chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Head titubation, Hypoaesthesia, Insomnia, Laboratory test
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lip injury, Mental impairment, Muscle twitching, Muscular weakness, Neurological symptom
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Pain in extremity, Paraesthesia, Peripheral swelling, Somnolence
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound Doppler, Urinary incontinence
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: Patient stated she had a knot with redness at the injection site. Upon examination, the knot had gone away, but redness still remained at the injection site 3 days post vaccine administration. Patient still complained of soreness in arm, but was able to move it more than had been in the previous days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Induration, Injected limb mobility decreased, Injection site pain
Clinical narrative: At point of injection at 315 pm patient tensed up left arm and pulled arm back. Patient described immediately that injection hurt. Called patient around 730 pm to check on patient and how she was feeling. Patient described arm pain. Described to patient to massage area, take ibuprofen 200 mg every 8 hours to help with pain. Also to ice area of soreness for 20 minutes and apply heat for 20 minutes. Patient called pharmacy 4/12/2018 at 846 am describing excruciating pain did not follow pharmacist advice however did take hydromorphone 4 mg to help with pain. Patient described arm could not be lifted and is hard to the touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tension
Clinical narrative: At point of injection at 315 pm patient tensed up left arm and pulled arm back. Patient described immediately that injection hurt. Called patient around 730 pm to check on patient and how she was feeling. Patient described arm pain. Described to patient to massage area, take ibuprofen 200 mg every 8 hours to help with pain. Also to ice area of soreness for 20 minutes and apply heat for 20 minutes. Patient called pharmacy 4/12/2018 at 846 am describing excruciating pain did not follow pharmacist advice however did take hydromorphone 4 mg to help with pain. Patient described arm could not be lifted and is hard to the touch.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE, FEVER, SHIVERS, HEADACHE, MUSCLE PAIN, NAUSEA.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE, FEVER, SHIVERS, HEADACHE, MUSCLE PAIN, NAUSEA.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling; left arm; up left shoulder. Hot to touch, redness, swelling.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: SEVERE LEFT ARM PAIN, SWELLING AND IMMOBILITY.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Biopsy skin abnormal, Cutaneous vasculitis, Erythema, Generalised vaccinia, Injection site erythema
Clinical narrative: Developed redness around the site of vaccine with  swelling, and pain along with body aches and lymphadenopathy at 7 days after vaccine. In ED this was thought to be cellulitis and treated with oral doxycycline with slow improvement over a week and resolution, but likely robust take. 8 days after vaccine developed itchy erythematous papules on the flank, breast, arms, and legs that coalesced into larger plaques with crusting. Treated with clobetasol ointment and slow improvement of lesions and improvement of pruritus up to current date 4/12/2018.  Diagnosed as generalized vaccinia.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain, Papule
Clinical narrative: Developed redness around the site of vaccine with  swelling, and pain along with body aches and lymphadenopathy at 7 days after vaccine. In ED this was thought to be cellulitis and treated with oral doxycycline with slow improvement over a week and resolution, but likely robust take. 8 days after vaccine developed itchy erythematous papules on the flank, breast, arms, and legs that coalesced into larger plaques with crusting. Treated with clobetasol ointment and slow improvement of lesions and improvement of pruritus up to current date 4/12/2018.  Diagnosed as generalized vaccinia.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Perivascular dermatitis, Pruritus, Scab, Skin plaque
Clinical narrative: Developed redness around the site of vaccine with  swelling, and pain along with body aches and lymphadenopathy at 7 days after vaccine. In ED this was thought to be cellulitis and treated with oral doxycycline with slow improvement over a week and resolution, but likely robust take. 8 days after vaccine developed itchy erythematous papules on the flank, breast, arms, and legs that coalesced into larger plaques with crusting. Treated with clobetasol ointment and slow improvement of lesions and improvement of pruritus up to current date 4/12/2018.  Diagnosed as generalized vaccinia.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Mobility decreased
Clinical narrative: 1)Pain, swelling, and redness at the injection site. Starting within 24 post-injection. 2)Left-arm muscle pain and limited mobility (opposite arm of the injection site). Increasing in severity. Starting apx. 30 hours post-injection. 3) Mild lethargy starting apx. 36 hours post-injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 1)Pain, swelling, and redness at the injection site. Starting within 24 post-injection. 2)Left-arm muscle pain and limited mobility (opposite arm of the injection site). Increasing in severity. Starting apx. 30 hours post-injection. 3) Mild lethargy starting apx. 36 hours post-injection.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Asthenia, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: Multiple bouts of diarrhea to the point of needing to change clothes 5 times in less than a 24 hour period. Baby was also very weak, unable to hold his head supported and seemed overall exhausted and unwell. Also had a very low grade fever, and developed a small bump on his butt very close to his rectum. It appears to look most closely to a hemmroid, we are currently on doctors orders to monitor it to ensure it doesn?t progress. Baby also had very unusual colored dirreah appearing almost neon yello which is unlike any stools he has passed before, they also had an unusual and very unbearable odor. Again, poop stinks but not like this. His cheeks were also very rosy later in the day after the vaccination but it appears this has gone away the following day. Baby also woke up in the middle of the night with diarrhea which seemed to be causing him an unusual amount of pain, he also had a decreased appetite but that seems to slowly be improving.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Faeces discoloured, Fatigue, Haemorrhoids, Malaise, Pain
Clinical narrative: Multiple bouts of diarrhea to the point of needing to change clothes 5 times in less than a 24 hour period. Baby was also very weak, unable to hold his head supported and seemed overall exhausted and unwell. Also had a very low grade fever, and developed a small bump on his butt very close to his rectum. It appears to look most closely to a hemmroid, we are currently on doctors orders to monitor it to ensure it doesn?t progress. Baby also had very unusual colored dirreah appearing almost neon yello which is unlike any stools he has passed before, they also had an unusual and very unbearable odor. Again, poop stinks but not like this. His cheeks were also very rosy later in the day after the vaccination but it appears this has gone away the following day. Baby also woke up in the middle of the night with diarrhea which seemed to be causing him an unusual amount of pain, he also had a decreased appetite but that seems to slowly be improving.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Posture abnormal, Pyrexia
Clinical narrative: Multiple bouts of diarrhea to the point of needing to change clothes 5 times in less than a 24 hour period. Baby was also very weak, unable to hold his head supported and seemed overall exhausted and unwell. Also had a very low grade fever, and developed a small bump on his butt very close to his rectum. It appears to look most closely to a hemmroid, we are currently on doctors orders to monitor it to ensure it doesn?t progress. Baby also had very unusual colored dirreah appearing almost neon yello which is unlike any stools he has passed before, they also had an unusual and very unbearable odor. Again, poop stinks but not like this. His cheeks were also very rosy later in the day after the vaccination but it appears this has gone away the following day. Baby also woke up in the middle of the night with diarrhea which seemed to be causing him an unusual amount of pain, he also had a decreased appetite but that seems to slowly be improving.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient woke up in morning complaining of "leg pain", and fever (101 F). Pt presented in office with localized mild edema approximately 4 inches around injection site. Minimal redness at site. Temp was normal at office. Mom had given ibuprofen at home. Mom reported pt had rash on trunk and limbs this morning.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: I was given the shot on 9-12-17 with no issues. I was then given the shot again on 3-30-18 and an hour after I felt dizzy, severe headache and my arm where I was given the shot was red and numb. I had diarrhea and was nauseous.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: I was given the shot on 9-12-17 with no issues. I was then given the shot again on 3-30-18 and an hour after I felt dizzy, severe headache and my arm where I was given the shot was red and numb. I had diarrhea and was nauseous.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Swelling
Clinical narrative: Red itchy swelling on both sides of neck and behind ears. Right arm red rash (not raised).
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Ear pruritus, Rash erythematous
Clinical narrative: Red itchy swelling on both sides of neck and behind ears. Right arm red rash (not raised).
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-OCT-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 28-MAY-2015, the patient was treated at an Urgent Care and Family Practice facility, for a burning vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient was prescribed famciclovir (FAMVIR) and capsaicin cream for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 06-APR-2018 the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N003984, expiry date: 19-NOV-2018), orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 10 degree celsius for a time frame of 26 minutes. No previous temperature excursions reported. No adverse effects were reported. There was a digital data logger involved. No product quality complaint involved.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a currently 21 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 21-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for prophylaxis (dose, lot # and expiration date were not reported) without any problems. On 28-FEB-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot # N022584 with expiration date 15-JUN-2020, for prophylaxis. On an unspecified date in 2018, after the second GARDASIL 9 vaccination, the patient passed out (loss of consciousness) at her beautician's office. The patient was seen at the emergency room and was released on an unspecified date in 2018 and was advised to follow up with a cardiologist. The patient reported to her physician that she was seen at the cardiologist and "everything was negative". Additionally, the patient was seen by an unspecified neurologist on an unspecified date in 2018 (no details were provided). At the time of reporting, the outcome of the event was unknown. The causality assessment between the events and GARDASIL 9 was not provided. Upon internal review, loss of consciousness was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or known allergies provided. On 11-APR-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M041083, expiry date 04-APR-2018, subcutaneously for prophylaxis. No known adverse effects were reported.
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Hyperhidrosis, Hypoaesthesia, Limb discomfort, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reporting for herself via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration a year ago (in 2017) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, fever, felt like there was a stone on her arm, sweating, discomfort, and numbness on an unspecified date after use of product. The outcome of all events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reporting for herself via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration a year ago (in 2017) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, fever, felt like there was a stone on her arm, sweating, discomfort, and numbness on an unspecified date after use of product. The outcome of all events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This is spontaneous report from a contactable healthcare professional. A 68-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced red bumpy rash in front and behind both ears on an unspecified date 3 or 4 days after receiving vaccine (reported as 06Apr, year unspecified) with outcome of recovering, rash was itchy on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Blister
Clinical narrative: This is a spontaneous report from a contactable physician. A 57-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) for immunisation. The  medical history and concomitant medications were not reported. The patient experienced allergy to the vaccination -"blisters". Event outcome was unknown.
Sex: M
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report from contactable physician via a Pfizer sales representative. An adolescent male patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The healthy teenager had chills after administration of meningococcal group b rlp2086 on an unspecified date. Followed up two days later and patient was fine. The outcome of event was recovered on an unspecified date.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria all over body. DECADRON 4 mg given IM. Rx for prednisone and BENADRYL elix.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Pt. was here on 4/10/18 for a 4 yr WCC. On 4/11/18 came back to the office with swelling and redness on (L) side area where vaccines were given.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: On 4/11/18 pt. stated arm hurts and can not lift.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Localized Rxn to vaccines on (L) arm and (R) arm, redness, hot to the touch swelling and painful.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Significant pain in major muscle groups (quads, upper arms, chest, neck) and joints (knees, wrists, lower back, neck); weakness and spasm in upper legs and lower arms. Pain persistent over one week span; pain lessened by TYLENOL (ex strength).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Peripheral swelling
Clinical narrative: Patient called in with symptoms of arm swelling and muscle pain. Pt stated she could barely move her arm up and down for a few days. Pt received vaccine on 4/6/18 and called in on 4/9/18 to report symptoms and at that time had stated her arm was doing better that day. Pt started taking Ibuprofen for the pain before calling in on 4/9/18. Orders to continue the Ibuprofen as needed, ice/heat to arm as needed and gentle ROM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: She reports pain and then a red rash around injection site. It had resolved to just a slight red rash by the date she came in 04/12/18.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Patient returned to our clinic on 04/04/2018. Her arm became red, swollen, tight, and hot to the touch. Instructed her to take OTC ibuprofen and APAP for pain/discomfort. Use ice for 20 minutes on and 20 minutes off. She should do this for 2 days and then can alternate heat with the ice therapy. Instructed to return to clinic if problem persist or worsen. Instructed to return go to ER if SOB, difficulty breathing, and/or feels like her throat is swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, tiredness, joint aches, 3 days pain at injection site.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Injection site erythema
Clinical narrative: 11/1/2017-Mom called stated after infant woke from nap he had redness to right thigh, back & stomach. She was worried this could be allergic reaction to shots received earlier today. Spoke with Associate from PCPs office and stated grandmother was on the other line regarding this as well. Associate instructed them to rotate MOTRIN and TYLENOL with BENADRYL every 6 hours. If redness or rash increases or any signs of SOB is noted that she should got to ER for evaluation. Also was concerned due to recent exposure to shingles. I viewed photos that mom sent and had CDNS to evaluate them, she suggested they follow instructions from PCP. Mom verbalized understanding, LPN. Spoke with mom on 4/10/2018 via phone to verify any further treatment needed and she stated that infant was seen by APN as documented above infant was given BENADRYL and sent home with instructions as noted above.. LPN.
Age: 12.0
Sex: M
Vaccine: HEPAB, HPV9, MNQ, TDAP
Symptoms: Injection site nodule, Peripheral swelling, Skin warm
Clinical narrative: Mom called to report that patient had a dime sized "knot" on his "left arm" lower injection site. States he notice it after showering that night about 9:00 p.m. They started with cool compresses on 04/10/2018 after it progressively worsen. By late 04/11/2018 she reports arm being warm and the size of a golf ball. Counseled to see PMD. Child is at school she plan to take him in a.m. Advised to use warm moist heat/ compress on it instead of dry heat.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: Redness around inj. site  Lt. arm (about size of softball) warm to touch. Hives down left leg. BENADRYL 25 mg at bedtime and TYLENOL for inj. site discomfort.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Administration site induration, Administration site pain, Chills, Injection site erythema, Pyrexia
Clinical narrative: Administration site redness and pain. Pain throughout upper arm. Hardness at administration. Fever/chills.
Age: 39.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Meningitis aseptic
Clinical narrative: I received a call from client's friend/co-worker today stating client has been hospitalized since April 10th. Diagnosed with aseptic meningitis. Infection control doctor (Dr.) thought it may be caused the yellow fever vaccine, along with ibuprofen. Client is still hospitalized as of April 12th.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a 6 year old male patient. Information on his medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 19-SEP-2013 the patient was vaccinated with second dose of VAQTA (strength: 25/0.5 units not reported) intramuscularly (lot#, dose, and expiry date unknown) for prophylaxis. On 30-MAR-2018, the patient received a third dose of VAQTA (strength: 25/0.5 units not reported) intramuscularly (lot # N014945, Exp date:30-AUG-2018) for prophylaxis (inappropriate schedule of drug administration). No adverse effect was reported. No product quality complaint (PQC) was present.
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain
Clinical narrative: This spontaneous report has been received from a 66 year old male patient concerning himself. Information regarding the patient's medical history, and concurrent conditions was not reported. Concomitant therapies included ascorbic acid, vitamin d  and calcium. Drug reactions or allergies included aspirin. On 23-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 ,5 ml, in the upper arm, by intramuscular route (strength, lot # and expiration date were not provided) for prophylaxis. Then on an unspecified date in 2018, reported as "a couple of days later", the patient developed pain and soreness at the injection site (injection site pain) and also a slight headache. The outcome of injection site pain and headache was reported as not resolved. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Heart rate increased, Pyrexia
Clinical narrative: Shortness of breath, shivering, rapid heart rate, fever, and fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient had a bad reaction after receiving the SHINGRIX. The healthcare professional had no details about what the reaction was. The reporter had no patient or vaccine information.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 18-year-old male patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional information was reported as follows: The age at vaccination was not reported. The band Hepatitis B vaccines was unknown. In 2000, the patient was vaccinated with the 1st and 2nd dose of Hepatitis B vaccine. In 2002, the patient was vaccinated with the 3rd dose of Hepatitis B vaccine, which led to drug dose administration interval too long. The patient was required to get an antibody titer drawn prior to entering the college. The titre after analysis showed as non-responsive, which led the patient to be therapy non-responder. Their was no laboratory proof, showing appropriate titer. The healthcare provider had planned for re-vaccinating the patient with another course (3 doses) by using ENGERIX-B.
Sex: F
Vaccine: FLU4, TTOX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included Tetanus vaccine. On an unknown date, the patient received Influenza vaccine Quadrivalent and Tetanus vaccine. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent and Tetanus vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent and Tetanus vaccine. Additional details were reported as follows: The age at vaccination was not reported. But, it could be 61 or 62 years old. In 2017, the patient received Influenza vaccine Quadrivalent and Tetanus shot on an unknown arm. The patient stated that, she was hardly sore after a tetanus shot and flu shot received in the present year. This case has been linked to case US2018GSK055626, reported for the same patient.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: Headache, difficulty breathing (tightness of chest), uncontrolled shaking, feeling extremely chilled (couldn't get hands or feet warm, had to use heating pad), woke up wet from sweating. Called primary care physician and he will keep in touch and monitor symptoms; he suggested going to ER if symptoms persist or get worse.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral coldness, Tremor
Clinical narrative: Headache, difficulty breathing (tightness of chest), uncontrolled shaking, feeling extremely chilled (couldn't get hands or feet warm, had to use heating pad), woke up wet from sweating. Called primary care physician and he will keep in touch and monitor symptoms; he suggested going to ER if symptoms persist or get worse.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Cough, Headache, Tremor
Clinical narrative: Headache, difficulty breathing (tightness of chest), uncontrolled shaking, feeling extremely chilled (couldn't get hands or feet warm, had to use heating pad), woke up wet from sweating. Called primary care physician and he will keep in touch and monitor symptoms; he suggested going to ER if symptoms persist or get worse.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hepatitis B DNA decreased, Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Injection site bruising
Clinical narrative: On 3/15/18, patient received Tdap in the left arm and hepatitis B vaccine (#1 in series)  in the right arm. She reports that right after the vaccine she had some swelling and induration in the right deltoid which continued throughout the weekend. She did not have any swelling in her face or shortness of breath. She reports that she applied ice to the site, but that it is still swollen, tender, and warm. Her left arm where she had the other vaccine was intact there is a small bruise however at both injection sites but the right deltoid where the hepatitis B vaccine was given shows reaction. Patient reports she's never had any history of hepatitis B in the past.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 3/15/18, patient received Tdap in the left arm and hepatitis B vaccine (#1 in series)  in the right arm. She reports that right after the vaccine she had some swelling and induration in the right deltoid which continued throughout the weekend. She did not have any swelling in her face or shortness of breath. She reports that she applied ice to the site, but that it is still swollen, tender, and warm. Her left arm where she had the other vaccine was intact there is a small bruise however at both injection sites but the right deltoid where the hepatitis B vaccine was given shows reaction. Patient reports she's never had any history of hepatitis B in the past.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: REDNESS, SWELLING, HOT, PAIN.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Nodule, Pyrexia, Skin warm, Tenderness
Clinical narrative: 2cmx2cm hot, tender knot with heat. Also fever 105 day of vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Local reaction, Pain
Clinical narrative: Redness and erythema at the injection site and a separate area 3 inches below. Dr. diagnosed localized reaction, not cellulitis. The patient also claimed generalized aches and joint pain.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient's wife reported that her husband's left arm is red, swollen and painful at the injection site. She was instructed to place an ice pack on affected area and have her husband take acetaminophen for the discomfort. I followed up with the patient 12 hours later and the patient's wife stated that most of the discomfort had subsided but the injection site was still red and swollen. I recommended that her husband take BENADRYL to help bring down the swelling and continue with cold compress.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient complains of redness and heat from injection site lasting 48 hours since injection. Informed pt to apply cold compress and to take TYLENOL and BENADRYL and if symptoms get worse to contact a dr.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Eye swelling, Injection site erythema, Injection site mass
Clinical narrative: Red lump at site of injection day after, day 2 bilateral eye swelling.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: FLUZONE Influenza High dose immunization Expiration Date 04/09/2018 given to patient in the left deltoid. Provider in charge notified, Health Care administered notified, Lead MD notified and patient notified. Patient has no reaction. Will continue to follow up with patient.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Injection site mass, Injection site swelling, Myalgia
Clinical narrative: Left arm is severly swollen from injection site down towards elbow, physical lump at injection site, muscle/ joint pain, fever and chills.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Left arm is severly swollen from injection site down towards elbow, physical lump at injection site, muscle/ joint pain, fever and chills.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Death, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Extreme congestion (runny nose, etc) starting about a week after birth/vaccination and up until his death on 10/28/17.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Blister, Herpes zoster, Oedema, Rash papular
Clinical narrative: Left posterior thigh with group of red edematous papules with central 1 mm vesicles, not painful to patient, although he has some neuropathy from his diabetes. Patient also didn't feel much pain during the biopsy process, so he either has a very high pain tolerance or doesn't have good sensation in his legs. Best fit is shingles. Bacterial infection felt to be less likely.
Age: 1.92
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had developed redness and swelling on injection site of right thigh 24 hours after receiving antibiotic. Redness is spreading from injection site. Apply warm soaks or warm compresses to the affected area two or three times a day. Call our office for a recheck appointment if there is increased pain, swelling, or redness, or no improvement in 48 hours.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-04-10.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Injected limb mobility decreased, Malaise, Nausea, Pain
Clinical narrative: Right Arm pain limiting range of motion with shooting pain down right arm, low grade fever, malaise, body aches, nausea, decreased appetite.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Right Arm pain limiting range of motion with shooting pain down right arm, low grade fever, malaise, body aches, nausea, decreased appetite.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Pt presented the next day with erythema to the upper left arm.
Age: 0.5
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme
Clinical narrative: ERYTHEMA MULTIFORME RASH - GIVEN ORAL STEROIDS AND ZYRTEC.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu like symptoms for 3 days. Fever of 101 degrees for 3 days. Chills/Headache/Sore body, Nauseous, Soreness at injection site, Sweating, Trouble sleeping, Trouble catching breath, Feeling swollen.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms for 3 days. Fever of 101 degrees for 3 days. Chills/Headache/Sore body, Nauseous, Soreness at injection site, Sweating, Trouble sleeping, Trouble catching breath, Feeling swollen.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Flu like symptoms for 3 days. Fever of 101 degrees for 3 days. Chills/Headache/Sore body, Nauseous, Soreness at injection site, Sweating, Trouble sleeping, Trouble catching breath, Feeling swollen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pain, Skin warm
Clinical narrative: 2nd day redness. Tired on second day. Sore, tender to touch, warm. 1 week aches all over and chills. IBU for treatment.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 2nd day redness. Tired on second day. Sore, tender to touch, warm. 1 week aches all over and chills. IBU for treatment.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 75 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 06-APR-2018 the patient was vaccinated with RECOMBIVAX HB (0.5 ml/ one dose)(pediatric formulation) from lot M037248 expiration date 21-FEB-2019 by intramuscular route (drug administered to patient of inappropriate age) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: The patient called 4/12/18 at 12:16 PM to report that she thought she might be having a reaction to the PREVNAR 13. Patient was ask when she started having symptoms and stated that the next day 4/7/18 her right arm was sore and by day 3 after injection 4/9/18 redness appeared around the site area. Patient then said that today 4/12/18 that the red area is 2" x 2", swollen, is warm to touch, and itches. Patient denies any shortness of breath. Patient was advise to use a cold compress, to take BENADRYL and if symptoms worsened or she became short of breath to go to the ER. Reaction was document in patient's chart and added to her allergy list and VAERS report filed.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: SHINGRIX caused patient allergic reaction, rash on all over her body, arms, trunk, face. She took OTC diphenhydramine, then the symptoms are getting better.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Local/redness/swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site, headache, fatigue.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever to 104 with seizure.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling
Clinical narrative: Rec'd vaccine 4/9, went to urgent care on 11th cc: redness, soreness, pain & swelling in arm.  Diagnosed with cellulitis and placed on 10 course of antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives - started approximately 3 to 4 hours after administration of vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Sore shoulder pain radiating into armpits and trouble moving arm.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb mass, Pain, Pain in extremity
Clinical narrative: Sore shoulder pain radiating into armpits and trouble moving arm.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction. Left lateral thigh with 2 areas of redness, one about 2 inches and the other about one inch. Both warm and tender to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had low grade fever for 2 days after the vaccination. Injection site was swollen and warm to the touch. Area of swelling was approximately 3"x4" in size. Area was reddish-pink in color. Tender pain at touch of site.
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoacusis, Loss of consciousness
Clinical narrative: Patient is a(n) 10 y.o. female who presents to clinic after fainting this morning. She was here for WCC yesterday afternoon, received TDAP, MENACTRA and HPV. We observed her for 15 min after vaccines, she felt great, went home. Her evening was uneventful. This morning, after waking, went to take a bath. While waiting for the tub to fill, she was standing in the tub and suddenly "felt weird." She then noticed she "couldn't see or hear," so went to get out of the tub and find her mom. The next thing she knew, she found herself on the floor. She heard water running, got up and turned off the tub, went to her mom and told her she was having trouble seeing and hearing, fainted again. Her mom said she was unresponsive for a brief period (seconds) and then awoke. After lying on the floor for a few minutes, she was acting normally, reported feeling only tired. Mom brought her in. She feels tired now and on and off has had a mild headache. She isn't sure whether she hit her head, denies any point tenderness to head or other part of body. She's never before fainted. She has several severe food allergies, has had multiple episodes of hives and angioedema.
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Patient is a(n) 10 y.o. female who presents to clinic after fainting this morning. She was here for WCC yesterday afternoon, received TDAP, MENACTRA and HPV. We observed her for 15 min after vaccines, she felt great, went home. Her evening was uneventful. This morning, after waking, went to take a bath. While waiting for the tub to fill, she was standing in the tub and suddenly "felt weird." She then noticed she "couldn't see or hear," so went to get out of the tub and find her mom. The next thing she knew, she found herself on the floor. She heard water running, got up and turned off the tub, went to her mom and told her she was having trouble seeing and hearing, fainted again. Her mom said she was unresponsive for a brief period (seconds) and then awoke. After lying on the floor for a few minutes, she was acting normally, reported feeling only tired. Mom brought her in. She feels tired now and on and off has had a mild headache. She isn't sure whether she hit her head, denies any point tenderness to head or other part of body. She's never before fainted. She has several severe food allergies, has had multiple episodes of hives and angioedema.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: In with parents for generalized hives noticed by mother 1 hour after receiving PNEUMOVAX (cochlear implant). Very itchy. No facial swelling, respiratory distress, or GI symptoms. He received IM Benadryl and was transferred to ER and treated with steroid and Epipen. He improved after IV Benadryl. No fever or recent viral illness. No recent new detergent or topical used. Please see ER notes for details. Hives are significantly improved. Has a few lesions 1 hour before the next Benadryl dose. He is otherwise acting well as usual.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Eye pruritus, Generalised erythema, Hypersensitivity, Pharyngeal oedema
Clinical narrative: Patient c/o itchy eyes, itchy and swollen throat and general body red, swollen, burning rash that began on 4/12/18. States she took a BENADRYL with some help. Dermatologist diagnosed as an allergic reaction to SHINGRIX.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Swelling, Throat irritation
Clinical narrative: Patient c/o itchy eyes, itchy and swollen throat and general body red, swollen, burning rash that began on 4/12/18. States she took a BENADRYL with some help. Dermatologist diagnosed as an allergic reaction to SHINGRIX.