chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Burning sensation, Dizziness, Herpes zoster
Clinical narrative: transient cerebral ischemia; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 01-DEC-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered abdominal pain and mid back pain along with a painful burning rash. Pt was diagnosed with herpes zoster. Pt also suffered numbness in her bilateral arms associated with lightheadedness and feelings of near syncope. Pt was hospitalized and diagnosed with ransient cerebral ischemia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and transient cerebral ischemia was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the events herpes zoster and transient cerebral ischemia to be disability.  Upon internal review, the event transient cerebral ischemia was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Presyncope, Rash, Transient ischaemic attack
Clinical narrative: transient cerebral ischemia; herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) (age and gender unknown). The pt's medical history, concurrent conditions and concomitant medication were not provided. On or around 01-DEC-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the pt suffered abdominal pain and mid back pain along with a painful burning rash. Pt was diagnosed with herpes zoster. Pt also suffered numbness in her bilateral arms associated with lightheadedness and feelings of near syncope. Pt was hospitalized and diagnosed with ransient cerebral ischemia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and transient cerebral ischemia was considered to be not recovered and causal relationship was assessed as related.  The reporter considered the events herpes zoster and transient cerebral ischemia to be disability.  Upon internal review, the event transient cerebral ischemia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Reaction to excipient
Clinical narrative: reaction to shingrix vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of allergic reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy. Concomitant products included estrogens conjugated (Premarin Vaginal Cream).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix with alpha gal allergy and had reaction to Shingrix vaccine, due to animal derived excipients. The premarin vaginal cream was applied intravaginally.  The premarin vaginal cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.  A mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine.  It was a mixture of sodium estrone sulfate and sodium equilin sulfate.  It contains as concomitant components, sodium sulfate conjugates, 17 a-dihydroequilin, 17 a-estradiol, and 17 ß-dihydroequilin.  Upon review of the core ingredients listed on the product label, they can confirm that animal derived excipients were present or may be present in the final composition.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm was sore; hasn't been able to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The reporter stated that after vaccination with 1st dose, the patient experienced sore arm for couple of days. The reporter stated that, the patient had not yet received dose 2 of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147943:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm was sore; hasn't been able to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband for her wife. The patient received 1st dose of Shingrix on left arm. The reporter stated that after vaccination with 1st dose, the patient experienced sore arm for couple of days. The reporter stated that, the patient had not yet received dose 2 of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147944:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fast heart rate; fever; This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a adult male patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   On 6th March 2020, the patient received the 1st dose of Shingrix. On 6th March 2020, less than a day after receiving Shingrix, the patient experienced heart rate increased and fever. On an unknown date, the outcome of the heart rate increased and fever were recovered/resolved.   It was unknown if the reporter considered the heart rate increased and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever and fast heart rate. The reporter consented to follow up.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: none
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: I felt incredibly tired, fatigued the evening after I got the shot in the morning.  I also had body aches all over.  These symptoms lasted approximately 60 hours.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: Next morning woke up with chills, low fever, headache, achy, slightly upset stomach- lasted all day. Took 1 Tylenol. Next day woke up fine.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: On 8/6/2020  c/o pain in area of the muscle on the left arm where her injection was placed. Pt had normal ROM with some discomfort. Referral to physical therapy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site reaction, Rash vesicular, Varicella post vaccine, Yellow skin
Clinical narrative: Afebrile. Blistered Rash @ vaccine site. Vaccine given 7/7/20. Noted today (7/14) circular area 2.5cm in diameter - Blistering in various stages, dried, vesicles & yellowish tinge consistent with Chicken Pox.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Bursitis, Chiropractic, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: I began to have noticeable pain in my shoulder, particularly in the joint. The pain got increasingly severe over time and has continued through today. It has led to restricted range of motion I called the nurses line and they recommended that I take ibuprofen. I took ibuprofen for 3 days but it had no impact on the pain. I scheduled a doctor's appointment on 07/30/2020 where they indicated I likely had an inflamed bursa and recommended prednisone. The only possible initiating event we were able to identify was the administration of the vaccine. I decided not to take it due to the significant side effect possibilities. Instead, I went to the chiropractor on 08/03/2020 and 08/07/2020. Since receiving that treatment, the pain has begun to fade, though it is still present.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines; This spontaneous report was received from a nurse 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 21-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Recombinant human albumin (rHA), lot # T006792, expiration date 24-AUG-2021 (exact dose and route of administration were not reported) for prophylaxis. Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis.     Digital Data logger was involved. The administered vaccine experienced temperature excursion of -13.5 degrees Celsius (C), -11.4 C, -1.8 C for 24 min, 27 min and 2 h 8 min. There was previous temperature excursion reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010893: US-009507513-2007USA010419: US-009507513-2007USA010252: US-009507513-2007USA010361: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
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 was received from a licensed practical nurse and refers a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications and drug reactions or allergies   On 30-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 and expiration date 09-JUN-2022 for prophylaxis (exact dose, route and site of administration were not reported). Administered dose of vaccine was exposed to the temperature of 50 degrees Fahrenheit (F) for 1 hour and 46 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse events were 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-009507513-2008USA000367: US-009507513-2008USA000372: US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2007USA012124: US-009507513-2007USA012061: US-009507513-2007USA012060: US-009507513-2007USA012054:
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Is there any shedding; This case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was not recovered/not resolved.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient asked if there was shedding with shingrix vaccine. The patient asked if the patient could infect/affect others after taking Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgias; Extreme fatigue; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date 21st December 2021) for prophylaxis.   Previously administered products included Shingrix (no reaction with 1st dose).   On 1st May 2020, the patient received the 2nd dose of Shingrix. On 1st May 2020, immediately after receiving Shingrix, the patient experienced myalgia and fatigue. On an unknown date, the outcome of the myalgia and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and since that time she has felt myalgias and extreme fatigue.  No reaction to first dose and no fever. The reporter asked was there any reports of longer duration side effects than the 2-3 days reported in the prescribing information.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Nausea, Pruritus
Clinical narrative: cold; fever; nausea; chills; low energy; dry heaves; itching; skin lesions; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her sister in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and dry heaves and skin lesion. This case linked with US2020147972, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147972:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Retching, Skin lesion
Clinical narrative: cold; fever; nausea; chills; low energy; dry heaves; itching; skin lesions; This case was reported by a consumer via call center representative and described the occurrence of cold sweat in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion. On an unknown date, the outcome of the cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the cold sweat, fever, nausea, chills, energy decreased, dry heaves, pruritus and skin lesion to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her sister in law. The age at vaccination was not reported. The patient received Shingrix and had symptoms that included cold Sweats, chills, fever, nausea, low energy, lesion, itching and dry heaves and skin lesion. This case linked with US2020147972, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147972:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Has not received dose 2 as of yet.; Had a shingles outbreak a few weeks  ago; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2020, between 11 and 12 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were 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. The patient received Shingrix and had shingles outbreak. The patient had not received dose 2 yet, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: significant reaction to the first shot; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had such a significant reaction. The reporter consented to follow up. Outbound call made to obtain more information no answer.  The reporter left voicemail for callback purposes. For tolerances of 2nd dose, refer case US2020AMR152226, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR152226:same reporter
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: experienced shingles rash; experienced shingles rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 4th August 2020, 8 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced shingles rash on L 10-11th rib cage. The adverse event was collected. The HCP unable to provide vaccine details. The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Cold urticaria, Laboratory test abnormal, Lip swelling, Paraesthesia, Pharyngeal swelling
Clinical narrative: Lip and throat swelling while eating anything cold/frozen. feet and hands tingle in air conditioned room.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Temperature intolerance, Urticaria
Clinical narrative: Lip and throat swelling while eating anything cold/frozen. feet and hands tingle in air conditioned room.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Rash
Clinical narrative: 1st day after tired,2nd day headache,dizzy,profuse sweating,vomitting,3rd day,slight rash on trunk
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 1st day after tired,2nd day headache,dizzy,profuse sweating,vomitting,3rd day,slight rash on trunk
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Lymphadenopathy, Rash
Clinical narrative: Rash at injection sight with swollen lympnodes under left arm pit and rash spreading around arm
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body ache, very swollen arm at the injection site, arm pain
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood lactic acid increased, Blood test, Fatigue, Headache, Peripheral swelling
Clinical narrative: Swelling & large, brilliant red, itchy rash that went from my shoulder to below my elbow and at points the full circumference around my arm, intense headache for 3 days,  extreme tiredness (3-4 naps a day), 105 degree fever (which broke after 4 days.  Emergency room administered IV of Benadryl, methylprednisolone, oxycodone, and sodium chloride.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic, SARS-CoV-2 test negative
Clinical narrative: Swelling & large, brilliant red, itchy rash that went from my shoulder to below my elbow and at points the full circumference around my arm, intense headache for 3 days,  extreme tiredness (3-4 naps a day), 105 degree fever (which broke after 4 days.  Emergency room administered IV of Benadryl, methylprednisolone, oxycodone, and sodium chloride.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Antinuclear antibody, Arthralgia, Beta-2 glycoprotein antibody, C-reactive protein
Clinical narrative: Received two doses of HPV vaccine. In the following months began to lose weight, lose hair, then experience pleurisy in the lungs. By March of 2018,  was experiencing more symptoms including arthritic and muscular pain, migraines, fever. Was diagnosed with Lupus SLE in May of 2018. Continue to have active lupus and now lupus nephritis.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiolipin antibody, Chest X-ray, Fibrin D dimer, Lupus nephritis, Migraine
Clinical narrative: Received two doses of HPV vaccine. In the following months began to lose weight, lose hair, then experience pleurisy in the lungs. By March of 2018,  was experiencing more symptoms including arthritic and muscular pain, migraines, fever. Was diagnosed with Lupus SLE in May of 2018. Continue to have active lupus and now lupus nephritis.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Pleurisy, Pyrexia, Russell's viper venom time, Systemic lupus erythematosus
Clinical narrative: Received two doses of HPV vaccine. In the following months began to lose weight, lose hair, then experience pleurisy in the lungs. By March of 2018,  was experiencing more symptoms including arthritic and muscular pain, migraines, fever. Was diagnosed with Lupus SLE in May of 2018. Continue to have active lupus and now lupus nephritis.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Weight decreased
Clinical narrative: Received two doses of HPV vaccine. In the following months began to lose weight, lose hair, then experience pleurisy in the lungs. By March of 2018,  was experiencing more symptoms including arthritic and muscular pain, migraines, fever. Was diagnosed with Lupus SLE in May of 2018. Continue to have active lupus and now lupus nephritis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccine site swelling, redness , warmth; slight improvement w/ swelling. possible due to administration technique?
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Patient had a fever of 103.7 and developed  a rash of red, slightly raised bumps on the front and back of  his torso, neck and face that lasted two days.  It started exactly one week from receiving the vaccines.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: The patient states that the few days after vaccination were slightly painful in the arm but has gotten progressively worse since then. She reported this information to us on 8/6. She states the pain is in her shoulder and radiating towards her neck. She also states she cannot lift her right arm up completely.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Headache, Nausea, Vaccination complication, Vision blurred
Clinical narrative: Mother called  office 8/6/20 to say that patient began having a bad headache, blurred vision and nausea the eve of August 5 a few hours after the injections were given.  Patient does have migraine headaches, however "this isn't the same feeling".  I called to check on child today, mom said that she hadn't seen her this morning because of parent work schedule, but the child was able to eat without nausea evening of 8/6/20,  and no further complaints of blurred vision. She did mention still having a headache and had been very tired.  No other complaints.  Reported per my request yesterday to family practitioner, who said it was an adverse reaction to vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Gaze palsy, Lethargy, Pallor, Posturing, Seizure
Clinical narrative: Patient arrived at office for 11yr well check at 830am accompanied by mother. Patient received scheduled vaccine tdap/left deltoid, menveo + hpv right deltoid) at 9am. Approximately 30 seconds after receiving injections she experienced a syncopal episode. Patient was still in exam room on bed. When Dr. arrived at bedside she remained unresponsive. After Dr. was at bedside for about 1 min she began to posture with tonic contraction of arms and fists, eyes rolled back and was unresponsive. The seizure episode lasted approximately 10 seconds. 911 was called. Dr. remained in exam room until arrival of EMS. Vital signs obtained. B/p 108/55, heart rate 110, Pulse ox 99%. Patient began talking a few minutes after seizure episode but she was still very pale and lethargic. EMS transported patient to ER for further evaluation.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: Patient arrived at office for 11yr well check at 830am accompanied by mother. Patient received scheduled vaccine tdap/left deltoid, menveo + hpv right deltoid) at 9am. Approximately 30 seconds after receiving injections she experienced a syncopal episode. Patient was still in exam room on bed. When Dr. arrived at bedside she remained unresponsive. After Dr. was at bedside for about 1 min she began to posture with tonic contraction of arms and fists, eyes rolled back and was unresponsive. The seizure episode lasted approximately 10 seconds. 911 was called. Dr. remained in exam room until arrival of EMS. Vital signs obtained. B/p 108/55, heart rate 110, Pulse ox 99%. Patient began talking a few minutes after seizure episode but she was still very pale and lethargic. EMS transported patient to ER for further evaluation.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: sleepy; a slight fever; on 12/26/2019, a female patient was administered both Varivax and Proquad; This spontaneous report was received from a nurse and refers to a 12 month old female patient. The patient had no medical history, drug reaction and concomitant medication. On 26-DEC-2020, the patient was vaccinated with properly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # reported as S021296 ( verified to by invalid lot #), expiration date 15-JUL-2021 (strength, dose and route of administration were not reported), for prophylaxis. On the same day, the patient was vaccinated with properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # S012533, expiration date 20-OCT-2020 (strength, dose and route of administration were not reported), for prophylaxis (Overdose was coded, however the reporter considered as the events was not a result of an overdose - term not highlighted by the reporter). The vaccines was reconstituted with sterile diluent (strength, dose, route of administration, lot # and expiration date were not reported). On 26-DEC-2019, the patient was sleepy and had a slight fever. The outcome of the events was reported as recovered on 27-JUL-2020. The causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Is there any shedding with Shingrix?; This case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin peeling. On an unknown date, the outcome of the skin peeling was unknown.   It was unknown if the reporter considered the skin peeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient asked if there was shedding with shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got mild case of shingles after dose of Shingrix. The reporter wanted to know could a 70 year old get a mild case of shingles after 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked how long does the side effect of body aches last after the Shringrix vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal pain, Pain, Pruritus
Clinical narrative: pain on touch; Pain then moved down spine of back; appearing as having a shingles outbreak; had pinpoint pain/Pain upon movement; area on back began itching / itching near lumbar region; swelling; pain when touching area on left side underneath shoulder; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced in 2010).   On an unknown date, the patient received the 1st dose of Shingrix. In July 2020, 36 hrs after receiving Shingrix, the patient experienced shingles, pain, pruritus, swelling, shoulder pain and back pain. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the shingles, swelling, shoulder pain, back pain and tenderness were unknown and the outcome of the pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, pruritus, swelling, shoulder pain, back pain and tenderness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient receiving 1st dose Shingrix approximately 1 to 2 weeks ago in left arm, and approximately 36 to 48 hours later consumer reported an area on back began itching. The patient looked in mirror but could not see anything and at that point only had pinpoint pain. The reporter stated swelling and then pain when touching area on left side underneath shoulder blade that lasted for one week. Pain then moved down spine of back near trunk on left side.  At the time of reporting, pain and itching now reportedly near lumbar region. The reporter appearing as having a shingles outbreak but not as bad as first case of shingles in 2010 prior to Shingrix vaccine.  The reporter consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Swelling, Tenderness
Clinical narrative: pain on touch; Pain then moved down spine of back; appearing as having a shingles outbreak; had pinpoint pain/Pain upon movement; area on back began itching / itching near lumbar region; swelling; pain when touching area on left side underneath shoulder; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced in 2010).   On an unknown date, the patient received the 1st dose of Shingrix. In July 2020, 36 hrs after receiving Shingrix, the patient experienced shingles, pain, pruritus, swelling, shoulder pain and back pain. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the shingles, swelling, shoulder pain, back pain and tenderness were unknown and the outcome of the pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, pruritus, swelling, shoulder pain, back pain and tenderness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient receiving 1st dose Shingrix approximately 1 to 2 weeks ago in left arm, and approximately 36 to 48 hours later consumer reported an area on back began itching. The patient looked in mirror but could not see anything and at that point only had pinpoint pain. The reporter stated swelling and then pain when touching area on left side underneath shoulder blade that lasted for one week. Pain then moved down spine of back near trunk on left side.  At the time of reporting, pain and itching now reportedly near lumbar region. The reporter appearing as having a shingles outbreak but not as bad as first case of shingles in 2010 prior to Shingrix vaccine.  The reporter consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Myalgia, Pyrexia
Clinical narrative: high grade fever of 105F; Extreme discomfort; Muscle Pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, 1 days after receiving Shingrix, the patient experienced fever, discomfort and muscle pain. On an unknown date, the outcome of the fever, discomfort and muscle pain were unknown.   It was unknown if the reporter considered the fever, discomfort and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced high grade fever of 105 degree F after receiving the 1st dose of Shingrix, next day development of symptoms. The patient also reported the patient complaint of extreme discomfort and muscle pain. The Pharmacist reported that he advised the patient to seek medical care at a local Emergency Room.The patient had not sought medical treatment at the time of the report. The reporter consent to follow up. This case has been linked with case US2020148712, reported by the same reporter.; Sender's Comments: A Pharmacist reported that a patient developed a high grade fever of 105F after receiving  the 1st dose of Shingrix. (next day development of symptoms) . He also reported the patient complaint of extreme discomfort and muscle pain.The Pharmacist reported that he advised the patient to seek medical care at a local Emergency Room.The patient had not sought medical treatment at the time of the report.  Consented to follow up. "The Vaccine Administration Facility is the same as Primary Reporter", US-GLAXOSMITHKLINE-US2020148712:same reporter
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, 1 days after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional case details were reported as follows: At 10 AM, the patient received the 1st dose of Shingrix. On 31st July 2020, the patient developed the effects. The reporter consent to follow up.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Blood pressure increased, Headache
Clinical narrative: severe heahdache; elevated blood pressure; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported an 18-year old patient received meningococcal group b rlp2086 (TRUMENBA, reported as Meningococcal Group B Vaccine) via an unspecific route of administration on an unspecific date at single dose for immunization. Medical history and concomitant drug were not reported. Physician mentioned that a patient had Trumenba administer had an adverse reaction. He said that the 18 years old patient had after 45 min of the administration of the vaccine a severe headache and elevated blood pressure that took the patient the ER (Emergency Room). Now the patient is fine but he wants to know if that has been reported. Outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of Trumenba and the onset of headache and elevated blood pressure cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Eye movement disorder, Head injury, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Client had never received any vaccinations prior to today's visit. Immediately after administering Tdap at 0845, client's eyes rolled back, skin became pale, body went limp, and lost consciousness for 5 seconds. Client hit head on chair but did not collapse to the floor. During 5 seconds , client's upper torso went rigid and there were 2-3 involuntary muscle spasms of the shoulders. Airway patent, no signs of respiratory distress. Client returned to consciousness without medical intervention. Client alert and aware x4 after return to consciousness, sat up without assistance. Client was unaware had fainted. RN informed client about syncope episode and hitting head. Client denied pain or any change in mentation. RN remained at client's side. Water and graham crackers were provided. Fan was utilized to circulate air. Client's color returned after 2 minutes. Continued to monitor for 15 minutes. Client denied any further lightheadedness/dizziness.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle rigidity, Muscle spasms, Pallor, Syncope
Clinical narrative: Client had never received any vaccinations prior to today's visit. Immediately after administering Tdap at 0845, client's eyes rolled back, skin became pale, body went limp, and lost consciousness for 5 seconds. Client hit head on chair but did not collapse to the floor. During 5 seconds , client's upper torso went rigid and there were 2-3 involuntary muscle spasms of the shoulders. Airway patent, no signs of respiratory distress. Client returned to consciousness without medical intervention. Client alert and aware x4 after return to consciousness, sat up without assistance. Client was unaware had fainted. RN informed client about syncope episode and hitting head. Client denied pain or any change in mentation. RN remained at client's side. Water and graham crackers were provided. Fan was utilized to circulate air. Client's color returned after 2 minutes. Continued to monitor for 15 minutes. Client denied any further lightheadedness/dizziness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling cold
Clinical narrative: Woke up from sleep having Uncontrollable shivering for approx 1 hour, could not get warm.  Temperature was 100.5 degree Fahrenheit. Eventually stopped shivering but elevated temp continued for approx eight hours.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Vaccine administered, patient appeared to tolerate well. Upon checkout process , patient stated she felt faint, lost color in face and had to be lowered to the floor where feet were elevated. She stayed in this position on the floor for 5-10 minutes before slowly sitting up and then standing. She reported to be feeling fine upon leaving the office.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for four days followed by rash for four days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Breath holding, Crying, Pain
Clinical narrative: Pt had pain, inconsolable crying and breath holding spell. Called 911, evaluated by paramedics.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: C-reactive protein normal, Decreased appetite, Full blood count normal, Immediate post-injection reaction, Injection site erythema
Clinical narrative: received vaccines 6/18/20 6/19/20 increased redness, itchy L Thigh 6/20/20 increased redness, Admit To hospital for iv Abx 17 month old male who presented with two days of local redness, swelling, urticaria and warmth of upper right thigh immediately following 15 mo vaccinations on 6/19. Had fever only on the 1st day after vaccines and decreased PO of solids. was otherwise acting at baseline and not ill appearing. CBC and CRP were within normal limits.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexia
Clinical narrative: received vaccines 6/18/20 6/19/20 increased redness, itchy L Thigh 6/20/20 increased redness, Admit To hospital for iv Abx 17 month old male who presented with two days of local redness, swelling, urticaria and warmth of upper right thigh immediately following 15 mo vaccinations on 6/19. Had fever only on the 1st day after vaccines and decreased PO of solids. was otherwise acting at baseline and not ill appearing. CBC and CRP were within normal limits.