chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lethargy, Nausea
Clinical narrative: Pain injection site started immediately, used ice when I got home, Swelling/redness  injection site started within an hour , took tylenol 500mg  Within 6 hours pain felt in shoulder joint  and redness/swelling in arm increased, 12 hours felt feverish, developed headache , took ibuprofen 400mg used ice, within 24 hours fever 101 severe injection site pain, redness swelling went back to bed on Tuesday AM severe fatigue, lethargy, nausea continued taking ibuprofen, 48 hours still in bed with severe injection site pain, redness , swelling , still taking ibuprofen , used hydrocortisone otc on injection site for severe itching , headache persisted.  36 hours still in bed with pain swelling, redness neasured rash 6 inches by 6 inches, eyes began itching with redness, itching on scalp, still continued otc ibuprofen, ice, hydrocortisone cream on rash. Spoke to RN at Drs office confirmed home measures appropriate
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Pain injection site started immediately, used ice when I got home, Swelling/redness  injection site started within an hour , took tylenol 500mg  Within 6 hours pain felt in shoulder joint  and redness/swelling in arm increased, 12 hours felt feverish, developed headache , took ibuprofen 400mg used ice, within 24 hours fever 101 severe injection site pain, redness swelling went back to bed on Tuesday AM severe fatigue, lethargy, nausea continued taking ibuprofen, 48 hours still in bed with severe injection site pain, redness , swelling , still taking ibuprofen , used hydrocortisone otc on injection site for severe itching , headache persisted.  36 hours still in bed with pain swelling, redness neasured rash 6 inches by 6 inches, eyes began itching with redness, itching on scalp, still continued otc ibuprofen, ice, hydrocortisone cream on rash. Spoke to RN at Drs office confirmed home measures appropriate
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, MMRV, RV1, UNK
Symptoms: Malaise, Opisthotonus, Screaming, Urticaria
Clinical narrative: Sickness. Constant screaming. Bowing of the body. Breaking out in whelps and hives.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: Pain swelling rash
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Pain, Pyrexia
Clinical narrative: Patient had high fever, localized pain, high blood pressure for a few days. Patient was admitted to ER on the first day due to really high blood pressure
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, warm to touch at both injection sites. (R) upper arm with  3"x3" area of pink, warmth, mild tenderness. (L) upper arm with 3.5"x3" area of pink warmth, mild tenderness. No induration.
Age: 37.0
Sex: F
Vaccine: HEPA, MEN, PPV
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Pain
Clinical narrative: PPSV23(1) and MenACWY vaccines in her left upper arm on 12 Apr 2019.She reports development of significant fever with rigors, severe headache, and body aches with onset the evening of vaccine receipt, and lasting 3 days. She also developed redness, warmth, pain, and swelling of her left upper arm surrounding the vaccination site. These symptoms worsened and patient sought evaluation in the Emergency Room on 16 Apr. She was diagnosed with Cellulitis and treated with oral antibiotics.
Age: 37.0
Sex: F
Vaccine: HEPA, MEN, PPV
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: PPSV23(1) and MenACWY vaccines in her left upper arm on 12 Apr 2019.She reports development of significant fever with rigors, severe headache, and body aches with onset the evening of vaccine receipt, and lasting 3 days. She also developed redness, warmth, pain, and swelling of her left upper arm surrounding the vaccination site. These symptoms worsened and patient sought evaluation in the Emergency Room on 16 Apr. She was diagnosed with Cellulitis and treated with oral antibiotics.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nasal congestion, Pruritus, Skin warm, Urticaria
Clinical narrative: woke up with a headache that hasn't subsided with taking Aleve and stuffy sinuses (these are listed as side effects). Around 9 pm started developing hives along my entire abdomen and around to my back, on both sides of my neck and upper chest to my shoulders, and at the hairline around my neck. They aren't raised, but they are warm and very itchy.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Severe diarrhea, dizziness, stomach pain, nausea, headache, tiredness, weakness, pain, redness and hot at injection sight, lightheaded.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Severe diarrhea, dizziness, stomach pain, nausea, headache, tiredness, weakness, pain, redness and hot at injection sight, lightheaded.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Headache (lasted 2 days) Fever (100.5 began 12 hours after vaccination; lasted for 30 hours) (Normal for me is 97) Chills and shivering (began 14 hours after vaccination; lasted for 8 hours) Body aches (began 6 hours after vaccination; lasted 36 hours) Severe arm pain and swelling ( began 12 hours after vaccination and still hurts at time of this report)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache (lasted 2 days) Fever (100.5 began 12 hours after vaccination; lasted for 30 hours) (Normal for me is 97) Chills and shivering (began 14 hours after vaccination; lasted for 8 hours) Body aches (began 6 hours after vaccination; lasted 36 hours) Severe arm pain and swelling ( began 12 hours after vaccination and still hurts at time of this report)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Herpes simplex, Neuralgia, Rash pruritic
Clinical narrative: Shingrix activated a severe episode of herpes 2 in me, resulting in symptoms identical to that of shingles: pain in hip area, raw nerve-endings, rash with extreme itching. Previous to the shot, I had not had a similar episode in over five years.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Almost complete loss of appetite within 4 hours of injection. Has not had a meal in almost 48 hours from lack of appetite. Vomited within 48 hours of vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain, Pain in extremity, Pulmonary pain
Clinical narrative: patient was fine for 3 days then she state she had arm pain that progressed to full body pain, muscle spasms and lung pain and believes it was tied to vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot
Clinical narrative: Within 3 minutes of receiving vaccine, pt felt hot and like she was about to faint.   RPh gave patient cold towel to put on her head and bottle of cold water from cooler and patient felt better.  Husband accompanied patient home.  RPh followed up later with the patient at home and she was feeling "1000% better".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient presented at the pharmacy on 8/9/2020 at about 1215pm, red rash, swelling and tenderness on the injection site, affected area is about 3 inches in diameter.  Advised patient to take Tylenol for pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Injection site reaction
Clinical narrative: On date of injection and for 3 days:     chills, fever, body aches (especially joints), dizzy episodes,  swelling under arm; injection site pain with red and itchy rash encircling arm 3  by 3 inches in size
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: On date of injection and for 3 days:     chills, fever, body aches (especially joints), dizzy episodes,  swelling under arm; injection site pain with red and itchy rash encircling arm 3  by 3 inches in size
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising
Clinical narrative: Large bruise at injection site
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient had woken up 08/09/2020 with signs of a rash ranging from her face down to her torso. She is not complaining of any other symptoms or discomfort other than the rash. I had instructed her to take otc benadryl for the rash and we would follow-up with her physician
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Loss of personal independence in daily activities, Malaise, Pain in extremity
Clinical narrative: Approximately 4 hours after injection, severe arm pain all the way to my hand. Next day, arm pain continued, fever of 100.1F (oral), headache, malaise. I was not able to do "normal activities." Took acetaminophen and ibuprofen and rested. The next day, the fever was gone and I felt nearly normal and resumed activities. Arm pain was down to manageable discomfort. Over the past couple of weeks, I have noticed my upper left arm is sore and does not seem to be getting better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Approximately 4 hours after injection, severe arm pain all the way to my hand. Next day, arm pain continued, fever of 100.1F (oral), headache, malaise. I was not able to do "normal activities." Took acetaminophen and ibuprofen and rested. The next day, the fever was gone and I felt nearly normal and resumed activities. Arm pain was down to manageable discomfort. Over the past couple of weeks, I have noticed my upper left arm is sore and does not seem to be getting better.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram normal, Eye movement disorder, Musculoskeletal stiffness, Tic
Clinical narrative: Tic like symptoms. stiffening up, rolling eyes
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Headache, Pyrexia, Rash
Clinical narrative: Adverse reaction occurred 2 weeks after MMR vaccine was administered. Symptoms included, bilateral conjunctivitis, extensive rash, severe fever (105 degrees), and severe headache for a duration of 5-7 days. All symptoms resolved within 10 days after onset.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site resolving slowly with ice
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Feeling abnormal, Pain
Clinical narrative: Intense pain, redness, rundown, temperature rise, but no fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Fatigue, Injection site erythema, Pain in extremity
Clinical narrative: Patient complained of weakness & fatigue on day 1 of administration of shingrix vaccine and has continued up to day 4 post vaccination. Patient also complained of pain in upper arm that extends to the back. Redness in injection site that was aproximately 2 inches in diameter. Pt has been taking tylenol to help with symptoms. But symptoms still persists. Advised patient to contact provider as symptoms have not subsided and pain in back is atypical.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Hyperhidrosis, Pallor
Clinical narrative: Patient was light headed, pulse rapid sweating and pale. we had him lay flat on the floor for a few minutes. He stated he hadn't eaten or had any water today. Once he was sitting upright he drank a bottle of water and ate a sleeve of crackers. He was also shaking like he was cold which lasted for about 15 minutes and then resolved. Patient was concious and talking the whole time. He also said he just didn't feel right.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Tremor
Clinical narrative: Patient was light headed, pulse rapid sweating and pale. we had him lay flat on the floor for a few minutes. He stated he hadn't eaten or had any water today. Once he was sitting upright he drank a bottle of water and ate a sleeve of crackers. He was also shaking like he was cold which lasted for about 15 minutes and then resolved. Patient was concious and talking the whole time. He also said he just didn't feel right.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Bruising near injection site
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Asthenia, Chest discomfort, Nausea, Throat tightness, Vomiting
Clinical narrative: Acute throat and chest constriction, nausea and vomiting, weakness
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Rash, Rash papular
Clinical narrative: Diffuse papular rash across body with areas of confluence on cheeks and injection site. Development of symptoms on 8/1/2020 (vaccine given 7/27/2020).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient reported having Bell's Palsy just a few days after receiving the vaccination and talking to her doctor
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: swollen sore arm around injection site. fever and sick the following day
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Patient administered IM in left deltoid. Patient became light headed. Patient laid down for 20 minutes. HR was 41. Patient denies any SOB chest pain. No wheezing noted. HR went up to 62. Patient provided fluids and father picked patient up. Patient encouraged EMS. Patient refused. ER symptoms provided
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Borrelia test negative, C-reactive protein increased, Culture throat negative, Decreased appetite, Delirium
Clinical narrative: Hard red swelling at site of vaccination on right arm followed by high fever of 105 degrees lasting 5 days and needing Tylenol/Ibuprofen q 3-4 hours to get fever down to 100 or 101 degrees x 5 days with symptoms of, lethargy, headaches, myalgia, lymphadenopathy, lack of appetite, delirium and difficulty moving off the bed or couch. Patient had never had a fever over 103 degrees prior to reaction.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Full blood count abnormal, Headache, Injection site erythema, Laboratory test normal, Lethargy
Clinical narrative: Hard red swelling at site of vaccination on right arm followed by high fever of 105 degrees lasting 5 days and needing Tylenol/Ibuprofen q 3-4 hours to get fever down to 100 or 101 degrees x 5 days with symptoms of, lethargy, headaches, myalgia, lymphadenopathy, lack of appetite, delirium and difficulty moving off the bed or couch. Patient had never had a fever over 103 degrees prior to reaction.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy, Mobility decreased, Myalgia, Neutropenia, Pyrexia
Clinical narrative: Hard red swelling at site of vaccination on right arm followed by high fever of 105 degrees lasting 5 days and needing Tylenol/Ibuprofen q 3-4 hours to get fever down to 100 or 101 degrees x 5 days with symptoms of, lethargy, headaches, myalgia, lymphadenopathy, lack of appetite, delirium and difficulty moving off the bed or couch. Patient had never had a fever over 103 degrees prior to reaction.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Streptococcus test negative, Vaccination site induration, Vaccination site swelling
Clinical narrative: Hard red swelling at site of vaccination on right arm followed by high fever of 105 degrees lasting 5 days and needing Tylenol/Ibuprofen q 3-4 hours to get fever down to 100 or 101 degrees x 5 days with symptoms of, lethargy, headaches, myalgia, lymphadenopathy, lack of appetite, delirium and difficulty moving off the bed or couch. Patient had never had a fever over 103 degrees prior to reaction.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient's wife called pharmacy on 8/9/2020 to report patient had been experiencing fever and soreness of the injection site since 8/8/2020. Patient was given vaccination on 8/7/2020, and asked to wait in pharmacy area for 10-15 minutes to monitor for any immediate adverse reactions. Patient waited, and did not exhibit any immediate adverse reaction from the vaccination.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Facial pain, Pain, Pain of skin, Pyrexia, Tenderness
Clinical narrative: Fever, body aches the next day for two days.  But about  10 days later i started getting pain on the right side of my  face and then my scalp Right side on 8/1/2020. I immediately started valtrex  until Monday  8/3 when i was told to take a 1000 mg 3 time a day for 7 days. on Tuesday my right ear was tender to the touch as well as the other pain described. Right now the pain has subsided. The pain was a 1-3 on the scale no big deal, but i was concerned about getting full blown shingles.  Right now the back of my scalp is very slightly painful, still,taking the meds.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Internal haemorrhage, Mobility decreased, Pain in extremity, X-ray limb
Clinical narrative: The pain gradually increases I couldn't lay down in bed from 11/14/2018 so I slept on couch. I had extremely sharp pain in my arm couldn't move from couch for hour 4th day of morning from vaccine date. So I went ER 11/17/2018 took Xray and had toradol shot. I went back to my PCP on 11/20/2018 8:30am took Xray again but Dr told me I must hit my arm somewhere because he see that trace of internal bleeding like bruise in my left arm but I don't have any discoloration surface of my arm. he said I should recover in 3month but I still have pain in my arm and can't lay on left side of body.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Middle insomnia, Pain
Clinical narrative: Later in the day I began to feel aches and pains all across my body. I woke up in the middle of the night with chills, aches, and an intense tenderness of the injection area.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: After vaccine administration, patient fainted, closed her eyes. After 1 to 2 minutes she woke up and said she had to vomit. After vomiting, she felt much better. Husband said pt has history of fainting w/ donated blood & some shots. Pt asked to received gardasiL at a different time. Pt wanted Gardasil vaccine after flu vaccine initially but we did not administer due to reaction after flushot.
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Pruritus
Clinical narrative: muscle spasms; itching; This spontaneous report as received from a medical assistant refers to a female patient of an unknown age. The patient had no pertinent medical history, concomitant medications, and drug reactions or allergies.  On 13-MAY-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R028656, expiration date 27-JUL-2020, intramuscularly (strength was not reported) for human papillomavirus (HPV) prevention.  On an unknown date, the patient experienced muscle spasms and itching. The patient did not receive any treatment for adverse events. No lab diagnostics or studies were performed. The patient sought medical attention and had an office visit on 22-JUL-2020. The outcome of muscle spasms and itching was reported as not recovered.  The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JUN-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot# S004119, expiration date: 11-FEB-2021, albumin status has been verified as recombinant human albumin (rHA) for prophylaxis (strength, dose, frequency, route of administration were not reported), which was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) (55.5 F) for 6 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse event was reported.
Sex: F
Vaccine: MMRV, UNK
Symptoms: Antibody test negative, Blood test, Measles antibody negative, Mumps antibody test negative, Product administered to patient of inappropriate age
Clinical narrative: the results came back on 07/17/2020 which showed that she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; 20-year-old patient was administered a dose of PROQUAD; the patient was administered a dose of PROQUAD instead of being administered a dose of MMR and Varicella vaccines seperately; This spontaneous report as received from a nurse refers to a 20-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUL-2020, the patient had titers drawn and the results came back on 17-JUL-2020, which showed that she did not have immunity to Measles, Mumps, Rubella or Varicella. On 17-JUL-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, subcutaneously, lot # S022104, expiration date: 12-JAN-2021, albumin status has been verified as recombinant human albumin (rHA), subcutaneously for titers (strength, exact dose, frequency were not reported), which was reconstituted with sterile diluent injection, lot #T000494, expiration date: 06-JUL-2022 (strength, dose, frequency, route of administration, indication  were not reported) as a treatment, instead of being administered any Measles, Mumps, Rubella or Varicella containing vaccines in the past. The patient had unspecified blood work done, but result were not reported.  Outcome of the events was reported as not recovered. The relatedness between the events and suspected therapies was not provided.
Sex: F
Vaccine: MMRV, UNK
Symptoms: Rubella antibody negative, Wrong product administered
Clinical narrative: the results came back on 07/17/2020 which showed that she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; she did not have immunity to MMR or Varicella; 20-year-old patient was administered a dose of PROQUAD; the patient was administered a dose of PROQUAD instead of being administered a dose of MMR and Varicella vaccines seperately; This spontaneous report as received from a nurse refers to a 20-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUL-2020, the patient had titers drawn and the results came back on 17-JUL-2020, which showed that she did not have immunity to Measles, Mumps, Rubella or Varicella. On 17-JUL-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, subcutaneously, lot # S022104, expiration date: 12-JAN-2021, albumin status has been verified as recombinant human albumin (rHA), subcutaneously for titers (strength, exact dose, frequency were not reported), which was reconstituted with sterile diluent injection, lot #T000494, expiration date: 06-JUL-2022 (strength, dose, frequency, route of administration, indication  were not reported) as a treatment, instead of being administered any Measles, Mumps, Rubella or Varicella containing vaccines in the past. The patient had unspecified blood work done, but result were not reported.  Outcome of the events was reported as not recovered. The relatedness between the events and suspected therapies was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 21-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S036635 and expiration date 14-NOV-2021) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. Properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) was used to reconstitute improperly stored vaccine. The temperatures to which the vaccine was exposed was from -14 degrees of Celsius (C) to -10C (-11.1C) and the time frame was reported as 2 hours, from -9 C to 8 C (2.2 C) and the time frame was reported as 9 hours and 30 minutes, from 14 C to -10 C (-9.8C) for 2 hours and 30 minutes, from -9 C to 8 C (0.4 C) for 3 hours. The vaccine underwent previous temperature excursion of temperature from -9 C to 8 C (-6.1C) for 8 hours. A digital data logger was involved. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The nurse verified a total of 9 administrations of improperly stored vaccines: 8 PROQUAD administrations and 1 VARIVAX administration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 20-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (0.5 ml, lot# T006792 and expiration date 24-AUG-2021; strength, route of administration were not reported) for prophylaxis (product storage error). The storage temperatures were -13.5 Celsius degrees for 24 minutes, -11.4 Celsius degrees for 27 minutes, -1.8 Celsius degrees for 2 hours and 8 minutes. There was previous temperature excursion. No product quality complaint (PQC) was involved in this case. Data logger was involved.  This is one of the 9 reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010334: US-009507513-2007USA010361: US-009507513-2007USA010374: US-009507513-2007USA010419: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010001: US-009507513-2007USA011962:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; Intramuscular formulation administered by other route; This spontaneous report has been received from an administrator, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 27-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via subcutaneous instead of intramuscularly (dose, frequency, lot number, expiration date and anatomical locations were not provided) for prophylaxis. No adverse effects reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: he was doing okay and no side effects were reported; An expired PROQUAD was inadvertently administered; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On an unspecified date in 2017 (reported as "when he was 1 year old"), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), second dose, 0.5 ml subcutaneous booster injection (anatomical location was not provided) (lot# S002490 with expiration date 23-JUL-2020) for vaccination.  At the time of the call, the patient was "doing okay" and no side effects were reported. As of 29-JUL-2020, it was unknown if he will receive another measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection.  This is one of two reports received from the same reporter (linked case was captured in # 2007USA012091).; Sender's Comments:  US-009507513-2007USA012091:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 was stored improperly and administered; This spontaneous report as received from a licensed practical nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JUL-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637651, expiration date 09-JUN-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was exposed to temperature of 50 degrees Fahrenheit for 1 hour and 46 minutes. There were no previous excursions reported. Digital data logger was involved. There was no additional adverse effect reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA012014: US-009507513-2007USA012054: US-009507513-2007USA012061: US-009507513-2008USA000266: US-009507513-2007USA012124: US-009507513-2008USA000307: US-009507513-2008USA000314: US-009507513-2008USA000367: US-009507513-2008USA000370: US-009507513-2008USA000372:
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; PROQUAD was administered to a 4 month old; This spontaneous report was received from a medical assistant concerning to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml (route not reported) (lot# S03021, expiration date 25-MAR-2021) for prophylaxis (product administered to patient of inappropriate age) which was diluted with sterile diluent (lot # N032756, expiration date 05-AUG-2020) (dose and frequency were not reported). No adverse event reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported; administered a dose of improperly stored VARIVAX; This spontaneous report as received from a study coordinator referring to a 13-month-old patient of unknown gender. Information about pertinent medical history, concomitant medication, drug reaction or allergy was not provided.      On 14-JUL-2020, the patient were vaccinated with a dose of improperly stored doses varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S007963, expiration date: 02-AUG-2021, but upon internal validation was non-valid lot #; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). The vaccines were reconstituted using a properly stored sterile diluent (lot # and expiration date not reported). It was reported that the vaccines were exposed to a temperature of -14 Celsius degree to -10 Celsius degree (-12.8 Celsius degree) for 46 minutes. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. The outcome of product storage error was unknown.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA000429: US-009507513-2008USA000587:
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported; an administered VAQTA vaccine that was expired; had a recent temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 08-FEB-2020 (also reported as 10-FEB-2020), hepatitis a vaccine, inactivated (VAQTA) 1ml (lot# S012250, expiration date 07-JUL-2020) had a temperature excursion with temperature above 47 degrees Fahrenheit (F) (66 F) and time frame of 26 hours.  On 03-AUG-2020, the patient was vaccinated with the hepatitis a vaccine, inactivated (VAQTA) (1ml, once) that was expired and had recent temperature excursion via unknown route for prophylaxis (expired vaccine used and improper storage of product in use).    No additional adverse event (AE) or product quality complaint (PQC) reported. The outcome of the events was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; serialnumber: 100030884661; udinumber: GTIN:00300064096026; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: administered MMR II that was improperly stored in the freezer; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 03-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Recombinant human albumin (rHA), lot # S020161, expiration date 30-JUN-2021 (exact dose and route of administration were not reported) for prophylaxis.  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as -10 degrees of F for an unknown time. There was a previous temperature excursion reported: below 36 degrees of F (10 degrees of F) for 50 minutes.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Social problem
Clinical narrative: Active shingles currently; Late second dose due to COVID; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix due to COVID and had an active case of shingles. The reporter was consented to follow up. This case was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148748:Same reporter US-GLAXOSMITHKLINE-US2020148750:Same reporter US-GLAXOSMITHKLINE-US2020148754:Same reporter
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope; Unconscious for approximately 1 minute; This case was reported by a other health professional via sales rep and described the occurrence of syncope in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 28th November 2021) for prophylaxis.   On an unknown date, the patient received Boostrix (intramuscular). On an unknown date, unknown after receiving Boostrix, the patient experienced syncope (serious criteria GSK medically significant) and unconscious (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope and unconscious were recovered/resolved.   It was unknown if the reporter considered the syncope and unconscious to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Boostrix and 2 other non-GlaxoSmithKline vaccines, the patient had a syncope event in which she was unconscious for approximately 1 minute.  The patient recovered and went home without requiring any treatment.  The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site rash, Mental impairment
Clinical narrative: Could not think straight; Swelling at the injection site; Redness, swelling, rash and swelling at the injection site; Rash and swelling at the injection site; Red injection site extended swelling, rash, pain; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, immediately after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroids). Shingrix was discontinued. On an unknown date, the outcome of the difficulty thinking was not recovered/not resolved and the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the difficulty thinking, extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was over 50 years old. Shortly after receiving Shingrix, the patient experienced a fever up to 105 F and redness, swelling, pain, rash and swelling at the injection site that extended all the way down to the patient's elbow.  The patient could not think straight.  As a measure, the patient received treatment at the emergency room and was given Benadryl and steroids.  The patient was considering not receiving the 2nd dose of Shingrix. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Could not think straight; Swelling at the injection site; Redness, swelling, rash and swelling at the injection site; Rash and swelling at the injection site; Red injection site extended swelling, rash, pain; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, immediately after receiving Shingrix, the patient experienced difficulty thinking (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroids). Shingrix was discontinued. On an unknown date, the outcome of the difficulty thinking was not recovered/not resolved and the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the difficulty thinking, extensive swelling of vaccinated limb, injection site erythema, injection site rash, injection site pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was over 50 years old. Shortly after receiving Shingrix, the patient experienced a fever up to 105 F and redness, swelling, pain, rash and swelling at the injection site that extended all the way down to the patient's elbow.  The patient could not think straight.  As a measure, the patient received treatment at the emergency room and was given Benadryl and steroids.  The patient was considering not receiving the 2nd dose of Shingrix. The reporter was consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: syncope event; Initial information received on 03-Aug-2020 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves three unknown demographic patients who had a syncope event (Syncope) following administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On an unknown date, patients received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6596AB and expiry date 24-May-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patients developed a serious syncope event (Syncope) immediately (exact latency not reported) after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant.  Details of laboratory data was not reported.  Final diagnosis was syncope.   It was not reported if the patient received any corrective treatment.  At the time of this report, outcome of the event was not reported (unknown).; Sender's Comments: This case concerns three unknown demographic patient who had syncope immediately after the vaccination with MENACTRA. The time to onset is compatible with the role of vaccine. However, patients medical history, concomitant medication, condition at time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pustule, Tenderness
Clinical narrative: Blisters on the head, mainly on the scalp area. Small areas appeared shortly after first shot, but became widespread across the scalp on the next day after the second shot .  This has continued since then with areas or individual blisters appearing on the scalp, neck and hairline of forehead. Very painful to touch and filled with puss like a large pimple.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Chills, shivering, severe headache, flu-like symptoms, tiredness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: left arm soreness but within hours became weak with muscle pain and fever; temp 99.8 progressing to 100.2 over the 24 to 30 hours.  Feeling fine by 48 hrs after administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site swelling, Injection site warmth
Clinical narrative: Day after immunizations had temp to 100.0. Site swelling, area warm to touch. Day 2 after immunizations area of swelling increased and is from shoulder to elbow. 13X10 cm. Area seems non tender but child is non verbal. Seen in office and started on Cephalexin.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Colonoscopy, Cytogenetic analysis, Injection site nodule, Injection site pain, Insomnia
Clinical narrative: indication: History of HPV; she is experiencing pain in her left shoulder; she can feel a knot underneath the skin at the injection site; This spontaneous report was received from a 45-year-old female patient, who was reporting on herself. The patient's concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included fexofenadine hydrochloride (ALLEGRA). The patient's medical history consisted of hysterectomy, two right hip surgeries, three ear surgeries and Human papilloma virus infection (HPV).  On 07-JUL-2020, 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) 1 dose, route of administration reported as injection, in her upper left arm (exact dose, lot number and expiry date were not reported) for prophylaxis (indication reported as history of HPV; product use in unapproved indication).  On the same date, she experienced pain in her left shoulder and could feel a knot underneath the skin at the injection site. It was also stated that she could not sleep on her arm because of the pain. The patient received a hot compress as a treatment for the events. It was reported that the patient sought medical attention and she notified her doctors. Following lab diagnostics or studies were performed: genetic test (reported as geno test) and colonoscopy however no results were provided. The outcome of the events was reported as not recovered.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.