chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: HPI: Seen here yesterday, received 12mo vaccines (MMR, Varicella, PCV, HIB), Here b/c of constant vomiting since 3am: not holding anything down since. Emesis is green/yellow, also milkstuff. Patient is wanting to drink liquid but vomiting immediately after- breastmilk, water & juice. Last emesis was on drive here. Total 10-11 times today. Reportedly projectile "turning on hose of water." Gassy and smelly farts, no diarrhea. Last dose of medication was at 10am motrin given threw up 5 minutes after. 1 wet diaper today at 8am & then again now. Fussy and fevers on and off. No temp taken, feels warm.    Vomiting (ICD-787.03) (ICD10-R11.10) Assessment: 13mo old F who received her 12mo vaccines yesterday, presented w/ 10-11 episodes of nonbilious emesis in 12 hours, associated w/ extreme fussines. She nursed in office but then had large emesis after we tried to give Zofran dose (yellow, milk stuff). Sent to ER for further eval & management (I had ordered the US & KUB while zofran was attempted, will cancel). Dehydration (ICD-276.51) (ICD10-E86.0) Assessment: lost about 200g since yesterday, mildly dehydrated- sent to ER for fluids & evaluation. Fussy infant (ICD-780.91) (ICD10-R68.12) Assessment: initially ordered rectal supp of tylenol to help with fussiness but canceled it since she vomited in office & was sent to the ER. Attempted to administer 2mg of orally disintegrating ondansetron - vomited up immediately. Patient was sent to ER for above diagnosis.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Resuscitation
Clinical narrative: Patient died at 5:15 the same day--- his wife performed cpr on patient until medical help arrived.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: On 02/26/18, I took my daughter for her 2nd series of Hep A vaccine. Not sure what brand or type. On 02/27/18, early AM hours, my mother noticed my daughter broke out in hives all over her body except her head. I called the pediatrician later on in the day. They suggested I take some pictures and give her about 1/2 teaspoon for the itching and to make it go away and bring her in for a sick visit the next day. On 2/28 I took her to the pediatrician they suggested that maybe it's from a virus and not the vaccine. No test was done but because my daughter developed a cold on Tuesday 2/27 that was the assumption. They gave her some benadryl and sent her home. The symptoms lasted about 4 days and then it went away. I did nothing new with my daughter (ie: no new clothes, detergent, food etc.....).
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Muscle pain, unable to lift arm above shoulder, fever, rash and swelling at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: PT CAME IN FOR SHINGRIX VACCINATION. HER SHINGRIX WAS RECONSTITUTED WITH A DIFFERENT DILUENT THAN ONE PROVIDED IN BOX WITH VACCINATION. AS A RESULT PATIENT DID NOT RECEIVE FULL POTENCY OF VACCINE. CONTACTED PATIENT AND EXPLAINED THAT BECAUSE OF ABOVE ERROR WILL WE REVACCINATE HER USING CORRECT DILUENT SO SHE RECEIVES FULL POTENCY AND PROTECTION.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Syncope
Clinical narrative: 30 minutes after PREVNAR vaccine, patient began to develop nausea, sweats and lightheadedness. 2 hours post vaccination, he had a witnessed syncopal spell and was unresponsive for 30 seconds. There was no convulsion, tongue biting, or incontinence. He felt better after he awakened. There was no shortness of breath, chest tightness, tongue swelling, abdominal pain, emesis or diarrhea. There was no local inflammation at the injection site.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: 30 minutes after PREVNAR vaccine, patient began to develop nausea, sweats and lightheadedness. 2 hours post vaccination, he had a witnessed syncopal spell and was unresponsive for 30 seconds. There was no convulsion, tongue biting, or incontinence. He felt better after he awakened. There was no shortness of breath, chest tightness, tongue swelling, abdominal pain, emesis or diarrhea. There was no local inflammation at the injection site.
Age: 44.0
Sex: M
Vaccine: HEPAB, MMR
Symptoms: Presyncope
Clinical narrative: Almost fainted.
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on chest and back, at left thigh. Patient given Benadryl 6.25 mg po x 1 with almost complete resolution of rash except at the injection site. Immunizations were given earlier that day at PCP's office, they should be able to know which injection went where.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Gait disturbance, Synovitis
Clinical narrative: Started with limp and diagnosed as toxic synovitis.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Altered state of consciousness, Asthenia, Blood test, Decreased appetite, General physical health deterioration
Clinical narrative: Second day after shot child was lethargic, irritable, decreased appetite, and decreased awareness. Before vaccine child was very active and interacted with us. Child's health began to deteriorate after vaccine was administered. At child's fifteen month wellness check up nurse ordered blood tests for child to find out why child was so weak and not recovering from current illnesses.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Irritability, Lethargy
Clinical narrative: Second day after shot child was lethargic, irritable, decreased appetite, and decreased awareness. Before vaccine child was very active and interacted with us. Child's health began to deteriorate after vaccine was administered. At child's fifteen month wellness check up nurse ordered blood tests for child to find out why child was so weak and not recovering from current illnesses.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain upper, Blood test, Bronchitis, Crying, Ear infection
Clinical narrative: Child was extremely irritable and crying uncontrollably for the whole day. We notice also that the child presented in pain with fever. One month after shots child was sick with upper respiratory infection and bronchitis. Child had blood in fecal matter multiple times and was rushed to emergency room  multiple times. Pediatrician did blood work and could not find reason for bloody stool but informed us it could possibly be from the Rota-virus Vaccine. Child has been struggling with chronic stomach ache and constant ear infections. We have been advised by our doctor to be cautious with the child receiving more vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Irritability, Malaise, Pain, Pyrexia
Clinical narrative: Child was extremely irritable and crying uncontrollably for the whole day. We notice also that the child presented in pain with fever. One month after shots child was sick with upper respiratory infection and bronchitis. Child had blood in fecal matter multiple times and was rushed to emergency room  multiple times. Pediatrician did blood work and could not find reason for bloody stool but informed us it could possibly be from the Rota-virus Vaccine. Child has been struggling with chronic stomach ache and constant ear infections. We have been advised by our doctor to be cautious with the child receiving more vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Stool analysis, Upper respiratory tract infection
Clinical narrative: Child was extremely irritable and crying uncontrollably for the whole day. We notice also that the child presented in pain with fever. One month after shots child was sick with upper respiratory infection and bronchitis. Child had blood in fecal matter multiple times and was rushed to emergency room  multiple times. Pediatrician did blood work and could not find reason for bloody stool but informed us it could possibly be from the Rota-virus Vaccine. Child has been struggling with chronic stomach ache and constant ear infections. We have been advised by our doctor to be cautious with the child receiving more vaccines.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Arm was very red and swollen. It was also very warm to the touch where the redness was. She also said she had felt more tired than normal since receiving the vaccination. Patient thought redness had spread over the past 36 hours. She said that the vaccine hurt a lot when she received it and that her arm was still very tender. She did not report any trouble breathing and said that the area did not itch. She had been using an ice pack on it and had taken some ibuprofen. She said that the ibuprofen seemed to help a little. I recommended that she take another dose of ibuprofen before bed (it had been 6 hours since her previous dose) and that she continue to ice it a little (15 minutes on and 15 minutes off). Since she said she thought the redness was spreading we used a black marker to make a small mark at the lowest and highest points of the redness and I told her that would allow her to see if it continued to spread or get better. If it continued to spread or got worse by tomorrow morning I recommended she go see her doctor. However, I told her if she had any trouble breathing tonight that I would go to an urgent care or emergency room immediately. I am a visiting pharmacist so I am going to make sure that the pharmacy manager follows up with her in the next 24 hours to see how she is doing. She stated she has never had a reaction to a vaccine like this before. According to her file she has received the PREVNAR 13 and HD FLUZONE from us in the past. Pregnancy is not a concern (patient is 80 years old). I am not the pharmacist that administered the vaccination. The patient came in tonight due to being worried about the reaction from having the vaccine the previous day. As of right now she has not gone to a doctor or clinic, but may do so if symptoms worsen overnight.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Arm was very red and swollen. It was also very warm to the touch where the redness was. She also said she had felt more tired than normal since receiving the vaccination. Patient thought redness had spread over the past 36 hours. She said that the vaccine hurt a lot when she received it and that her arm was still very tender. She did not report any trouble breathing and said that the area did not itch. She had been using an ice pack on it and had taken some ibuprofen. She said that the ibuprofen seemed to help a little. I recommended that she take another dose of ibuprofen before bed (it had been 6 hours since her previous dose) and that she continue to ice it a little (15 minutes on and 15 minutes off). Since she said she thought the redness was spreading we used a black marker to make a small mark at the lowest and highest points of the redness and I told her that would allow her to see if it continued to spread or get better. If it continued to spread or got worse by tomorrow morning I recommended she go see her doctor. However, I told her if she had any trouble breathing tonight that I would go to an urgent care or emergency room immediately. I am a visiting pharmacist so I am going to make sure that the pharmacy manager follows up with her in the next 24 hours to see how she is doing. She stated she has never had a reaction to a vaccine like this before. According to her file she has received the PREVNAR 13 and HD FLUZONE from us in the past. Pregnancy is not a concern (patient is 80 years old). I am not the pharmacist that administered the vaccination. The patient came in tonight due to being worried about the reaction from having the vaccine the previous day. As of right now she has not gone to a doctor or clinic, but may do so if symptoms worsen overnight.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Gave ped v pt adult dose of HAVRIX. No adverse symptoms, client bigger than nurse.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site rash
Clinical narrative: 3 days after receiving MMR-V vaccine in (L) thigh, patient developed a rah in the opposite site of the vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Pt started with (L) arm pain at injection site, that kept him up at night after receiving BEXSERO vaccine. Pain lasted for 2 days. (L) upper arm swollen 1 day after receiving vaccine. Patient presents in office on 3/6/18 w/(R) upper arm at 12cm redness, swelling, warm to touch. Pt prescribed AUGMENTIN Rx.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Discomfort, Dysstasia, Electrocardiogram, Fear
Clinical narrative: Arm started to ache/throb 2 hrs post shot. Called pharmacy to ask if this was normal, pharmacist said "no". Called my husband to come home immediately because I couldn't stand the discomfort, was nauseous and frightened. Husband called the pharmacy and pharmacist said to call our family Dr. Dr. office said go to local urgent care. I was in extreme discomfort that is hard to describe. I could barely walk and couldn't stand up straight. I was bent over and my left arm was dangling. Once my husband got me in the urgent care facility they took one look at me and said they couldn't do anything and I needed to go to the hospital or some other ER. I wanted to go to the ER not far from our home. I was in the ER from 4-8? I was hooked up to an IV for nausea. I had an IV for discomfort. I had bloodwork. I had an EKG. I had X-rays. Left the facility around 8 AM with a prescription for Naproxen and recommended Tramadol (I had this at home for arthritis when needed).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Nausea, Pain in extremity, X-ray
Clinical narrative: Arm started to ache/throb 2 hrs post shot. Called pharmacy to ask if this was normal, pharmacist said "no". Called my husband to come home immediately because I couldn't stand the discomfort, was nauseous and frightened. Husband called the pharmacy and pharmacist said to call our family Dr. Dr. office said go to local urgent care. I was in extreme discomfort that is hard to describe. I could barely walk and couldn't stand up straight. I was bent over and my left arm was dangling. Once my husband got me in the urgent care facility they took one look at me and said they couldn't do anything and I needed to go to the hospital or some other ER. I wanted to go to the ER not far from our home. I was in the ER from 4-8? I was hooked up to an IV for nausea. I had an IV for discomfort. I had bloodwork. I had an EKG. I had X-rays. Left the facility around 8 AM with a prescription for Naproxen and recommended Tramadol (I had this at home for arthritis when needed).
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia
Clinical narrative: After injecting the vaccine, patient experienced immediately tingling in the arms, hands and upper lip (face). She felt dizzy and after a few minutes she also developed a headache.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Headache, Paraesthesia, Paraesthesia oral
Clinical narrative: After injecting the vaccine, patient experienced immediately tingling in the arms, hands and upper lip (face). She felt dizzy and after a few minutes she also developed a headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Loss of personal independence in daily activities, Poor quality sleep, Pyrexia
Clinical narrative: Restless sleep. After taking shower, felt very dizzy, head buzzing, while drying my hair I fell to the floor but did not actually lose consciousness; took my temperature 99.4 (as the day progressed to went up to as much as 100.7 using an ear thermometer); felt "other-worldly," was unable to go through my normal daily routine and activities; slept from 9 to 11am and from 1-3pm. Called doctor's office and was advised that it probably was a virus, and an episode of hypoglycemia? not a reaction. Told to take 1 TYLENOL, which I did, but fever remained, and increased towards evening. Able to eat dinner normally. No fever the following morning. No dizziness. No buzzing in my head. Restful sleep. Able to go about my usual routine on 3/8/18.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Viral infection
Clinical narrative: Restless sleep. After taking shower, felt very dizzy, head buzzing, while drying my hair I fell to the floor but did not actually lose consciousness; took my temperature 99.4 (as the day progressed to went up to as much as 100.7 using an ear thermometer); felt "other-worldly," was unable to go through my normal daily routine and activities; slept from 9 to 11am and from 1-3pm. Called doctor's office and was advised that it probably was a virus, and an episode of hypoglycemia? not a reaction. Told to take 1 TYLENOL, which I did, but fever remained, and increased towards evening. Able to eat dinner normally. No fever the following morning. No dizziness. No buzzing in my head. Restful sleep. Able to go about my usual routine on 3/8/18.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Left deltoid pain since the vaccination. Pain is present at rest but does not hinder movement. Patient evaluated 06MAR2018 for the first time for this complaint. Exam without focal nodule or mass. Mild tenderness to palpation of the body of the left deltoid and moderate tenderness at the insertion site of the deltoid.
Sex: U
Vaccine: HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant medications and drug allergies/reactions were not reported. On an unknown date approximately in February 2018 (reported as on or after 02-FEB-2018) the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number N019838, expiry date 16-FEB-2019) (dosing regimen and frequency unknown) or (OMPC) PEDVAXHIB (unknown lot number and expiry date) (dosing regimen and frequency unknown) for prophylaxis (Product storage error). It was reported that the vaccines experienced a temperature excursion of 1 degrees Centigrade for 10 hours. It was reported that there no previous temperature excursion (details unspecified). No adverse effects were reported. It was reported that this case was reported due to a digital data logger. There was no product quality complaint reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with an improperly stored Oka-Merck vaccine PROQUAD lot #N021730, expiration date on 06-FEB-2019 or lot # and expiration date reported as N025719, on 17-MAR-2019, for prophylaxis (strength, dose and route were not reported), that was reconstituted, concomitantly, with MERCK STERILE DILUENT. The vaccine was improperly stored at a temperature between 6°F to 14°F (6.1°F) during a time frame of 30 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 34 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. It was reported that the patient was "very adamant" in receiving a dose of GARDASIL 9. The nurse stated that on 28-FEB-2018 (reported as today), the patient would most likely be administered with GARDASIL 9 injection (strength, dose and route of administration were not reported) (lot # N019103, expiration date: 03-FEB-2020) for prophylaxis (drug administered to patient of inappropriate age, circumstance or information capable of leading to medication error). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 23.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inflammation, Injection site swelling, Malaise, Peripheral swelling, Vaccination site movement impairment
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 23 year old female patient. The patient's concurrent condition included asthma and used an unspecified inhaler. Concomitant medication included a flu shot (manufacturer unknown) on same day as PNEUMOVAX 23 but it was unclear if both shots given in same arm. On an unknown date (reported as recent past), the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly in the arm (lot#, expiry date and dosage not reported) for pneumococcal prevention. On an unknown date, the patient "felt ill" (not specified) and experienced "a lot of swelling, inflammation to the point where there was no movement in her arm." The patient's parents sought medical attention, contacted pharmacy. The patient went to an emergency room (ER) and was subsequently admitted to an unspecified hospital for an unknown duration of time. It was unknown how the patient was treated in the hospital and when patient was discharged. It was unknown the time frame for the patient's arm to swell and visit to ER/hospital admission. There was no product quality complaint (PQC) involved. The outcome of all the events was unknown. The reporting pharmacist did not provide causality assessment for the events. The event "a lot of swelling, inflammation to the point where there was no movement in her arm" led to patient's disability.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 31-AUG-2017, the patient was vaccinated with the first dose of VAQTA for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 05-OCT-2017, the patient was vaccinated with the second dose of VAQTA lot # N002921 with expiration date of 08-APR-2018, for prophylaxis (dose and route of administration were not reported). Sender's Comments: US-009507513-1803USA002923:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 24-JUL-2007 and 17-MAY-2011, patient was vaccinated with Oka/Merck VARIVAX (dose, units, route and frequency not reported) (lot# and expiration date not reported) and on 08-AUG-2007 and 27-MAY-2011, patient was also vaccinated with (wistar ra 27-3) M-M-R II (dose, units, route and frequency not reported) (lot# and expiration date not reported). Patient was administered vaccines less than 4 weeks apart (inappropriate schedule of drug administration). No product quality complaint involved.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 31-AUG-2017, the patient was vaccinated with the first dose of VAQTA for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 05-OCT-2017, the patient was vaccinated with the second dose of VAQTA lot # N002921 with expiration date of 08-APR-2018, for prophylaxis (dose and route of administration were not reported). Sender's Comments: US-009507513-1803USA001780.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Depressed level of consciousness, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Events: Pain, Swelling, Fever, Redness of the skin, clouding of consciousness. Treatment: Went to emergency room was treated and prescribed antibiotic and BENADRYL. Discussed with provider over the phone. Outcome: After taking BENADRYL, symptoms immediately started to disappear.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30 January 2020). On 23rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th February 2018, 1 days after receiving SHINGRIX, the patient experienced shingles and painful rash. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and painful rash were recovering/resolving. The reporter considered the shingles and painful rash to be probably related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that, on the pre vaccination form, the patient did answer yes to steroid treatment with the last 3 months. The reason was not known. The HCP believed, the patient had completed that treatment approximately 2 months ago. No other known medication or medical history was significant for the patient. The patient did not experience a previous outbreak of Shingles. On 23rd February 2018, at 11:30 hours, the patient received SHINGRIX on right deltoid. The patient developed a painful rash down one side of her back. The patient visited her doctor (date unknown) and was diagnosed with Shingles. The patient was prescribed with Valacyclovir.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Arthralgia, Asthenia, Dizziness, Fatigue
Clinical narrative: Upon receiving shot immediately felt light headed. Got better after about 5-10 minutes and left facility. Felt weak and tired throughout day until about 7 pm. Felt fine after that and went to bed. Woke next morning to pain throughout body from torso to head. Specifically, pain in lower right abdomen, severe pain in left kidney, bad headache, and shooting nerve pain in head behind both ears (much like a shingles attack). This persisted throughout the entire day.  Woke up this morning with all symptoms relieved. Currently have a wrung out feeling but other than joint soreness throughout body, most other symptoms have abetted.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Neuralgia, Pain, Renal pain
Clinical narrative: Upon receiving shot immediately felt light headed. Got better after about 5-10 minutes and left facility. Felt weak and tired throughout day until about 7 pm. Felt fine after that and went to bed. Woke next morning to pain throughout body from torso to head. Specifically, pain in lower right abdomen, severe pain in left kidney, bad headache, and shooting nerve pain in head behind both ears (much like a shingles attack). This persisted throughout the entire day.  Woke up this morning with all symptoms relieved. Currently have a wrung out feeling but other than joint soreness throughout body, most other symptoms have abetted.
Age: 0.5
Sex: M
Vaccine: 6VAX-F, FLUX, PNC13, RVX
Symptoms: Vomiting
Clinical narrative: My son presented for his 6 month shots including the flu shot. He was given 4 injections total which included TDap, oral rotovirus, flu shot, Hib, Hep B, Polio, and PCV13. My son vomited after waking from a nap at daycare the day after his vaccines. They gave him 5 oz of breastmilk after he threw up and he drank the entire bottle. He has not thrown up since. This was reported because my son has never thrown up before.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Angiogram cerebral abnormal, Basal ganglia haematoma, Basal ganglia haemorrhage, Cough, Facial paralysis
Clinical narrative: Patient presented to the outpatient clinic on 2/2/18 for evaluation of viral URI symptoms and right-sided facial droop. On evaluation, she was found to have a right-sided hemiparesis. Fever, cough, and runny nose initially started 1/23/18, the day after immunization occurred. URI symptoms slightly improved, and then around 1/28/18, family noted right-sided facial droop and possible right-sided weakness (R arm > R leg). These symptoms stayed the same, but fevers and respiratory symptoms began again in the day or 2 prior to presentation in clinic on 2/2/18. Examination revealed right-sided hemiparesis and she was referred to the Emergency Department for evaluation by Neurology. MRI on 2/3/18 revealed a large left basal ganglia bleed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Hemiparesis, Hydrocephalus, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: Patient presented to the outpatient clinic on 2/2/18 for evaluation of viral URI symptoms and right-sided facial droop. On evaluation, she was found to have a right-sided hemiparesis. Fever, cough, and runny nose initially started 1/23/18, the day after immunization occurred. URI symptoms slightly improved, and then around 1/28/18, family noted right-sided facial droop and possible right-sided weakness (R arm > R leg). These symptoms stayed the same, but fevers and respiratory symptoms began again in the day or 2 prior to presentation in clinic on 2/2/18. Examination revealed right-sided hemiparesis and she was referred to the Emergency Department for evaluation by Neurology. MRI on 2/3/18 revealed a large left basal ganglia bleed.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Vasogenic cerebral oedema, Viral upper respiratory tract infection
Clinical narrative: Patient presented to the outpatient clinic on 2/2/18 for evaluation of viral URI symptoms and right-sided facial droop. On evaluation, she was found to have a right-sided hemiparesis. Fever, cough, and runny nose initially started 1/23/18, the day after immunization occurred. URI symptoms slightly improved, and then around 1/28/18, family noted right-sided facial droop and possible right-sided weakness (R arm > R leg). These symptoms stayed the same, but fevers and respiratory symptoms began again in the day or 2 prior to presentation in clinic on 2/2/18. Examination revealed right-sided hemiparesis and she was referred to the Emergency Department for evaluation by Neurology. MRI on 2/3/18 revealed a large left basal ganglia bleed.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Fibromyalgia, Gait inability, Hypermobility syndrome, Hypertension, Migraine with aura
Clinical narrative: After receiving the vaccination, could not walk due to muscle spasms in back. No have fibromyalgia and severe pain throughout body. Chronic migraines with aura and now a racing heart rate. Blood pressure is significantly high now. Treated with PERCOCET after the incident and then TOPAMAX, Propranolol, EFFEXOR, CYMBALTA, and extensive amounts of BOTOX injections. Received multiple injections in back and hips. Directly after the injection, could not walk and was put on a profile from the doctors.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle spasms, Pain, Palpitations, Tachycardia
Clinical narrative: After receiving the vaccination, could not walk due to muscle spasms in back. No have fibromyalgia and severe pain throughout body. Chronic migraines with aura and now a racing heart rate. Blood pressure is significantly high now. Treated with PERCOCET after the incident and then TOPAMAX, Propranolol, EFFEXOR, CYMBALTA, and extensive amounts of BOTOX injections. Received multiple injections in back and hips. Directly after the injection, could not walk and was put on a profile from the doctors.
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and gender. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On an unspecified dates the patients were vaccinated with improperly stored GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported), VAQTA for prophylaxis, (strength, dose, frequency, route of administration, lot number and expiration date were not reported) and ROTATEQ orally, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). Temperature-Time frame: -0.3C for 35 Hours below 0°C, 9°C to 25°C (9.8C) for 20 Hours according to digital data logger. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On 05-MAR-2018, the patient was vaccinated with second dose of GARDASIL 9 (lot # L045700 and expiry date: 22-FEB-2018) (strength, frequency, dose and route not reported) for prophylaxis (Expired product administered). No adverse event was reported. No further information was provided. A product quality complaint was not present.
Age: 72.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable patient reported for himself. A 72-year-old male patient received the second dose of PREVNAR 13, (lot S43277) on 17Oct2017 12:05 via an unspecified route at 0,.ml single dose, in the right arm for immunization, on the same date the patient also had received the first dose of Zoster, (lot M038350) for immunization in the left arm. On 16Jan2015 he had received the first dose of PREVNAR 13 from lot: J67643 in the right arm and previously, on 18Sep2007 a dose of PNEUMOVAX 23 (from lot#06984) and on 18Sep2012, other dose of the PNEUMOVAX 23 (from lot LOT#H013581). The patient had received Zoster vaccine 9 years ago and then he had mild shingles again. The patient also was on digoxin and COLUMADIN and taken off because his pacemaker is showing he does not have atrial fibrillation anymore. Concomitant medications included Aspirin at 325 mg on 10Aug2014 ongoing for blood thinner by mouth each night, benazepril HCL for blood pressure from 15Jan2001 and ongoing, at 10 mg, 1x/day, carvedilol since  15May2008 and ongoing for blood pressure and atrial fibrillation at 1.5mg 1 at breakfast and one at bedtime, BENADRYL for allergies at 25 mg, 1x/day since 20Aug2013 and ongoing, ALLEGRA for Allergies at 180 mg, daily since 20Aug2013 and ongoing, metronidazole topical cream at .75% rub on nose every morning and every night, to prevent the pointy nose, adult acne since 14Aug2008 and ongoing, SINGULAIR for sinus congestion since 20Aug2013 at 10 mg, daily and ongoing, PRILOSEC for Barrett's esophagus and acid reflux at 20 mg, daily since 31Oct2007 ongoing, ZOCOR at 20 mg, daily for cholesterol since 01Dec2005 and  ongoing, gabapentin for nerve pain caused by shingles on 17Oct2017and ongoing at 300 mg, 2x/day and VALTREX since 17Oct2017 and ongoing. Medical history included blood pressure diagnosed in 1994-1995, atrial fibrillation since Feb1994, cholesterol since 2002, spinal stenosis since Oct2016, allergies since he was a kids allergic to dust and cats and stuff like that, Barrett's esophagus found in 2002 or 2003, dual lead Medtronic's pacemaker (the latest was Sep2014, the first one lasted 12 years for atrial fibrillation, he has good plumbing, no stents. Took COUMADIN and Digoxin and he no longer takes it because they took him off of it because he is doing so well with his pacemaker),  Horseshoe kidney in the front, diagnosed at birth, it is a birth defect, blood thinner, acne, sinus congestion, acid reflux, post herpetic neuralgia. The patient received two doses of the vaccine and experienced who had some soreness around injection sites, upper arm area for 36 hours, the outcome was unknown. Follow-up (05Mar2018) Additional information receive from the same contactable patient includes information on concomitant medications. Event injection site pain added.
Sex: F
Vaccine: PNC13
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient of 65 and older age of unspecified race received PREVNAR 13 for immunization at single dose on unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced swollen and painful. The outcome of the events was unknown.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old male patient who received SHINGRIX. On 20th February 2018, the patient received SHINGRIX. In February 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash on his back about a week after receiving the SHINGRIX vaccine. Call was transferred to medical information (MI) for follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 60-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd March 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the nurse who administered the vaccine to the patient. This case was previously not reported to anyone. The patient called to report that they were diagnosed with shingles on 2nd March 2018. The caller was transferred to medical information for discussion.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Dysgeusia
Clinical narrative: The adverse event reported is distorted taste (dysgeusia).
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received MENACTRA vaccine in her left arm on Tuesday 3/6/2018. That night, she developed redness and itching at the site which has become a little swollen and increasing size of redness. At time of evaluation on Thursday 3/8/2018, she had 1.5in x 1.5in round area of redness that is mildly swollen. No systemic signs of reaction.
Age: 1.42
Sex: F
Vaccine: DTAPIPV, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was overdue for her 15 month old vaccines and was to receive PEDIARIX and was given KINRIX. No evidence of any reaction to dose or injection. The adverse event was a medication error.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Anxiety, Arthralgia, Ataxia, Blood test, Borrelia test negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: CSF culture negative, CSF immunoglobulin, CSF protein increased, CSF white blood cell count increased, Chest X-ray
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Computerised tomogram head, Cryptococcus test, Culture negative, Diplopia, HIV antibody negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Laboratory test normal, Myalgia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Polymerase chain reaction
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Pyrexia, Treponema test negative, Yellow fever vaccine-associated neurotropic disease
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Anxiety, Arthralgia, Ataxia, Borrelia test negative, CSF culture negative
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: CSF protein increased, CSF white blood cell count increased, Chest X-ray, Computerised tomogram head, Cryptococcus test
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Culture negative, Diplopia, Flavivirus test, HIV antibody negative, Myalgia
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 70.0
Sex: M
Vaccine: PNC13, YF, PNC13, YF
Symptoms: Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Pyrexia, Treponema test negative, Yellow fever vaccine-associated neurotropic disease
Clinical narrative: Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed redness, swelling and warmth around injection site approximately 16 hrs after injection. Pt went to primary care who confirmed allergic reaction. Pt was prescribed BACTRIM for cellulitis prophylaxis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. Concomitant products included ACIPHEX, CELEBREX, fish oil, Multivitamin and Muscle Relaxant. On 22nd February 2018, the patient received SHINGRIX. On 22nd February 2018, less than a minute after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. The reporter considered the injection site pain and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's left arm was sore within a minute after vaccination. The soreness lasted 4 days, and was just beginning to improve. Injection site redness began at the site and spread down her arm about 4 inches. The redness started several hours after the vaccination. The patient denied to contact the physician.