chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: YF
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 7/2/19--given immunization as noted--no reaction noted at that time. 7/6/19 in late afternoon-early evening patient began with fever--100 F, general body aches, "nagging" headache. Denied any unusual activity or insect bites as he had been outdoors during that time. Patient has been taking Aleeve and has had some relief of symptoms reported today. Recommended patient see PCP or go to Urgent Care for evaluation due to distance from clinic. Declined by patient as he was getting to travel for business. Recommended patient continue current plan of care--rest, fluids, OTC pain medications and go to Urgent Care or ED is symptoms do not improve or get worse. Patient verbalized understanding and to contact clinic.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Product administration error, Refusal of treatment by relative
Clinical narrative: Pt's mother did not immunization done due to religious reasons. Mother addressed with MA after injection given.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Child had fever on 7/7/19 followed by 5-10 second generalized seizure
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Child had fever on 7/7/19 followed by 5-10 second generalized seizure
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain upper, Feeling of body temperature change, Headache, Myalgia, Peripheral swelling
Clinical narrative: The day after she got the vaccines she started developing symptoms such as the arm being hot, swollen, and tender to touch.  She has experienced headache, hot/cold flashes, muscle aches, stomach aches, and a fever of 103 degrees that started two days after receiving the vaccines.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: The day after she got the vaccines she started developing symptoms such as the arm being hot, swollen, and tender to touch.  She has experienced headache, hot/cold flashes, muscle aches, stomach aches, and a fever of 103 degrees that started two days after receiving the vaccines.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: Mild headache, shoulder and arm ache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, Chills, Body Aches, Headache, Nausea
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Fall, Fatigue, Impaired driving ability
Clinical narrative: Arm ached for first 2 days.  On 5/10/19, I threw up for no reason. On 6/2/19 at 9:30 PM, I found myself on the floor and so debilitated with vertigo that I had to call an ambulance to take me to the hospital where I stayed until 6/5/19 This date, 7/5/19, I am functioning at 90%. I could not drive until 7/1/19. My balance is still a little shakey and I'm still taking meclizine 3x per day. Between 5/10 - 6/2/19 I was overly tired and achey. I have since found out that Shingrex can cause 1/100 to get vertigo. I'm really healthy and and until now have never had a reaction to any shot or medication. I get a cold once a year and never have headaches or earaches. The last time I threw up, before this event, was 45 years ago and the result of food poisoning. I still can't believe that I got vertigo so badly that I had to be hospitalized It will be six weeks on Sunday and I'm still not well.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Pain, Pain in extremity, Vertigo
Clinical narrative: Arm ached for first 2 days.  On 5/10/19, I threw up for no reason. On 6/2/19 at 9:30 PM, I found myself on the floor and so debilitated with vertigo that I had to call an ambulance to take me to the hospital where I stayed until 6/5/19 This date, 7/5/19, I am functioning at 90%. I could not drive until 7/1/19. My balance is still a little shakey and I'm still taking meclizine 3x per day. Between 5/10 - 6/2/19 I was overly tired and achey. I have since found out that Shingrex can cause 1/100 to get vertigo. I'm really healthy and and until now have never had a reaction to any shot or medication. I get a cold once a year and never have headaches or earaches. The last time I threw up, before this event, was 45 years ago and the result of food poisoning. I still can't believe that I got vertigo so badly that I had to be hospitalized It will be six weeks on Sunday and I'm still not well.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Arm ached for first 2 days.  On 5/10/19, I threw up for no reason. On 6/2/19 at 9:30 PM, I found myself on the floor and so debilitated with vertigo that I had to call an ambulance to take me to the hospital where I stayed until 6/5/19 This date, 7/5/19, I am functioning at 90%. I could not drive until 7/1/19. My balance is still a little shakey and I'm still taking meclizine 3x per day. Between 5/10 - 6/2/19 I was overly tired and achey. I have since found out that Shingrex can cause 1/100 to get vertigo. I'm really healthy and and until now have never had a reaction to any shot or medication. I get a cold once a year and never have headaches or earaches. The last time I threw up, before this event, was 45 years ago and the result of food poisoning. I still can't believe that I got vertigo so badly that I had to be hospitalized It will be six weeks on Sunday and I'm still not well.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: -Trembling/felt cold -Extremely fatigued - exhausted, tired -Severe headache -Queasy - not vomit -Injection site very sore & red for 5 days (symptoms finally subsided by 3rd day) -Call CDC - asked if I could take Tylenol for pain
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor
Clinical narrative: -Trembling/felt cold -Extremely fatigued - exhausted, tired -Severe headache -Queasy - not vomit -Injection site very sore & red for 5 days (symptoms finally subsided by 3rd day) -Call CDC - asked if I could take Tylenol for pain
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported.; the physician mentioned a patient was vaccinated with PREVNAR 13 (manufacturer unknown) on 5/21/2019 and the patient was vaccinated with PNEUMOVAX 23 on 6/19/2019.; Information has been received from a physician referring to an unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 21-MAY-2019, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, route, lot # and expiration date were not reported) and the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route, lot # and expiration date were not reported) on 19-JUN-2019 for prophylaxis (inappropriate schedule of product administration). No adverse symptoms reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000889: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 03-JUN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R007150 with expiration date in 15-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001808: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Erythema, Flushing, Pallor, Visual impairment
Clinical narrative: the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date in March 2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot# and expiration date were not reported), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, strengths, lot # and expiration dates of all products were unknown) all via intramuscular route as routine vaccines and patient experienced flushing, dizziness, pallor, erythema and visual impairment after receiving the vaccines. The patient has not sought medical attention as the event occurred during office visit and was addressed immediately. The patient was monitored and recovered on the same day and was able to go home. No overdose and product quality complaint (PQC) involved. The reporter's causality assessment between the events and the suspect therapies was not provided.  This case has been cross linked to 1907USA004108 (sibling case).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 81-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a by a healthcare provider. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live ( ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure fluctuation, Dizziness, Erythema, Flushing, Pallor
Clinical narrative: the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; blood pressure was fluctuating; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date in March 2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot# and expiration date were not reported), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, strengths, lot # and expiration dates of all products were unknown) all via intramuscular route as routine vaccines and patient experienced flushing, dizziness, pallor, erythema and visual impairment after receiving the vaccines and was transported by an ambulance to an unknown hospital but the patient was not admitted, as his blood pressure was fluctuating (blood pressure fluctuation). It was also reported that the ambulance may put the patient on oxygen. No overdose and product quality complaint (PQC) involved. The outcome of events was unknown. The reporter's causality assessment between the events and the suspect therapies was not provided.  The reporter considered all the events as medically significant.  This case has been cross linked to 1907USA002813 (sibling case).
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; blood pressure was fluctuating; the patient experienced flushing, dizziness, palor, erythema and visual impairment after receiving the vaccines; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date in March 2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot# and expiration date were not reported), meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, strengths, lot # and expiration dates of all products were unknown) all via intramuscular route as routine vaccines and patient experienced flushing, dizziness, pallor, erythema and visual impairment after receiving the vaccines and was transported by an ambulance to an unknown hospital but the patient was not admitted, as his blood pressure was fluctuating (blood pressure fluctuation). It was also reported that the ambulance may put the patient on oxygen. No overdose and product quality complaint (PQC) involved. The outcome of events was unknown. The reporter's causality assessment between the events and the suspect therapies was not provided.  The reporter considered all the events as medically significant.  This case has been cross linked to 1907USA002813 (sibling case).
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: My mother got a pneumonia vaccine and died of pneumonia.; My mother got a pneumonia vaccine and died ofpneumonia.; This is a spontaneous report from a contactable consumer (patient's son/daughter) from a Pfizer Sponsored Program Comscore DTC Ad Testing with Pricing Language.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history and concomitant medications were not reported.  The patient got a pneumonia vaccine on an unspecified date and died of pneumonia on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia
Age: 60.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Mass, Skin warm, Swelling
Clinical narrative: Patient experienced Big lump, presented hot and swollen about quarter-sized. Resolved on its own after 4-5 days
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Mild Hives & erythematous rash on trunk & arms.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Rash papular
Clinical narrative: Seen in our office on 7/19/19 hx fever 103x2days. On 7/9 broke out in rash on trunk 30 small red papules on trunk ? some with clear vesicles. Timing could be consistent with MMR or Varicella vaccine dischg home. To call increase fever inc rash
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Lethargy, Pyrexia, Vomiting
Clinical narrative: About 12 hrs after receiving had chills, fever (unmeasured), emesis, lethargy, but did not feel sick, next day was without symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: mother called and states that Patient had a rash on his body from head to toe.  they were red raised bumps that blanched when touched.  mother states they appeared to be hives.  patient is complaining of being very itchy, but no signs of shortness of breath or difficulty breathing.  mother does not recall patient coming in contact or ingesting anything new other than patient having received the vaccination.  she was instructed to give Benadryl to assist with a possible allergic reaction and provider was notified.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Dyspnoea, Fatigue, Injection site pain, Nausea
Clinical narrative: (1) Pain at injection site (3 days) (2) Fatigue  (at 12-48 hours after vaccination)  (3) Nausea  (at 12-36 hours after vaccination) (4) Elevated temperature  (at 24-36 hours after vaccination) (5) Dyspnea (self-limited) (at around 30 hours after vaccination)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever of 102,  large red, swollen area around injection site, feeling very tired
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: At the time of the vaccination, this patient was 17 years old and 6 months but received an adult dose
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Pain in extremity
Clinical narrative: PATIENT BP increased to 170/90. arm became very red and painful.
Age: 2.5
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Tdap given instead of Dtap for 4th dose of series
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Hyperhidrosis, Insomnia, Mobility decreased, Pain
Clinical narrative: Patient had initiial pain and then it went away almost immediately.  She went home and cut up strawberries and felt sweaty with GI upset.  She had this intense pain for about 15 hours.  Patient couldn't move her arm, so she tried Tylenol, but it didn't touch the pain. Patient iced injection site and started taking Motrin. Patient did not sleep all night due to the pain. Patient stated the pain was worse than giving birth (and she has done that 3 times).
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: Pediatrician?s office administered an expired HIB vaccine. Expiration date of 11/14/17 administered on 11/17/2017.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Musculoskeletal stiffness, Tremor, Unresponsive to stimuli
Clinical narrative: Client fell back in his chair, seem to get stiff and did a few body shakes. Was not responsive for 5-10 seconds. He said that  did not remember the episode. His mother requested that he be taken to the hospital for testing and evaluation.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Burning sensation, Chills, Erythema, Headache, Injected limb mobility decreased
Clinical narrative: 7/2/19 complaining of chills, body aches, headache, body on fire--7/3/19 wokeup headache better but body aches continue through today.  Left arm red and swollen in the elbow area, not at the injection site starting 7/5 making bending arm & movement difficult.  Seen by provider 7/9/19 area still pink, swelling decreased.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: 7/2/19 complaining of chills, body aches, headache, body on fire--7/3/19 wokeup headache better but body aches continue through today.  Left arm red and swollen in the elbow area, not at the injection site starting 7/5 making bending arm & movement difficult.  Seen by provider 7/9/19 area still pink, swelling decreased.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Hypotension, Loss of consciousness, Nausea, Pallor
Clinical narrative: patient felt dizzy 15 minutes after receiving vaccines. sat down and then passed out. came to after a few seconds, and was then nauseous. she was very pale , BP low at 96/50, pulse 53. treatment was rest,  oral fluids and monitoring of vital signs. after 45 minutes BP was 102/62, pulse 68 and color back to normal. patient felt better, left office
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Erythema, warm and red to arm, very painful, reported temp as high as 100 degree F. Area tenderness to palpation to the elbow. Pt was treated with Clindamycin 300 mg TID x 7 days and follow up in 2 days at the clinic.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Rash
Clinical narrative: Painful bumps on the right arm around the Injection site, pops up every few months. It goes away  for a while when customer squeezes  out the bumps. It keeps come back. Customer thinks these is due to vaccine administration.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 09-MAY-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001811: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: patient was administered Trumenba yesterday from another pharmacy but was supposed to receive Menactra for school; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient (age unknown) who received vaccines TRUMENBA instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site instead of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site..  It was an actual medication error due to wrong vaccine administered.  It was reported that patient was administered Trumenba yesterday from another pharmacy but was supposed to receive Menactra for school.  It was unknown whether patient experienced any adverse reaction after the injection.   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.  List of documents held by sender: none. Information on batch number was requested for this case.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menactra stored at minus 1 degrees C due to an unstable refrigerator and exact temperature not in a specific time frame; Initial information received on 05-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone.  This case was linked to case 2019SA184495 (same reporter).  This case involves a patient of unknown demographics was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to product storage error temperature too low because Menactra stored at minus 1 degrees C due to an unstable refrigerator and exact temperature not in a specific time frame.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Information on batch number was requested.  Documents held by the sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Abdominal discomfort, Allergy to vaccine, Swelling
Clinical narrative: Drug Allergies; upset stomach; swelling; Initial information received on 04-Jul-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer).  This case involves a patient (age and gender unknown) who experienced drug allergies, while he/she received vaccine TETANUS TOXOID.  The patients past medical history, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Dialysis with prescription of Lyrica 50 mg 1 PO daily post dialysis.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious drug allergies (allergy to vaccine) with unknown latency following the administration of TETANUS TOXOID. On an unknown date, the patient developed a non-serious upset stomach (abdominal discomfort) with unknown latency following the administration of TETANUS TOXOID. On an unknown date, the patient developed a non-serious swelling with unknown latency following the administration of TETANUS TOXOID.  Lab data was not provided.  Final diagnosis was drug allergies.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for drug allergies, as Unknown for upset stomach and as Unknown for swelling.  List of documents held by sender: none. Information batch number was requested for this case.
Age: 65.0
Sex: F
Vaccine: HEP, IPV, MMRV, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was receiving MMR and Varicella and the medical assistant administered ProQuad instead of each vaccine separately.  ProQuad is not recommended for this age group.  Patient has not reported any adverse effects from the combination vaccine but was recommended that this report be placed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pain right upper shoulder to upper arm just above elbow since 1430 today.  Given shingles injection at 1300 today same arm; bandaid noted to right shoulder.  Pain worse with movement.  Took Ibuprofen 800 mg at 1530 with no relief.  She was given oral Decadron in the ED. Patient is encouraged to take prednisone daily to help with inflammation.  Norco for severe pain.  Should not drive or drink alcohol with this.  Ice to the affected area 20 minutes 3-4 times daily.  Gentle massage and range of motion as tolerated.  If symptoms not improving recommend she follow-up with orthopedics.  Return here with any new or worsening symptoms including redness or fevers.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Neuralgia
Clinical narrative: Headache, full body discomfort and nerve pain.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Oral disorder, Rash, Skin lesion
Clinical narrative: Chief Complaint Patient presents with o Rash  HPI  16 yo female with PMH significant for Addison's Ds under the care of endocrinology, takes fludrocortisone and hydrocortisone.  Noted hypothyroid.  Denies other significant health issues.  She presented to Urgent Care with new onset anular rash that began on flexor forearms and anterior thighs.  Progressed to hands and feet including palms and soles.  Few lesions noted on bilateral legs and lower abdomen.  Mom notes new peri-oral lesions including external lip involvement. No recent fever, chills, viral prodrome.  No known viral illness.  Travel ~ 1 month ago.  No noted insect or tick bite.  No n/v or diarrhea.  No blood in stool.  No hematuria.  No history of STD or STD exposure.  No reported pharyngitis.   No recent change in medication aside from stress doses hydrocortisone recommended and begun today by endocrinologist.  No antibiotics, no anticonvulsants
Age: 43.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Flushing, Pruritus
Clinical narrative: Patient came back to clinic at 1:20pm complaning of itching and facial flushing. Provider assessed and given Benadryl 25mg PO x 1 in clinic. Patient monitored for 1 hr and no severity of symptoms noted. Per patient itching is much lesser. Patient in formed to go to nearest ED if SOB or severe symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Lymph node under armpit on the same side as the injection swelled up.  I noticed it the morning after the injection and it lasted 6 days.  The only other reactions I had to the injection were expected (extremely tired for one day after, soreness at injection site for 5 days).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills late evening of the shot 6/18.  Fever and chills upon awakening the following day 6/19/2019.  Fever topped at 101.6 in early afternoon.  Took ibuprofen.   Started feeling better late that evening.  Fatigue 6/20/2019.  Fully recovered 6/21.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster
Clinical narrative: Pt experienced shingles outbreak 1 week post-vaccine. Shingles outbreak was confirmed via dr's office. Shingles was on the left side (same side as the vaccine given). Left eye and left ear was affected due to outbreak.  Pt has never had an outbreak of shingles until after vaccine was given. Pt was treated for shingles with valacyclovir 1mg three times daily for 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Patient developed rash and blisters on upper arm/shoulder. Patient's son states he popped a golf ball size blister on Sat. Blister oozed initially and now appears  to be healing . Blister was posterior to injection site,.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: The patient called the pharmacy and told the pharmacist that he had red rash on his arm. Patient stated he didnt have a fever or anything just mild rash. Patient came up to pharmacy and showed pharmacist patient was instructed to take benadryl and if rash got any bigger to go to ER or MD.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired DTaP vaccine. No adverse effects reported. Re-administered at a later date.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired DTaP vaccine. No adverse effects reported. Vaccine re-administered at a later date.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Paraesthesia
Clinical narrative: Patient experienced tingling in arms and legs the day after vaccination.  She also states that she periodically experiences flushing/redness in her forearms that comes and goes, with tingling happening before the flushing occurs.  She visited the ER on 6/24/19 to check into the tingling sensation.  The ER physician referred her to her primary care physician.  The primary care physician referred her to a dermatologist.  The dermatologist that she saw on 7/8/19 stated that they thought she was experiencing an adverse reaction from her vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Gastritis viral
Clinical narrative: Patient got blisters between her fingers and states she had viral gastritis
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: Patient called to report that she went to doctor with rash with blisters covering her arm.  She also had body aches.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Injection site soreness  makes it painful to lift arm   Fatigue Headache Swollen lymph node in left armpit  Treated with ibuprofen to minimal effect
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Chills, Fatigue, Injection site vesicles, Nausea
Clinical narrative: PATIENT CAME TO THE PHARMACY TO SHOW ME HER ARM ....SHE HAD BROWN SKIN PEELING DUE TO BLISTERING ....PATIENT REPORTED THAT THIS REACTION DID NOT HAPPEN WITH THE FIRST INJECTION AT ALL.   SHE DEVELOPED A HUGE BLISTER AT THE SITE OF INJECTION.   SHE ALSO EXPERIENCED FEVER, CHILLS, NAUSEA, AND FATIGUE.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: PATIENT CAME TO THE PHARMACY TO SHOW ME HER ARM ....SHE HAD BROWN SKIN PEELING DUE TO BLISTERING ....PATIENT REPORTED THAT THIS REACTION DID NOT HAPPEN WITH THE FIRST INJECTION AT ALL.   SHE DEVELOPED A HUGE BLISTER AT THE SITE OF INJECTION.   SHE ALSO EXPERIENCED FEVER, CHILLS, NAUSEA, AND FATIGUE.