chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site redness; injection site swollen; injection site soreness; Body temperature increased; This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included eculizumab (Soliris) for myasthenia gravis.   On 10th June 2019, the patient received Bexsero. On 11th June 2019, the patient started Soliris (intrvenous push) 10 mg/ml at an unknown frequency. In June 2019, less than a week after receiving Bexsero, the patient experienced injection site erythema, injection site swelling, injection site pain and body temperature increased. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved and the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and body temperature increased to be related to Bexsero.  Additional details were received as follows: The age vaccination was not reported. The patient stated that the area around where received the vaccine was red, sore ans swollen. The patient body temperature was 99 something but the patient had not considered it as fever. Treatment was not reported. At the time of reporting the action taken with soliris was not reported. No additional information has been requested since the reporter did not consent for follow up. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and body temperature increased to be related to soliris as well.      Lab Comments: On an unknown date body temperature was recorded.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Vaccine administered at inappropriate site; Sore left leg; This case was reported by a nurse via sales rep and described the occurrence of leg pain in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENACTRA.   On 20th July 2018, the patient received Bexsero. On 20th July 2018, unknown after receiving Bexsero, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the leg pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero on left thigh because the patient did not want an sporting event that weekend and did not want to have a sore right arm, this led to vaccine administered at inappropriate site. The patient expereinced soreness in left leg for almost a month. The patient did not have rash or swelling.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Pt. was having difficulty Breathing one of the side effects.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Rash
Clinical narrative: Patient called with questions regarding side effects with Enbrel and Shingrix Vaccine. Patient has noticed an increase in pain and discomfort after receiving the first series of Shingrix (6/31/19) Shortly after the shot (2-3 days) on 7/1/19 she developed a rash indicative of active shingles and wanted to know if it was related to use.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Received first dose of shingles vaccine on 7/4. Eight hours later experienced chills, sweating, extreme exhaustion, headaches, muscle and joint pain. Slept 11 hours. Today feel tired and wiped out- unable to get out of bed or perform normal activities.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Received first dose of shingles vaccine on 7/4. Eight hours later experienced chills, sweating, extreme exhaustion, headaches, muscle and joint pain. Slept 11 hours. Today feel tired and wiped out- unable to get out of bed or perform normal activities.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site mass, Pain, Skin warm
Clinical narrative: Pharmacy, 1100est, today, left Deltoid im, of pneumovax 23 inj 25mcg/0.5ml PF SYR. Dosage, 0.5. Approx. 1700est noticed a large lump of the left deltoid with pain on movement of shoulder (8), tympanic temp, 100.0F. Slightly warm area. No discoloration or rash. Approx. 5x5inch diameter. Pharmacy notified, triage nurse notified my PCP office. Instructed to take Tylenol and or ibuprofen and apply ice. Continue vitals. If Sx worsen, go to emergency department or wait until Saturday morning and call PCP office for appointment tomorrow.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I received the second dose of the shingrix vaccine at the same time/place as annual flu vaccination/injectable. I developed a fever peaking at 103 about 8 hours later. I did not seek outside medical care because my wife is a medical professional. Fever subsided within 24 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Faeces discoloured, Fatigue, Hypersomnia
Clinical narrative: patient received her 2nd dose of SHINGRIX vaccine on 7/2/19 and stated on 7/4/19 she was in the shower in the morning and felt dizzy, had heart palpitations and had to sit in the shower. She came out wet and decided to go lay down because she was feeling nauseous. Next thing she remembers is waking up on floor. She had passed out. She slept for the past 20 hours on and off but mainly sleeping. She reported extreme diarrhea, black tarry stools but is starting to feel better today (7/5/19). She is tired, her bowel movements are more 'normal' but they are still dark in color.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Melaena, Nausea, Palpitations
Clinical narrative: patient received her 2nd dose of SHINGRIX vaccine on 7/2/19 and stated on 7/4/19 she was in the shower in the morning and felt dizzy, had heart palpitations and had to sit in the shower. She came out wet and decided to go lay down because she was feeling nauseous. Next thing she remembers is waking up on floor. She had passed out. She slept for the past 20 hours on and off but mainly sleeping. She reported extreme diarrhea, black tarry stools but is starting to feel better today (7/5/19). She is tired, her bowel movements are more 'normal' but they are still dark in color.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Chills, Decreased appetite, Dyspnoea, Eye pruritus
Clinical narrative: Fever lasted 7 days at a point being high of 104.2 . Chills, Vomiting, hard time breathing felt like she was stuffed up. Itchy red eyes, fatigue, abdominal pain and of Loss of appetite.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Nasal congestion, Ocular hyperaemia, Pyrexia, Vomiting
Clinical narrative: Fever lasted 7 days at a point being high of 104.2 . Chills, Vomiting, hard time breathing felt like she was stuffed up. Itchy red eyes, fatigue, abdominal pain and of Loss of appetite.
Age: 89.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Seizure, Syncope
Clinical narrative: According to Medical assistant taking call:  Daughter called stating that father had received 2nd dose of Shingrix vaccine 7/10/2019, and he waited 30 minutes after for any reaction.  When patient got home, he collapsed and started to have a seizure, EMS were called and patient was take to Hospital.
Age: 89.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Seizure, Syncope
Clinical narrative: Daughter called stating that father had received 2nd dose of Shingrix vaccine 07/10/2019 and he waited 30 minutes after for any reaction. When patient got home, he collapsed and started to have a seizure, EMS were called and patient was taken to Hospital.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat at DTAP site from 2 days prior.  Diagnosis of cellulitis and treated with Keflex.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Lethargy, Muscle spasms, Pneumonia
Clinical narrative: Tired, leg cramps, weak, lethargic
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pneumonia bacterial, Sepsis
Clinical narrative: Tired, leg cramps, weak, lethargic
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: patient describes next day whole body hurt and wanted to go to er.  Had pain, warm, redness at site of injection.  She still has significant pain at area of injection.
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 04-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, Lot# R034700, expiry date 16-JUN-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-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000884: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: 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-009507513-1907USA000903: 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:
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 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees 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-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: 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-009507513-1907USA000903: 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-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000862:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No adverse effects were reported in the patient; a patient received a dose of GARDASIL-9 in November 2018 (lot/exp unknown), and a second dose in July 2019.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On an unknown date in November 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, site of administration, lot# and expiration date was not reported) for prophylaxis. On an unknown date in July 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot# N019103, expiration date 03-FEB-2020) (site of administration was not reported). No adverse effects were reported.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: feeling unwell; injection site redness; injection site hot; injection site swell; injection site hurts; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old patient who received Herpes zoster (Shingrix) for an unknown indication.   On 15th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced feeling unwell, injection site erythema, injection site warmth, injection site swelling and injection site pain. On an unknown date, the outcome of the feeling unwell, injection site erythema, injection site warmth, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell, injection site erythema, injection site warmth, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient after receiving vaccine was not feeling well. The patient had a injection site very red, hot to the touch, swollen and pain.
Sex: F
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: Felt pretty sick; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the vaccine made her felt pretty sick on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Allergies: Penicillin, Sulfa drugs, Pneumococcal vaccines; This is a spontaneous report from a contactable physician. A 58-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies to penicillin, sulfa drugs, pneumococcal vaccines on an unspecified date. Outcome of the event was unknwon.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Patient stated he had seizure later that night after leaving pharmacy.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: cellulitis and arm swelling/pain - resolved after abx
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: cellulitis and arm swelling/pain - resolved after abx
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: cellulitis and arm swelling/pain - resolved after abx
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt noted to have 4cm red circular welt on both arms in area of vaccine 48 hours post shots. Pt prescribed cephalexin 250mg/5ml oral suspension to take 15ml PO BID for 7 days. Pt also prescribed Benadryl Allergy 12.5mg/5ml oral liquid to take 5ml PO TID for 5 days. Pt will be referred to Allergy/Immunology.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red circular, warm, raised area on arm, diameter 2-3"
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm, Tenderness
Clinical narrative: Patient says that she had swelling and redness from her elbow and up on the injected arm. Arm was tender and hot to the touch.  Patient denied having any compromised breathing ability. Patient acknowledged dialing 911 or going to hospital if any tingling or swelling of lips, tongue, or throat occurred.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Small bump at injection site, Erythematous, inflamed.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: ProQuad given instead of Varivax. No adverse reactions reported by patient.
Age: 74.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: Vesicular dermatomal rash (R) thorax on erythematous base developed less than 24hr after Zostavax administration.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose, Blood thyroid stimulating hormone, Dysphagia, Ear pain, Glycosylated haemoglobin
Clinical narrative: 1. Swollen arm, arm pain, ear pain and neck pain within 24 hrs after the vaccination. Neck and ear pain re-occur sometimes. 2. Muscle craps in feet, hand, legs. 3. 9-27-18 neck pain, muscle pain in left side of arm and neck date 10-19-18 - acute high blood pressure I never had acute high blood pressure before. LVN told me to make a follow up appt. with my doctor. The next day my pressure was down and has not been that high again. I did not seek follow up because I was ok the next day. Date 10-5-18 - urgent care (nausea) Date 10-25-18 - Routine ear and hearing exam.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Hypertension, Hypoaesthesia, Laboratory test, Muscle spasms, Myalgia
Clinical narrative: 1. Swollen arm, arm pain, ear pain and neck pain within 24 hrs after the vaccination. Neck and ear pain re-occur sometimes. 2. Muscle craps in feet, hand, legs. 3. 9-27-18 neck pain, muscle pain in left side of arm and neck date 10-19-18 - acute high blood pressure I never had acute high blood pressure before. LVN told me to make a follow up appt. with my doctor. The next day my pressure was down and has not been that high again. I did not seek follow up because I was ok the next day. Date 10-5-18 - urgent care (nausea) Date 10-25-18 - Routine ear and hearing exam.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: 1. Swollen arm, arm pain, ear pain and neck pain within 24 hrs after the vaccination. Neck and ear pain re-occur sometimes. 2. Muscle craps in feet, hand, legs. 3. 9-27-18 neck pain, muscle pain in left side of arm and neck date 10-19-18 - acute high blood pressure I never had acute high blood pressure before. LVN told me to make a follow up appt. with my doctor. The next day my pressure was down and has not been that high again. I did not seek follow up because I was ok the next day. Date 10-5-18 - urgent care (nausea) Date 10-25-18 - Routine ear and hearing exam.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Treponema test, Vitamin B12
Clinical narrative: 1. Swollen arm, arm pain, ear pain and neck pain within 24 hrs after the vaccination. Neck and ear pain re-occur sometimes. 2. Muscle craps in feet, hand, legs. 3. 9-27-18 neck pain, muscle pain in left side of arm and neck date 10-19-18 - acute high blood pressure I never had acute high blood pressure before. LVN told me to make a follow up appt. with my doctor. The next day my pressure was down and has not been that high again. I did not seek follow up because I was ok the next day. Date 10-5-18 - urgent care (nausea) Date 10-25-18 - Routine ear and hearing exam.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pain and itching on the site as well as the whole upper arm. Redness is spreading and have not got any better in last 6 days. patient has taken tylenol for pain and will take benadryl
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling, pain and itching on the site as well as the whole upper arm. Redness is spreading and have not got any better in last 6 days. patient has taken tylenol for pain and will take benadryl
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Body temperature increased, Heart rate increased, Herpes zoster
Clinical narrative: I awoke 12-15 hours after injection with rapid heartbeat (145-150 bpm)(fitbit), and a temperature that was 6 degrees above normal. I took ibuprophen and temperature got down closer to normal in next 12 hours. heartbeat also returned to normal resting state (60-70bpm). Additionally it appears to have triggered a shingles outbreak as I now have new blisters in my scalp.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given Adult Hep A
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Abnormal loss of weight, Decreased appetite, Fatigue
Clinical narrative: Within 48 hours had extreme stomach pain, sweating, exhaustion, bloating and nausea  and could not eat properly. Ate with extreme difficulty and lost 18 pounds. Symptoms
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Within 48 hours had extreme stomach pain, sweating, exhaustion, bloating and nausea  and could not eat properly. Ate with extreme difficulty and lost 18 pounds. Symptoms
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Moderate to severe rash developed around waistline which spread to both breasts, back, buttocks, back of thighs, inner thighs, ankles and underarms. Saw Dr. on 07/10/19 and decided to wait until filling RX he prescribed to see if symptoms would subside.  Used oatmeal cream and Gold Bond powder and symptoms are finally started to subside somewhat and I think are no longer spreading.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Heart rate increased, Musculoskeletal pain
Clinical narrative: Chills, shivering, low fever, Heart rate at 150 to 160 bpm for a period of an hour on the morning after injection from 7am till 8am. Sore shoulder and general body aches. Soreness in joints. Very fatigued and poor sleeping the evening after vaccination
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Poor quality sleep, Pyrexia
Clinical narrative: Chills, shivering, low fever, Heart rate at 150 to 160 bpm for a period of an hour on the morning after injection from 7am till 8am. Sore shoulder and general body aches. Soreness in joints. Very fatigued and poor sleeping the evening after vaccination
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse effect reported; patient was inadvertently administered a second dose of PNEUMOVAX 23; Information has been received from a physician referring to a 68 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug/ allergies reactions were not provided.  The patient was administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number and expiration date, frequency and route were not provided) for prophylaxis in May 2018. On 11-JUN-2019, the patient was inadvertently administered a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot R027298, expiration date 09-APR-2020, route was intramuscular) instead of an intended dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (lot number and expiration date, frequency, indication and route were not provided). The physician reported the error occurred because he mistakenly thought the patient had already received pneumococcal 13v conj vaccine (crm197) (PREVNAR 13), then after the dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered, he discovered that the patient had already previously received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (wrong product administered). No adverse effect was 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 24-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 Fahrenheit degrees 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-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000862: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: 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-009507513-1907USA000903: 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-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
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 25-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 Fahrenheit degrees 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-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000862: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000937: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: 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-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924:
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 06-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees 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-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000862: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-0095075131907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: 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-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
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 14-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees 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-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000862: 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-009507513-1907USA000903: 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-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blood potassium decreased, Dizziness
Clinical narrative: been dizzy; Potassium down; This case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis.   In June 2019, the patient received Shingrix and PREVNAR 13. In June 2019, less than a day after receiving Shingrix, the patient experienced dizziness and potassium decreased. On an unknown date, the outcome of the dizziness was unknown and the outcome of the potassium decreased was not recovered/not resolved.   It was unknown if the reporter considered the dizziness and potassium decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix and Prevenar 13 last week at the same time at pharmacy. The patient did not know, if the administered vaccines bringing her potassium down. The patient ate banana and felt little better, but in the morning of reporting day, the patient woke up and felt dizzy again.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was been updated as adult as per vaccine indication. The reporter stated that, the patient's arm was sore immediately the next day after vaccination. This case has been linked with case US2019118444, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Injection site extravasation, Underdose
Clinical narrative: vaccine leaked out of injection site; Underdose; Inadvertent exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm, please see case US2019AMR124438).   On 30th June 2019, the patient received the 2nd dose of Shingrix. On 30th June 2019, immediately after receiving Shingrix, the patient experienced injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age grp was been updated as adult as per vaccine indication. The reporter stated that, the patient received 2nd dose of vaccine but some of the vaccine leaked out of the injection site after injection which led to underdose and injection site leaking. The reporter stated that his colleague administered the vaccine and he had limited details available. The reporter declined to provide any further information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st July 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported sore arm about 2 to 3 hours after receiving Shingrix. The reporter did not consent to follow up. The batch number was not avaialble.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; fever; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced general body pain and fever. On an unknown date, the outcome of the pain in arm, general body pain and fever were recovered/resolved.   The reporter considered the pain in arm, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. The patient experienced arm pain the day of the injection that got worse over the next few days and then resolved. On an unknown date less than a year after receiving a dose of Shingrix, the patient also noted extreme body aches all over that last a few days and resolved. The patient also had fever that resolved. This was 2 of 3 cases reported by same reporter. There is a discrepancy with respect to the outcome of the events redness, arm pain, arm pain and Fever outcome is reported as recovered. the outcome reported in the source document was recovered with sequel.  The outcome for all the events retains as per the structural field.
Sex: U
Vaccine: FLU4
Symptoms: Product dose omission
Clinical narrative: a child who only received one of the two dose series last year; Upon second medical examination of the case during internal review, a significant correction was performed on 11-Jul-2019 to update the case "non-case" to "valid case".  Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves child patient of unknown age who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that a child who only received one of the two dose series last year.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to missed dose.  It was unknown if the patient had any adverse event.  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.  Information on the batch number was requested.  List of documents held by sender: none.  Addendum: Upon second medical examination of the case during internal review, a significant correction was performed on 11-Jul-2019 to update the case "non-case" to "valid case".
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient received Adacel after excursion to -2C (excursion occurred because of malfunction of older refrigerator); Initial information received on 05-Jul-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional (other-pharmacy) by phone.  This case involves a patient of unknown demographics was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (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 Patient received Adacel after excursion to -2C (excursion occurred because of malfunction of older refrigerator)  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 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.   Information on batch number was requested.  Documents held by the sender: none.