chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself via a Pfizer sales representative. It was reported that a male patient of unknown age received PREVNAR 13 at a single dose for immunization on an 08Feb2018. Patient medical history and concomitant medications were not reported. It was mentioned that the patient experienced chills the same day of vaccine administration. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA. No adverse reaction reported.
Age: 17.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA. No adverse reaction reported to facility.
Age: 13.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Wrong drug administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient was in office on 04/24/2018 for well visit, received her 2nd hep A during this visit. Mom called on 04/26/2018 to report a rash that appear that morning was informed by provider to give child BENADRYL 2.5 ml every 8 hours for rash and if not better to bring into office on 04/27/2018. Mom present in office this morning with child still having red rash that had not improved but spread even more. Provider is currently treating with hydroxyzine.
Age: 19.0
Sex: M
Vaccine: UNK
Symptoms: Chest discomfort, Dyspnoea, Rash
Clinical narrative: Tightness in chest, shortness of breath, rash on arms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: According to the patient on 4/26/18, he has called on 4/25/18 reported to RPH about the pain, redness, swollen and warm to touch around the injection site, which was most intense on the first day. He was advised by RPH to circle the redness site and see MD when it got bigger. Patient said the redness got bigger on 4/25/18 night and so he went to see MD on 4/26/18. Patient said MD didn't suspect of any infection but on the safe side he gave cephalexin 500 mg as a prophylaxis, which was filled and dispensed to patient on 4/26/18.
Age: 13.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA.  No adverse reaction reported.
Age: 11.0
Sex: F
Vaccine: DTAPIPV, HPV9, MNQ
Symptoms: Wrong drug administered
Clinical narrative: The patient was given a KINRIX (DTaP+IPV), but should have been administered a TDAP.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site pain, Pain
Clinical narrative: Very sore at injection site and red for 4 days. Chills and entire body aches for 2 days. Could not get warm.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Burning sensation, Chills, Condition aggravated, Diarrhoea
Clinical narrative: I received the Td vaccine on Friday, December 22, 2017, at approximately 5:30pm. Overnight, at aproximately 2:30 am, I awoke feeling very unwell with nausea, itching, body twitches and lightheaded while lying flat. I fell back asleep and woke up at approximately 8:30am, on December 23, 2017, with extreme fatigue, chills, itching, nausea, dry heaves, diarrhea, dizziness, strange sensation the left side of my face, reactivation of my otherwise quiet trigeminal neuralgia and neck sapsm. My heart rate was also in the 120s just lying still. I spent the day in bed taking Benadryl, Ibuprofen and lots of fluids. By Sunday, 12/24/17, I went to the ER and was later discharged.  Christmas Day, 12/25/17, I continued to experience all of the above with less diarrhea, and the addition of generalized lymph node and joint pain. Tuesday, 12/26/17, I was too ill to walk and called the Physician who prescribes my IVIG and my Husband wheeled me into his Office. I stayed at the Clinic for a few hours receiving I liter of N/S, Decadron 10 mg IV and Zofran 16mg IV. I left feeling much less nausea but with all the other concerns.  Later, the evening of 12/26/17,  my legs began to feel very wrong. They were weak and burning with tingling in feet working its way to the knees. I went to the ER and was hospitalized for a few days for what the Hospitalist told my Husband and I was an acute vaccine reaction and serum sickness.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Electrocardiogram abnormal, Fatigue, Gait inability, Lymph node pain
Clinical narrative: I received the Td vaccine on Friday, December 22, 2017, at approximately 5:30pm. Overnight, at aproximately 2:30 am, I awoke feeling very unwell with nausea, itching, body twitches and lightheaded while lying flat. I fell back asleep and woke up at approximately 8:30am, on December 23, 2017, with extreme fatigue, chills, itching, nausea, dry heaves, diarrhea, dizziness, strange sensation the left side of my face, reactivation of my otherwise quiet trigeminal neuralgia and neck sapsm. My heart rate was also in the 120s just lying still. I spent the day in bed taking Benadryl, Ibuprofen and lots of fluids. By Sunday, 12/24/17, I went to the ER and was later discharged.  Christmas Day, 12/25/17, I continued to experience all of the above with less diarrhea, and the addition of generalized lymph node and joint pain. Tuesday, 12/26/17, I was too ill to walk and called the Physician who prescribes my IVIG and my Husband wheeled me into his Office. I stayed at the Clinic for a few hours receiving I liter of N/S, Decadron 10 mg IV and Zofran 16mg IV. I left feeling much less nausea but with all the other concerns.  Later, the evening of 12/26/17,  my legs began to feel very wrong. They were weak and burning with tingling in feet working its way to the knees. I went to the ER and was hospitalized for a few days for what the Hospitalist told my Husband and I was an acute vaccine reaction and serum sickness.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Muscle spasms, Muscle twitching, Muscular weakness, Nausea
Clinical narrative: I received the Td vaccine on Friday, December 22, 2017, at approximately 5:30pm. Overnight, at aproximately 2:30 am, I awoke feeling very unwell with nausea, itching, body twitches and lightheaded while lying flat. I fell back asleep and woke up at approximately 8:30am, on December 23, 2017, with extreme fatigue, chills, itching, nausea, dry heaves, diarrhea, dizziness, strange sensation the left side of my face, reactivation of my otherwise quiet trigeminal neuralgia and neck sapsm. My heart rate was also in the 120s just lying still. I spent the day in bed taking Benadryl, Ibuprofen and lots of fluids. By Sunday, 12/24/17, I went to the ER and was later discharged.  Christmas Day, 12/25/17, I continued to experience all of the above with less diarrhea, and the addition of generalized lymph node and joint pain. Tuesday, 12/26/17, I was too ill to walk and called the Physician who prescribes my IVIG and my Husband wheeled me into his Office. I stayed at the Clinic for a few hours receiving I liter of N/S, Decadron 10 mg IV and Zofran 16mg IV. I left feeling much less nausea but with all the other concerns.  Later, the evening of 12/26/17,  my legs began to feel very wrong. They were weak and burning with tingling in feet working its way to the knees. I went to the ER and was hospitalized for a few days for what the Hospitalist told my Husband and I was an acute vaccine reaction and serum sickness.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia, Pruritus, Red blood cell sedimentation rate increased, Retching, Sensory disturbance
Clinical narrative: I received the Td vaccine on Friday, December 22, 2017, at approximately 5:30pm. Overnight, at aproximately 2:30 am, I awoke feeling very unwell with nausea, itching, body twitches and lightheaded while lying flat. I fell back asleep and woke up at approximately 8:30am, on December 23, 2017, with extreme fatigue, chills, itching, nausea, dry heaves, diarrhea, dizziness, strange sensation the left side of my face, reactivation of my otherwise quiet trigeminal neuralgia and neck sapsm. My heart rate was also in the 120s just lying still. I spent the day in bed taking Benadryl, Ibuprofen and lots of fluids. By Sunday, 12/24/17, I went to the ER and was later discharged.  Christmas Day, 12/25/17, I continued to experience all of the above with less diarrhea, and the addition of generalized lymph node and joint pain. Tuesday, 12/26/17, I was too ill to walk and called the Physician who prescribes my IVIG and my Husband wheeled me into his Office. I stayed at the Clinic for a few hours receiving I liter of N/S, Decadron 10 mg IV and Zofran 16mg IV. I left feeling much less nausea but with all the other concerns.  Later, the evening of 12/26/17,  my legs began to feel very wrong. They were weak and burning with tingling in feet working its way to the knees. I went to the ER and was hospitalized for a few days for what the Hospitalist told my Husband and I was an acute vaccine reaction and serum sickness.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Serum sickness, Tachycardia, Trigeminal neuralgia, Vaccination complication, White blood cell count
Clinical narrative: I received the Td vaccine on Friday, December 22, 2017, at approximately 5:30pm. Overnight, at aproximately 2:30 am, I awoke feeling very unwell with nausea, itching, body twitches and lightheaded while lying flat. I fell back asleep and woke up at approximately 8:30am, on December 23, 2017, with extreme fatigue, chills, itching, nausea, dry heaves, diarrhea, dizziness, strange sensation the left side of my face, reactivation of my otherwise quiet trigeminal neuralgia and neck sapsm. My heart rate was also in the 120s just lying still. I spent the day in bed taking Benadryl, Ibuprofen and lots of fluids. By Sunday, 12/24/17, I went to the ER and was later discharged.  Christmas Day, 12/25/17, I continued to experience all of the above with less diarrhea, and the addition of generalized lymph node and joint pain. Tuesday, 12/26/17, I was too ill to walk and called the Physician who prescribes my IVIG and my Husband wheeled me into his Office. I stayed at the Clinic for a few hours receiving I liter of N/S, Decadron 10 mg IV and Zofran 16mg IV. I left feeling much less nausea but with all the other concerns.  Later, the evening of 12/26/17,  my legs began to feel very wrong. They were weak and burning with tingling in feet working its way to the knees. I went to the ER and was hospitalized for a few days for what the Hospitalist told my Husband and I was an acute vaccine reaction and serum sickness.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Right upper arm pain at site of injection. It is throbbing and constant. Moderately limits activities. Hard to lift arm due to pain. Ice arm.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Asthenia, Chest X-ray, Differential white blood cell count, Dizziness
Clinical narrative: At around 10pm patient began having heart palpitations, dizziness, weakness, and headache. Patient also felt nauseated. She was brought to the ER for evaluation. ER felt symptoms were related to anxiety. Labs were completed, chest x-ray and EKG.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Headache, Metabolic function test
Clinical narrative: At around 10pm patient began having heart palpitations, dizziness, weakness, and headache. Patient also felt nauseated. She was brought to the ER for evaluation. ER felt symptoms were related to anxiety. Labs were completed, chest x-ray and EKG.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Palpitations, Pregnancy test urine, Urine analysis
Clinical narrative: At around 10pm patient began having heart palpitations, dizziness, weakness, and headache. Patient also felt nauseated. She was brought to the ER for evaluation. ER felt symptoms were related to anxiety. Labs were completed, chest x-ray and EKG.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient's throat was swollen, had difficulty breathing, was dizzy, said his mind felt "foggy". Said he should've gone to ER but was too stubborn. 99.2 degree fever.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever after immunizations.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Client contacted health dept. on 4/27/18 to report reaction to vaccine. Client stating she experienced severe shaking, chills, and trembling several hours after receiving vaccine. Advised client to see PCP if symptoms persist. Should hives or airway closure occur see emergency dept.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX and developed erythema going down her arm from the injection site approximately the size of a softball. The reported batch number of SHINGRIX B5EKZ did not exist and was updated to B5EK2 as per sales data sheet.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Local reaction, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site induration. On an unknown date, the outcome of the fever and injection site induration were unknown. It was unknown if the reporter considered the fever and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. After receiving SHINGRIX, the health care professional reported that she experienced greater than expected local and systemic reaction (induration about 80 into 100 mm, fever over 100.5 degree F and lesser side effects). No vaccine lot number or expiry date and no date of birth provided.
Sex: M
Vaccine: FLU4
Symptoms: Cerebral ataxia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebral ataxia in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced cerebral ataxia. On an unknown date, the outcome of the cerebral ataxia was unknown. It was unknown if the reporter considered the cerebral ataxia to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The healthcare professional reported that, the patient experienced cerebral ataxia after receiving an unknown brand flu vaccine. The HCP declined to provided patient's date of birth. No additional information would be obtained.
Age: 11.0
Sex: M
Vaccine: HPV4, MENHIB, TDAP
Symptoms: Gait disturbance, Injection site abscess, Injection site pain
Clinical narrative: On 4/20/18, pt went to school nurse complaining of pain in right leg. There was a large area of redness. Mom picked him up and he complained of difficulty walking. Used ice pack and pain improved. On exam, approximately 22 cm oval area of erythema, feathery border, W/O induration. BENADRYL given for 1-2d and did well.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: On 4-18-18 child was given 2 vaccines: PENTACEL and Hep A-left thigh. On 4-19-18 child developed hives, axilla and legs.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Was given the vaccine subcutaneous in underside of left upper arm - supposed to be given IM in deltoid - vesicle formation, severe pain, warmth, swelling and erythema from axilla to elbow - Pain scale- immobile- 6/10 with mobility 10/10.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Was given the vaccine subcutaneous in underside of left upper arm - supposed to be given IM in deltoid - vesicle formation, severe pain, warmth, swelling and erythema from axilla to elbow - Pain scale- immobile- 6/10 with mobility 10/10.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Pt developed fever of 101.2 F PO and mild headache approximately 12 hours post-administration. Complaint reported by pt's mother via telephone. Fever decreased to 99.8 F PO at 8:30 am the following day. No treatment recommended aside from watch and wait.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: The pt's mother reported that the pt had experienced a bad headache, fever and site swelling approximately 4 hours after administration. The pt took Ibuprofen 600 mg at 1500 and then 400 mg q6h after that. The pt's mother gave the pt Compazine 10 mg PO at 1700. The pt's mother reported that the pt's symptoms resolved on 4/26/18.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling cold, Feeling hot, Injection site haemorrhage, Injection site pain
Clinical narrative: At about 12:30 p.m. I received the 1st SHINGRIX shot in the series. The shot hurt like the dickens, and I bled quite a bit (I believe it is because my shirt sleeve was so tight, but it's better to be safe than sorry when providing the details). I went on with my day and about 10 p.m. is when the symptoms began. It started with the feeling I could not get warm and immediately turned into when I laid down to go to sleep my hands and feet were freezing, but my body was on fire. I did not sleep at all that night. The symptoms began getting progressively worse by the minute. At the height of the reaction, I felt like I was on fire, yet freezing and every nerve ending, and I mean every single nerve ending hurt. I began by taking a single 500 mg acetaminophen to attempt to curb the fever and the pain. There was also a feeling of nausea, but I never became physically ill. I grabbed a heating pad to try to rid myself of the back pain, and while it did provide relief, I believe it wasn't until I was finally able to sleep from about 2 p.m. - 4 p.m. that I noticed the symptoms beginning to diminish. I took ibuprofen at 4 p.m. (600 mg) just to try to get rid of the body aches. I went to bed at 8 p.m. that night and woke up the next morning symptom free.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Neuralgia, Pain, Peripheral coldness
Clinical narrative: At about 12:30 p.m. I received the 1st SHINGRIX shot in the series. The shot hurt like the dickens, and I bled quite a bit (I believe it is because my shirt sleeve was so tight, but it's better to be safe than sorry when providing the details). I went on with my day and about 10 p.m. is when the symptoms began. It started with the feeling I could not get warm and immediately turned into when I laid down to go to sleep my hands and feet were freezing, but my body was on fire. I did not sleep at all that night. The symptoms began getting progressively worse by the minute. At the height of the reaction, I felt like I was on fire, yet freezing and every nerve ending, and I mean every single nerve ending hurt. I began by taking a single 500 mg acetaminophen to attempt to curb the fever and the pain. There was also a feeling of nausea, but I never became physically ill. I grabbed a heating pad to try to rid myself of the back pain, and while it did provide relief, I believe it wasn't until I was finally able to sleep from about 2 p.m. - 4 p.m. that I noticed the symptoms beginning to diminish. I took ibuprofen at 4 p.m. (600 mg) just to try to get rid of the body aches. I went to bed at 8 p.m. that night and woke up the next morning symptom free.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: At about 12:30 p.m. I received the 1st SHINGRIX shot in the series. The shot hurt like the dickens, and I bled quite a bit (I believe it is because my shirt sleeve was so tight, but it's better to be safe than sorry when providing the details). I went on with my day and about 10 p.m. is when the symptoms began. It started with the feeling I could not get warm and immediately turned into when I laid down to go to sleep my hands and feet were freezing, but my body was on fire. I did not sleep at all that night. The symptoms began getting progressively worse by the minute. At the height of the reaction, I felt like I was on fire, yet freezing and every nerve ending, and I mean every single nerve ending hurt. I began by taking a single 500 mg acetaminophen to attempt to curb the fever and the pain. There was also a feeling of nausea, but I never became physically ill. I grabbed a heating pad to try to rid myself of the back pain, and while it did provide relief, I believe it wasn't until I was finally able to sleep from about 2 p.m. - 4 p.m. that I noticed the symptoms beginning to diminish. I took ibuprofen at 4 p.m. (600 mg) just to try to get rid of the body aches. I went to bed at 8 p.m. that night and woke up the next morning symptom free.
Age: 24.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 24 year old male patient. Information regarding patient's medical history, concurrent conditions, concomitant medication, drug reaction, allergies and past therapies were not reported. Concomitant therapies included DTAP. On 26-MAR-2018 the 24 year old patient was vaccinated with a PROQUAD (lot # N020615, expiry date 22-JAN-2019) (dosing regimen and frequency unknown) for prophylaxis. It was reported that the PROQUAD was reconstituted with a properly stored sterile diluent (manufacturer unknown) (Lot # M017520, Expiry date 25-SEP-2018). It was reported that the PROQUAD had no temperature excursions prior to being administered. On 26-MAR-2018 the patient was also administered with first dose of M-M-R II (lot number N020615, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the left deltoid for prophylaxis. It was also reported as the PROQUAD was administered instead of M-M-R II and VARIVAX. It was reported that the medication error occurred during the preparation for administration and during administration. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with private funds. No adverse events were reported and no prescription drug treatment was needed. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. No Product quality complaint was reported. Lot number N020615 is an invalid lot number for M-M-R II.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information on the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 11-APR-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD injection (lot # M041509, expiry date: 09-APR-2018) subcutaneously (strength and dose were not reported) for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: HIV test negative, Intensive care, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a pharmacist regarding an 18 year old male patient. The patient did not have any pertinent medical history or drug reactions or allergies. On 09-APR-2018, the patient was vaccinated with VARIVAX (lot # N028713, expiry date: 13-OCT-2019) (dose not reported) with sterile diluent (manufacturer unknown) subcutaneously for varicella prevention. His concomitant therapies included hepatitis a vaccine, inactivated (manufacturer unknown), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), influenza virus vaccine (unspecified), hepatitis b vaccine (recombinant) (manufacturer unknown), poliovirus vaccine inactivated (unspecified), meningococcal conj vaccine (unspecified), and tuberculin purified protein derivative. On 12-APR-2018, the patient broke out in varicella rash. The patient sought medical attention. The patient denied any exposure to varicella. On 15-APR-2018, the patient was treated with TYLENOL, BENADRYL and calamine lotion for the events. The patient was not hospitalized but on an unknown date in April 2018, the patient was transferred to medical intensive care unit at the detention center in order to prevent any spread of varicella to other inmates. On an unknown date in April 2018, the patient was tested for Human immunodeficiency virus (HIV) which was negative. The patient recovered from the events on 18-APR-2018. On an unknown date, the patient was discharged and returned to the general population of the detention center. Causality for the events was not reported but the patient considered that he got the event from the shot. Product quality complaint (PQC) was not filed.
Sex: M
Vaccine: PPV
Symptoms: Adverse event, Chemotherapy
Clinical narrative: This Spontaneous report has been received from a pharmacist, regarding a male patient of unknown age. The patient medical history, concurrent conditions and concomitant medications were not reported. In approximately 2008 (reported as "10 years ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (strength, route of administration, lot# and expiration date were not reported). At the reporting time, the patient was on an unknown chemotherapy treatment for an unspecified reason (adverse event) since an unspecified date the outcome of the event was unknown. The causal relationship between the event and PNEUMOVAX 23 was not reported. Upon internal review, the adverse event was determined to be medically significant due to the treatment with chemotherapy.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from Medical assistant regarding a 52-year-old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions or allergies were not reported. On 10-APR-2018, the patient was vaccinated with a dose of PROQUAD lot # N010867 (dose, units, frequency and route were not reported) for prophylaxis and sterile diluent (manufacturer unknown) (lot number and expiration unknown by reporter). On the same day, the patient was also vaccinated with a dose of VARIVAX lot # N015476 (dose, units, frequency and route were not reported for prophylaxis and sterile diluent (manufacturer unknown) (lot number and expiration unknown by reporter). No adverse effects reported. No product quality compliant (PQC) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 25-APR-2018 the patient was vaccinated with improperly stored doses of ROTATEQ lot # N006285, expiration date 07-OCT-2018, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of 47 Fahrenheit degrees (°F) to 77 (°F), during 36 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling of right arm, painful to touch, constant burning, red swell at injection site approximate size 2.5" by 1.5".
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Swelling face
Clinical narrative: Fever (subjective) and facial swelling starting the evening after immunizations, No rash, difficulty breathing, swallowing. May have been exposed to measles on April 14.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site urticaria, Urticaria, Vaccination site swelling
Clinical narrative: Within 4 hours, patient experienced redness, swelling and puffiness at the site of vaccination on the right thigh. 8 hours later, developed hives over the legs, private area and later in the day hives over trunk and neck and few areas on the back. No cough, stridor or difficulty breathing.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Warm painful and palpable are [about 4 inch] of upper right arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The provider ordered the Hepatitis A vaccine to be administered, but patient was given PREVNAR 13 inadvertently. The provider was informed in a timely manner. The patients parents were also notified of the error and no adverse reactions were noted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Shortly after vaccine was administered, patient reported light headedness. Patient stated she was fine. She felt the dizziness was not a result of the vaccine, but a result of lack of food during the day. She remained seated and was provided orange juice. Pharmacist took patient's blood pressure (135/76). Patient reports this blood pressure was elevated in comparison to her normal blood pressure. Patient remained stationary in waiting area for approximately 10 minutes. At that point, she stated she felt fine and has made a full recovery. However, pharmacist escorted patient to the immunization room for further observation to ensure recovery. Patient remained under pharmacist observation for approximately 30 additional minutes. During the full observation, patient declined any supportive care: EMS, driver to assist in getting home, cool cloths, placing head between knees. She felt as if any supportive care was unnecessary. Patient made full recovery. Pharmacist called patient to ensure she made it home safely. Again at this point, patient indicated she was no longer symptomatic.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After receiving SHINGRIX injection on 4/3/18, patient experienced slight soreness and redness that appeared around the site of injection on her left deltoid on 4/4/18. As of 4/5/18, patient came to the pharmacy and reported that a 5 inch diameter area around the site of injection was red, hot to touch, swollen and tender. Patient was advised to put ice pack on it and take OTC ibuprofen for pain and monitor for any changes.
Age: 72.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Discomfort, Feeling abnormal
Clinical narrative: Patient is a 72 year old Male with: Hx shoulder DJD and chronic cough x years comes to the ER 5 days after getting a PNEUMOVAX and SHINGRIX vaccine in clinic. He states that he woke the next morning w/a profound feeling of weakness, malaise, decreased appetite and feeling mentally cloudy. He usually sleeps only 3.5 hours per night, but has been sleeping more like 7-8 hours per night since his vaccination. He feels heavy and weak with no energy to do anything. He felt subj chilled and feverish 1-2 days following the immunization - this is less pronounced now.
Age: 72.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient is a 72 year old Male with: Hx shoulder DJD and chronic cough x years comes to the ER 5 days after getting a PNEUMOVAX and SHINGRIX vaccine in clinic. He states that he woke the next morning w/a profound feeling of weakness, malaise, decreased appetite and feeling mentally cloudy. He usually sleeps only 3.5 hours per night, but has been sleeping more like 7-8 hours per night since his vaccination. He feels heavy and weak with no energy to do anything. He felt subj chilled and feverish 1-2 days following the immunization - this is less pronounced now.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Parent brings child to ED with itchy red rash on left deltoid. Child had received childhood immunizations 24 hours prior to ED admit.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate normal
Clinical narrative: REDNESS OF FINGERTIPS ON ALL FOUR FINGERS (BEHIND FINGERNAILS) AND SEVERE SWELLING OF TWO FINGERS WITH DISCOLORATION R HAND. ALSO FEW PAINFUL VESICLES ON FINGERTIPS OR FINGER PADS. SWELLING SUBSIDED IN FIVE DAYS. THE FINGER TIPS REMAIN RED AND FINGERS APPEAR TO BE HEALING. THE SWELLING OCCURRED ABOUT 2 MOS. AFTER INJ. THE FINGER TIPS REMAIN RED. VESICLES APPEAR TO SUBSIDE. I'M WONDERING IF ANYONE EVER REPORTED SUCH FINDINGS.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Urine analysis normal
Clinical narrative: REDNESS OF FINGERTIPS ON ALL FOUR FINGERS (BEHIND FINGERNAILS) AND SEVERE SWELLING OF TWO FINGERS WITH DISCOLORATION R HAND. ALSO FEW PAINFUL VESICLES ON FINGERTIPS OR FINGER PADS. SWELLING SUBSIDED IN FIVE DAYS. THE FINGER TIPS REMAIN RED AND FINGERS APPEAR TO BE HEALING. THE SWELLING OCCURRED ABOUT 2 MOS. AFTER INJ. THE FINGER TIPS REMAIN RED. VESICLES APPEAR TO SUBSIDE. I'M WONDERING IF ANYONE EVER REPORTED SUCH FINDINGS.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site pustule, Injection site swelling
Clinical narrative: Patient received vaccination on afternoon of 04/25/18. Returned 2 days later on 04/27/18 with complaints of swelling at the site of the injection. Noted to have cellulitis, with well defined pustule at injection site. Prescribed KEFLEX for treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeling abnormal, Injected limb mobility decreased
Clinical narrative: 04-25-2018: Pain, swelling, redness at injection site, muscle pain and limited mobility shoulder to elbow beginning at about 11:30 AM. 04-25-2018: MOTRIN, ice and heat modalities on left arm. 04-26-2018: Severe shakiness, and nausea, extreme tiredness, sleepiness, weakness, "spacey", loss of appetite, beginning at 4:00 AM. 04-27-2018: Appointment with MD at 1:00 PM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: 04-25-2018: Pain, swelling, redness at injection site, muscle pain and limited mobility shoulder to elbow beginning at about 11:30 AM. 04-25-2018: MOTRIN, ice and heat modalities on left arm. 04-26-2018: Severe shakiness, and nausea, extreme tiredness, sleepiness, weakness, "spacey", loss of appetite, beginning at 4:00 AM. 04-27-2018: Appointment with MD at 1:00 PM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Tremor
Clinical narrative: 04-25-2018: Pain, swelling, redness at injection site, muscle pain and limited mobility shoulder to elbow beginning at about 11:30 AM. 04-25-2018: MOTRIN, ice and heat modalities on left arm. 04-26-2018: Severe shakiness, and nausea, extreme tiredness, sleepiness, weakness, "spacey", loss of appetite, beginning at 4:00 AM. 04-27-2018: Appointment with MD at 1:00 PM.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given. Expiration date 4-24-18.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pain/red ring around site/hot to touch/hard lump.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injected limb mobility decreased, Pain, Swelling
Clinical narrative: She experienced swelling, soreness, redness, and burning sensation the night when she had a shot. She couldn't lift her left arm. Her symptoms have been getting better.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood culture, Febrile convulsion, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever started 04/25/2018. Febrile seizure 04/26/2018 around 430pm. Still with fever at present but hasn't had another fever.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urine analysis
Clinical narrative: Fever started 04/25/2018. Febrile seizure 04/26/2018 around 430pm. Still with fever at present but hasn't had another fever.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Eye disorder, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Grandmother of patient called to Vaccination Information Line to report an adverse event after receiving vaccines on 07JUN2017. Grandmother reported after her grandson received the following vaccines, Hepatitis A, DTaP/Tdap, Hib, and Polio on 07JUN2017 he had a cold, runny nose, and an "eye thing". The grandmother was not able to provide the exact date this occurred except that it was after the vaccines and it occurred in 2017. Additionally, the grandmother could not recall which eye was affected. The child was seen by a doctor and was treated with TYLENOL and eye drops. All symptoms resolved on an unknown date. The names the vaccines are not known. No additional information was provided.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Symptoms began with general fatigue and slight nausea, followed by slight headache about 3 hours later, chills at bedtime with fever throughout the night and into the morning until about 10 am.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. On 16th April 2018, the patient came to the pharmacy with a possible case of Shingles. The pharmacist was unsure if the patient developed shingles or another form of rash and she was advised to consult a physician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eye disorder in a 68-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 16th April 2018 13:00, the patient received the 1st dose of SHINGRIX. On 16th April 2018, 15 min after receiving SHINGRIX, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was not recovered/not resolved. The reporter considered the eye disorder to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient received SHINGRIX dose and developed a black dot on the left eye about 15 minutes after the injection.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 39-year-old male patient who received ENGERIX B (batch number EB993, expiry date 13th March 2019). Co-suspect products included ENGERIX B (batch number 94S22, expiry date 4th September 2020). On 12th March 2018, the patient received the 1st dose of ENGERIX B (intramuscular) 20 ug. On 13th April 2018, the patient received the 2nd dose of ENGERIX B (intramuscular) 20 ug). On 13th April 2018, not applicable after receiving ENGERIX B and immediately after receiving ENGERIX B, the patient experienced injection site pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and injection site pain were unknown. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. The reporter considered the injection site pain to be almost certainly related to ENGERIX B. Additional details were provided as follows: The pharmacist reported that the patient experienced pain at the injection site after receiving ENGERIX-B. At 3:30, the patient received 2nd dose on right deltoid. The patient experienced much more severe pain in the middle of the injection compared to the 1st dose. The patient commented that this dose hurt much more than the 1st dose.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Spontaneous report was received from a physician, referring an identified patient, age and gender was not reported. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-APR-2018, the patient was vaccinated with an expired dose of VAQTA (lot # M027879 and expiration date 24-JAN-2018), 25U /0.5 ml, intramuscular for prophylaxis (anatomical location of vaccine was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011371.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Spontaneous report was received from a physician, referring an identified patient, age and gender was not reported. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-APR-2018, the patient was vaccinated with an expired dose of VAQTA (lot # M027879 and expiration date 24-JAN-2018), 25U /0.5 ml, intramuscular for prophylaxis (anatomical location of vaccine was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011357.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a health professional via medical representative concerning a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal), on an unknown date for flu vaccine. On an unknown date, the patient had a bad response a couple of years ago and patient got the flu. Treatment with FLUMIST QUADRIVALENT (intranasal) was discontinued. The outcome of patient got the flu and patient had a bad response a couple of years ago was unknown. Company physician assessed patient got the flu and patient had a bad response a couple of years ago to be non-serious.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Site reaction-possible cellulitis at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Rash macular
Clinical narrative: 2x3 cm mild erythema-blotchy no warmth or edema.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had a large, round, red mark at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient came in complaining of all over severe joint pain. The pain was to a point where she as she had trouble sitting still.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Visit to ER--EPIPEN given for future use.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Generalised erythema, Pruritus
Clinical narrative: Whole body red, itchy. Treated with Prednisone and steroid cream (patient does not remember name). Rash has diminished and is being treated again with Prednisone and more cream.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient described a red swelling around the injection site and pain at the injection site. Patient stated that the pain got better, but the swelling was increasing in size.