chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Mumps antibody test negative, Mycotic allergy, Rheumatoid arthritis, Rubber sensitivity
Clinical narrative: Pertinent Medical History: "RHEUMATOID ARTHRITIS"; Drug Reactions/Allergies: 'LATEX, LEVOFLOXACIN, FENTANYL, ASPIRIN, EGGS, MOLD, CEPHALASPORINS, OTHER UNKNOWN ALLERGIES; Drug Reactions/Allergies: 'LATEX, LEVOFLOXACIN, FENTANYL, ASPIRIN, EGGS, MOLD, CEPHALASPORINS, OTHER UNKNOWN ALLERGIES; Drug Reactions/Allergies: 'LATEX, LEVOFLOXACIN, FENTANYL, ASPIRIN, EGGS, MOLD, CEPHALASPORINS, OTHER UNKNOWN ALLERGIES; Drug Reactions/Allergies: 'LATEX, LEVOFLOXACIN, FENTANYL, ASPIRIN, EGGS, MOLD, CEPHALASPORINS, OTHER UNKNOWN ALLERGIES; Drug Reactions/Allergies: 'LATEX, LEVOFLOXACIN, FENTANYL, ASPIRIN, EGGS, MOLD, CEPHALASPORINS, OTHER UNKNOWN ALLERGIES; the patient bad negative titers for Mumps; Route of Administration: "INTRAMUSCULAR"; This spontaneous report as received from a registered nurse refers to a female patient reported to currently be 30 years old. Her concomitant medications were unknown by the reporter.   In 1988, the patient was vaccinated with suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). In 1989, she received another measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); both were administered intramuscularly (incorrect route of product administration) for the prevention of measles, mumps, and rubella (concentration, administered doses, frequency of vaccination scheme, anatomical location of vaccination, lot numbers, and expiration dates were unknown).   Other suspect therapies, administered to the patient on unspecified dates, included levofloxacin, fentanyl, aspirin, and unspecified cephalosporins; to which the patient experienced reactions/allergies (drug hypersensitivity) on unspecified dates. The action taken with these products was not reported.   On unspecified dates, the patient experienced allergies to latex (rubber sensitivity), eggs (food allergy), mold (mycotic allergy), other unknown allergies (multiple allergies), and rheumatoid arthritis; her outcome from these events was not reported.   On 10-MAR-2020, the patient sought medical attention by visiting the physician's office for blood work that showed that she had negative titers for mumps (antibody test negative) which she did not receive treatment for and was reported to be resolved.        The reporter's causality assessment between suspect products and the occurrence of the events was not provided.   Upon internal review, rheumatoid arthritis was considered to be a medically significant event.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: on 3/11/2020 patient had Varicella titers drawn after VARIVAX was administered on 8/28/2019.; Information has been received from a licensed practical nurse referring to a 13 years old female patient. The patient had no pertinent medical history, no drug reactions or allergies and no concomitant medications.  On 28-AUG-2019, the patient was administered with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis (reported as for routine school vaccination).         On 11-MAR-2020, the patient had varicella titers drawn. Titers were positive. The patient sought medical attention and there was no treatment given for the event. The outcome of the event was recovered in March 2020. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005659:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: headache, arm soreness, arm redness
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA) (lot # R022571, expiration date 04-FEB-2020) (route of administration was not reported) for prophylaxis, diluted in sterile diluent (dose, lot # and expiration date were not reported).  No adverse symptoms were reported.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; VARIVAX given intramuscular instead of subcutaneous; This spontaneous report as received from a healthcare professional refers to a 31 years old female patient. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent(MERCK STERILE DILUENT).       On 11-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneous in the right deltoid (lot # and expiry date was not reported) for prophylaxis (incorrect route of product administration). The patient had no adverse event. There was no product quality complaint reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Patient stated that she noticed redness, swelling, and patches of hives beginning to form around her arm. She said they were itchy, red, swollen, and painful. She only self-treated with rubbing alcohol which she said helped, and took some Tylenol for the pain which she said helped a little. She denied taking any allergy type medications.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Impaired work ability, Pain, Peripheral swelling
Clinical narrative: Patient has fever and body aches, a swollen red hot arm and headache .cannot go to work
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient has fever and body aches, a swollen red hot arm and headache .cannot go to work
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Influenza virus test, Laboratory test, Petechiae
Clinical narrative: Pt had severe headache and vomiting 40 mins after injection. Followed by facial swelling, dizziness, and petechial rash to face and chest. Pt was treated in ER with iv fluids, toradol and reglan IV.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Streptococcus test, Swelling face, Urine analysis, Vomiting
Clinical narrative: Pt had severe headache and vomiting 40 mins after injection. Followed by facial swelling, dizziness, and petechial rash to face and chest. Pt was treated in ER with iv fluids, toradol and reglan IV.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hypersensitivity, Subcutaneous abscess
Clinical narrative: Allergic reaction caused by vaccine DTaP/HIBAbscess of skin and/or subcutaneous tissue Provided skin abscess in children: care instructions Start sulfamethoxazole 200 mg-trimethoprim 40 mg/5 mL oral suspension 6 mL 2 times a day for 10 days Start mupirocin 2 % topical ointment 1 application 2 times a day with meals for 7 days
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood test, Computerised tomogram head, Ear pain, Eye pain, Headache
Clinical narrative: Headache, nausea and vomiting, ear, eye and neck pain day after immunization., headache and neck pain persisted, pt was seen in ER on 2/27. Treated in ER with IV fluids, IV reglan, toradol and benadryl.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Neck pain, Pharyngitis, Urinary tract infection, Vomiting
Clinical narrative: Headache, nausea and vomiting, ear, eye and neck pain day after immunization., headache and neck pain persisted, pt was seen in ER on 2/27. Treated in ER with IV fluids, IV reglan, toradol and benadryl.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Malaise, Presyncope
Clinical narrative: Patient received vaccine and after 20 seconds stated he did not feel well and had a vasovagal response
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Patient reported that she experienced red blistery rash on Left upper arm.  Bumps developed 3-4 days after vaccine administered.  The red bumps turned in to blistery bumps that were itchy and at times pain "shot through the area on her arm".  Within a week, the bumps had dried up.
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Hispanic boy vomited after administration; This spontaneous report was received from a physician and refers to a male patient (reported as boy) of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On unknown date, approximately in 2015 (reported as about 4 or 5 years ago), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, dose number, lot # expiration date were not reported) for prophylaxis. On unknown date approximately in 2015 (reported as about 4 or 5 years ago), after the vaccine administration the boy vomited. The patient did not seek medical attention, and did not receive any treatment. On an unknown date, the patient recovered from the event. Causality assessment between vomiting and vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA009379: US-009507513-2002USA009378:
Sex: U
Vaccine: HEPA, HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; patient was administered an improperlystored dose of either VAQTA, PEDVAX HIB, or GARDASIL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number S010727 has been verified to be a valid, expiration date reported and validated as 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S006471 has been verified to be a valid, expiration date reported and validated as 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1621926 has been verified to be a valid, expiration date reported and validated as 28-NOV-2021), as prophylaxis (for all vaccines concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  According to the reporter, the temperature excursion was 34.9 degrees Fahrenheit for a time frame of 7 minutes and 48.2 degrees Fahrenheit for a time frame of 5 hours, on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.
Age: 17.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse event; the 17-year-old patient received an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 03-MAR-2020, the patient was vaccinated with and adult dose of hepatitis a vaccine, inactivated (VAQTA) strength 50/0.1 units per milliliter (U/mL) (number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S025258 has been verified to be a valid, expiration date reported and validated as 05-NOV-2020) as prophylaxis (product administered to patient of inappropriate age). No adverse events were reported for the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Pain, Pain in extremity
Clinical narrative: constant pain with occasional sbooting pain in his right ann since the VAQTA administration; This spontaneous report as received from a pharmacist refers to a 69-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 05-DEC-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) in the right arm (dose, lot # and expiration date were not reported) for prophylaxis.   On an unknown date, the patient experienced constant pain with occasional shooting pain in his right arm since the hepatitis a vaccine, inactivated (VAQTA) administration. The patient sought for medical attention by visiting the pharmacist.  The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Age: 0.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no known adverse effects; a patient received a dose of PROQUAD 5 days before the patient's 1st birthday; This spontaneous report was received from a registered nurse, referring to a 11-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 30-NOV-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection as prophylaxis (dosage regimen, route of administration and anatomical location were not reported; lot number and expiration date were unknown by the reporter) 5 days before the patient's first birthday (product administered to patient of inappropriate age). No known adverse effects.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO additional adverse etfect; was administered adose of expired VAQTA; This spontaneous report as received from a nurse 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 11-MAR-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S001360, expiration date 06-MAR-2020, intramuscularly (dose was not reported) for prophylaxis. There was no adverse event reported.
Age: 34.0
Sex: M
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Presyncope
Clinical narrative: After receiving vaccines patient had vasovagal response that lasted about 20 seconds.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Pain
Clinical narrative: pt presented to office with a reaction she believes came from her getting the Pneumovax 23.  pt arm was red at injection site which went around arm and some pain at site which resolved with Tylenol, some arm pain when lifting and this has improved.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Adverse reaction, Feeling abnormal, Immediate post-injection reaction, Posture abnormal, Tremor
Clinical narrative: Immediately following receiving the Menactra injection, patient's head became limp and I asked her to lay her head on my shoulder. She did not comply so I started to lay patient back on the exam table on which she was seated. As she was being laid back, she started either shaking  or seizing (I could not determine which). I sat her up again and she said, 'That was weird, what just happened?'. I explained that she had had an adverse reaction after her vaccine and asked her to lie back again, which she did. I then opened the exam room door and summoned the PCP, who came in the room immediately and examined the patient while she remained laying down. Her pulse and BP were taken and recorded. The patient was then given some water to drink. She stood without dizziness and was walked out to the waiting room to her sister, who had accompanied her to the office. She was asked to remain another 15 minutes and told she could leave at that time if no further reactions were noted.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test, Pruritus, Rash, Urticaria
Clinical narrative: Shortly After I got the (Fluzone) Flu shot,. I started itching I right away I started using Clamine lotion to try to stop the itching. It did not stop, then I start seeing a lot of bumps all over my Arms, And legs. Immediately I went to my PC Doctor, she said I have hives. She diagnosis it And prescripted medication for me to take, After taking A number of different prescriptions, Knowing seemingly had helped. Dr. suggested that I go to An Allergist And Dermatologist. I have been under the Allergist cares I still have bad Breakouts(Hives)?
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: swollen tongue
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Dizziness, Facial bones fracture, Haemorrhage
Clinical narrative: shot was given around 1:30pm 12-30-2019: nausea started soon afterwards as did arm pain - both of which continued throughout the night. I had periods of intense shivering off and on all night as well as dizziness. At one point I attempted to get out of bed to go to the bathroom to throw up, passed out, hit a dresser and broke my nose causing severe bleeding, and a bruise below my eye leaving a permanent mark.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Laboratory test normal, Loss of consciousness, Nasal injury, Nausea
Clinical narrative: shot was given around 1:30pm 12-30-2019: nausea started soon afterwards as did arm pain - both of which continued throughout the night. I had periods of intense shivering off and on all night as well as dizziness. At one point I attempted to get out of bed to go to the bathroom to throw up, passed out, hit a dresser and broke my nose causing severe bleeding, and a bruise below my eye leaving a permanent mark.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Scar
Clinical narrative: shot was given around 1:30pm 12-30-2019: nausea started soon afterwards as did arm pain - both of which continued throughout the night. I had periods of intense shivering off and on all night as well as dizziness. At one point I attempted to get out of bed to go to the bathroom to throw up, passed out, hit a dresser and broke my nose causing severe bleeding, and a bruise below my eye leaving a permanent mark.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Seizure about 10 minutes after receiving first dose of Shingrix vaccine. This was reported today 3/7/20 but vaccine was administered 10/22/19
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Dyspepsia, Injection site pain, Injection site swelling, Swelling
Clinical narrative: The spot I got the shot swelled up like I Had a Golf Ball under my skin for a month my whole Shoulder was swelled up and pain. Shoulder still hurts it is a deep pain like in side bone. Secound month had spot on right side of gutt swell up that had a lot of Heart burn
Sex: U
Vaccine: HEPA, HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored vaccines administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 28-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number S010727 has been verified to be a valid, expiration date reported and validated as 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S006471 has been verified to be a valid, expiration date reported and validated as 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1621926 has been verified to be a valid, expiration date reported and validated as 28-NOV-2021), as prophylaxis (for all vaccines concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  According to the reporter, the temperature excursion was 34.9 degrees Fahrenheit for a time frame of 7 minutes and 48.2 degrees Fahrenheit for a time frame of 5 hours, on an unspecified date, as recorded by data logger.  The vaccines had no previous temperature excursion; there was no PQC reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hordeolum, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: she has pain and redness on the injection site. She had fever up to 103F for 3 days. She had nausea but no vomit. She had bodyache. She had a stye appearing within hours of bodyache on her right eye.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: she has pain and redness on the injection site. She had fever up to 103F for 3 days. She had nausea but no vomit. She had bodyache. She had a stye appearing within hours of bodyache on her right eye.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Constipation, Diarrhoea, Fatigue
Clinical narrative: Chills, shivers, extreme fatigue, nausea, vomiting, diarrhea, abdominal pain, headache. Ibuprofen and Tylenol had little effect. Zofran helped nausea a tiny bit but causes constipation. Side effects lasted 8 days....could not work/care for grandson and family five of those days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Loss of personal independence in daily activities, Nausea, Vomiting
Clinical narrative: Chills, shivers, extreme fatigue, nausea, vomiting, diarrhea, abdominal pain, headache. Ibuprofen and Tylenol had little effect. Zofran helped nausea a tiny bit but causes constipation. Side effects lasted 8 days....could not work/care for grandson and family five of those days
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: MMR was given on 12/12/19 prior to patient being aware she was pregnant.  LMP 12/1/19.  EDC 9/6/20.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm was swollen and red around injection site and warm to touch. Six days later, it is less red but still visible.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: 03/09/2020: Monday evening patient has arm, neck, and shoulder pain. Patient also had a headache. These symptoms lasted until Wednesday. 03/10/2020: Tuesday night patient started to experience fatigue "almost like the flu" 03/11/2020: Wednesday night 1st blister appeared on face 03/12/2020: Thursday morning patient woke up to blisters and red/raw feeling on face. Patient has had shingles 2-3 times in the past and had a prescription for Valtrex at home. Patient started taking Valtrex 500 mg on 03/12/2020 with directions 1 tablet by mouth twice daily
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Skin erosion
Clinical narrative: 03/09/2020: Monday evening patient has arm, neck, and shoulder pain. Patient also had a headache. These symptoms lasted until Wednesday. 03/10/2020: Tuesday night patient started to experience fatigue "almost like the flu" 03/11/2020: Wednesday night 1st blister appeared on face 03/12/2020: Thursday morning patient woke up to blisters and red/raw feeling on face. Patient has had shingles 2-3 times in the past and had a prescription for Valtrex at home. Patient started taking Valtrex 500 mg on 03/12/2020 with directions 1 tablet by mouth twice daily
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Headache, Injection site inflammation, Pyrexia
Clinical narrative: Fever to 103.7, headache, chills, anorexia, inflammation at injection site
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Injection site erythema, Injection site pain
Clinical narrative: Large, raised, red, painful arm near injection site.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient began developing swelling around injection site on Friday (next day). Parents noticed swelling, redness, rash around injection site; denies fever. Parent called provider's office on Monday morning (3/16/20) to inform of symptoms.  Dr. recommended applying ice pack to injection site, to take Benadryl.
Age: 65.0
Sex: U
Vaccine: UNK
Symptoms: Injection site pain, Pruritus, Rash, Skin ulcer, Urticaria
Clinical narrative: On the day of the Injection, I felt the usual pain as the first injection. That evening I began to feel itching on my palms and in between my fingers on both hands. The next day the itching continued and that morning I broke out with a rash (hives) on my arms, forearms, underarms and on my torso front and back. I called the dr's office and spoke to a triage nurse that advised me to take over the counter meds to treat the symptoms ,(itching and hives). The symptoms continued and I made an appointment to see a dr on Sunday. I had a sore that appeared on my left buttock. I realized that it was in the same area that I had acquired shingles a few years before. (Con't)
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: upper left arm was very painful from 3 pm of the day I got the shot until 4 days later.  I could hardly move it and had to take sleeping pill at nite.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pruritus
Clinical narrative: patient states started to fill itchiness and discomfort on 3/14/20 (4 days after injection). Went to md office today (3/16/20) and was diagnosed with active shingles. patient was prescribed valacyclovir 1 gram tid #21
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills, nausea, headache, fever of 101 F
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Rash maculo-papular
Clinical narrative: Maculopapular rash at injection site; pain right deltoid area; pain severe for two days, gradually diminishing but slight limitation of use of arm remains.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node in (R) supraclavicular Loss a became moderately tender & swollen within 24 hours of vaccine
Age: 2.0
Sex: U
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of Left Leg after receiving Pediarix (DtaP-IPV, Hep B) on Left Leg on 2/6/20
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, Swollen, painful @ injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information had been received from a lawyer regarding a case in litigation and refers to a patient of currently 67 years old of unknown gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. On or about 15-MAR-2016, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) vaccine (dose, route, site of administration, lot # and expiration date were not provided) by a pharmacist for the long-term prevention of shingles and zoster-related conditions in a pharmacy. Later, on an unspecified date, the patient was treated by a physician for the following injuries resulting from patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles. The outcome of the singles was unknown and the causality between this event and the vaccination with Zoster Vaccine Live (ZOSTAVAX) was reported as related.
Age: 66.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Headache, Inflammation, Peripheral swelling, Pyrexia, Rash
Clinical narrative: the patient was hospitalized in an unspecified hospital on an unspecified date after administration of the PNEUMOVAX 23; inflammation of the arm into which the PNEUMOVAX was administered; vomiting; headache; rash/ it is unknown where on the patient's body the rash was located; the patient experienced fever; This initial spontaneous report was received from a physician, via company representative, regarding a 66-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were unknown by the reporter.  On 28-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, in his arm, (strength, dose, route of administration and vaccination scheme were not reported; lot number: S021740, expiration date 25-MAR-2021) as prophylaxis. On the same date, the patient was injected with ketorolac tromethamine (strength, dose, route of administration, anatomical site of injection, lot number, expiration date or indication were not reported).  On an unspecified date in 2020 (reported as "within a few days after the dose was administered"), the patient experienced fever (pyrexia), vomiting, headache, inflammation of the arm into which the vaccine was administered (peripheral swelling) and a rash at an unknown location. The reporter mentioned that the patient sought medical attention.  On an unknown date in 2020, the patient was hospitalized (adverse event). The patient was treated for the events (unspecified), however it was unknown if he had  any laboratories/studies performed due to the adverse events.  The action taken with ketorolac tromethamine regarding the adverse event, rash, peripheral swelling, headache, vomiting and pyrexia, was not reported. The outcome of the aforementioned events, was unknown by the reporter. The causality assessment between the therapies pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and ketorolac tromethamine, and the aforementioned events, was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S021740; expirationdate: 25-MAR-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA003872: US-009507513-2003USA003225:
Age: 66.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Vomiting
Clinical narrative: the patient was hospitalized in an unspecified hospital on an unspecified date after administration of the PNEUMOVAX 23; inflammation of the arm into which the PNEUMOVAX was administered; vomiting; headache; rash/ it is unknown where on the patient's body the rash was located; the patient experienced fever; This initial spontaneous report was received from a physician, via company representative, regarding a 66-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were unknown by the reporter.  On 28-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, in his arm, (strength, dose, route of administration and vaccination scheme were not reported; lot number: S021740, expiration date 25-MAR-2021) as prophylaxis. On the same date, the patient was injected with ketorolac tromethamine (strength, dose, route of administration, anatomical site of injection, lot number, expiration date or indication were not reported).  On an unspecified date in 2020 (reported as "within a few days after the dose was administered"), the patient experienced fever (pyrexia), vomiting, headache, inflammation of the arm into which the vaccine was administered (peripheral swelling) and a rash at an unknown location. The reporter mentioned that the patient sought medical attention.  On an unknown date in 2020, the patient was hospitalized (adverse event). The patient was treated for the events (unspecified), however it was unknown if he had  any laboratories/studies performed due to the adverse events.  The action taken with ketorolac tromethamine regarding the adverse event, rash, peripheral swelling, headache, vomiting and pyrexia, was not reported. The outcome of the aforementioned events, was unknown by the reporter. The causality assessment between the therapies pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and ketorolac tromethamine, and the aforementioned events, was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S021740; expirationdate: 25-MAR-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA003872: US-009507513-2003USA003225:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Unevaluable event
Clinical narrative: 1.6-fold increase in central nervous system demyelinating conditions like multiple sclerosis; 1.6-fold increase in central nervous system demyelinating conditions like multiple sclerosis; 7.6- fold increase lupus; 5.6-fold increase in rheumatoid arthritis; 15-fold increase in ovarian damage; Autoimmune adverse events; They found a 4.6-fold increase risk of serious autoimmune adverse events outcomes of gastroenteritis; 10-fold increase of irritable bowel syndrome in women and girls who were given the Gardasil vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; I've seen young girls suffer premature ovarian failure, total body hair loss, and arthritis after taking the vaccine.; This spontaneous report was received from a physician via online article, referring to an unspecified number of female patients of unknown ages. The patients' pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.       On an unknown date, an unidentified Merck human papillomavirus (HPV) vaccine (name and lot number not provided) (strength, dose, dosage regimen, frequency, route of administration, anatomical location, and expiration dates were not reported for any vaccine) was administered to the patients as a prevention of the HPV.  On unspecified dates, it was reported that the patients were experiencing autoimmune events linked to the HPV vaccines. They found a 4.6-fold increase risk of serious autoimmune adverse events (autoimmune disorder) outcomes of gastroenteritis, a 7.6- fold increase lupus (systemic lupus erythematosus), 5.6-fold increase in rheumatoid arthritis, 1.6-fold increase in central nervous system demyelinating conditions (demyelination) like multiple sclerosis, 15-fold increase in ovarian damage (ovarian injury), and a 10-fold increase of irritable bowel syndrome in women and girls who were given the vaccines. The physician had seen young girls suffer premature ovarian failure (premature menopause), total body hair loss (alopecia), and arthritis after taking the vaccine.  The outcome of the aforementioned events was not reported.  The reporter considered the events to be linked to the suspect vaccines.  Upon internal review, multiple sclerosis, demyelination, ovarian injury, rheumatoid arthritis, systemic lupus erythematosus, autoimmune disorder were determined to be medically significant. Additionally, the reporter considered the event gastroenteritis to be serious.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: adverse event; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for prophylaxis. On an unspecified date, the patient experienced unspecified adverse event. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Burning sensation, Ear discomfort, Pruritus
Clinical narrative: burning sensation on her face and ears; burning sensation on her face and ears; she has been experiencing intense itching; This spontaneous report was received from a 77-year-old female consumer, referring to herself. The patient's pertinent medical history included asthma, glaucoma and gastrooesophageal reflux disease (GERD). Her concomitant therapies included fluticasone propionate (FLOVENT), ipratropium bromide (ATROVENT HFA), pantoprazole, diazepam and brimonidine tartrate. As previous drug reactions/allergies, the patient mentioned an unspecified penicillin, an unspecified sulfa and clarithromycin (BIAXIN).  On 06-MAR-2020, the patient was vaccinated with one shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left upper arm, (strength, route of administration, vaccination scheme, lot number and expiration date were unknown), as prophylaxis.  On 06-MAR-2020, the patient experienced intense itching (pruritus), and burning sensation on her face and ears (burning sensation and ear discomfort). The patient sought medical attention as she spoke to the physician's office. As treatment, the patient had recommended diphenhydramine (benadryl). It was reported that the patient had a blood work performed due to the adverse events, however, no results were reported.  At the time of the report, the patient had not recovered from ear discomfort, pruritus and burning sensation. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms were reported; patient was inadvertently administered one dose of VAQTA which was expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 12-MAR-2020, the patient was inadvertently vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) strength 50/1.0 units per milliliter (U/ml), 1 dose as prophylaxis (vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S001360, and expiration date reported 06-MAR-2020) (expired product administered). The product had not undergone any temperature excursions and no symptoms were reported for the patient.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 28-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 21-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005901: US-009507513-2003USA005908:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient was inadvertently administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 10-MAR-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot number S021322, expiration date 09-JUL-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored diluent MRK (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of (-8.3C) for 24 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-2003USA005878:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 10-FEB-2020, the patient was vaccinated with dose one of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) administered oraly as prophylaxis (lot number 1660112 has been verified to be valid, expiration date reported and validated as 18-OCT-2020). No additional adverse effect reported.  The temperature of multiple excursions was reported below 2 degrees Celsius (1.28 degrees Celsius) for 2 hours and 30 hours. No previous temperature excursions reported, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005852: US-009507513-2003USA005829: US-009507513-2003USA005831: US-009507513-2003USA005884: US-009507513-2003USA005892: US-009507513-2003USA005901: US-009507513-2003USA005908: US-009507513-2003USA005910: US-009507513-2003USA005916: US-009507513-2003USA005917: US-009507513-2003USA005942: US-009507513-2003USA005946: US-009507513-2003USA005962: US-009507513-2003USA005967: US-009507513-2003USA005983: US-009507513-2003USA005996:
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse event.; inadvertent administration of MMR II and Varivax via intramuscular rather than subcutaneous route; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 13-MAR-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live ( (unknown albumin status) (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) both for prophylaxis, via intramuscular route instead of the subcutaneous route (incorrect route of product administration) (concentration and anatomical location of vaccination were not reported for either therapy; dose, frequency of vaccination scheme, lot number, and the expiry date was unknown by the reporter for both therapies) Other suspect therapy included the sterile diluent (indication, concentration, and dose were not reported; lot number and expiry date were unknown to the reporter).   No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 12-MAR-2020, the patient was vaccinated with an improperly dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S021322 has been verified to be valid, expiration date reported and validated as 09-JUL-2021). The sterile diluent (MERCK STERILE DILUENT) that was used to reconstitute the vaccine was stored properly. No additional adverse event reported.     The temperature excursion reported was of -8.3 degrees Celsius for 24 minutes. No previous temperature excursion as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005839: US-009507513-2003USA005888: US-009507513-2003USA005896: US-009507513-2003USA005961: