chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Scar, Ulcerative keratitis, Viral uveitis
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-AUG-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 zoster causing severe eye disorders. Beginning on 15-JAN-2015, the patient was treated for eye  disorders,  that were then identified as corneal band keratopathy. Throughout 2015, the patient was treated  over the course of twelve medical encounters for treatment of severe and worsening disorder, diagnosed as corneal band keratopathy, herpetic uveitis, scarring and opacity, corneal band nuclear sclerosis of both eyes, blisters on the eye, corneal edema, corneal ulcer, and Edta chelation, which doctors observed had flared up after her vaccination when she broke out with shingles in 2013 which has spread to her eyes, causing secondary complications from zoster infections in the eye. The patient underwent multiple surgeries to remove corneal epithelium and eventually sustained a corneal transplant in attempts to curb her condition and vision loss. The patient has continued to suffer, and was treated throughout seven encounters and procedures in 2016  for continued treatment of her condition. On or about 21-APR-2017, she began to suffer facial pain in addition to her eye disorders, which was then diagnosed as post-herpetic neuralgia of the face, a chronic  condition of nerve damage and residual and secondary to zoster  infections. The patient has sustained additional treatments on eight  additional medical encounters in 2017 for treatment of these extensive  zoster complications and vision. In addition to aggressive treatments and surgical interventions, she has been prescribed dorzolamide hydrochloride, timolol maleate (COSOPT), difuprednate (DUREZOL), acyclovir, prednisolone acetate, ofloaxin, prednisolone acetate (PRED FORTE), ofloxacin (OCUFLOX), brimonidine, moxifloxacin hydrochloride (VIGAMOX),  "sistane"  ointment, and artificial tears for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, she has 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, pain and suffering, and other damages. Upon internal review, zoster infections in the eye, corneal opacity, corneal ulcer, herpetic uvetis, Edta chelation, vision loss, multiple surgeries to remove epithelium, corneal transplant, were determined medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-FEB-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On an unknown date, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 26-JAN-2017, 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. 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, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patients' concurrent conditions, medical history and historical drugs were not reported. Concomitant therapy included sterile diluent. On 07-FEB-2018, the patient was vaccinated with first dose of VARIVAX lot # L048468, expiry date: L048468 (strength, frequency, route of administration were not reported) for prophylaxis (expired product administered). No adverse effects was reported. No product quality compliant was reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient received his flu shot on 01/26/18, noted some pain days after the vaccine and started to be concerned around 02/09/18 when he called the pharmacy for the first time. He reports difficulty when lifting certain things and with certain ranges of motion. He noted the pain most while shoveling. At that time I instructed him to call his doctor for a follow up because most pain subsides within days. Patient spoke with staff 02/13/2018 and picked up a copy of VIS and monograph at this time. Patient went to his doctor's office on 02/13/2018. I called to follow up today and he has said he had read about this online extensively. He stated the pain moves to different parts of his arm and shoulder at different times. He says it's like a deep bee sting that won't go away and often feels like he slept on his arm wrong.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Balance disorder, Blood thyroid stimulating hormone normal, Dizziness, Full blood count normal
Clinical narrative: Shortly after getting the 1st HPV vaccine pt began to feel dizzy and weak. She is still feeling this way at day 9. She has obvious loss of balance and is very dizzy. She also started to develop swelling at the injection site at day 8 which has continued. No redness or evidence of infection present.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Metabolic function test normal, Red blood cell count increased
Clinical narrative: Shortly after getting the 1st HPV vaccine pt began to feel dizzy and weak. She is still feeling this way at day 9. She has obvious loss of balance and is very dizzy. She also started to develop swelling at the injection site at day 8 which has continued. No redness or evidence of infection present.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Dyspnoea, Gait disturbance
Clinical narrative: Severe SOB requiring ER visit, oxygen level 87%, inability to walk very short distances, and hospitalized for 6 days. Treatment with oxygen (4 days), prednisone, DUONEB for a nebulizer, and LEVAQUIN. Sent home with same medications, and symptoms gradually improved.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Rash, Rash erythematous
Clinical narrative: Nurse gave the patient the Rotavirus vaccine orally and a bright red rash on face and neck with tiny little bumps appeared within 2 minutes. The nurse and NP assessed the child and there was no respiratory distress and patient was breathing normal. Patient was sent to the Emergency Room for observation, rash was already starting to fade at this time.
Age: 71.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient called late 2/13/17 to notify the pharmacy that she has had a fever since the day after the vaccination 2/27/2018. She stated that she was tired and achy but that could be due to her underlying fibromyalgia. She stated that taking OTC TYLENOL does bring the fever down.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: PNEUMOVAX 23 administered IM on 2/5/18. Pt called 2/7/18 stating she had a cellulitis. Pt is a physician. Shot was a pre-filled syringe.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 13-year-old male patient who received FLUARIX QUADRIVALENT (batch number 572KT, expiry date 26th May 2018). On 27th January 2018 14:30, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 28th January 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injection site swelling. The patient was treated with BENADRYL (NOS), BENADRYL Cream. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved. The reporter considered the injection site pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter was the patient's mother. The patient received FLUARIX QUADRIVALENT vaccine on right deltoid. On the next day, the patient's entire deltoid was swollen and sore. BENADRYL cream was rubbed on his arm and the symptoms were resolved after a couple of days.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a 13-year-old male patient who received BOOSTRIX. On 2nd February 2018, the patient received BOOSTRIX. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown. It was unknown if the reporter considered the stomach pain to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by an occupational therapist. The reporter was the patient's mother who reported that the patient had the BOOSTRIX vaccine six days ago and had been experiencing severe stomach pains. The caller was being transferred and the caller was no longer on the line. The reporter had been provided the phone number.
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza, Influenza B virus test positive, Vaccination failure
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a elderly female patient who received Influenza vaccine Quadrivalent. Previously administered products included BREO ELLIPTA with an associated reaction of nasopharyngitis (inhalation, was taking for about one year, for tolerance refer case US2018GSK008155) and INCRUSE ELLIPTA with an associated reaction of bronchitis (inhalation, was taking about 6 months, for tolerance refer case US2018GSK008155). Concurrent medical conditions included chronic bronchitis, chronic obstructive pulmonary disease and asthma. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and cough. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, influenza and cough to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was received from the consumer via the vaccine patient assistance program (PAP). The age at vaccination was not reported. The patient had flu for three weeks and was feeling better at the reporting time. The patient had influenza strain B that was going around. This case was considered to be a suspected vaccination failure as the exact time to onset for the event was unknown. This case was not associated with product complaint. The reporter agreed to have GlaxoSmithKline Biologicals safety team to follow up with them via postal mail.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a 30 year old male patient concerning himself. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 04-JUL-2017, the patient was vaccinated with the first dose of GARDASIL, and on 06-SEP-2017, he was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. It was unknown if the patient received the third dose. No adverse event.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non valid spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown ages and gender. The patients' medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, anatomical place of vaccination and concentration were not provided) with lot # N022977 with expiration date of 23-AUG-2019, N023958 with expiration date of 01-SEP-2019 and N024567 with expiration date of 07-SEP-2019, for prophylaxis. Other suspect therapies included M-M-R II (dose, route, anatomical place of vaccination and concentration were not provided), with lot # N010496 with expiration date of 31-MAR-2019 and N013295 with expiration date of 28-APR-2019 which were diluted with sterile diluent. No adverse event was reported. Temperature/Time frame: -9 C to 8 C (-7.6F) for 190 Minutes. Previous temperature excursion: Yes. -14 C to-10 C (-10F) for 3 Hours. Was call because of a data logger: Yes.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history, concomitant medications were not reported. On 07-FEB-2018, the patient was vaccinated with expired dose of VARIVAX (lot # M002061 and expiration date 12-JAN-2018) (dose, units and frequency unknown) via subcutaneous route for prophylaxis. No adverse effects were reported. No product quality compliant reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 12-FEB-2018, the patient was vaccinated with an expired dose of ROTATEQ lot # M011832 and expiration date of 25-JAN-2018, for prophylaxis.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: HIB was not mixed with DTaP. Patient received vaccine w/o reaction. Patient must return to clinic for ACTHIB.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: PATIENT CALLED ON 2/14/18 AROUND 10 AM TO REPORT THAT A FEW HOURS AFTER RECEIVING HER FIRST DOSE OF SHINGRIX VACCINE SHE HAD A FEVER, SHAKES AND HEADACHE. SHE TOOK TYLENOL TO RELIEVE SOME OF SYMPTOMS BUT FEVER STILL AROUND 100 DEGREES F, THIS MORNING.
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Antibody test positive
Clinical narrative: Member had a titer lab done on 14 April 2017 that said he is a reactive to this shot. No symptoms or signs noticed on 11 Feb 2018.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests, Nausea, Vertigo
Clinical narrative: 15 November - I had the flu shot at treatment facility. 17 November - developed vertigo 2 days after vaccine. 18 November - Went to an urgent care clinic with vertigo and nausea. 20 November - Continued vertigo. Saw primary care physician but was no help. He suggested an ENT. 22 November - ENT did some initial work and suggested it was most likely BPPV and would go away after some time, which it did not. They checked my hearing and did other tests but was not helpful 29 November - saw the same ENT and they suggested physical therapy. 6 December 2017 - Went to physical therapist and did some PT, and it cleared up.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Headache, Myalgia, Tinnitus
Clinical narrative: He reports following his second dose of Anthrax vaccine (administered subcutaneously in December 2007) he developed limited local swelling after 1-2 days that resolved and then recurred as large local swelling (shoulder to elbow) one week later; he was treated with oral antibiotics with gradual improvement. He complained of headache and chills with this episodes but denies fever, myalgias, and arthralgias. In December 2008 he was evaluated by Allergy and it was recommended he receive his subsequent Anthrax doses via IM injection in conjunction with taking an oral antihistamine. He denies adverse reaction with this (his third) and subsequent doses in 2009 (fourth dose) and 2010 (he received two doses listed as fourth and fifth). In 2012 he received his next dose (seventh but listed as sixth) and reports he developed chills/rigors, myalgias, severe headache, and ringing in his ears the evening and following morning after receiving the vaccine. His symptoms lasted for the following 24 hours and then resolved. He denies rhino-conjunctival, cutaneous, laryngeal, pulmonary, and GI symptoms with this episode. He received Typhoid vaccine with his last Anthrax dose but has since received and tolerated Typhoid without adverse reaction. He denies adverse reactions to other vaccinations.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: PATIENT APPROACHED PHARMACY WITH A RASH ON RIGHT ARM, APPROXIMATELY 1.5 INCHES IN WIDTH. AND APPROXIMATELY 2 INCHES IN LENGTH (LIKE A BAND ON THE ARM). RXN WAS RED AND SLIGHTLY INFLAMMED. PATIENT SAID SHE FELT PAIN LAST NIGHT BUT DID NOT NOTICE A RASH UNTIL THIS MORNING. MD WAS IMMEDIATELY NOTIFIED. MD TO CALL PATIENT AND PROVIDE MEDICAL DIRECTION/ADVICE.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient has had pain in her left arm since receiving the flu shot on 9/26/17. She states that her left arm has begun to have weakness in addition to the pain, with an increased intensity in the last several days. She also reported that her fingers are sometimes numb, tingly, and swollen (compared to her other hand). Prescriber has been contacted and will follow up with patient.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Heart rate increased, Irritability, Respiratory rate increased, Skin warm
Clinical narrative: Around 7 pm child was more fussy, 9-10 pm seemed to be breathing rapidly with abdominal breathing, felt warm, temp 37 axillary. Rapid heart rate. More concerned because mother had a reaction of tachycardia with Tdap vaccine. Gave 1 ml of BENADRYL, child calmed down and went to sleep. Today child is better now, laughing, eating fine.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-FEB-2009, the patient was vaccinated by a  physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 01-APR-2016, she sought subsequent treatment by a physician for the onset of severe zoster conjunctivitis also known as shingles in the eye. The patient has been prescribed gabapentin and valacyclovir (VALTREX) for management of her painful condition. 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. Upon internal review,severe zoster conjunctivitis also known as shingles in the eye was determined medically significant. Additional information has been requested.
Sex: M
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 male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date the patient was vaccinated with ZOSTAVAX, 1 DF, (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 08-MAR-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 severe herpes zoster or shingles. The patient has been prescribed VALTREX for management of his symptoms and pain. 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, pain and suffering, and other damages. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient said that she got shingles a few days after receiving the shingles vaccine.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported redness, swelling and tenderness at injection site 5 days after receiving vaccine.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Patient reported 5 minutes after the vaccination that she was itching, I gave her benadryl 25 mg and she said she was feeling better, monitored patient, patient took benadryl home to use just in case, contacted pcp to let them know as well that patient had allergic reaction.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: When receiving the tetanus vaccine the injection was placed near my left shoulder instead of the deltoid muscle. Receiving the injection was extremely painful. Since the vaccine, I am experiencing loss of shoulder function, strength, and am in extreme pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: PATIENT SAID ARM IS STILL SORE EVEN ONE MONTH AFTER VACCINATION; DESCRIBES IT AS "TRAVELING PAIN" FROM ARM DOWN TO WRIST; SHARP PAIN FROM ELBOW TO WRIST, SOME DAYS BAD, SOME DAYS GOOD, UNABLE TO PICK UP THINGS- HOWEVER STILL HAS NOT GONE TO SEE A DOCTOR AS SHE DOES NOT HAVE A PRIMARY PHYSICIAN.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness
Clinical narrative: Pt got shots, that time he was fine. After couple of hrs he felt dizzy, later at night it worst, but he slept well last night. Today morning again dizziness. So he called here, and complain about dizziness. He was not sure why it happened. Last year he got FLUZONE HD and PREVNAR, nothing happened. I as pharmacist told him to check blood pressure and blood sugar. Again i called in the evening at 6.30 pm, he is still dizzy but less severe. He contacted his daughter who is nurse,  told him to drink lots of water and just watch for symptoms. If too severe go urgent care.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electroencephalogram abnormal, Infantile spasms, Muscle spasms, Seizure
Clinical narrative: Child had a seizure on the evening following vaccine administration (approximately 10 hours later). Following the seizure, developed spasms later diagnosed as infantile spasms.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Asthenia, Back pain, Cough, Gait disturbance, Hypoaesthesia
Clinical narrative: Developed generalized body aches, mainly in her back and neck, and a low grade fever the evening of the day she received the vaccines. She continued to have sore throat and low grade fever,  and on 2/10/18  she felt weak and numb to the point where she was having a hard time walking. The patient did end up falling after slamming a  door, and when she went to step away, she collapsed.   Her mother took her to emergency department 2/10/2018. The ED physician felt the patient was having an inflammatory response to the vaccines she received. Seen for follow up 2/14/2018 with PCP and 1) General malaise, sore throat, cough consistent with viral syndrome. Unclear if this was already brewing before the immunizations were given. 2) Apparent reaction to vaccines with myalgias and some degree of resolving muscle weakness. Patient reports steady improvement.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Inflammation, Malaise, Muscular weakness, Neck pain, Oropharyngeal pain
Clinical narrative: Developed generalized body aches, mainly in her back and neck, and a low grade fever the evening of the day she received the vaccines. She continued to have sore throat and low grade fever,  and on 2/10/18  she felt weak and numb to the point where she was having a hard time walking. The patient did end up falling after slamming a  door, and when she went to step away, she collapsed.   Her mother took her to emergency department 2/10/2018. The ED physician felt the patient was having an inflammatory response to the vaccines she received. Seen for follow up 2/14/2018 with PCP and 1) General malaise, sore throat, cough consistent with viral syndrome. Unclear if this was already brewing before the immunizations were given. 2) Apparent reaction to vaccines with myalgias and some degree of resolving muscle weakness. Patient reports steady improvement.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain, Pyrexia, Syncope, Viral infection
Clinical narrative: Developed generalized body aches, mainly in her back and neck, and a low grade fever the evening of the day she received the vaccines. She continued to have sore throat and low grade fever,  and on 2/10/18  she felt weak and numb to the point where she was having a hard time walking. The patient did end up falling after slamming a  door, and when she went to step away, she collapsed.   Her mother took her to emergency department 2/10/2018. The ED physician felt the patient was having an inflammatory response to the vaccines she received. Seen for follow up 2/14/2018 with PCP and 1) General malaise, sore throat, cough consistent with viral syndrome. Unclear if this was already brewing before the immunizations were given. 2) Apparent reaction to vaccines with myalgias and some degree of resolving muscle weakness. Patient reports steady improvement.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: This shot was given at pharmacy. I had severe shoulder pain and arm numbness had MRI and CAT scans done after 3 months diagnosed with Parsonage Turner syndrome.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: This shot was given at pharmacy. I had severe shoulder pain and arm numbness had MRI and CAT scans done after 3 months diagnosed with Parsonage Turner syndrome.
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Neuralgic amyotrophy
Clinical narrative: This shot was given at pharmacy. I had severe shoulder pain and arm numbness had MRI and CAT scans done after 3 months diagnosed with Parsonage Turner syndrome.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Headache, Injection site induration, Injection site pain
Clinical narrative: At site of injection: circular rash, skin is hard and swollen, painful to the touch. Injection given Saturday, early afternoon; today is Wednesday early evening and symptoms have not lessened. Also, it may be coincidental, but starting yesterday (2/13/18) I have had a sore throat, cough, fever and chills, and headache.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Injection site swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: At site of injection: circular rash, skin is hard and swollen, painful to the touch. Injection given Saturday, early afternoon; today is Wednesday early evening and symptoms have not lessened. Also, it may be coincidental, but starting yesterday (2/13/18) I have had a sore throat, cough, fever and chills, and headache.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dry skin, Erythema
Clinical narrative: Patient reports noticing some red dry patches ( non itchy)  to all over body within 2 to 7 days of receiving vaccine. Patient is not sure if it is due to the vaccine or not. Patient was recommended to consult the doctor in regards to this. And pt was notified that we will report to VAERS.  Patient did not mention anything about doing any treatment.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Vaccination site pain
Clinical narrative: Constant shoulder pain for the last month. Gets far worse at night, when pressure is applied, and when I make certain movements. Pain radiates from top, outside of shoulder exactly where the vaccination was administered.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood creatine phosphokinase, C-reactive protein, Cytomegalovirus test, Epstein-Barr virus test, Full blood count
Clinical narrative: Guillain-Barre Syndrome.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Metabolic function test, Mononucleosis heterophile test, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate
Clinical narrative: Guillain-Barre Syndrome.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal crampy pains in a 13-year-old male patient who received BOOSTRIX. Concomitant products included Anastrozole. On 1st February 2018, the patient received BOOSTRIX (intramuscular). On 5th February 2018, 4 days after receiving BOOSTRIX, the patient experienced abdominal crampy pains. In February 2018, the patient experienced nausea. On an unknown date, the outcome of the abdominal pains was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the abdominal crampy pains to be related to BOOSTRIX. The reporter considered the nausea to be possibly related to BOOSTRIX. Additional details were provided as follows: This case was reported by the patient's mother. Concomitant medications also included Omnitel. At 17:30, the patient received Tdap vaccination on the right am. She believed that it was GSK brand BOOSTRIX. The patient experienced abdominal cramping that comes and goes. About every 15 minutes he experienced very painful cramps. In February 2018, less than a month after receiving BOOSTRIX, the patient experienced nausea. The patient had not been out and about for the previous 2 weeks before the reporting date, so she did not believe it was an infection that was causing these symptoms.
Sex: M
Vaccine: RAB
Symptoms: Muscle tightness, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of jaw pain in a adult male patient who received RABAVERT. On an unknown date, the patient received RABAVERT. In January 2018, less than a month after receiving RABAVERT, the patient experienced jaw pain and neck tightness. On an unknown date, the outcome of the jaw pain and neck tightness were unknown. It was unknown if the reporter considered the jaw pain and neck tightness to be related to RABAVERT. Additional details were provided as follows: This case was previously reported to manufacturer. The patient received booster shot of RABAVERT about two weeks before from the date of reporting. In 2018, the patient had a lower jaw pain and neck tightness after vaccination. The reporter asked multiple questions regarding if there was or had been a vaccine recall, for which the patient was advised there had not been a vaccine recall. The patient concerned if he would have acquired Rabies secondary to vaccine. The patient had been advised that he would need to follow up with his physician to be tested and assessed for any diagnosis of rabies. The patient had denied permission to contact their physician. The patient had no complaints of edema in neck. The patient had been advised to follow up with physician for an assessment as they were not allowed to give medical advice. The reporter asked, if the RABAVERT was a live vaccine or if it was mislabeled as synthetic, but actually it was live. The patient had been advised that the RABAVERT was not a live vaccine, it was a synthetically prepared.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, dizziness, headache, skin warm, chills and increased blood pressure. In February 2018, the outcome of the injection site pain, skin warm and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the dizziness, headache and chills were unknown. The reporter considered the injection site pain, dizziness, headache, skin warm, chills and increased blood pressure to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced a little soreness at the injection site, facial warmth and her blood pressure was elevated to 183 per 85 however it was back to normal at the time of reporting. The reporter advised the patient to consult with her doctor. The patient told to the reporter that, she wanted to be contacted by someone directly.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, 1 day 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, dizziness, headache, skin warm, chills and increased blood pressure. In February 2018, the outcome of the injection site pain, skin warm and increased blood pressure were recovered/resolved. On an unknown date, the outcome of the dizziness, headache and chills were unknown. The reporter considered the injection site pain, dizziness, headache, skin warm, chills and increased blood pressure to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced a little soreness at the injection site, facial warmth and her blood pressure was elevated to 183 per 85 however it was back to normal at the time of reporting. The reporter advised the patient to consult with her doctor. The patient told to the reporter that, she wanted to be contacted by someone directly.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female 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 injection site reaction. On an unknown date, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient demographic details (date of birth or initials) were unknown. The batch number and expiry date of suspect vaccine were unknown. The injection site reaction was lasted for 3 to 4 days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Depressed level of consciousness, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: Fever, extreme fussiness, fast breathing and reported change in color and level of alertness starting in the evening after receiving vaccines. PE-NL in office except for intermittent fussiness/crying.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever. Self resolved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 51-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2010) and (batch number 5942P ?, expiry date unknown). Concurrent medical conditions included hypothyroidism. On 2nd February 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On an  unknown date, the dose was an unknown dose. On 2nd February 2018 06:00, 6 hrs after receiving SHINGRIX, the patient experienced chills and pain in extremity. On 2nd February 2018, the outcome of the chills and pain in extremity were recovered/resolved. The reporter considered the chills and pain in extremity to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient had shivering, chills, shooting pain in foot and leg all occurred at the same time and patient was in bed for 36 hours post vaccine administration. The vaccine was given at 12 pm and the side effects happened 6 hours after administration at 6 pm. The reported Adjuvant Lot number 942P did not match with any GlaxoSmithKline lot number. Clarification has been requested. The SHINGRIX lot number and expiration date was listed above in the form.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Patient came to pharmacy on the evening of 2-13-18 at approximately 7 pm. She stated that the evening that she received shot she experienced extreme pain in her arm and was hardly able to lift it. This progressed to large area of redness from the deltoid to about half way down to the elbow. Area was hard with constant itching. When she came to the pharmacy she stated that she had gone to see her doctor because she was concerned that it was still red so long after the shot. She said her doctor told her to come to our pharmacy and have us fill out this report. She also stated that the doctor had recommended she use cold compress and BENADRYL for itching.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site swelling
Clinical narrative: 1 inch by 1.5 inch red hard bump on right thigh where vaccines were given. Itchy for patient. Advised cool wash cloth and provider advised BENADRYL, dose appropriate for weight.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old female patient who received Influenza vaccine Quadrivalent. Previously administered products included Influenza vaccine (no adverse events). Concurrent medical conditions included spleen disorder (the patient does not have spleen). In October 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. The reporter considered the tiredness to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The consumer reported that she got vaccinated in the fall season of 2017, with quadrivalent flu vaccine where the manufacturer is unknown. She stated that, she had received the flu vaccine before also but had not experienced tiredness earlier. She also stated her doctor stated that the tired feeling was because of her body making antibodies. The reporter's healthcare professional was not asked. The caller might call back with identification of the manufacturer.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza
Clinical narrative: This is a serious spontaneous case, initially received from other health professional on 02-Feb-2018, concerning a male patient of an unspecified age. On 30-Sep-2017, the patient was administered with FLUCELVAX (QIV) PFS (batch number: 195210, dose, route of administration, anatomical location, expiry date: not reported). On 02-Jan-2018 (on Friday), after 3 months 4 days of vaccination, the patient was diagnosed with flu. It was reported that patient had influenza (type A). At the time of this report, the outcome of the event (flu/ influenza type A) was not reported.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pyrexia, Vomiting
Clinical narrative: Pain injection site, 5 hrs later, fever up to 101 degrees F, still has fever day 2 taking TYLENOL for fever, vomiting x1 last night.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative
Clinical narrative: Client received 2nd dose of Varicella vaccine, at the appointment client was tested for pregnancy, test was negative. The LMP prior to the vaccine date was 9-10-17. Client returned to clinic 2-13-18 with concern because they are now pregnant with an estimated due date of July 10, 2018. Client states LMP after Varicella vaccine was 10-11-17.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Anxiety, Cold sweat, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Feeling cold, Hyperhidrosis, Muscular weakness, Nausea, Peripheral coldness
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP, YF, YF, YF
Symptoms: Presyncope, Pyrexia, Sinus disorder
Clinical narrative: Initial unsolicited report received from pharmacist on 12-Jan-2018. This case involves a 39-year-old female (reported as 40 year old) patient who was vaccinated with 0.5 ml dose once of YELLOW FEVER VACCINE - US (YF-VAX) (Batch number, expiration date, dose, and site of administration was not reported) via subcutaneous route on 05 Jan 2018. On an unspecified date, following the vaccination, the patient had syncope, vitals and had fever. On 09 Jan 2017, the patient was seen in the emergency room. It was also reported that, the patient followed up with PCP on 11 Jan 2017. Lab data were normal (unspecified). Corrective treatment was not reported. The patient was recovering from events. Follow up information received from pharmacist on 31-Jan-2018. Patient age was updated as 40-years. It was reported that the patient was vaccinated with 0.5 ml dose of YELLOW FEVER VACCINE - FR (STAMARIL) (Batch number, expiration date, dose, dose in series and site of administration was not reported) via subcutaneous route on 05 Jan 2018, which was initially reported as YF-VAX. On 09-Jan-2018, four days following the vaccination, patient experienced syncope, dizziness, fever and headache. The patient was still recovering from syncope and fever and also the patient had not yet recovered from dizziness and headache at the time of reporting. List of documents held by sender: none.