chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Maternal exposure before pregnancy
Clinical narrative: This spontaneous retrospective report was received from a female patient of an unknown age, who was reporting on herself. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #, dose, route and site of administration and expiration date were not reported) with sterile diluent (STERILE DILUENT). On an unknown date, after receiving VARIVAX, the patient had low titers. On an unknown date, the patient got pregnant. At the time of the report, she stated that she was no longer pregnant. The last menstrual period (LMP) date and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was unknown and the fetal outcome was unknown. The outcome of the event was not provided. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 30-MAY-2017 (reported as "today"), the patient was vaccinated with an expired dose of VAQTA 50 U/1.0 ml, injection (lot # M040421, expiration date: 26-MAY-2017; exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA003473:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. It was unknown if data logger was involved or if previous excursions were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of two different lot # of GARDASIL 9, lot # M031557, expiration date 07-APR-2019 and/or lot # M037770 expiration date 01-JUN-2019 (dose and route of administration were not provided) for prophylaxis. On an unspecified date, the GARDASIL 9 were exposed to temperature ranges between 32° Fahrenheit (F) to 35°F during a time frame of 4 hours. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA004563.
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported.   On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route, lot#, expiration date were not provided) for prophylaxis. The patient's concomitant medications were not reported. On an unspecified date, the patient was ordered on Prednisone, 20mg, 2 tablets once daily for inflammation (unspecified). At the time of this report, the outcome of inflammation was unknown. The causality between ZOSTAVAX and inflammation was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of VAQTA (dose and route of administration were not reported) lot # reported as M037019, expiration date: 04-NOV-2018. No adverse effects were reported. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 4 hours. Digital Data Logger was not involved. The vaccines underwent a previous temperature excursion for 45 minutes in the temperature between 47 and 77 degrees Fahrenheit. This is one of several reports received from the same reporter. Lot number M037019 is an invalid lot number for VAQTA. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1706USA000901:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M047519 with expiration date on 04-AUG-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 47 Fahrenheit (F) to 77 F during 240 hours, it was also confirmed that the vaccines did not have previous temperature excursions or a digital data logger involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA007410; US-009507513-1706USA007411:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Brain scan abnormal, Multiple sclerosis
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative and refers to her daughter, a currently 30 year old female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. In approximately 2008 (reported as 8-9 years ago), the patient was vaccinated with a dose of GARDASIL, for prophylaxis (dose, route, lot number and expiration date were not provided). On an unknown date (reported as a couple of months after administration of GARDASIL, it was reported that the patient developed "symptoms of Multiple Sclerosis". Subsequently on an unspecified date, the patient had a brain scan that revealed lesions indicative of multiple sclerosis. As a result, the patient was diagnosed with multiple sclerosis and was prescribed with an unspecified medication. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of multiple sclerosis was unknown. The causal relationship between GARDASIL and multiple sclerosis was not provided. Upon internal review, multiple sclerosis was determined to be a medically significant event. Additional information is not expected as no contact details to contact the physician were provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). There was no information about diluent provided. After receiving the dose on 10-MAY-2017, the patient learned at a later unspecified date, that she was pregnant. The last menstrual period (LMP) was estimated to be on an unknown date in 2017, estimated date of conception was in 2017. The estimated date of delivery (EDD) was not known and could not be calculated. At the time of this report, the pregnancy outcome was pending. The foetal outcome was unknown. At this point in time, the patient stated that she was uncertain if she was going to continue with the pregnancy or terminate the pregnancy. Additional information is not expected as the reporter's contact details were not provided and there was no consent to contact the patient's physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, starting on or after 02-FEB-2017, the patients were vaccinated with doses of improperly stored VAQTA lot # M033611 with expiration date on 02-MAR-2018 (dose of administration were not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 2 hours. Digital data logger was used to record the excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA014611:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reaction or allergies were not reported. On 08-JUN-2017 the patient was vaccinated with M-M-R II, albumin status unknown; and with VARIVAX (dose, frequeny, administration route, lot number, expiration date and indication were not reported for both vaccines). A sterile diluent (manufacturer unknown) (lot number and expiration date were not reported) was used in the vaccination. It was reported that on 08-JUN-2017, the patient was diagnosed with cellulitis after receive M-M-R II and VARIVAX. The pharmacist also reported two additional patients, who experienced the same reaction after vaccination (the patients' experience was captured in MARRS number 1706USA005020). The pharmacist also stated that on 08-JUN-2017, the patient went to the emergency room of an unspecified hospital. The patient's outcome was reported as not recovered. The causality assessment between M-M-R II; VARIVAX, the sterile diluent (manufacturer unknown) and the cellulitis event was unknown at the time of reporting. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested. Sender's Comments: US-009507513-1706USA005020.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.     On an unspecified date in 2017, the patient was vaccinated with an expired dose of VAQTA 50/1 U/ml, intramuscularly, expiration date:26-MAY-2017, as prophylaxis (Dose and lot # were not reported). No adverse effects were reported. Additional information is not expected as contact details were not provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report concerning a patient of unknown age and gender, was received from the patient's mother. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9, intramuscularly for prophylaxis (lot # and expiration date were unknown), which was not indicated in the prescribing information (extra dose administered). No adverse events were reported. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M046373 with expiration date on 04-NOV-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 47 Fahrenheit (F) to 77 F during 240 hours, it was also confirmed that the vaccines did not have previous temperature excursions or a digital data logger involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005516: US-009507513-1706USA007411:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005605 with expiration date on 08-APR-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 47 Fahrenheit (F) to 77 F during 240 hours, it was also confirmed that the vaccines did not have previous temperature excursions or a digital data logger involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005516: US-009507513-1706USA007410:
Age: 0.17
Sex: F
Vaccine: HIBV, IPV, RV5
Symptoms: Erythema, Urticaria
Clinical narrative: Redness and hives developed on left cheek within a few minutes of administering vaccines and resolved within 15 minutes with only slight redness on left cheek.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immunodeficiency, Injection site reaction, Rash generalised, Rash pustular, Rash vesicular
Clinical narrative: Pt developed inj. site varicella-like lesions approximately 5 days after and over following week progressed to generalized vesicular-papular rash which covered/spread over a week to (L) UE and (R) LE - >100 lesions.
Sex: F
Vaccine: RAB
Symptoms: Upper respiratory tract infection
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of upper respiratory tract infection in a female patient who received RABAVERT. On 15th May 2017, the patient received the 2nd dose of RABAVERT (intramuscular) 1 ml. On 26th May 2017, 11 days after receiving RABAVERT, the patient experienced upper respiratory tract infection. The patient was treated with methylprednisolone, methylprednisolone, MEDROL DOSEPAK. RABAVERT was continued with no change. On 31st May 2017, the outcome of the upper respiratory tract infection was recovered/resolved. The reporter considered the upper respiratory tract infection to be unrelated to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The date of birth of patient was unknown. The case was a pre-exposure vaccination case of RABAVERT. The upper respiratory infection resolved without sequelae after treating with a course of MEDROL DOSEPAK. The case was reported by veterinary assistant.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 22-year-old male patient who received BEXSERO (batch number 156801A, expiry date August 2017). On 6th March 2017, the patient received the 1st dose of BEXSERO. In March 2017, 1 day after receiving BEXSERO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. The reporter considered the injection site swelling and injection site pain to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received on left deltoid and 1 to 2 days after experienced swelling and pain in left deltoid. The patient required emergency room visit. The symptoms eventually subsided but health care professional was not sure of the exact date.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash, Streptococcus test positive
Clinical narrative: Patient broke out with what seem to be insect bites all over her legs on Saturday morning. After about 30 minutes the insect bites were all over her arms, back, stomach and legs. After allergy medicine to stop the itching, the bumps went away for approx. 4 hours and then it began all over again the next morning. This is the third continuous day of this routine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Anti-GAD antibody positive, Ataxia, Borrelia test, Cognitive disorder, Cytomegalovirus test
Clinical narrative: Oct. 17-2014. Decline of neurologic symptoms w/fatigue, ataxia, cognitive changes, neuropathy.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Neurological symptom, Neuropathy peripheral, Varicella virus test
Clinical narrative: Oct. 17-2014. Decline of neurologic symptoms w/fatigue, ataxia, cognitive changes, neuropathy.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Nausea, Syncope
Clinical narrative: Pt. faint after 3rd shot (HPV). Improved after lying down and feet elevated, cool cloth. Advised to lie down or sit for 15 minutes. While I stepped out of the room to get water and crackers. Mom reported pt was nauseated and stood to lean over trash can when pt. fainted. Mom reported pt. hit forehead on trash bin. Improved after 30 min.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Varicella post vaccine
Clinical narrative: Patient with varicella rash that developed about 3 weeks after getting varicella vaccine. Has approximately 25 lesions total on trunk, extremities, head. Recommended supportive Tx with antihistamine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Localised oedema, Pruritus
Clinical narrative: Edema, erythema 7 cm x 7 cm inferior to injection site, itching. Treated with ATARAX and hydrocortisone cream.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Mom states swelling did not happen on 6/7/17 or 6/8/17 states noted 6/9/17. Also reports tender to touch and redness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Patient called day after vaccine given (L) arm swollen, red and warm, skin was stretched. Used ice/Ibuprofen. Patient stopped at store on 6/8/17, 2 days later, arm still red, hot 6-8 inch swollen on inner arm, 2 inch red line around arm. Patient contacted family MD told her ice/Ibuprofen. Otherwise patient felt ok.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Right thigh with moderate erythema to majority of thigh, warm to touch and puncture site in middle or the erythema. Erythema is Blanchable, with some blotching noted. There is no pain, no tenderness with palpation. Follow-up in 2 days unless worsens, will be seen sooner.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Approximately 10 1/2 hours after having TRUMENBA and MENVEO patient developed hives and itchiness. Mother gave her CLARITIN tab. p.o once a day x 2 days.
Age: 20.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema
Clinical narrative: PATIENT REPORTED A RED RAISED LINE AROUND DIAMETER OF UPPER Right ARM (6 INCHES IN LENGTH), 3 INCHES BELOW WHERE VACCINE WAS ADMINISTERED. No fever reported. Patient states feeling normal. Called patient on 6/16/2017 for follow up to reaction. States that area is less swollen and less red. Continuing to do normal daily activities with no problems.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Induration, Rash, Swelling
Clinical narrative: Per mother report on 06/16/2017 ~ pt developed swelling, induration and rash to left leg after receiving Hep A.
Age: 17.0
Sex: F
Vaccine: MENB, TD
Symptoms: Bruxism, Dyskinesia, Dyspnoea, Eye movement disorder, Full blood count normal
Clinical narrative: Within seconds after administering Meningococcal B (BEXSERO) the patient appeared unconscious. Pt then started to breathe heavy, teeth clenched, stiffening up and pupils dilated with eyes rolling into back of her head. Pt then urinated, was layed down and was tight and stiff with all four extremities flailing. Pt clearly was having a seizure with no history of this.
Age: 17.0
Sex: F
Vaccine: MENB, TD
Symptoms: Loss of consciousness, Metabolic function test normal, Musculoskeletal stiffness, Mydriasis, Seizure
Clinical narrative: Within seconds after administering Meningococcal B (BEXSERO) the patient appeared unconscious. Pt then started to breathe heavy, teeth clenched, stiffening up and pupils dilated with eyes rolling into back of her head. Pt then urinated, was layed down and was tight and stiff with all four extremities flailing. Pt clearly was having a seizure with no history of this.
Age: 17.0
Sex: F
Vaccine: MENB, TD
Symptoms: Urinary incontinence
Clinical narrative: Within seconds after administering Meningococcal B (BEXSERO) the patient appeared unconscious. Pt then started to breathe heavy, teeth clenched, stiffening up and pupils dilated with eyes rolling into back of her head. Pt then urinated, was layed down and was tight and stiff with all four extremities flailing. Pt clearly was having a seizure with no history of this.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt. reported redness and itching around injection site on Left arm (started the day after injection). Pt. took BENADRYL and redness began to disap.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: The site of the vaccine is red and very hard, warm to the touch, very fussy. Given TYLENOL and children's BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Leg is red, swollen, itchy. Given TYLENOL and BENADRYL.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Rash macular
Clinical narrative: Pt. was crying and blotchy all over body. Administered 3ml children's BENADRYL. Lasting seconds, then disappearing.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling, Pruritus, Rash
Clinical narrative: Received DTaP 6/12/17. Noted red swollen (L) upper arm 6/13/17. Itching arm. No constitutional SXs. Negative F/CH/SW/N/V/D. Rash not spreading. Given antihistamines and NSAIDS, cool compresses.
Sex: F
Vaccine: RV1
Symptoms: Accidental exposure to product, Laceration, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injury in a female health care professional wit ROTARIX lyophilized formulation (batch number A41CB558A, expiry date unknown). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced injury, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the injury, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injury to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The age at vaccination was not applicable for this report. The vial cap of ROTARIX lyophilized formulation popped off which then broke and lead to cutting self (injury) and was exposed to vaccine which led to inadvertent exposure to vaccine. It was reported that, the pressure related issue occurred more than once as the altitude was 5000 feet (exploding issues). No side effects were reported. The expiry date of vaccine and the date of birth of the patient were not reported. This case was one of the 4 cases reported by the same reporter.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site discolouration, Injection site pain, Injection site vesicles, Secretion discharge, Skin operation
Clinical narrative: Pt presented for travel evaluation on June 5th and received the yellow fever and typhoid vaccine. The following day she noted a small blister in the area the yellow fever vaccine was administered and some pain.  Over the following days multiple vesicles developed and some coalesced into larger blistered. No significant erythema, warmth or fevers.  She went to the ER 5 days after the vaccine was given and in the ER the blistered were drained and the overlying skin was removed.  The following day she noted hyperpigmented lesions around the area of the denuded skin which has increased in size. Last night after running she noted that the hyperpigmented skin has started to blister. The fluid in the blistered always appeared serosangenous. She still remains afebrile, no significant erythema or purulent drainage.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Wound drainage
Clinical narrative: Pt presented for travel evaluation on June 5th and received the yellow fever and typhoid vaccine. The following day she noted a small blister in the area the yellow fever vaccine was administered and some pain.  Over the following days multiple vesicles developed and some coalesced into larger blistered. No significant erythema, warmth or fevers.  She went to the ER 5 days after the vaccine was given and in the ER the blistered were drained and the overlying skin was removed.  The following day she noted hyperpigmented lesions around the area of the denuded skin which has increased in size. Last night after running she noted that the hyperpigmented skin has started to blister. The fluid in the blistered always appeared serosangenous. She still remains afebrile, no significant erythema or purulent drainage.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Headaches.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Swollen at injection site, said her glands felt swollen.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Pain
Clinical narrative: Nausea and soreness.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Balance disorder, Bladder catheterisation, Blood test, Central nervous system lesion
Clinical narrative: I became unable to urinate and walk. I went to the ER. They did a neuro exam and determined there was serious issues. After a MRI it was discovered that I had lesions in my spine. I was diagnosed with transverse myelitis. I spent about 2 weeks in medical center receiving IV steroids and doing physical therapy to try to regain my ability to walk. I have had many flare ups, and still use catheters to urinate. I have been hospitalized many times. I have nerve pain, memory issues, balance problems.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Lumbar puncture, Memory impairment, Myelitis transverse, Neuralgia, Neurological examination abnormal
Clinical narrative: I became unable to urinate and walk. I went to the ER. They did a neuro exam and determined there was serious issues. After a MRI it was discovered that I had lesions in my spine. I was diagnosed with transverse myelitis. I spent about 2 weeks in medical center receiving IV steroids and doing physical therapy to try to regain my ability to walk. I have had many flare ups, and still use catheters to urinate. I have been hospitalized many times. I have nerve pain, memory issues, balance problems.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Urinary retention
Clinical narrative: I became unable to urinate and walk. I went to the ER. They did a neuro exam and determined there was serious issues. After a MRI it was discovered that I had lesions in my spine. I was diagnosed with transverse myelitis. I spent about 2 weeks in medical center receiving IV steroids and doing physical therapy to try to regain my ability to walk. I have had many flare ups, and still use catheters to urinate. I have been hospitalized many times. I have nerve pain, memory issues, balance problems.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: The area around the site of injection had a rash, redness and mild swelling that extended approximately 4 inches down from the injection site.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Torticollis, X-ray normal
Clinical narrative: She started tilting her head to left (torticollis) in the afternoon after the vaccine (vaccine was in the morning). It progressed where it became more consistent that she was tilting her head. No know injury. She saw physical therapy and did stretching exercises which led to resolution of the torticollis over several weeks.
Age: 47.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Pain, Rash, Swelling
Clinical narrative: Swelling, redness rash pain. The patient went to seek doctor care and was given antibiotics and steroid. patient is fine now.
Age: 0.5
Sex: F
Vaccine: FLU4, PNC13, RV5
Symptoms: C-reactive protein, Chest X-ray, Febrile convulsion, Full blood count, Immediate post-injection reaction
Clinical narrative: Vaccination on 10/21/2015 and immediate pain with fever following. 10/25/15 called with complaints of fussy, temp and drowsiness. 10/26/15 experienced atypical febrile seizure. 10/27/17 still fever, with another atypical febrile seizure, received final dx of pneumonia.
Age: 0.5
Sex: F
Vaccine: FLU4, PNC13, RV5
Symptoms: Irritability, Metabolic function test, Pain, Pneumonia, Pyrexia
Clinical narrative: Vaccination on 10/21/2015 and immediate pain with fever following. 10/25/15 called with complaints of fussy, temp and drowsiness. 10/26/15 experienced atypical febrile seizure. 10/27/17 still fever, with another atypical febrile seizure, received final dx of pneumonia.
Age: 0.5
Sex: F
Vaccine: FLU4, PNC13, RV5
Symptoms: Red blood cell sedimentation rate, Somnolence
Clinical narrative: Vaccination on 10/21/2015 and immediate pain with fever following. 10/25/15 called with complaints of fussy, temp and drowsiness. 10/26/15 experienced atypical febrile seizure. 10/27/17 still fever, with another atypical febrile seizure, received final dx of pneumonia.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Eye movement disorder, Feeling hot, Gait disturbance, Memory impairment, Moaning
Clinical narrative: The patient had a seizure; back arched, eyes rolled back in head, arms went rigid, she made moaning sounds and has no memory of the event. She was very hot and pale and could barely walk.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Muscle rigidity, Opisthotonus, Pallor, Seizure
Clinical narrative: The patient had a seizure; back arched, eyes rolled back in head, arms went rigid, she made moaning sounds and has no memory of the event. She was very hot and pale and could barely walk.
Age: 25.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient reported hives all over body, did not contact clinic.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event. Patient requested pneumonia vaccine. Stated last pneumonia was at age 61. State website had no vaccine information. Faxed family physician after vaccination. They stated that they had given PREVNAR 13 on 6/7 and had told patient to get Tdap. No adverse reaction at site of administration on 6/16/17. Patient had no ill effects.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 6/14/17 Tenderness and redness at left upper arm injection site. 6/15/17 Increased tenderness/pain, redness, swelling from site to below elbow. Treated with ibuprofen, pain medication.  6/16/17 Symptoms decreased in PM.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Syncope
Clinical narrative: About 5 minutes after patient received HPV and meningococcal B vaccines, patient fainted. After a few minutes later patient was ok and left the clinic in good condition.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: PT NAUSEA AND VOMITING TOLD PT HE MAY WANT TO TRY EMETROL OR MECLIZINE.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: Headache, nausea, abd pain x1hr. No treatment, ate breakfast.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS EXTENDING AROUND ARM FROM INJECTION SITE.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: The night of injection had headache, fever, chills, redness and swelling at injection site. Day 2- felt weak, tired and had temperature of 101.0. Day 3- no fever today but bad headache and baseball size swelling on arm. Day 4-seen in office with arm redness and warmth.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The night of injection had headache, fever, chills, redness and swelling at injection site. Day 2- felt weak, tired and had temperature of 101.0. Day 3- no fever today but bad headache and baseball size swelling on arm. Day 4-seen in office with arm redness and warmth.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Irritability, Pyrexia
Clinical narrative: HIGH FEVER. HIGHLY IRRITABLE. HEAD ACHE.
Age: 49.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Blood test, Injection site pain, Myalgia
Clinical narrative: MUSCLE PAIN AT INJECTION SITE AS WELL AS THE SIDE OF ABDOMEN AND RIGHT BUTTOCK.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site warmth, Limb discomfort, Pain in extremity
Clinical narrative: Had vaccine with discomfort to arm after-ward. By Saturday afternoon (6/10), LUE was warm to touch. KEFLEX started. By 6/11/17 eve. arm red, warm and painful. Went to ED for eval. Had allergic reaction to KEFELX as well.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Had vaccine with discomfort to arm after-ward. By Saturday afternoon (6/10), LUE was warm to touch. KEFLEX started. By 6/11/17 eve. arm red, warm and painful. Went to ED for eval. Had allergic reaction to KEFELX as well.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Joint range of motion decreased, Mass, Rash, Swelling
Clinical narrative: Redness, lump, decrease ROM, swelling, rash.
Age: 10.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness and warm to touch in right deltoid.
Age: 1.42
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Generalized seizures for a minute with fever. Pt seen in emergency room.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 31-year-old female patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). On 30th May 2017, the patient received BOOSTRIX .5 ml. On 30th May 2017, less than a day after receiving BOOSTRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. The reporter considered the shoulder pain to be almost certainly related to BOOSTRIX. Additional details were reported as follows: The pain had lasted for 7 days and had not subsided.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired GARDASIL 5/27/17 given 6/7/17. No adverse reaction.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired GARDASIL 5/27/17 given 6/7/17. No adverse reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Right inner thigh with erythematous swelling measuring 10cmx12cm, slight edema noted. Ice over area TID, Ibuprofen for pain, BENADRYL for swelling.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Inflammation
Clinical narrative: Inflammatory reaction (patient said cellulitis). Treatment MEDROL DOS PAK 4 mg.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site oedema, Injection site rash, Injection site warmth
Clinical narrative: Patient developed large rash around injection site following day. Warm to touch, mild edema. Treated for cellulitis.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on injection site. Denies fever.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood culture, C-reactive protein, Erythema, Full blood count, Metabolic function test
Clinical narrative: Shot received 6/14/17. Fevers 6/15/17 (morning). Red spot/stopped putting pressure on leg 6/15/17 (afternoon). Dr. appt 6/16/17.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Shot received 6/14/17. Fevers 6/15/17 (morning). Red spot/stopped putting pressure on leg 6/15/17 (afternoon). Dr. appt 6/16/17.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 11.5"cm x 7"cm area of erythema and increased warmth to right thigh.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Autism spectrum disorder, Injection site irritation, Irritability, Pyrexia
Clinical narrative: Fever, irritation to site, irritability.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash pruritic
Clinical narrative: Itchy bumps on face and thigh.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration
Clinical narrative: HARD TO TOUCH.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reaction to PREVNAR 13. Known reaction with redness, swelling and pain localized around injection site area for past 4-5 days and since vaccine.
Age: 44.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Rash, fever, pneumonia.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Pain over deltoid and bicep, could not raise arm over head, redness spreading inward around arm, and hot.
Age: 30.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Dyspepsia, Sensation of foreign body
Clinical narrative: Pt stopped at pharmacy at about 3 pm and told me that he started feeling like he had a heartburn-like feeling about 20 minutes after receiving the shot. That would have been around 12:35. He didn't tell me about it until about 2:45 pm. I asked if he had any difficulty breathing or feelings of swelling in his mouth, lips, throat. He denied having any such symptoms. I showed him diphenhydramine (Benadryl) OTC and instructed him to take 50 mg every 4 hours until him symptoms subsided and to seek immediate medical attn if he noticed any difficulty breathing and to please follow up with me in an hour to let me know how he was doing. The patient took the 50 mg diphenhydramine. He stopped by the pharmacy again at around 3:15 pm and said that he felt like the heartburn had stopped but he felt like he had a small lump in his throat. He was somewhat worked up and was nervous. He did not say he was having any difficulty breathing, just that he felt he had a lump in his throat. I offered to call 911 for him but he said he would rather have a friend drive him to an ER just to be safe. He left the pharmacy with myself under the assumption that he was heading to the ER.
Age: 30.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Dyspepsia, Dyspnoea, Hypokinesia
Clinical narrative: Pt stopped at pharmacy at about 3 pm and told me that he started feeling like he had a heartburn-like feeling about 20 minutes after receiving the shot. That would have been around 12:35. He didn't tell me about it until about 2:45 pm. I asked if he had any difficulty breathing or feelings of swelling in his mouth, lips, throat. He denied having any such symptoms. I showed him diphenhydramine (Benadryl) OTC and instructed him to take 50 mg every 4 hours until him symptoms subsided and to seek immediate medical attn if he noticed any difficulty breathing and to please follow up with me in an hour to let me know how he was doing. The patient took the 50 mg diphenhydramine. He stopped by the pharmacy again at around 3:15 pm and said that he felt like the heartburn had stopped but he felt like he had a small lump in his throat. He was somewhat worked up and was nervous. He did not say he was having any difficulty breathing, just that he felt he had a lump in his throat. I offered to call 911 for him but he said he would rather have a friend drive him to an ER just to be safe. He left the pharmacy with myself under the assumption that he was heading to the ER.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: EMLOYEE STATED SHE FELT LIGHT-HEADED, NAUSEOUS, BLURRED VISION. SHE ALSO MENTIONED SHE HAD NOT EATEN ANYTHING AND USUALLY DOESNT EAT AT WORK DUE TO IBS (IRRITABLE BOWEL SYNDROME) AFTER RESTING AND GIVEN CRACKERS AND WATER SHE FELT MUCH BETTER. FROM THE TIME OF INJECTION TO THE SYMPTOMS SUBSIDING, SYMPTOMS LASTED 40 MIN.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, tenderness, and itchiness at the injection site. Patient advised to apply ice pack at injection site and take oral Tylenol. Observe the site in the next 48 hrs if the swelling gets worse must find pcp and follow up with dr.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Local swelling
Clinical narrative: Localized swelling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis. Redness and swelling on left arm.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site reaction, Osteomyelitis, Staphylococcus test positive, Subperiosteal abscess
Clinical narrative: Patient developed osteomyelitis with subperiosteal abscess of the right distal thigh. Blood culture and abscess culture were positive for MRSA.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, hot painful at injection site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy with localized swelling, pain, redness, and heat at injection site and surrounding areas.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Probably vasovagal syncope. Pt was in line checking out groceries and passed out. Came to immediately, paramedics checked him over, BP/pulse normal. Pt left under his own power.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt's husband stated on 6-17-17 that since pt got immunization, her left arm has been extremely painful and sometimes not relieved by APAP, ibuprofen, or oxy/APAP. Advised pt to inform her doctor.
Age: 60.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Oropharyngeal pain
Clinical narrative: After receiving Hep A&B and Tdap pt reported sudden onset of sore throat with no other symptoms. She was given diphenhydramine and monitored for approx 20min with no further progression of symptoms. 4 hours later she reported only a sore throat and no further symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Urticaria
Clinical narrative: Headache/rash/hives.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain
Clinical narrative: Without action, I was sitting in the library at school and moved my shoulder and noticed a pain in my rotator cuff that was extreme and outside of the realm of the normal soreness after a flu shot. When the symptoms did not go away, I went to my doctors on November 20th 2016 to have them look at it. They prescribed a round of steroids and ibuprofen and I immobilized it for a few weeks. When the symptoms did not subside, I went to Physical Therapy in February and after a few sessions I was able to rebuild the muscle in my shoulder so that I could move my arm above my head again. I still experience limited discomfort when using my arm strenuously, but this is now 8 months after the vaccine.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Peripheral swelling, Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives on neck and face swelling of feet and face fever numbness.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Burning sensation, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: Very bad skin rash, puffiness of the face, itching, burning, hives. Also evident on arms.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: About 6-8 hrs. after receiving the Tdap vaccine, patient broke out in a rash - hives.
Age: 72.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Swelling, redness, pain (L) upper arm 5/27 went to Urgent Care-"diagnosed with cellulitis secondary to her body's reaction to vaccine" (per pt.). Received Rx for Clindamycin and Prednisone to treat.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Patient received vaccines at approximately 1800 6/15/17. Approx. 1.5 hrs after (1940) he developed a rash which started on face and hands. The rash progressed overnight - at 10:30 (6/16) became hives/swelling over entire body.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Blood test normal, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Lethargy
Clinical narrative: Fainted and tonic seizure immediately following injection of GARDASIL. Low blood pressure, nausea, vomiting, sweaty, lethargic, pale. Went to ER after leaving clinic. Received IV with anti-nausea meds. Discharged one hour later.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Nausea, Pallor, Syncope, Tonic convulsion, Vomiting
Clinical narrative: Fainted and tonic seizure immediately following injection of GARDASIL. Low blood pressure, nausea, vomiting, sweaty, lethargic, pale. Went to ER after leaving clinic. Received IV with anti-nausea meds. Discharged one hour later.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Muscle contractions involuntary, Tremor, Vomiting
Clinical narrative: Fainted and tonic seizure immediately following injection of GARDASIL. Low blood pressure, nausea, vomiting, sweaty, lethargic, pale. Went to ER after leaving clinic. Received IV with anti-nausea meds. Discharged one hour later.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: SWELLING/REDNESS OF UPPER ARM EXTENDING TO THE ELBOW.