patient became extremely pale and unable to stand. He was laid down on bench and legs were elevated. He had a weak thready pulse, color was extremely pale. Child did not lose consciousness. 3 L oxygen was placed via face mask. EMT was called. he was elevated after approx 5 min. Pt. could talk and stated he felt better. EMT arrived and monitored him. He began to feel light headed again and they transferred him to Hospital ED. F/U with mom and mom stated by the time he arrived at the ED his color improved and he was more alert. He was monitored in the ED shortly, received food and drink, and he was D/C'd with no further issues.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Muscle spasms
Clinical narrative: Patient came in 15 days later to inform me that day after receiving PREVNAR-13 he had experienced lower back pain (pelvic area), spasms, that are getting better. The patient did mention having back surgery years ago.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: 11:30 am Patient almost fainted in waiting room after receiving HPV9 and MCV4 vaccine. Patient states he felt nauseous and felt like vomiting. BP 90/60. Patient taken to back room to lie down; wet hand towels placed on his forehead and neck: BP taken again at 11:45 110/70. Mother gave him a candy to suck on. Pt states he feels better now; refused EMS services.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Malaise, Pallor, Vomiting
Clinical narrative: Pt went to lobby told mom felt sick, threw up got very pale nurse brought back into clinic. Placed in lab chair that could lie back got VS 105/69 Pulse 60. Cold compress monitored, rev VS 108/72 pulse 62 continued to monitor BP 108/72 pulse 68. Stated felt better raised in increments. Pt able to stand and leave stating felt much better 8/21/17 12:40.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Patient developed a red, bumpy, blistering rash over her body around 8/10/17-8/12/17 (approximately 17-20 days after vaccination).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Rash, Type IV hypersensitivity reaction
Clinical narrative: Pt. seen 8/22/17; 11 days post vaccination Lt arm swollen at MMR site on 8/12 red wheel with urticaria. Rash continued to spread to all extremities and trunk. Probable delayed hypersensitivity to the MMR.
Sex: M
Vaccine: PNC13, TDAP, HIBV
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging, Sleep disorder, Soft tissue disorder, Vaccination failure
Clinical narrative: Left deltoid tissue circumference changes. Vaccine failure. Only able to sleep on the side since event.
Sex: M
Vaccine: PNC13, TDAP, HIBV
Symptoms: X-ray
Clinical narrative: Left deltoid tissue circumference changes. Vaccine failure. Only able to sleep on the side since event.
Sex: M
Vaccine: PNC13, TDAP, HIBV
Symptoms: Nuclear magnetic resonance imaging, Sleep disorder, X-ray
Clinical narrative: Left deltoid tissue circumference changes. Vaccine failure. Only able to sleep on the side since event.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test, Pericardial effusion, Pericarditis
Clinical narrative: Patient reported onset of initial chest pain within weeks of smallpox vaccine receipt. Chest pain described as "very mild (1-2/10) pain soon into the deployment" (Apr 2008). "I thought it was from wearing a 70 pound flak jacket everydaychest tightening. Very early in the job I felt my heart beat...could see the blood pumping in veins on (his) head." "didn't seem at all bad until coming home went to a 5-6/10 and would sometimes last 1- 2 weeks, but only occurred about 2-3 times per year."  Patient sought evaluation between Feb  Aug 2010 - "the pain went to 8-9/10went to BAS a few timessaid it was heartburn"  - SEE CONTINUATION PAGE AND ADDITIONAL DOCUMENTATION
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest discomfort, Chest pain, Pericarditis
Clinical narrative: Patient reported onset of initial chest pain within weeks of smallpox vaccine receipt. Chest pain described as "very mild (1-2/10) pain soon into the deployment" (Apr 2008). "I thought it was from wearing a 70 pound flak jacket everydaychest tightening. Very early in the job I felt my heart beat...could see the blood pumping in veins on (his) head." "didn't seem at all bad until coming home went to a 5-6/10 and would sometimes last 1- 2 weeks, but only occurred about 2-3 times per year."  Patient sought evaluation between Feb  Aug 2010 - "the pain went to 8-9/10went to BAS a few timessaid it was heartburn"  - SEE CONTINUATION PAGE AND ADDITIONAL DOCUMENTATION
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Myalgia, Pyrexia, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable pharmacy intern reported on behalf of the Pharmacist for a patient. A 65-year-old male patient started to receive PREVNAR 13 (NDC #: 0005197102, lot#R70446, Expiry Date: Apr2018), intramuscularly on 14Aug2017 at 0.5 ml, single, right arm for recommended pneumonia shot. The medical history was not reported. Concomitant medication included ZOSTAVAX (Lot#: L025375, Expiry Date: 18Jan2018, manufacturer: Merck), subcutaneous at right arm, on 14Aug2017 for immunization, BOOSTRIX (Lot#: 7Z9Z5, Expiry Date: 27May2019, manufacturer: GSK), intramuscular at left arm on 14Aug2017 for immunization, FLUAD (Lot#: 178303, Expiry Date: Apr2018, manufacturer: Seqirus), intramuscular at left arm on 14Aug2017 for immunization, meloxicam from unspecified date and ongoing at 15 mg, as need for pain prophylaxis. The patient experienced tinnitus on 15Aug2017 with outcome of not recovered. Vaccination Facility Type: Pharmacy/Drug Store. The reporter considered there was no causality relationship with pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently provided, the company concurs with the causality assessment expressed by the reporting pharmacist, considering the reported event of tinnitus is not related to the use of PREVNAR 13.  Tinnitus more likely represents the patient's intercurrent medical condition.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable pharmacy intern reported on behalf of the Pharmacist for a patient. A 65-year-old male patient started to receive PREVNAR 13 (NDC #: 0005197102, lot#R70446, Expiry Date: Apr2018), intramuscularly on 14Aug2017 at 0.5 ml, single, right arm for recommended pneumonia shot. The medical history was not reported. Concomitant medication included ZOSTAVAX (Lot#: L025375, Expiry Date: 18Jan2018, manufacturer: Merck), subcutaneous at right arm, on 14Aug2017 for immunization, BOOSTRIX (Lot#: 7Z9Z5, Expiry Date: 27May2019, manufacturer: GSK), intramuscular at left arm on 14Aug2017 for immunization, FLUAD (Lot#: 178303, Expiry Date: Apr2018, manufacturer: Seqirus), intramuscular at left arm on 14Aug2017 for immunization, meloxicam from unspecified date and ongoing at 15 mg, as need for pain prophylaxis. The patient experienced tinnitus on 15Aug2017 with outcome of not recovered. Vaccination Facility Type: Pharmacy/Drug Store. The reporter considered there was no causality relationship with pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently provided, the company concurs with the causality assessment expressed by the reporting pharmacist, considering the reported event of tinnitus is not related to the use of PREVNAR 13.  Tinnitus more likely represents the patient's intercurrent medical condition.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3, PNC13, TDAP, VARZOS, FLUA3
Symptoms: Headache, Injection site pain, Pyrexia, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable pharmacy intern reported on behalf of the Pharmacist for a patient. A 65-year-old male patient started to receive PREVNAR 13 (NDC #: 0005197102, lot#R70446, Expiry Date: Apr2018), intramuscularly on 14Aug2017 at 0.5 ml, single, right arm for recommended pneumonia shot. The medical history was not reported. Concomitant medication included ZOSTAVAX (Lot#: L025375, Expiry Date: 18Jan2018, manufacturer: Merck), subcutaneous at right arm, on 14Aug2017 for immunization, BOOSTRIX (Lot#: 7Z9Z5, Expiry Date: 27May2019, manufacturer: GSK), intramuscular at left arm on 14Aug2017 for immunization, FLUAD (Lot#: 178303, Expiry Date: Apr2018, manufacturer: Seqirus), intramuscular at left arm on 14Aug2017 for immunization, meloxicam from unspecified date and ongoing at 15 mg, as need for pain prophylaxis. The patient experienced tinnitus on 15Aug2017 with outcome of not recovered. Vaccination Facility Type: Pharmacy/Drug Store. The reporter considered there was no causality relationship with pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently provided, the company concurs with the causality assessment expressed by the reporting pharmacist, considering the reported event of tinnitus is not related to the use of PREVNAR 13.  Tinnitus more likely represents the patient's intercurrent medical condition.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Communication disorder, Developmental regression
Clinical narrative: Fever, slept a lot. Regressed completely within the week, stopped saying mom, waving, playing... diagnosed with Autism a year later. Never regained speech, communication. Didn't walk till almost 2. He became another child after the vaccine.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: Fever, slept a lot. Regressed completely within the week, stopped saying mom, waving, playing... diagnosed with Autism a year later. Never regained speech, communication. Didn't walk till almost 2. He became another child after the vaccine.
Age: 39.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The PREVNAR injection site is two inches from the flu injection site. The PREVNAR site is hot, raised, red, itchy, and tender/sore/swollen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Mother reported that four hours after the vaccines were given patient began complaining of headache and dizziness. Mother then states that patient woke the mother up at 0600 the next morning with complaints of abdominal pain, nausea, vomiting, and diarrhea. Mother contacted the pediatric clinic and is pending an appointment with a pediatrician.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Mother reported that four hours after the vaccines were given patient began complaining of headache and dizziness. Mother then states that patient woke the mother up at 0600 the next morning with complaints of abdominal pain, nausea, vomiting, and diarrhea. Mother contacted the pediatric clinic and is pending an appointment with a pediatrician.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: Swelling and itching at vaccine administration site x 1 day. Treatment plan of ice and ibuprofen for swelling. Call office if no improvement.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, for prophylaxis. On an unknown date the patient experienced no adverse event.; Sender's Comments: US-009507513-1708USA004110: US-009507513-1708USA004111: US-009507513-1708USA004112: US-009507513-1708USA004113: US-009507513-1708USA004114: US-009507513-1708USA004115: US-009507513-1708USA004127: US-009507513-1708USA004117: US-009507513-1708USA004118: US-009507513-1708USA004119: US-009507513-1708USA004120: US-009507513-1708USA004121: US-009507513-1708USA004122: US-009507513-1708USA004123: US-009507513-1708USA004124: US-009507513-1708USA004125: US-009507513-1708USA004126: US-009507513-1708USA004109: US-009507513-1708USA004108: US-009507513-1708USA004116:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 03-JUL-2017 at 15:02, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Age: 2.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 2 year-old patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 21-JUN-2017 at 09:37, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M042495 with the expiration date of 19-OCT-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of VAQTA. Administered dose of VARIVAX experienced the temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year-old female patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 22-JUN-2017 at 09:32, the patient was vaccinated with improperly stored second dose of VARIVAX, one unspecified dose in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DTAP) and poliovirus vaccine inactivated (unspecified) (IPV). The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Age: 1.08
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 29-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II and pneumococcal vaccine (unspecified). The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 14-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, or prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800: Original Case: 1708USA002800.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018,  for prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800: Original Case: 1708USA002800.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-JUL-2017 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number M042324 expiration date: 10-JUN-2018, lot number: M044564 expiration date: 22-OCT-2018, lot number: N001007 expiration date: 09-SEP-2018) for prophylaxis (digital data logger). No adverse effects reported. Sender's Comments: US-009507513-1708USA002800.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 13-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018, for prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Information has been received from a pharmacist referring to a 17 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 04-AUG-2017, the patient was administered the first dose of the HPV immunization series as GARDASIL 9 (strength, dose and frequency unknown, lot # M007764, expiration date 30-JAN-2018) intramuscularly as routine vaccination for prophylaxis. On the same day, the patient experienced "dizziness for 30 minutes after the administration of the vaccine". The primary reported that "having the patient drink water and having the patient sitting for 30 minutes" was treatment for the patient's dizziness. The patient "recovered from the dizziness the same day, 04-AUG-2017". No lab diagnostics was performed. Action taken with the vaccine was not applicable. The relationship between the event and the vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via a representative referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug allergy were not reported. On 07-AUG-2017, the patient received an improperly dose of stored VARIVAX (lot# L048466, expiration date 02-DEC-2017, exact dose and route not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 to 14 Fahrenheit (F) for unknown time frame. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported.
Age: 3.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 18-AUG-2017 the patient was vaccinated with M-M-R II lot # L028273 for prophylaxis. Concomitant therapies included sterile diluent. On 18-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age with prophylaxis. The medical history, concurrent conditions and concomitant medications are not reported. On 17-AUG-2017, the patient was vaccinated with a dose of VARIVAX (N014371 09-MAY-2019) reconstituted with sterile diluent (manufacturer unknown) M042852 30-May-2019 for prophylaxis. No adverse effects were reported. Temperature was reported as 6 degree Fahrenheit to 14 degree Fahrenheit and time frame of 10 minutes. There was no previous temperature excursion. There was data logger. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 76 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in July 2010, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously (dose, anatomical location, lot# and expiration date were not reported) for prevention of herpes zoster. On 21-AUG-2017, the patient developed shingles. The outcome of herpes zoster was reported as not recovered/not resolved. The causality between the event and vaccination with ZOSTAVAX was not reported. The product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (lot # N014470, expiration date 27-JUN-2019) for prophylaxis. This vaccine was exposed to 21 degrees Celsius (°C) for 1.5 hours. No adverse effects were reported in the patient. There was no previous temperature excursion. The call was made because there was a "data logger".
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant regarding an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that on unspecified dates an unspecified number of patients were administered improperly stored doses of GARDASIL 9 (lot # M042853 expiration 17-JUL-2019) unknown route for prophylaxis. No adverse effects were reported. The vaccines were stored at the temperature range of 47 degrees Fahrenheit and 77 degrees Fahrenheit for the time frame of 15 minutes. There were no previous temperature excursions. The call was made due to a data logger. All telephone attempts to obtain follow up information had been unsuccessful. Sender's Comments: US-009507513-1707USA002112: US-009507513-1708USA009538.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (lot # N000238, expiry date: 25-OCT-2019) for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 50 degree Fahrenheit for 30 minutes. No data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009707: