chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally gave Quadracel instead of Pentacel/no AE; accidentally gave Quadracel to 15 months old instead of Pentacel/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was mistakenly vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5755AB, dosing details 0.5 ml, fourth dose and expiry date 10-JUL-2022) via intramuscular route in the left thigh unknown date for prophylactic vaccination(product administered to patient of inappropriate age) and  (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Allergy; Initial information received on 25-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves patient of unknown age and gender who experienced allergy, while he/she received vaccine TETANUS TOXOID.  At the time of the event, the patient had ongoing Drugs hypersensitivity with Phenytoin, Tetanus toxoid, Chlorhexidine topical, Talwin, Tegretol, Depakote, Vistaril, IV contrast and Oxycodone., peach allergy and peanuts allergy.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergy (hypersensitivity) (Unknown latency) following the administration of TETANUS TOXOID.  No laboratory data not reported.  Final diagnosis was hypersensitivity.   It was not reported if the patient received a corrective treatment.  The outcome was Unknown for the event hypersensitivity.  There will be n information on the batch number for this case.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a 18 year male patient received Menactra instead of Menveo vaccine,No AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 18 year old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination instead of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) [MENVEO].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a THIRD DOSE of Shingrix. Pt did not report any ADR when questioned after the fact.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy, Neuropathy peripheral, Ultrasound scan
Clinical narrative: Left supra- clavicular adenopathy. Neuropathy of L arm and hand
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: redness, warmth, pain, swelling treated with doxycycline
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fall, Loss of consciousness, Neurological examination normal, Syncope
Clinical narrative: Syncope- LOC last a couple seconds, patient fell to the ground.  VS were taken.  Physical examination including neurological assessment was completed.  Patient was  monitored  for over 20 minutes. He remained asymptomatic after initial episode.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: PATIENT EXPERIENCED INJECTION SITE REDNESS, SHORTNESS OF BREATH, AND CHEST PAIN AND WAS SEEN AT THE EMERGENCY DEPARTMENT.  REFERRED PATIENT TO SEE HEART DOCTOR AND ICE INJECTION SITE.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Metabolic function test, Troponin, Urine analysis
Clinical narrative: PATIENT EXPERIENCED INJECTION SITE REDNESS, SHORTNESS OF BREATH, AND CHEST PAIN AND WAS SEEN AT THE EMERGENCY DEPARTMENT.  REFERRED PATIENT TO SEE HEART DOCTOR AND ICE INJECTION SITE.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Sore arm for last 10 days
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: SWOLLEN, RED, ITCHY FROM DELTOID TO ELBOW
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever up to 100.8  for 4 days duration thus far, myalgias day 1 now resolved
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site rash, Rash
Clinical narrative: Fatigue, mild headache, joint pain. On day two, I developed a rash on the injection site. That rash went away today (day 3) but now I have another rash on my neck, above the collarbone. The headache is better but I am still very tired and still have joint pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Electrocardiogram normal, Loss of consciousness, Nausea, Tremor
Clinical narrative: PT felt dizzy and about to faint, was put in a chair, right after she lost her consciousness completely, start generalized shaking episodes for few seconds, wake up very nauseous, tried to throw up so  many times, did not remember what happened beside feeling dizzy before the accident, pt was given im shot for vomiting, and felt better, pt was sent to ER, for further evaluation
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Loss of consciousness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: PT RECEIVED 2ND SHINGRIX VACCINE ON 6/25. HE HAD HEADACHE, SORE ARM, FEVER NAUSEA. ON 6/26 HE WAS UNCONSCIOUS  AND HE CALLED 911 AND WENT TO EMERGENCY ROOM. HE WAS GIVEN IV FLUIDS AND HE WAS BACK HOME IN 5 HOURS. ON 6/29 HE HAD HEADACHE AND SORE ARM.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Fatigue, Gait inability, Malaise, Mobility decreased
Clinical narrative: Patient had significant "sickly feeling" following administration of her first HPV vaccine in March 2017 that lasted for 2 weeks. She reports fatigue, nausea, and weakness with inability to sit upright and ambulate well following administration of the vaccine. She remembers a prolonged period of need for rest and inability to move off the couch following administration of the vaccine.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Posture abnormal
Clinical narrative: Patient had significant "sickly feeling" following administration of her first HPV vaccine in March 2017 that lasted for 2 weeks. She reports fatigue, nausea, and weakness with inability to sit upright and ambulate well following administration of the vaccine. She remembers a prolonged period of need for rest and inability to move off the couch following administration of the vaccine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Decreased appetite, Fatigue, Heart rate increased, Joint swelling
Clinical narrative: Our son had sever joint pain and swelling several days after the vaccination when his heart rate elevated after playing tennis. His response - everything hurt.  This past weekend had a 102 fever. Was tested for covid and strep - negative. Has mono symptoms with sever ulcers in his throat and mouth. Continued fatigue and loss of appetite.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Mononucleosis heterophile test, Mouth ulceration, Pain, Pharyngeal ulceration, Pyrexia
Clinical narrative: Our son had sever joint pain and swelling several days after the vaccination when his heart rate elevated after playing tennis. His response - everything hurt.  This past weekend had a 102 fever. Was tested for covid and strep - negative. Has mono symptoms with sever ulcers in his throat and mouth. Continued fatigue and loss of appetite.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Our son had sever joint pain and swelling several days after the vaccination when his heart rate elevated after playing tennis. His response - everything hurt.  This past weekend had a 102 fever. Was tested for covid and strep - negative. Has mono symptoms with sever ulcers in his throat and mouth. Continued fatigue and loss of appetite.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Pallor, Syncope
Clinical narrative: Patient entered clinic for HPV gardisil 9 vaccine and MCV4 menactra vaccine.  Verified name, DOB, insurance, and ID.   Verified no allergies, or previous reactions to vaccines before. She has no record of these vaccines before.  Patient stated she was not sick at time of vaccine encounter.   Administered MCV4 and Gardisil-9 vaccine in the left arm.   Approximately 1-2 minutes after vaccination, patient  was seated on the tablet in an upright position and when I turned aroung to hand her paperwork she started to faint and I got up, went to help her steady, alerted family outside, and called 911 immediately after patient was safe on exam table. She was very pale and then came to awareness awaiting EMS arrival. Upon arrival of EMS they confirmed the following vitals: temp 98.4, BP 74/41, 85 blood glucose, and initated a bag of IV fluids before escorting her to ER via ambulance. Patient stated verbally she was feeling back to normal before leaving, and also her mother and sister said she had nothing to eat today, was not drinking fluids throughout the day. They also stated she had one previous incident of fainting, 3-4 years ago, unrelated to vaccine.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient stating that since her appointment for Tdap and Varicella vaccines on 06/15/2020 at 9:30 am she has had left should / joint pain from the Tdap. She reports feeling the needle go into the joint at the time of administration and reports it ?felt like the worst shot ever.? She states the pain has progressively gotten worst each day since. States that today she cannot lift her elbow above her shoulder, and that at times moving her wrist also causes pain in the shoulder joint. She denies any redness, swelling at the site. She reports that she is using a sling for the left arm, applying an ice pack, and taking 800 mg ibuprofen for pain. Tdap vaccine was administered IM using a 25 gauge 1? needle in the deltoid muscle 1-2? below the acromion process as required. Varicella vaccine was administered SQ in the posterior section of the upper left arm using a 25 gauge 5/8? needle.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint range of motion decreased
Clinical narrative: Patient stating that since her appointment for Tdap and Varicella vaccines on 06/15/2020 at 9:30 am she has had left should / joint pain from the Tdap. She reports feeling the needle go into the joint at the time of administration and reports it ?felt like the worst shot ever.? She states the pain has progressively gotten worst each day since. States that today she cannot lift her elbow above her shoulder, and that at times moving her wrist also causes pain in the shoulder joint. She denies any redness, swelling at the site. She reports that she is using a sling for the left arm, applying an ice pack, and taking 800 mg ibuprofen for pain. Tdap vaccine was administered IM using a 25 gauge 1? needle in the deltoid muscle 1-2? below the acromion process as required. Varicella vaccine was administered SQ in the posterior section of the upper left arm using a 25 gauge 5/8? needle.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain, Product administered at inappropriate site
Clinical narrative: Patient stating that since her appointment for Tdap and Varicella vaccines on 06/15/2020 at 9:30 am she has had left should / joint pain from the Tdap. She reports feeling the needle go into the joint at the time of administration and reports it ?felt like the worst shot ever.? She states the pain has progressively gotten worst each day since. States that today she cannot lift her elbow above her shoulder, and that at times moving her wrist also causes pain in the shoulder joint. She denies any redness, swelling at the site. She reports that she is using a sling for the left arm, applying an ice pack, and taking 800 mg ibuprofen for pain. Tdap vaccine was administered IM using a 25 gauge 1? needle in the deltoid muscle 1-2? below the acromion process as required. Varicella vaccine was administered SQ in the posterior section of the upper left arm using a 25 gauge 5/8? needle.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Eye pain, Impaired work ability
Clinical narrative: 1) Arm began hurting approximately 3 hours after the injection. Terrible pain. Took 2 extra strength  Tylenol which did nothing to help. Applied ice to injection site, which also did nothing to help pain which continued to worsen. Have had many injections in my life for the purpose of vaccination. Prior to this, the west was tetanus. This injection made tetanus feel like a tickle in comparison.Started feeling feverish at bedtime, around 9pm. Awoke at approximately 1am on 6/29 with a fever of 101.8 and terrible chills. Took more Tylenol (2 extra strength). Felt weak the entire next day (Friday, June 29th.) Loss of appetite, no energy. Stayed home from work. Gradually improved and was able to return to work on Monday July 2, 2018, but still did not have my usual energy.  Two weeks after the vaccine, on Saturday July 14, 2018 at approximately 3am, I awoke with a horrible pain in my left eye, which felt as though someone had inserted a huge needle into my eyeball and just left it there. I used warm compresses after carefully washing my hands, to no avail.I also took two extra strength Tylenol which did nothing to alleviate the pain in my eye. When my husband awakened at about 7 am, I had him look in my eye, which he said was exceedingly red. By 8:30am, I phoned my eye doctor, Dr. He saw me in his office at approximately 10:30 that morning and diagnosed a torn cornea. Although my vision is no longer 20/20, I basically only need glasses to read and have NEVER had any eye or visual difficulties. I asked Dr. if the torn cornea might possible be related to the Shingrix vaccine and his response was that he could not rule it out. He prescribed an antibiotic eye drop and Refresh Artificial tears (daytime use) and Genteal Gel for nighttime use. I recovered from the pain of the  torn cornea in a couple of weeks, but it took longer to heal completely but still use the drops and gel to this day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injury corneal, Ocular hyperaemia, Pain in extremity, Pyrexia
Clinical narrative: 1) Arm began hurting approximately 3 hours after the injection. Terrible pain. Took 2 extra strength  Tylenol which did nothing to help. Applied ice to injection site, which also did nothing to help pain which continued to worsen. Have had many injections in my life for the purpose of vaccination. Prior to this, the west was tetanus. This injection made tetanus feel like a tickle in comparison.Started feeling feverish at bedtime, around 9pm. Awoke at approximately 1am on 6/29 with a fever of 101.8 and terrible chills. Took more Tylenol (2 extra strength). Felt weak the entire next day (Friday, June 29th.) Loss of appetite, no energy. Stayed home from work. Gradually improved and was able to return to work on Monday July 2, 2018, but still did not have my usual energy.  Two weeks after the vaccine, on Saturday July 14, 2018 at approximately 3am, I awoke with a horrible pain in my left eye, which felt as though someone had inserted a huge needle into my eyeball and just left it there. I used warm compresses after carefully washing my hands, to no avail.I also took two extra strength Tylenol which did nothing to alleviate the pain in my eye. When my husband awakened at about 7 am, I had him look in my eye, which he said was exceedingly red. By 8:30am, I phoned my eye doctor, Dr. He saw me in his office at approximately 10:30 that morning and diagnosed a torn cornea. Although my vision is no longer 20/20, I basically only need glasses to read and have NEVER had any eye or visual difficulties. I asked Dr. if the torn cornea might possible be related to the Shingrix vaccine and his response was that he could not rule it out. He prescribed an antibiotic eye drop and Refresh Artificial tears (daytime use) and Genteal Gel for nighttime use. I recovered from the pain of the  torn cornea in a couple of weeks, but it took longer to heal completely but still use the drops and gel to this day.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MENB, MNQ
Symptoms: Dizziness, Pallor, Syncope, Vision blurred
Clinical narrative: Syncope, 88/52, O2-99%, pale - happened less then one minute after vaccines. Given crackers, sprite O2 @ 1L per nasal canula, Patient layed down, wash cloth placed on forehead. Dr requested call 911. Patient C/O dizziness, blurred vision. Within 5 minutes BP 122/68, P-70, & O2 99%. EMS arrived - Patient in their care.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: & Swelling, itchingin, pain to injection site
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Rash
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Arthralgia, Chest discomfort, Condition aggravated, Discomfort
Clinical narrative: Pt got the shot on 6/11/2020, said he was fine. On 6/13/2020, he said he started experiencing joint pain and shoulder pain (Rheumatoid Arthritis). He felt pressure on back and chest, like passing out. Lasted for about 20-30 minutes. the next morning he was up and well playing golf.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Rheumatoid arthritis
Clinical narrative: Pt got the shot on 6/11/2020, said he was fine. On 6/13/2020, he said he started experiencing joint pain and shoulder pain (Rheumatoid Arthritis). He felt pressure on back and chest, like passing out. Lasted for about 20-30 minutes. the next morning he was up and well playing golf.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Myalgia
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Pain, Rash
Clinical narrative: Patient presented back to Primacy Care Clinic one week  following flu shot administration with reports of right  upper arm pain with erythema.  SkinRash & Pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Pt. came in for vaccines during 17 yr pe in 2019, was never charted or in notes. Third Bexsero was given after further investigation 2nd Bexsero was given during the 17 yr pe.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Hallucination, auditory, Hallucination, visual, Injection site pain, Insomnia
Clinical narrative: After receiving her vaccinations around 9:45am, Patient had been uncomfortable all afternoon, complaining about her left leg being sore and hurting. She was whining often and asking to be carried around. At dinner that evening she didn't want to eat so at 7pm I gave her 7.5mL of Children's Motrin (100mg/5mL) and put her to bed. She didn't go to sleep until after 8:30pm to the best of my knowledge. At 12:45am she came and got in my bed and was wide awake. Around 2am I went and laid down in her bed with her, but I don't think she had gone back to sleep when I returned to my bed at 3am. At 3:50am she started yelling for me, and when I went to her room she told me she was seeing things moving in her room. For example, the fur on her stuffed animals was moving, her ceramic unicorns on her dresser were nodding their heads up and down, and the light fixture on the ceiling was shaking and she was afraid it was going to fall. I quickly realized she was hallucinating and took her to my room and woke up my husband. Around 4:30am I called our doctor to tell her what was happening. I had taken Patient's temperature before calling the doctor and her temperature was only 99.5. She had no rash, no swelling, and so I was encouraged to take her to the emergency room because the doctor was concerned she had ingested something that was causing this episode. However, because her vitals all seemed normal, I was 99.9% confident that she hadn't ingested anything that would cause her to hallucinate (no vomiting, no diarrhea, and no narcotics or prescription drugs in our home), I chose not to take her to the emergency room. A little after 5:15am she finally fell asleep and slept until around 8am when she woke up and asked to go see if the things in her room were still moving. She could recall all of what had happened that evening, but she has not had any episodes like this since then.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Body temperature increased, Decreased appetite, Discomfort, Hallucination, visual, Injection site movement impairment
Clinical narrative: After receiving her vaccinations around 9:45am, Patient had been uncomfortable all afternoon, complaining about her left leg being sore and hurting. She was whining often and asking to be carried around. At dinner that evening she didn't want to eat so at 7pm I gave her 7.5mL of Children's Motrin (100mg/5mL) and put her to bed. She didn't go to sleep until after 8:30pm to the best of my knowledge. At 12:45am she came and got in my bed and was wide awake. Around 2am I went and laid down in her bed with her, but I don't think she had gone back to sleep when I returned to my bed at 3am. At 3:50am she started yelling for me, and when I went to her room she told me she was seeing things moving in her room. For example, the fur on her stuffed animals was moving, her ceramic unicorns on her dresser were nodding their heads up and down, and the light fixture on the ceiling was shaking and she was afraid it was going to fall. I quickly realized she was hallucinating and took her to my room and woke up my husband. Around 4:30am I called our doctor to tell her what was happening. I had taken Patient's temperature before calling the doctor and her temperature was only 99.5. She had no rash, no swelling, and so I was encouraged to take her to the emergency room because the doctor was concerned she had ingested something that was causing this episode. However, because her vitals all seemed normal, I was 99.9% confident that she hadn't ingested anything that would cause her to hallucinate (no vomiting, no diarrhea, and no narcotics or prescription drugs in our home), I chose not to take her to the emergency room. A little after 5:15am she finally fell asleep and slept until around 8am when she woke up and asked to go see if the things in her room were still moving. She could recall all of what had happened that evening, but she has not had any episodes like this since then.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Insomnia
Clinical narrative: After receiving her vaccinations around 9:45am, Patient had been uncomfortable all afternoon, complaining about her left leg being sore and hurting. She was whining often and asking to be carried around. At dinner that evening she didn't want to eat so at 7pm I gave her 7.5mL of Children's Motrin (100mg/5mL) and put her to bed. She didn't go to sleep until after 8:30pm to the best of my knowledge. At 12:45am she came and got in my bed and was wide awake. Around 2am I went and laid down in her bed with her, but I don't think she had gone back to sleep when I returned to my bed at 3am. At 3:50am she started yelling for me, and when I went to her room she told me she was seeing things moving in her room. For example, the fur on her stuffed animals was moving, her ceramic unicorns on her dresser were nodding their heads up and down, and the light fixture on the ceiling was shaking and she was afraid it was going to fall. I quickly realized she was hallucinating and took her to my room and woke up my husband. Around 4:30am I called our doctor to tell her what was happening. I had taken Patient's temperature before calling the doctor and her temperature was only 99.5. She had no rash, no swelling, and so I was encouraged to take her to the emergency room because the doctor was concerned she had ingested something that was causing this episode. However, because her vitals all seemed normal, I was 99.9% confident that she hadn't ingested anything that would cause her to hallucinate (no vomiting, no diarrhea, and no narcotics or prescription drugs in our home), I chose not to take her to the emergency room. A little after 5:15am she finally fell asleep and slept until around 8am when she woke up and asked to go see if the things in her room were still moving. She could recall all of what had happened that evening, but she has not had any episodes like this since then.
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: A 74-year-old male received GARDASIL 9 immunization series in 2019; A 74-year-old male received GARDASIL 9 immunization series in 2019; This spontaneous report was received from a pharmacist via vaccine employee and refers to a 74-year-old male patient. The patient's historical condition included throat cancer. The patient's historical drugs, previous drug reactions, allergies, concurrent conditions and concomitant therapies were not reported.   On an unspecified date in 2019, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on an unspecified date in October 2019, with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)      (formulations, strengths, doses, frequencies, routes of administration, anatomical locations, indications, lot numbers, and expiration dates were not reported for the three doses).  The patient had a prescription from an unidentified specialist for patient to receive vaccine as patient had a history of throat cancer (product prescribing issue; product administered to patient of inappropriate age).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Malaise
Clinical narrative: pt was not well; her first dose of Shingrix on 15Aug2018 and her second dose on 16Mar2020; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th August 2018).   On 16th March 2020, the patient received the 2nd dose of Shingrix. On 16th March 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her second dose late which led to lengthening of vaccination schedule.   Follow up report received from physician on 17th June 2020: The patient demographic details were updated. On 15th August 2018, the patient received 1st dose of Shingrix. On an unknown date, the patient experienced malaise after 1st dose of Shingrix. The patient was not feeling well when she was at nursing home. The patient received 2nd dose of Shingrix (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.  The patient received 2nd dose outside the recommended 2 to 6 month window. The patient was not given 3rd dose. No follow up received from nursing home. It was unknown if the reporter considered the malaise to be related to Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Inappropriate schedule of product administration
Clinical narrative: dose 1 in August 2019, and dose 2 June 11, 2020; side effect listed for two weeks after the injection; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On 11th June 2020, the patient received the 2nd dose of Shingrix. On 11th June 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, On August 2019, received 1st dose of Shingrix and 2nd dose on 11th June 2020 and experienced every side effects listed for 2 weeks after the injection. Less than 2 years after vaccination with 1st dose of Shingrix, the patient experienced side effects, listed for 2 weeks after vaccination.  The patient received 2nd dose late than the recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Lymph node pain, Lymphadenitis, Odynophagia, Tonsillar exudate
Clinical narrative: I was scheduled to receive a TB test on Tuesday, 06/23/2020. I went to my appointment as scheduled and received a subcutaneous injection that I believed to be the TB skin test. I was scheduled to return Thursday to have my test read. Upon returning Thursday, I was informed that I had been given the wrong injection. I inquired about what I was given and was told that I received a tDap vaccine. When told this, I thought it would be okay because I also need a tDap vaccination. However, I was informed that I received the wrong dose of that vaccine as well, receiving .1 (unsure of units) instead of .5 (unsure of units) plus it was the wrong route of administration so it would not be valid. While at the doctor?s office, I scheduled an appointment for the next day to get the correct shots, TB skin test and tDap, but cancelled the next morning because I did not feel comfortable going due to the incident that occurred. I had no physical symptoms after receiving the shot on Tuesday 6/23/2020 until Sunday 6/28/2020. I woke up with inflamed and tender lymph nodes in my neck, pain with swallowing and whitish/grey exudates on my tonsils. Today is Tuesday 6/30/2020 and I have experienced these symptoms continuously since Sunday 6/28/2020.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Underdose, Wrong product administered
Clinical narrative: I was scheduled to receive a TB test on Tuesday, 06/23/2020. I went to my appointment as scheduled and received a subcutaneous injection that I believed to be the TB skin test. I was scheduled to return Thursday to have my test read. Upon returning Thursday, I was informed that I had been given the wrong injection. I inquired about what I was given and was told that I received a tDap vaccine. When told this, I thought it would be okay because I also need a tDap vaccination. However, I was informed that I received the wrong dose of that vaccine as well, receiving .1 (unsure of units) instead of .5 (unsure of units) plus it was the wrong route of administration so it would not be valid. While at the doctor?s office, I scheduled an appointment for the next day to get the correct shots, TB skin test and tDap, but cancelled the next morning because I did not feel comfortable going due to the incident that occurred. I had no physical symptoms after receiving the shot on Tuesday 6/23/2020 until Sunday 6/28/2020. I woke up with inflamed and tender lymph nodes in my neck, pain with swallowing and whitish/grey exudates on my tonsils. Today is Tuesday 6/30/2020 and I have experienced these symptoms continuously since Sunday 6/28/2020.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Decreased appetite, Irritability, Rash morbilliform
Clinical narrative: Patient developed morbilliform rash starting on torso on 27Jun2020, with spread to extremities and face and associated decreased appetite and fussiness but tolerating liquids and breastfeeding well with normal hydration status. Has been gradually but slowly improving since onset of the rash
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Flushing, Headache, Injection site induration, Injection site warmth
Clinical narrative: Patient was experiencing throat swelling, facial flushing, headache, chest tightness, and nausea. Patient states that the injection site is still hard and warm to the touch.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pharyngeal swelling
Clinical narrative: Patient was experiencing throat swelling, facial flushing, headache, chest tightness, and nausea. Patient states that the injection site is still hard and warm to the touch.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving injection patient walked about 40 feet to register and indicated she felt dizzy.  We gave her a chair to sit in and then she completely passed out.  We laid her down on the floor and called 911.  She came to right after we laid her down.  She said this has happened in the past but had been at least 5 years.  She indicated it was nothing to worry about as she was fine.  The Ambulance service arrived and they checked her blood pressure, pulse and blood sugar which were all okay.  She said when she was younger they thought she was having seizures but they determined it to be vasovagal syncope.  She did not tell us this until after we gave her the injection and she had passed out and came to.  She refused transfer to the emergency room as she said she was fine.  She sat in a chair for 5 minutes or so and then she walked to her car and her mother, who was with her, drove her home.
Age: 1.5
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ADMINISTERED ROTOVIRUS ORALLY AFTER 1 YEAR OF AGE. PATIENT NOTIFIED. NO ADVERSE EFFECTS.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No other adverse effects were reported in the patient; Nurse reports that a patient was inadvertently given a dose of MMR II via the intramuscular route; This spontaneous report was received from a registered nurse, referring to an unknown age and gender patient. The patient's pertinent medical history and drug reactions/ allergies were not provided. Concomitant therapy included sterile diluent (dose: 0.5 milliliter)  On 19-JUN-2020, the patient was inadvertently given a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# was reported as S012530; strength, dose and expiration date were unknown) via the intramuscular route for prophylaxis (inappropriate route of vaccination). No other adverse effects were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; A patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were not provided. The patient's concomitant therapy included sterile diluent.     On 25-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: digital data logger) (PROQUAD) (lot # S012533, expiration date reported as 20-OCT-2020) (dose, frequency and anatomical location were not provided) via subcutaneous route for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (lot# N035974 and expiration date reported as 25-AUG-2020) that was stored properly. The patient had not experienced any symptoms (no adverse event). The administered dose of the vaccine experienced temperature excursion of 10 degree Fahrenheit for 1 hour and 30 minutes as recorded by a data logger. The vaccine had no previous temperature excursion. Product quality complaint (PQC) was not associated with this report.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Rash pruritic, Scab
Clinical narrative: chicken pox lesions; appear as if they are a white head / blistered appearance; little painful; little itchy; sloughing off in many skin sheets; leaving red skin; lesions were on only one side of my face and most near my mouth and a few on my cheeks/appearing on the other side of my face.; skin scab; This case was reported by a consumer and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chickenpox, blister, pain, itchy rash, exfoliation, erythema, skin lesion and scab. On an unknown date, the outcome of the chickenpox, blister, pain, itchy rash, exfoliation, erythema, skin lesion and scab were not recovered/not resolved.   The reporter considered the chickenpox, blister, pain, itchy rash, exfoliation, erythema and skin lesion to be related to Shingrix. It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and first noticed a side effect that are chicken pox lesions appearing however, the patient belief was that it was a number of months since the onset of these lesions and did take a photo of a lesion in mid March. These lesions initially appear as if they are a white head, but they did not feel like an acne type blemish, nor do they develop like one. The lesions are a little painful and a little itchy. They would arise within in a few hours and then within a day or more, the blistered appearance would scab over and then the skin would start sloughing off in many skin sheets over days, finally leaving red skin behind, the color of which seems to fade only very gradually. Initially, the lesions were on only one side of face and most near mouth and a few on cheeks, but after some months started appearing on the other side of my face. Because of the one-sided nature of how they presented, the patient thought they might be a side effect of the Shingrix vaccine, but when the reporter looked at the CDC information, that was not listed. So, the patient just kept hoping they would go away and that did not need to solve the mystery. Because of the corona virus shut down also had not sought medical care, since the lesions did not seem like any kind of emergency. However, as time has passed, the patient looked again at chicken pox and finally pulled up pictures of the pox and read a description of how the pox develops and heals and it was a description of the lesion the patient was experiencing.  So, at the time of reporting the patient feel pretty confident that my lesions are a result of the Shingrix vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin lesion, Varicella
Clinical narrative: chicken pox lesions; appear as if they are a white head / blistered appearance; little painful; little itchy; sloughing off in many skin sheets; leaving red skin; lesions were on only one side of my face and most near my mouth and a few on my cheeks/appearing on the other side of my face.; skin scab; This case was reported by a consumer and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chickenpox, blister, pain, itchy rash, exfoliation, erythema, skin lesion and scab. On an unknown date, the outcome of the chickenpox, blister, pain, itchy rash, exfoliation, erythema, skin lesion and scab were not recovered/not resolved.   The reporter considered the chickenpox, blister, pain, itchy rash, exfoliation, erythema and skin lesion to be related to Shingrix. It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and first noticed a side effect that are chicken pox lesions appearing however, the patient belief was that it was a number of months since the onset of these lesions and did take a photo of a lesion in mid March. These lesions initially appear as if they are a white head, but they did not feel like an acne type blemish, nor do they develop like one. The lesions are a little painful and a little itchy. They would arise within in a few hours and then within a day or more, the blistered appearance would scab over and then the skin would start sloughing off in many skin sheets over days, finally leaving red skin behind, the color of which seems to fade only very gradually. Initially, the lesions were on only one side of face and most near mouth and a few on cheeks, but after some months started appearing on the other side of my face. Because of the one-sided nature of how they presented, the patient thought they might be a side effect of the Shingrix vaccine, but when the reporter looked at the CDC information, that was not listed. So, the patient just kept hoping they would go away and that did not need to solve the mystery. Because of the corona virus shut down also had not sought medical care, since the lesions did not seem like any kind of emergency. However, as time has passed, the patient looked again at chicken pox and finally pulled up pictures of the pox and read a description of how the pox develops and heals and it was a description of the lesion the patient was experiencing.  So, at the time of reporting the patient feel pretty confident that my lesions are a result of the Shingrix vaccination.
Sex: M
Vaccine: MENB
Symptoms: C-reactive protein increased, Headache, Hepatic enzyme increased, Intensive care, Pyrexia
Clinical narrative: Feeling progressively worse / Hospitalized / ICU due to elevated lab (liver enzymes, CRP); Fever; Headache; Vomited; This case was reported by a nurse via sales rep and described the occurrence of condition aggravated in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date unknown) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 2 days after receiving Bexsero, the patient experienced condition aggravated (serious criteria hospitalization), fever, headache and vomiting. On an unknown date, the outcome of the condition aggravated, fever, headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the condition aggravated, fever, headache and vomiting to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned she gave Bexsero to a patient which seemed to developed fever, headache and vomiting approximately 2 days after vaccination. The patient was then feeling progressively worse and was hospitalized and subsequently transferred to The intensive care unit due to elevated lab (liver enzymes, c reactive protein). Patient was in intensive care unit for 4 days and got discharged and was fully recovered at time of reporting.
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Feeling progressively worse / Hospitalized / ICU due to elevated lab (liver enzymes, CRP); Fever; Headache; Vomited; This case was reported by a nurse via sales rep and described the occurrence of condition aggravated in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date unknown) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 2 days after receiving Bexsero, the patient experienced condition aggravated (serious criteria hospitalization), fever, headache and vomiting. On an unknown date, the outcome of the condition aggravated, fever, headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the condition aggravated, fever, headache and vomiting to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter mentioned she gave Bexsero to a patient which seemed to developed fever, headache and vomiting approximately 2 days after vaccination. The patient was then feeling progressively worse and was hospitalized and subsequently transferred to The intensive care unit due to elevated lab (liver enzymes, c reactive protein). Patient was in intensive care unit for 4 days and got discharged and was fully recovered at time of reporting.