chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 5 year old patient of unknown gender. On an unknown date the patient was vaccinated an expired dose of with PROQUAD lot # M002053 (expiration date: 11-JUL-2017) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 07-OCT-2013 at a family practice as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2015, patient was treated by a physician at the family practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with interference into the eyes. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster, or shingles with interference into the eyes was determined to be a medically significant event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 07-OCT-2013 at a family practice as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2015, patient was treated by a physician at the family practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with interference into the eyes. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster, or shingles with interference into the eyes was determined to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and allergic reactions were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX dose 0.5 ml, subcutaneously (Lot #M044349 with expiry date 04-NOV-2018, lot #M012991 with expiry date 14-MAR-2018) for prophylaxis. The nurse could not provide the lot number and expiration date for the properly stored sterile water diluent used to reconstitute the doses of VARIVAX. The vaccines were exposed to a temperature 23 F for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. Digital data logger was involved.  No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA005344.
Sex: U
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # N001533 for prophylaxis. Other suspect therapies included PEDVAXHIB lot # M014925. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Catatonia, Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a registered nurse who was also the office manager and refers to a 18-year-old female patient with none pertinent medical history and none drug reactions or allergies. The patient's concomitant therapies included ethinyl estradiol, ferrous fumarate, norethindrone acetate(LO LOESTRIN FE). On 19-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for vaccination. Then on 09-AUG-2017, the patient was vaccinated with the second dose of GARDASIL 9 as the same dosage regimen above described. On 09-AUG-2017, the patient fainted shortly after receiving the GARDASIL 9 and was in a catatonic state for one minute (syncope and catatonia). Additionally, the patient experienced tonic-clonic movements for one minute. The only treatment that the patient received for this reaction was an unknown person holding her legs down during the event to prevented injury in the patient. The patient sought medical attention as the event occurred at the office visit, no laboratories diagnostics were performed. At the time of the report, the patient fully recovered on the same date before leave the office. The physician had not decided whether to finished the 3 dose series for the patient. Upon internal review, tonic clonic movements was determined to be medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and allergic reactions were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PROQUAD dose 0.5 ml, subcutaneously (Lot # M043310 with expiry date 24-APR-2018) for prophylaxis. The nurse could not provide the lot number and expiration date for the properly stored sterile water diluent used to reconstitute the doses of the vaccine. The vaccines were exposed to a temperature 23 F for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. Digital data logger was involved.  No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004916.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Product storage error, Pyrexia, Rash, Rash pustular
Clinical narrative: Patient developed a mild fever and rash the evening of 6/16/2017.  The rash continued and spread for 10 days. All pox scabbed over by day 14. On 07/16/2017 she developed a rash on forehead, face, neck and around her ears following 3 days of elevated temperatures. This rash spread and continued for 1 week.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: Patient developed a mild fever and rash the evening of 6/16/2017.  The rash continued and spread for 10 days. All pox scabbed over by day 14. On 07/16/2017 she developed a rash on forehead, face, neck and around her ears following 3 days of elevated temperatures. This rash spread and continued for 1 week.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RVX
Symptoms: Abnormal behaviour, Crying, Decreased appetite
Clinical narrative: My baby started crying hysterically and uncontrollably in the early evening after his shots. He never was a baby that cried as soon as I would nurse him he would instantly stop so this was VERY out of character for him. He would not nurse or take a bottle. We took him to urgent care once I told them he had his shots that morning they said that is probably why he won't eat and was upset. He did not eat for 36 hours except one small nighttime nursing session. Complete loss of appetite due to the shots I believe. It came back and he was back to being normal 36 hours later.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: 7 days post vaccine, patient developed an approximately 5 cm area of pink erythema. Edges not well demarcated, some central clearing. Warm to touch but non-tender. Concern that shot may have been given subcutaneously (parents report skin buckled up as soon as shot was given, but resorbed quickly). No lesions until today. Child otherwise well.  6 day old newborn in home is of some concern.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient presents with apparent rash across upper arm, sx appeared on day of vaccination. SOB reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, 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 medications were not provided.  On or about 19-MAR-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was subsequently treated by a physician for ongoing and worsening symptoms of herpes zoster. As a direct and proximate result of these malfunctions, 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: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old male patient. The patient had no pertinent medical history or drug reaction/allergies. There was no concomitant medication. On 07-AUG-2017, the patient was vaccinated with first dose of GARDASIL 9 (site: left arm, dose, strength, route, lot, expiry date unspecified) in 2 dose immunization series for prophylaxis. The patient's family sought medical attention and contacted physician's office since the patient experienced left arm injection site pain, redness, swelling and nausea in approximately August 2017. There was no real treatment given other than suggestion for ice to injection site and unspecified home remedies to reduce nausea. The outcome of the events and causality was unknown. Product quality complaint (PQC) was not involved. No further information was provided.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 53 year old patient of unknown gender with allergy to naproxen and penicillin (drug hypersensitivity). On 03-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M041085, subcutaneous for prophylaxis in the lower abdominal quadrant for an unspecified reason. Concomitant therapies included escitalopram oxalate (LEXAPRO). On 03-AUG-2017, 1 day after onset of therapy the patient experienced injection site erythema, and injection site swelling. The outcome of injection site erythema and injection site swelling was reported as recovered/resolved.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site warmth, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer, reportinfg for herself. This 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date to an unspecified date in Jul2017 at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received an unspecified pneumococcal vaccine 7 years before. The patient experienced a "red-band" around the arm 2 inches wide and red band around arm with outcome of not recovered, half way around arm it was hot, the site warm,  on an unspecified date with outcome of recovering.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported that a patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and pain at injection site after use of product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got the pneumococcal 13-val conj vac (dipht crm197 protein) injection at his or her doctor's office last Tuesday and had about 10 inches red band around half of his or her arm on an unspecified date. The patient asked was that normal after a week? The outcome was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had developed a dry cough after had a pneumococcal 13-val conj vac (dipht crm197 protein) vaccination. The outcome of the event was unknown.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "IBCC (Inbound Call Center for HCPs)" from a contactable pharmacist. A 18 year old male patient received the first dose of TRUMENBA on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the first shot of meningococcal group b rlp2086, the patient became ill. It was also reported that the second shot was pushed back due to the illness. At time of this report, the second dose was not received. The patient recovered from malaise on an unspecified date. The event adverse event, malaise, was classified as serious (medically significant) and assessed as unrelated to meningococcal group b rlp2086.; Sender's Comments: The company agrees with the assessment of the investigator and does not attribute the case to study therapy based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the event.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Headache, Nausea, Pyrexia
Clinical narrative: Pt complained of "very bad" headache and stomach ache. He had a fever of 101.2. Pt napped and when he woke he said the headache was the worse he has ever had and his stomach was both nauseous and he was unsure if he needed to use the restroom. Fever reduced with ibuprofen. Sx completely resolved in 24 hours.
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Alopecia, Arthralgia, Arthritis, Autoimmune disorder, Autoimmune thyroiditis
Clinical narrative: see below
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Bone scan abnormal, Exostosis, Fatigue, Fibula fracture, Hypothyroidism
Clinical narrative: see below
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Musculoskeletal stiffness, Neck pain, Onychoclasis, Pain, Rheumatoid arthritis
Clinical narrative: see below
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Scar, Spinal X-ray abnormal, Stress fracture, Temperature intolerance, Thyroid cyst
Clinical narrative: see below
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Weight increased
Clinical narrative: see below
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine, Loss of consciousness, Pyrexia, Syncope
Clinical narrative: see below
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Paraesthesia, Tracheostomy
Clinical narrative: Patient stated to me that he was fine when he woke up the next morning after the injection, then mid morning his face started feeling weird and tingling and his son called the ambulance. The next thing he knew he was in the Hospital. Not sure what all happened while in the hospital but patient sates he was there over a week and he still had a trach in when he came by pharmacy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nervousness
Clinical narrative: After immunization, patient stayed near pharmacy as advised as she was nervous about the shot. After a few minutes, she stated she felt dizzy. She laid down as she stated she feels better that way when she usually gets dizzy. She rested for a little, she drank some water, and EMT arrived to check her blood pressure. She sat up, and said she felt much better after EMT cleared her to leave. She stayed sitting for another 5-10 minutes before leaving and stating that she is fine. Total time course was approximately 20 minutes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema
Clinical narrative: Patient presented to pharmacy on 8/11/17 with generalized redness on bicep. Patient was prescribed medrol dosepak by her family physician, Dr and was told to purchase and use over the counter hydrocortisone cream.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discharge, Injection site reaction, Injection site scab, Skin lesion
Clinical narrative: Patient presented 8 days after receiving the vaccine with an open, dime-sized, crusty scabbed lesion over injection site. Area was draining clear yellow fluid.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to pharmacy the morning of 8/11/2017 with what appeared to be an infection at the injection site. The red area resembled cellulitis and was approximately 7x5 inches in area. Patient stated this started the day after the vaccination was administered and had gotten worse by the time she reported to the pharmacy. Patient was advised to seek medical attention and was seen on 8/11/17 by a local provider. She was prescribed keflex/claritin/Ibuprofen for a suspected cellulitis/potential allergic reaction/and pain respectively. Patient was provided these prescriptions here at the pharmacy and will follow up with us here if the condition doesn't improve.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT CAME INTO PHARMACY FOR PREVNAR VACCINE ON 8/4/2017. SHE WAS TOLERATING WELL WITH THE VACCINE. SHE CALLED PHARMACY ON 8/11/2017  AND REPORTED REDNESS AROUND SITE OF INJECTION AS SIZE OF A DOLLAR COIN. PATIENT SAID SHE HAD NO FEVER BUT A SLIGHT WARMTH AND  AROUND SITE OF INJECTION.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: On 7/6/17 approximately 7 hours after receiving the HBV vaccine, I began to experience mild malaise that by the following morning progressed to moderate-severe malaise, severe myalgias (particularly in my upper and lower back, pelvis, and thighs), headache, dizziness, and low-grade fever (Tmax 100F). The low-grade fever and other symptoms did not sufficiently respond to ibuprofen 600 mg, and I noted sufficient relief only after beginning to alternate acetaminophen 1000 mg and ibuprofen 800 mg (staggered on Q8H dosing). These symptoms persisted for approximately 2.5 days from the time of vaccination and at that point resolved entirely without any noticeable residuals effects.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Head discomfort, Headache, Mobility decreased, Musculoskeletal stiffness, Vision blurred
Clinical narrative: Headache, head heaviness, blurred vision, and neck stiffness.  Unable to touch chin to chest.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspepsia, Dyspnoea, Lip swelling, Rash
Clinical narrative: In the evening after receiving injection patient broke out in a rash, lips began to become swollen, little bit of trouble breathing and heartburn all night. Following day patient went in to for appointment at Doctor's office and was given a prescription for Zyrtec 10 mg to take twice daily. By time patient came in to pick up prescription in the evening lips were no longer swollen and no trouble breathing.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Aggression, Crying, Fear, Feeling abnormal, Injection site erythema
Clinical narrative: Started screaming middle of night randomly (appeared scared). Then crying/ screaming/ tantruming all day. Get injection site started to get red today and progressed as day went on. She's been miserable. Then around 445 pm she started vomiting. Also not sure exact vaccine - just know it was dtap with polio combo.
Age: 1.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Screaming, Vomiting
Clinical narrative: Started screaming middle of night randomly (appeared scared). Then crying/ screaming/ tantruming all day. Get injection site started to get red today and progressed as day went on. She's been miserable. Then around 445 pm she started vomiting. Also not sure exact vaccine - just know it was dtap with polio combo.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Excoriation, Pruritus, Rash, Rash papular, Skin lesion
Clinical narrative: ONSET 1 DAY AFTER VACCINATION. PURITIC. EXTENSIVE SCATTERING OF 1 MM PAPULES OVER CHEST, ARMS AND L LEG EXTENSOR SURFACES. EXCORIATED. RX: BENADRYL PO; TRIAMCINOLONE CREAM AND BACTRABAN OINTMENT TO LESIONS.
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Blood carbon monoxide increased, Blood glucose increased, Erythema, Eye movement disorder, Hyperhidrosis
Clinical narrative: Patient left consultation room after vaccines administered and was sitting in waiting area. After approximately 5 min or so she was noticed to be sitting stiff in her chair with head back and mouth open. Patient was red in face with whole upper body tensed up. 911 was called and pharmacist went over to assess patient. She was stiff a few moments and then slumped, waking herself up with her eyes twitching back and forth. She turned pale and sweaty, said she was nauseated and began throwing up. Paramedics responded and evaluated finding blood sugar high (188) and later evaluated pharmacy for CO due to labs coming back with carbon monoxide levels found in patients blood (still determining source).
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Muscle tightness, Musculoskeletal stiffness, Nausea, Pallor, Posture abnormal
Clinical narrative: Patient left consultation room after vaccines administered and was sitting in waiting area. After approximately 5 min or so she was noticed to be sitting stiff in her chair with head back and mouth open. Patient was red in face with whole upper body tensed up. 911 was called and pharmacist went over to assess patient. She was stiff a few moments and then slumped, waking herself up with her eyes twitching back and forth. She turned pale and sweaty, said she was nauseated and began throwing up. Paramedics responded and evaluated finding blood sugar high (188) and later evaluated pharmacy for CO due to labs coming back with carbon monoxide levels found in patients blood (still determining source).
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Vomiting
Clinical narrative: Patient left consultation room after vaccines administered and was sitting in waiting area. After approximately 5 min or so she was noticed to be sitting stiff in her chair with head back and mouth open. Patient was red in face with whole upper body tensed up. 911 was called and pharmacist went over to assess patient. She was stiff a few moments and then slumped, waking herself up with her eyes twitching back and forth. She turned pale and sweaty, said she was nauseated and began throwing up. Paramedics responded and evaluated finding blood sugar high (188) and later evaluated pharmacy for CO due to labs coming back with carbon monoxide levels found in patients blood (still determining source).
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Biopsy skin abnormal, Chest X-ray, Eczema, Laboratory test, Mycosis fungoides
Clinical narrative: After my son and daughter received this vaccine in November, my daughter and son both began to get a rash on their skin from their neck to their ankles. After a few weeks, my son's rash went away while my daughter's only got worse. We saw a family doctor who originally thought it was eczema. After no resolution, she referred my daughter to a dermatologist who took biopsies and said that most likely she had pityriasis lichenoides but that it could be lymphomatoid papulosis. We travelled to different doctors who treated the skin condition with a trial of methotrexate, UV therapy, and Triamcinolone. The rash resolved in most areas of her skin except a large patch on her right leg and a small patch on her left leg. Additional biopsies were taken in November 2016 and an official diagnosis of Mycosis Fungoides (a Cutaneous T-cell Lymphoma) was given. A follow-up with an oncologist was made in January of 2017 and the cancer was staged at 1A. Increased light therapy was ordered along with Imiquimod 5%. The patches are still present and she has to see a dermatologist every 3 months to monitor the areas.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Parapsoriasis, Rash, Skin cancer, UV light therapy
Clinical narrative: After my son and daughter received this vaccine in November, my daughter and son both began to get a rash on their skin from their neck to their ankles. After a few weeks, my son's rash went away while my daughter's only got worse. We saw a family doctor who originally thought it was eczema. After no resolution, she referred my daughter to a dermatologist who took biopsies and said that most likely she had pityriasis lichenoides but that it could be lymphomatoid papulosis. We travelled to different doctors who treated the skin condition with a trial of methotrexate, UV therapy, and Triamcinolone. The rash resolved in most areas of her skin except a large patch on her right leg and a small patch on her left leg. Additional biopsies were taken in November 2016 and an official diagnosis of Mycosis Fungoides (a Cutaneous T-cell Lymphoma) was given. A follow-up with an oncologist was made in January of 2017 and the cancer was staged at 1A. Increased light therapy was ordered along with Imiquimod 5%. The patches are still present and she has to see a dermatologist every 3 months to monitor the areas.
Sex: F
Vaccine: RAB
Symptoms: Immediate post-injection reaction, Injury associated with device
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of needle injury in a patient who received RABAVERT (batch number 627011A, expiry date 31st March 2020) and (batch number 564011A, expiry date 31st May 2018). On an unknown date, the patient received RABAVERT. On an unknown date, the dose was an unknown dose. On an unknown date, immediately after receiving RABAVERT, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. Healthcare professional reported that, an employee had a needle stick injury after administering a dose of RABAVERT to the patient. The needle was recapped by the employee. The healthcare professional had limited information. No patient information was available.
Sex: F
Vaccine: RAB
Symptoms: Adverse event, Paranoia
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, less than a week after receiving RABAVERT, the patient experienced adverse event and paranoid state. On an unknown date, the outcome of the adverse event and paranoid state were unknown. It was unknown if the reporter considered the adverse event and paranoid state to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received vaccine last night. The patient experienced some side effects and thought she was just getting paranoid. The patient wanted to know how long these side effects would last.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: Mom called at 1:31 pm today stating the patient's left arm was warm to the touch, painful and red at injection site. Mom says it started last night but looks worse today. Arm feels bumpy, hives-like at injection site. Nurse practitioner informed. Phone encounter charted in medical file. Advised to use BENADRYL as needed for allergic reaction. Keep skin clean and dry, ice pack, monitor for new and/or worsening symptoms. If symptoms persist and/or worsen patient needs to be seen in nearest emergency room or urgent care center. Call if no improvement to be seen in office. Second vaccine will not be administered per Nurse practitioner.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site warmth
Clinical narrative: Mom called at 1:31 pm today stating the patient's left arm was warm to the touch, painful and red at injection site. Mom says it started last night but looks worse today. Arm feels bumpy, hives-like at injection site. Nurse practitioner informed. Phone encounter charted in medical file. Advised to use BENADRYL as needed for allergic reaction. Keep skin clean and dry, ice pack, monitor for new and/or worsening symptoms. If symptoms persist and/or worsen patient needs to be seen in nearest emergency room or urgent care center. Call if no improvement to be seen in office. Second vaccine will not be administered per Nurse practitioner.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Fatigue, Feeling hot, Swelling, Urticaria
Clinical narrative: Mom called at 1:31 pm today stating the patient's left arm was warm to the touch, painful and red at injection site. Mom says it started last night but looks worse today. Arm feels bumpy, hives-like at injection site. Nurse practitioner informed. Phone encounter charted in medical file. Advised to use BENADRYL as needed for allergic reaction. Keep skin clean and dry, ice pack, monitor for new and/or worsening symptoms. If symptoms persist and/or worsen patient needs to be seen in nearest emergency room or urgent care center. Call if no improvement to be seen in office. Second vaccine will not be administered per Nurse practitioner.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of light headedness in a patient who received BEXSERO. Co-suspect products included MENACTRA. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown. It was unknown if the reporter considered the light headedness to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the office manager could answer any further questions. The contact details for the same was also provided.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Reaction to BEXSERO; (R) arm red and splotchy at vaccine site. ? delayed allergic reaction vs. 2nd infection. KEFLEX started to cover for 2nd infection. Continue BENADRYL and cool compresses.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis, Tremor
Clinical narrative: Profuse sweating. Dizziness. Shakiness, unsteady on feet.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen below site sore left arm. Pt. advised to go to urgent care.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: Patient received diluent of ROTARIX, but did not receive actual vaccine due to it not being mixes before administration. No negative effects noted or reported. No treatment necessary.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site swelling, Injection site warmth
Clinical narrative: C/o-swelling and warmth from left deltoid to elbow. Temp 99.9
Age: 15.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 15-year-old male patient who received BEXSERO. Concomitant products included HPV vaccine. In June 2017, the patient received the 1st dose of BEXSERO .5 ml. In June 2017, less than a day after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site warmth. On an unknown date, the patient experienced headache. The patient was treated with TYLENOL and ibuprofen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and headache were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and headache to be related to BEXSERO. Additional details were provided as follows: In June 2017, the patient received BEXSERO on an arm but no specific date was given. On the same day, the patient received the HPV vaccine but in a different arm. In the arm that BEXSERO was administer, on the day of the vaccination the patient's arm became very sore, swollen and red hot from the upper arm past the elbow and was quite painful. Less than a week after vaccination, the patient had headache but it was unknown what day this started. All symptoms were resolved within 3 to 4 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: Red palm sized rash around injection site. Warm to the touch.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Musculoskeletal pain
Clinical narrative: Pt had pain in shoulder and swelling of upper vaccinated arm.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Facial pain, Headache, Migraine
Clinical narrative: Migraine headache, dizziness, weakness, face pain and the whole right side of my head, face and neck pains.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Migraine headache, dizziness, weakness, face pain and the whole right side of my head, face and neck pains.
Age: 65.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Pain, Skin warm
Clinical narrative: Redness at site of injection, body aches, warm to touch.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Has severe shoulder pain. Pt took Ibuprofen and felt better.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen bump on (L) arm (upper). Warm to touch.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Severe hives - all over the body.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Malaise, Nausea, Pain, Pollakiuria
Clinical narrative: Rash, excessive urination, malaise, soreness, mild nausea, chills. Ht: Prednisone 60 mg once daily for 5 days.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Rash, excessive urination, malaise, soreness, mild nausea, chills. Ht: Prednisone 60 mg once daily for 5 days.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, tender, swollen, hot area to medial left thigh.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: (L) arm pain/redness/swelling at injection site, myalgias felt like flu symptoms. Was warm/subjective fever, took ADVIL. Temp in office 99.4, feels better now.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia, Skin warm
Clinical narrative: (L) arm pain/redness/swelling at injection site, myalgias felt like flu symptoms. Was warm/subjective fever, took ADVIL. Temp in office 99.4, feels better now.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Erythema, Swelling face, Urticaria
Clinical narrative: Redness/swelling of face, hives, cough.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Contusion, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 79 yr. old female presents with concerns over recent vaccination with PREVNAR 13, was itchy and painful at time of injection and scratched periodically and noted expanding redness, warmth, around the site. No dyspnea, wheezing, or swelling of the mouth or tongue. Blood pressure is elevated today and is intermittently but prior significantly higher. She is on lisinopril and normally takes as prescribed. She does have a bruise near the region but husband notes was there prior to vaccination reaction, not applying any over the counter meds. A dog caused the bruise, she does take AKA daily.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: 79 yr. old female presents with concerns over recent vaccination with PREVNAR 13, was itchy and painful at time of injection and scratched periodically and noted expanding redness, warmth, around the site. No dyspnea, wheezing, or swelling of the mouth or tongue. Blood pressure is elevated today and is intermittently but prior significantly higher. She is on lisinopril and normally takes as prescribed. She does have a bruise near the region but husband notes was there prior to vaccination reaction, not applying any over the counter meds. A dog caused the bruise, she does take AKA daily.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode approximately 10 minutes after three vaccines had been administered. HPV, meningococcal, tdap. No temp. 106/64 BP.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: (L) arm developed a large square area that was red, swollen, itchy. Inside the wheal itself was a knot. Measurements of square approx: 14x14cm - Knot 3x4cm.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swollen arm, itching.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Red injection site-MD. Treated w/KEFLEX.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient received the vaccine in (L) top part of deltoid muscle - she had sharp shooting pain down her arm and the pain progressed over eve and difficult to move arm - pain severe.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain
Clinical narrative: The patient received the vaccine in (L) top part of deltoid muscle - she had sharp shooting pain down her arm and the pain progressed over eve and difficult to move arm - pain severe.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test, Injection site rash, Injection site reaction
Clinical narrative: Mother states that on Wednesday 8/19/17 when she arrived home she notice patient had a quarter size reaction on the injection site. Mother brought patient in today 8/11/17 for blood work and informed us that the patients left arm had a rash were vaccines were administer on Tuesday 8/8/17. Reaction size: 13.5 x 12 cm.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash face/neck/shoulders.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, IPV, RV5, UNK
Symptoms: Rash generalised
Clinical narrative: Rash through out all her body for 5 days. Treatment was benadryl and prednisolone.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Developed acute swelling  and induration of L deltoid (11cm x 8cm) about 1 week after vaccine was given - unclear if cellulitis or vaccine localized reaction.  Started empirically on Keflex on 8/11/2017.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Ear infection, Pyrexia, Rash
Clinical narrative: FEVER AND RASH, BUT ALSO HAD AN EAR INFECTION DIAGNOSED WITH THE RASH.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain, Rash erythematous
Clinical narrative: Severe pain in right upper arm and shoulder beginning the night of the injection. Pain decreased the following day, but tender areas remained around the insertion of the Deltoid muscle and upper back of the shoulder. Pain with movement and range of moriong of right shoulder with stiffness in the right neck and side of the face. Red circular patches noted the morning of the first day following injections.  These patches increased in size by the 2nd morning. They are located on the front of the right upper arm and one on the back of the upper right shoulder. Treatment has consisted of Naproxin Sodium, active and passive exercise.
Age: 24.0
Sex: F
Vaccine: HPV9, PPV
Symptoms: Eye pain, Mobility decreased, Myalgia, Tenderness
Clinical narrative: Extreme sight pain. Muscle pain. Unable to move arm up or down. Even the slightest touch hurts.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT RECEIVED VACCINE ON 08-09-2017, PATIENT CALLED 08-11-2017 SAID THAT NIGHT HER ARM GOT SWALLOW AND RED FROM DELTOID TO ELBOW. SHE SAID IT WAS STARTING TO GO DOWN BUT IT WAS STILL RED BY HER ELBOW. I ADVISED HER TO CONTACT HER DR AND THAT SHE COULD TAKE BENADRYL TO HELP WITH SWELLING/REDNESS.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction, redness at site and progressing down arm. Warm. Pain at injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Approximately two weeks after administration, patient developed shingles like rash on both arms and legs and required treatment by medical facility.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: 8/9/17-8/11/17 diarrhea and extreme fussiness. 8/12/17- lack of energy and little appetite. Fever of 104.9.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness, swelling, warmth to the touch, beginning to blister some near injection site, recommended ibuprofen or tylenol, taking an antihistamine, and ice to reduce swelling.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Hypersensitivity, Pruritus, Skin warm
Clinical narrative: Patient came in the next day reporting that the area where they received the vaccination was red, itchy, sensitive, and warm to touch. They went to the doctor's office and were informed that the adverse event was an allergic reaction.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia
Clinical narrative: Neuropathic pain radiating down left arm from deltoid.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Electroencephalogram, Eye movement disorder, Gastrooesophageal reflux disease, Vaccination complication
Clinical narrative: On June 29th, 2017, pt got her DTap and Hib vaccinations around 9:15am. On July 1st, 2017 around 11:00am, I noticed that she had rolled her eyes up to the back of her head briefly about 3 times within the span of an hour and a half. It concerned me at the time, but since it stopped, I assumed it was a fluke thing happening. On July 3rd, 2017, she starting rolling her eyes in the back of her head in the same exact way that she did on July 1st, this time it was one time after the other, sometimes with less than a minute in between times, and sometimes with 30 minutes in between times, repeatedly within about a 7 hour time frame. I would say about 20 times total. When this started that day (July 3rd) I happened to be at pharmacy picking up a prescription around 11:45am. I panicked when she started doing it and went straight to urgent care (where she was too young to be seen) and they sent me to pediatrics. The doctors were on lunch, but the nurses took us back and took her vitals: Pulse:145, Temp: 99.4, O2:100%. She didn?t have any ?episodes? while the nurses had us back there, but I showed them a short video clip that I was able to capture and they told me that it looked like she was just ?looking up? and that she was fine, but to call or come back if anything else happens.  Over the next 2 days she was sporadically having ?episodes?, averaging about 3-4 times a day.  I knew in my gut that she wasn?t just ?looking up?, as these ?episodes? appeared extremely involuntary. I took her in to see Dr. on July 6th, 2017 and showed her the video clip that we had of one of her ?episodes?. It is there that we got a referral for an EEG and to see a pediatric Neurologist.  On July 10th, 2017, we saw Dr, a Doctor of Chiropractic and Board Eligible Chiropractic Neurologist. He examined pt, and saw the video, and was certain that this was a reaction due to her vaccinations. Pt spent an hour in a hyperbaric chamber, and Dr. performed chiropractic treatment and he recommended some supplements for pt to start taking. We had the EEG done on July 11th, 2017 and saw the pediatric neurologist, Dr. on July 13th, 2017. We were completely dissatisfied with our appointment with Dr., as he was very dismissive of our concerns, and diagnosed her ?episodes? as Acid Reflux, BEFORE even seeing the video that we had of her having one of her ?episodes?. I am not a Doctor, however, I KNOW that her ?episodes? were not due to acid reflux. She has NEVER done anything like this before, and yes, she is on reflux medication, but it is more of a preventive measure due to her laryngomalacia condition. On August 8th, 2017, we saw Functional Medicine Doctor. Dr.  agrees that it is likely a vaccine reaction, and recommends to hold off vaccinating further until she is the age of 2 or 3 years old. She also recommended vitamins and supplements to help pt with her immune system.