chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Beginning on 6/25approx late afternoon, patient felt like there was a weight on her chest,. Parent took her to ED at 2100 hours-did an EKG, lung sounds were clear to auscultation, vitals stable. Return call from parent on 6/26  chest feeling better today and doesn't have a headache like yesterday, or feel like weight on chest, today she has upset stomach, and vomiting. Afebrile.  Continue follow up phone triage/care
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Seizure
Clinical narrative: On6/25/20 around 2AM patient had a temp of 103'F and experienced 10 seconds of seizure activity.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Headache, Injection site pain, Pain
Clinical narrative: Headache Site soreness radiating to (R) breast area and down the (R) side of her torso.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Local reaction, Tenderness
Clinical narrative: Telehealth visit on 6/25/2020. Localized reaction. Recommended Ice, motrin. Skin: circular 1 1/2 dollar moderately erythematous, slightly tender to palpation
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; on 6/11/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T003833, expiration date 01-AUG-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) for prophylaxis. Diluent (lot # T000494, expiration date 06-JUL-2022) was properly stored.  Administered dose of vaccine was exposed to the temperature excursion of 43.8 degrees Fahrenheit for 29 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved. The patient experienced no symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC; She received the GARDASIL vaccine in July 2013 (first dose) and 2014 (second dose). Patient did not mention that she ever received the third dose ofGARDASIL.; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In July 2013, patient was vaccinated with her first dose, and on an unknown date in 2014 ,with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, route, dose, frequency, anatomical location,lot # and expiration date were unknown) for prophylaxis.   The patient did not mention that she ever received the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). No additional adverse events were reported.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Induration
Clinical narrative: had induration; This case was reported by a physician via sales rep and described the occurrence of induration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced induration. On an unknown date, the outcome of the induration was recovered/resolved.   It was unknown if the reporter considered the induration to be related to Pediarix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Pediarix and experienced induration which lasted approximately 2 weeks. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Headache, Insomnia, Social problem
Clinical narrative: bad headache; sleepless; chills; bedredden; Social problem; This case was reported by a consumer and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced headache, sleeplessness, chills, bedridden and social problem. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, sleeplessness, chills, bedridden and social problem were unknown.   It was unknown if the reporter considered the headache, sleeplessness, chills and bedridden to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had no special health issues The patient experienced bad reaction after the first dose for one and a half days in bed sleepless, bad headache, chills, etc. The Tylenol helped a bit. Due to the pandemic and high risk family members, the patient had been staying home as much as possible to reduce the risk of Covid 19, which led to social problem.   The patient had delayed going in to my local pharmacy to get the second shot.  The patient called them two days ago, they have a supply, but when the patient went in today they said the at the CDC is advising against vaccines due to various Covid 19 issues. The patient asked what was the consequence of getting the second dose after the six month date. If I or the pharmacy has eased restrictions in say 1, 2, or 3 months from now, would the 2nd dose be ok then.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Somnolence, Vaccine positive rechallenge
Clinical narrative: sleeping a lot from exhaustion; sleeping a lot; spending most of each day in bed; This case was reported by a consumer and described the occurrence of bedridden in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of bedridden (1st dose received 6 months back on unknown date. Please refer the case US2020AMR106664).   On 18th June 2020, the patient received the 2nd dose of Shingrix. On 19th June 2020, 1 days after receiving Shingrix, the patient experienced bedridden. On 21st June 2020, the patient experienced exhaustion and somnolence. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bedridden, exhaustion and somnolence were unknown.   It was unknown if the reporter considered the bedridden, exhaustion and somnolence to be related to Shingrix.  Additional case details were reported as follows: Approximately 6 months later after 21st dose on (last Thursday), the patient had booster shot.  The reaction was similar but not quite as bad.  After spending most of each day (starting Friday) in bed, in the late afternoon patient was finally up to getting out of bed. On Sunday, patient was in bed (except for the bathroom) in bed, even sleeping a lot from exhaustion.  This day was the worst of all from the booster shot. The patient was a fairly resilient person, having some very tough.  The patient did not expect to have such an exhausting reaction to the booster shot, even though patient had experienced it with the initial shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106664:same patient (1st dose)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes virus infection, Pain, Pruritus, Rash
Clinical narrative: Wondered if she may have had a herpes outbreak / would then affect her glaucoma; Pain above her eyebrow / Sore to the touch; sore to the touch; Rash; Itch; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included herpes virus infection and glaucoma. Concomitant products included acyclovir.   On 24th January 2020, the patient received the 1st dose of Shingrix. In March 2020, between 1 and 3 months after receiving Shingrix and acyclovir and an unknown time after starting Alcohol, the patient experienced herpes virus infection, facial pain, pain, rash and pruritus. The patient was treated with ethanol (Alcohol). On an unknown date, the outcome of the herpes virus infection, facial pain, pain, rash and pruritus were unknown.   It was unknown if the reporter considered the herpes virus infection, facial pain, pain, rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient takes Acyclovir to keep her herpes suppressed and it has been years since she had a breakout.   The patient received Shingrix and started to have pain above her eyebrow and was sore to the touch.  The patient eye doctor asked if she had shingles and said no then a little later wondered if she may have had a herpes outbreak.  The patient remembers an area around her waist that had no bumps but did itch to which she applied alcohol.   The patient did had outbreaks when she was stressed.   The patient was concerned if the Shingrix could triggered a herpes outbreak which would then affect her glaucoma.  The patient was trying to determine whether she should get the second dose of Shingrix.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: SORE ARM; It was not as mobile as it is normally; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 4 and 6 months after receiving Shingrix, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the movements reduced was unknown.   It was unknown if the reporter considered the pain in arm and movements reduced to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had her first dose in January and experienced a sore arm for about a week. It was not as mobile as it was normally. The reporter consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR107469.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR107469:same patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after the first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease. Concomitant products included  (Humera).   On 29th May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: After receiving the 1st dose of Shingrix the patient developed shingles. The patient needs to take Humera because had Crohn's disease  The reporter did not consent to follow up.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: cellulitis of right arm.   redness, swelling, tender to touch
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash erythematous, Rash papular
Clinical narrative: developed shingles 1 day after receiving shingrix vaccine (burning papular erythematous rash along dermatomal pattern on right flank
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Cellulitis of arm, redness, swelling, tender to touch
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Febrile convulsion, Pyrexia, SARS-CoV-2 test negative, Seizure, Seizure cluster
Clinical narrative: Patient has a seizure disorder.  the vaccine provoked ongoing fever spikes for 5 days.  these caused intermittent febrile seizures and clusters of seizures that were very different from her baseline seizures. some lasted a few minutes but others clustered for over an hour
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Viral test negative
Clinical narrative: Patient has a seizure disorder.  the vaccine provoked ongoing fever spikes for 5 days.  these caused intermittent febrile seizures and clusters of seizures that were very different from her baseline seizures. some lasted a few minutes but others clustered for over an hour
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized cellulitis (redness, pain, swelling, warmth) at injection site (Lt gluteal) x2days.  Alternative site was requested by pt due to adverse effects by previous vaccines in deltoids.  Treated successfully with cephalexin by the Clinic.
Sex: U
Vaccine: MMRV
Symptoms: Ill-defined disorder
Clinical narrative: his child had a PROQUAD vaccine on an unspecified date and has had "nothing but problems"; This spontaneous report was received from the patient's father, referring to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) administered as prophylaxis (dose, route of administration, vaccination scheme, frequency, anatomical injection site, lot number and expiration date were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported). The reporter stated that the patient had the vaccine and had had "nothing but problems" (ill-defined disorder).   The outcome of the event ill-defined disorder and the causal relationship between the aforementioned event with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) and sterile diluent (MERCK STERILE DILUENT) were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Reaction to preservatives
Clinical narrative: sick; Reaction to preservatives; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and reaction to preservatives. On an unknown date, the outcome of the sickness and reaction to preservatives were recovered/resolved.   It was unknown if the reporter considered the sickness and reaction to preservatives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported The reporter stated the first 5 to 7 years, the patient got the flu vaccine, and she got sick. She stated it was not until later on that she realized it was probably due to the preservatives in the vaccine. The reporter wasn't able to provide specific time or product manufacturer. The reporter consulted employee health nurse when receiving the vaccine several years ago at which time the nurse recommended to obtain only preservative free form of annual mandatory vaccines. The reporter was uncertain which year this conversation occurred. This case has been linked with case US2020029088, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020029088:same patient
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was adminitered vaccine which was exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/No AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA161064, 2020SA161182, 2020SA161183, 2020SA161184 and 2020SA161203 (same reporter).  This case involves a six month and twenty days old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 10-Jun-2020, the patient received 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-OCT-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine exposed at 30-32 degrees F for one hour due to opening and closing of refrigerator door/no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician  This case is linked to cases 2020SA161181, 2020SA161064, 2020SA161183, 2020SA161184 and 2020SA161203(same reporter).  This case involves a 2 months old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door(product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 10-Jun-2020, the patient received first dose 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-Oct-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2020SA161181, 2020SA161182, 2020SA161183, 2020SA161064 and 2020SA161203 (same reporter).  This case involves a 4 month old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 15-Jun-2020, the patient received second 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-Oct-2020) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Ipol was administered inadvertently instead of Tubersol/No AE; Ipol was administered by intradermal route/No AE; Initial information received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old female patient who was inadvertently vaccinated with vaccine IPV (VERO) [IPOL] (lot P1F541M and expiry date 07-Dec-2020) via intradermal route in the right forearm instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 23-Jun-2020 (wrong product administered and incorrect route of product administration).   The patient's medical history, past medical treatment(s), vaccination(s) and  family history were not provided. No concomitant medications  were reported.   It was an actual medication error case due to wrong vaccine administered and inappropriate route of vaccination.  At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Pt left clinic, no reactions reported by patient mother. States that daughter was having c/o pain to site but did not check as she thought that it was normal. Noted this morning that pt had rash to SQ  vaccine area. States arm has active rash with some rased bumps that progressed to upper back.  Plan; pt was instructed to administer Benadryl to patient per provider hand out for dose. If able to come in for an appointment.  Rash is reducing but still pressent. Will continue to monitor.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Hep A vaccine instead of Hep B vaccine. Spoke with CDC regarding error and was told the administration of vaccine would not cause any harm to patient. Spoke with patients mother and patient is "doing fine."
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PCV13  & Rotavirus vaccines administered error on 06/26/2020.  No adverse event observed. Parent aware and will call office if symptoms occur.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient reported urticaria and itching on multiple areas of her body that lasted about 5 days.  Patient also reported itching, redness, and swelling at the injection site for about 3 days.  She states that all this started the morning after the vaccine was administered.  She did not seek medical attention but was able to self-treat with Zyrtec and anti-itch cream.    Patient reports that the rash, some red streaks, and itching came back 1 and 1/2 weeks after the previous incidence but less severe this time.  She is self-treating with Zyrtec.    Patient's primary care physician has been notified of these adverse events.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: 4 days after receving vaccine around mid-day, patient noticed a red rash across the groin, stomach, and lower chest. some of the bumps are raised and blister like. Rashes were not ther when she woke up that day
Age: 1.92
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Child came in for a well child check. Patient was supposed to receive Pentacel (DTap-Hib-IPV) instead patient received Tdap. Parent was contacted and informed of vaccine administration error. Parent was advised to monitor patient closely and if any symptoms occurred patient should be brought into clinic. Parent was also advised to bring patient in for an appointment two days after he was given wrong vaccine. Parent didn't bring child into the clinic as advised.
Age: 0.33
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A vaccine given in error too early.  Patient is less than the recommended age.
Age: 1.83
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: fine papular rash on abdomen treatment recommended: hydrocortisone cream and oral benadryl for itching as needed
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Endotracheal intubation, Intensive care, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Generalized seizures leading status epilepticus requiring intubation and pediatric intensive care. MRI and eeg normal, started on Keppra. Since then has had two episodes of seizures with fevers requiring intubation again with picu care.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Seizure, Status epilepticus
Clinical narrative: Generalized seizures leading status epilepticus requiring intubation and pediatric intensive care. MRI and eeg normal, started on Keppra. Since then has had two episodes of seizures with fevers requiring intubation again with picu care.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever for 16-18 hours. Left arm hot & swollen up for at least 4 days, ached all over, like the flu, fatigued & tired for a very long time, several weeks.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Fever for 16-18 hours. Left arm hot & swollen up for at least 4 days, ached all over, like the flu, fatigued & tired for a very long time, several weeks.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever, right arm, hot and large swelling at injection site and hurt for 4 days, flu like symptoms, fatigue and exhaustion for 5 days. Still feel extremely tired, after 2-3 hours of moving around, have to sit down, worn out.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, right arm, hot and large swelling at injection site and hurt for 4 days, flu like symptoms, fatigue and exhaustion for 5 days. Still feel extremely tired, after 2-3 hours of moving around, have to sit down, worn out.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Whole body muscle ache. Fever 101.0 F   Sore injection site.  Headache.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Neuralgia, Pain
Clinical narrative: Headache, body aches, chills, fever, neuralgia and fatigue.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, body aches, chills, fever, neuralgia and fatigue.
Age: 83.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever of 100.2 degrees F that started the evening of vaccination (vaccination was given around afternoon); still unresolved at time of reporting (afternoon the following day).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: a itchy red rash started around the site of the injection and the over the course of the next 48 hours has spread across her chest and neck, although is better now at this writing than it was this am.  Still itchy, but "drying up" per mom.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Within a couple of hours, I started have body aches and feeling feverish.  I missed two days of work.  Stayed in bed over 24-hours straight at one point.  Now, after 50+hours, I am just starting to feel better, but, am probably a day or so away from feeling "normal" again.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Erythema, Injection site pain, Loss of consciousness, Muscle contracture
Clinical narrative: Patient and his wife came in for TWINRIX vaccine around 12:30pm on 06/26/20. Patient filled out Vaccine Consent and Administration Record form. . Verified birthday and name and seated patient on chair in immunization section of pharmacy. I Cleaned the patients deltoid with alcohol, waited 30 seconds or so and administered twinrix prefilled syringe. Injected patient in the deltoid in the correct location. I was eye level with injection site. Patient felt dizziness and injection site pain after administration. I instructed patient to remain seated so I could monitor for 10 to 15 minutes before administiring vaccine to his wife. Patient became more dizzy after a few minutes and stated that he felt tired and laid his head back and appeared to faint. Patient was unrepsonsive so I immediately instructed technician to call 911 and they did. The patient appeared to seize (leg muscles contracted and arms contracted but no actual seizing/repetitve contraction) and some foam/saliva appeared at his mouth. Patient face was turning very red and appeared to be not breathing. I lowered the patient from the chair and was going to begin administer CPR when patient regained consciousness. I laid the patient on side as 911 operator instructed. The patient was unconscious for about one or two minutes and EMT arrived and took over care soon after patient regained consciousness. EMT stated unliklely a seizure due to lack of incontence and not allergic reaction because no hives. patient was transported to medical facility by ambulance
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Resuscitation, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Patient and his wife came in for TWINRIX vaccine around 12:30pm on 06/26/20. Patient filled out Vaccine Consent and Administration Record form. . Verified birthday and name and seated patient on chair in immunization section of pharmacy. I Cleaned the patients deltoid with alcohol, waited 30 seconds or so and administered twinrix prefilled syringe. Injected patient in the deltoid in the correct location. I was eye level with injection site. Patient felt dizziness and injection site pain after administration. I instructed patient to remain seated so I could monitor for 10 to 15 minutes before administiring vaccine to his wife. Patient became more dizzy after a few minutes and stated that he felt tired and laid his head back and appeared to faint. Patient was unrepsonsive so I immediately instructed technician to call 911 and they did. The patient appeared to seize (leg muscles contracted and arms contracted but no actual seizing/repetitve contraction) and some foam/saliva appeared at his mouth. Patient face was turning very red and appeared to be not breathing. I lowered the patient from the chair and was going to begin administer CPR when patient regained consciousness. I laid the patient on side as 911 operator instructed. The patient was unconscious for about one or two minutes and EMT arrived and took over care soon after patient regained consciousness. EMT stated unliklely a seizure due to lack of incontence and not allergic reaction because no hives. patient was transported to medical facility by ambulance
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: HER LEFT ARM WAS SWOLLEN AND PAINFUL  AROUND THE  INJECTION SITE.  SHE VISITED ER AND SHE WAS PRESCRIBED NORCO BY ER DOCTOR .
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Electroencephalogram, Intervertebral disc protrusion, Menstruation irregular, Seizure
Clinical narrative: Seizures occurred and still occur mostly 2 to 3 hours after sleep; irregular menstrual cycle for a couple of months; lower back disc on nerve (possibly from falling from the jerks).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Sleep study
Clinical narrative: Seizures occurred and still occur mostly 2 to 3 hours after sleep; irregular menstrual cycle for a couple of months; lower back disc on nerve (possibly from falling from the jerks).
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient came in and stated that her upper left arm is sore from a flu shot given to her at our location on October 16, 2019. She has come in before but has not complained of the soreness. However, as of late, patient states that her arm is more noticeably sore especially when sleeping on that arm. I recommended some heat and ice and some over-the-counter pain medications if needed to help with the soreness and that I would contact her doctor for further recommendations and to check to see if there are other preexisting issues that may cause soreness. I have not heard back from the doctor after leaving several messages. I have also followed up with patient to see if there has been any improvement or lack there of and no response thus far after initial complaint.
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Chest X-ray, Injection site pain, Intensive care, Magnetic resonance imaging, Mechanical ventilation
Clinical narrative: Injection given into right shoulder joint causing extreme pain. She ended up with a tear in her rotator cuff and pneumonia. Causing her to be admitted the the ICU and placed on the ventulator
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Pneumonia, Product administered at inappropriate site, Rotator cuff syndrome, X-ray limb
Clinical narrative: Injection given into right shoulder joint causing extreme pain. She ended up with a tear in her rotator cuff and pneumonia. Causing her to be admitted the the ICU and placed on the ventulator
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Arthralgia, Death, Magnetic resonance imaging, Pneumonia, Respiratory disorder
Clinical narrative: Injection given into right shoulder joint causing extreme pain. She ended up with a tear in her rotator cuff and pneumonia. Causing her to be admitted the the ICU and placed on the ventulator
Age: 86.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Rotator cuff syndrome
Clinical narrative: Injection given into right shoulder joint causing extreme pain. She ended up with a tear in her rotator cuff and pneumonia. Causing her to be admitted the the ICU and placed on the ventulator
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nightmare, Restlessness
Clinical narrative: Night mares that wouldn't stop. Big time pain at shot location. Restlessness big time . Stayed in bed all day.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site extending to (R) knee
Age: 11.0
Sex: M
Vaccine: HPV2, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: ARM SWOLLEN, RED, AND HOT TO THE TOUCH. RIGHT ARM.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: ARM SWOLLEN, SORE, RED, AND HOT TO TOUCH. RIGHT ARM.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Arthralgia, Full blood count normal, Injection site oedema
Clinical narrative: Knee, pain, thigh edema onset 24' post injection. (L) thigh CBC normal. Pt was started on Cephalexin & Benadryl q6h. Resolution
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child rcv'd Menveo in RD on 06-25-20 & HPV in LD..mom states that on 06-26-20-dad noticed RD swollen, Red, warm to touch called PCP to get an appt for allergic RXN to Menveo. In office child was noted to have a 10cm x 8cm RXN. Continue cool compresses & Benadryl--no abx prescribed. F/u as needed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: ABOVE AVERAGE REDNESS AND SWELLING ON THE RIGHT LEG; FEVER & FUSSY AFTER 24 HOURS; RED AREA WARM TO TOUCH; SUSPECT VACCINE REACTION ON TREATMENT FOR CELLULITIS: CEPHALEXIN 250mg/5ml oral suspension ON 6/25/20 @ 9:50am OFFICE EXAM but area still swollen no longer red warm to touch
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: ABOVE AVERAGE REDNESS AND SWELLING ON THE RIGHT LEG; FEVER & FUSSY AFTER 24 HOURS; RED AREA WARM TO TOUCH; SUSPECT VACCINE REACTION ON TREATMENT FOR CELLULITIS: CEPHALEXIN 250mg/5ml oral suspension ON 6/25/20 @ 9:50am OFFICE EXAM but area still swollen no longer red warm to touch
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines exposed at 30-32 degrees F for one hour due to opening and closing of refrigerator door/no AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2020SA161183, 2020SA161064, 2020SA161181, 2020SA161182 and 2020SA161184(same reporter)  This case involves a 12 years old male patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed at 30-32 degrees Fahrenheit for one hour due to opening and closing of refrigerator door(product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jun-2020, the patient received first dose 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6543AB and expiry date 23-Feb-2021) via intramuscular route in the right arm and first dose 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5602AA and expiry date 19-Mar-2021) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: skin turned bright pink like a sunburn for 3 days
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Pain
Clinical narrative: arm pain, painful rash that is streak down arm about 4 inches from injection site, body aches, chill, headache, hives on neck and chest that resolved within an hour
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: arm pain, painful rash that is streak down arm about 4 inches from injection site, body aches, chill, headache, hives on neck and chest that resolved within an hour
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: INJECTION SITE REACTION W/SWELLING AND REDNESS. PT DID NOT CALL IN TO REPORT DISCOMFORT, AND ALSO APPLIED HEAT TO SITE OF REACTION INSTEAD OF ICE AND WORSENED THE REDNESS AND HARDNESS OF THE AREA. CAME TO PHARMACY THIS AM. AREA IS APPROXIMATELY 4 INCHES IN DIAMETER. RED AND HARD-TO-THE TOUCH IN THE CENTER. PT WAS GIVEN CLARITIN TO USE DAILY AND WAS ASKED TO SWITCH FROM TYLENOL ONLY TO IBUPROFEN TO HELP WITH THE REDNESS AND SWELLING. PT WAS ALSO ASKED TO APPLY ICE FOR DISCOMFORT. PT WAS ASKED TO CHECK BACK IN WITH PHARMACIST ON MONDAY.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Patient developed significant bruising on arm around injection site and surrounding axila area first seen the morning after the injection. Patient also reported pain in injection site at time of injection and myalgia which had fully resolved upon follow up call 6/26/2020.  Bruising was still present according to patient upon follow up call 6/26/2020 but was continuing to go away. Patient also reported feeling like her axillary lymph nodes were swollen prompting us to refer her to her physician. Upon follow up questioning she reported that her doctor believed it was a blood clot and not lymph node swelling.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Thrombosis
Clinical narrative: Patient developed significant bruising on arm around injection site and surrounding axila area first seen the morning after the injection. Patient also reported pain in injection site at time of injection and myalgia which had fully resolved upon follow up call 6/26/2020.  Bruising was still present according to patient upon follow up call 6/26/2020 but was continuing to go away. Patient also reported feeling like her axillary lymph nodes were swollen prompting us to refer her to her physician. Upon follow up questioning she reported that her doctor believed it was a blood clot and not lymph node swelling.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Developmental regression, Electroencephalogram abnormal, Fatigue, Infantile spasms, Irritability
Clinical narrative: Patient was irritable and more tired than usual for the remainder of the day after receiving six month vaccinations,  Infantile Spasms first recorded on 11/10/2018 at 9:35am. Episodes/Clusters of spasms increased in frequency and intensity until finally diagnosed with EEG on 12/07/2018.  Developmental  skills were also lost between receiving vaccines on 11/05/2018 and diagnosis of Infantile Spasms on 12/07/2018(child stopped rolling, stopped babbling, stopped smiling and laughing, and became less alert)
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Magnetic resonance imaging normal
Clinical narrative: Patient was irritable and more tired than usual for the remainder of the day after receiving six month vaccinations,  Infantile Spasms first recorded on 11/10/2018 at 9:35am. Episodes/Clusters of spasms increased in frequency and intensity until finally diagnosed with EEG on 12/07/2018.  Developmental  skills were also lost between receiving vaccines on 11/05/2018 and diagnosis of Infantile Spasms on 12/07/2018(child stopped rolling, stopped babbling, stopped smiling and laughing, and became less alert)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Injection site pain, Injection site rash
Clinical narrative: skin rash on upper left arm, painful to touch,  body aches/discomfort, shivers, fatigue
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: skin rash on upper left arm, painful to touch,  body aches/discomfort, shivers, fatigue
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Influenza like illness, Nausea, Rash
Clinical narrative: Flu like achy headache sick to stomach weak for 3 days. After that developed a rash with bumps. Some bumps had tiny blisters. They would flake away and reform. On left side of forehead. After a month it moved down to eye level on same side face and over to eye lid. Contacted my Dr. received Valacyclovir 3 times a day for 7 days. Symptoms disappeared after that.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Flu like achy headache sick to stomach weak for 3 days. After that developed a rash with bumps. Some bumps had tiny blisters. They would flake away and reform. On left side of forehead. After a month it moved down to eye level on same side face and over to eye lid. Contacted my Dr. received Valacyclovir 3 times a day for 7 days. Symptoms disappeared after that.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient described reddness at injection site about 3 inches across. No pain, tingling, or swelling.