chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Allergy to metals, Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Allergies:- Metals, Codeine, Etodolac, Augmentin, Bactrim, Pneumococcal Vaccines; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways. A contactable physician reported for a 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization, codeine, etodolac, amoxicillin, clavulanic acid (AUGMENTIN), sulfamethoxazole, trimethoprim (BACTRIM) all with unspecified route, date and dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: metals, codeine, etodolac, augmentin, bactrim, pneumococcal vaccines on an unspecified date. The action taken for codeine, etodolac was unknown. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache, Injection site haemorrhage, Injection site pain
Clinical narrative: Nausea; Extreme fatigue; Light headedness; Headache; Pain at injection site; Bleeding at injection site more than normal; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CH2637, expiration date: 28Feb2022, NDC number: 0005010005) on 21Aug2020 11:30 first dose at single dose for recommended vaccine. Medical history and concomitant medications were not reported. Patient experienced Nausea after injection, extreme fatigue, light headedness, and headache, definitely pain at injection site, she said it is bleeding at injection site more than normal, all on 21Aug2020. She is taking ibuprofen and Tylenol for treatment. She got vaccine at 11:30 and they had side effects like 3' O clock. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: Nausea; Extreme fatigue; Light headedness; Headache; Pain at injection site; Bleeding at injection site more than normal; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CH2637, expiration date: 28Feb2022, NDC number: 0005010005) on 21Aug2020 11:30 first dose at single dose for recommended vaccine. Medical history and concomitant medications were not reported. Patient experienced Nausea after injection, extreme fatigue, light headedness, and headache, definitely pain at injection site, she said it is bleeding at injection site more than normal, all on 21Aug2020. She is taking ibuprofen and Tylenol for treatment. She got vaccine at 11:30 and they had side effects like 3' O clock. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Choking, Fatigue, Headache, Pain
Clinical narrative: Choke; Achiness; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient's mother). The reporter reported for her two daughters, this is the second daughter report. A 19-year-old female patient received 2nd dose of meningococcal group b rlp2086 (TRUMENBA, lot# CH2637, expiration date: 28Feb2022, NDC number: 0005010005), via an unspecified route of administration on 21Aug2020 11:30 at single dose for Immunization/Meningitis B. Medical history and concomitant medications were none. The patient experienced choke, achiness, chills, headache, fatigue on 21Aug2020 15:00. And she was still in bed. Ibuprofen and acetaminophen, tylenol was given to the patent after events. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020326661 Same reporter/drug, similar event, different patient
Sex: U
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: Swelling; Pain; This is a spontaneous report from a contactable other health professional via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and pain both on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT SAID SHE GOT THE SHINGLE AND SHE GOT RASH AND ITCHING UNDER HER BREAST
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain in extremity
Clinical narrative: Abnormal pain throughout arm and hand; nausea
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain
Clinical narrative: 2 hours after vaccination, sudden onset of fatigue, stomach upset, headache, whole body ache. Symptoms lasted for 3 days and patient could not get up to leave home. Patient did not experience these symptoms after 1st dose of Shingrix 2 months earlier.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site bruising
Clinical narrative: Large bruise at vaccine site, looked like bleeding occurred underneath the skin as if the patient was on blood thinners (review of her medication list showed Fish Oil and prednisone). Patient reported no pain at the injection site. Suggested the patient contact her doctor's office and see if they could do a telehealth appointment to look at the bruise and see if any further action was required.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation
Clinical narrative: Burning (sunburn-like) all over body starting 2 days after vaccine. Hasnt taken anything for it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in 2015, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, 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 would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Syringe issue, Underdose
Clinical narrative: leaky syringe during injection of vaccine; Poor quality device used; This spontaneous report as received from a pharmacist and refers to a female patient of an unknown age. No information regarding patient's concurrent conditions, pertinent medical history and concomitant therapies was provided.   On 17-AUG-2020, while the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 ml (route of administration, indication were not provided)  (lot # S027979, expiration date: 30-MAY-2021), prefilled syringe, a leaky syringe occurred. It was reported that the leaking occurred between the syringe hub/luer lock and syringe needle, while giving the injection (and also after the injection was given). The syringe was disposed of in a sharps container and not available to be returned. The pharmacist asked, if there was any recommendation on revaccination and/or if the patient should have titres tested to see if another dose is needed. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient inadvertently received Adacel, while was supposed to receive Tubersol, no AE; Initial information received on 14-Aug-2020 regarding an unsolicited valid non-serious case from other health professional. This case involves a 22 years old female patient who inadvertently received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number 5723N and expiration date 19-Nov-2022), via intradermal route in the forearm as prophylactic vaccination instead of getting tested with TUBERCULIN TEST [TUBERSOL] (lot number and expiration date were not reported) on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication were not given to the patient.  It was unknown that if she was pregnant.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction, Pain
Clinical narrative: Profuse bleeding causing the provider to remark on it. Immediate severe bruising 2.5 inches in diameter. Throbbing and soreness immediately followed. Throbbing X 1 week. Soreness until present day. Bruising still visible until present day.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chest pain, Chills, Headache, Pyrexia
Clinical narrative: 2 HOURS AFTER VACCINE CHILLS, HEADACHE, CHEST PAIN, ABDOMINAL PAIN, VOMITED, FEVER. 2 DAYS AFTER FELT OK
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: 2 HOURS AFTER VACCINE CHILLS, HEADACHE, CHEST PAIN, ABDOMINAL PAIN, VOMITED, FEVER. 2 DAYS AFTER FELT OK
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and Vomited one time.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: mom reports that the patient complained of not feeling well the night the vaccine was given, with mild errythema and swelling. Patient had intermittent pain to her Left arm (site of vaccination) that continued to the next day. tempurature was 99.4, site of injection on 8/18/20 was more swollen, red, warm and painful. complained of mild puritis. has history of receiving flu vaccines with no previous reactions. PainEase spray was used prior to vaccine administration and patient has also used it in the past without incident.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Malaise, Pruritus, Swelling, Vaccination site pain
Clinical narrative: mom reports that the patient complained of not feeling well the night the vaccine was given, with mild errythema and swelling. Patient had intermittent pain to her Left arm (site of vaccination) that continued to the next day. tempurature was 99.4, site of injection on 8/18/20 was more swollen, red, warm and painful. complained of mild puritis. has history of receiving flu vaccines with no previous reactions. PainEase spray was used prior to vaccine administration and patient has also used it in the past without incident.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site bruise, Erythema, Limb discomfort, Pain in extremity, Skin warm
Clinical narrative: Two hours after receiving Fluarix (8/23), the patient stated that her left arm started to feel sore and heavy. In response, the patient self administered two tablets of over the counter Tylenol. Around evening time, the symptoms had progressed (red and warm to touch). By the next morning (8/24), the swelling had become the size of a soft ball and it was hot to touch. Today (8/26), the patient states symptoms had subsided a little. The reaction site is not as hot, there is less swelling, and now there is bruising on top of the site of administration.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Two hours after receiving Fluarix (8/23), the patient stated that her left arm started to feel sore and heavy. In response, the patient self administered two tablets of over the counter Tylenol. Around evening time, the symptoms had progressed (red and warm to touch). By the next morning (8/24), the swelling had become the size of a soft ball and it was hot to touch. Today (8/26), the patient states symptoms had subsided a little. The reaction site is not as hot, there is less swelling, and now there is bruising on top of the site of administration.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix was given instead of Hepatitis A. Pt did not return to clinic due to any adverse affect from wrong vaccine given. I called and spoke with Father about the incident and recommended he bring patient back in to complete the Hepatitis A series.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: A few days after the Singrex vaccine I developed a sore throat and swollen glands. It has persisted for 4 days now. The pharmacist told me to take vitamin C for a few days which I did but she did not tell me why.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Pallor, Seizure, Syncope
Clinical narrative: administered Boostirx and Menactra was fine. Then administered Garadasil and client with in 1 minute became white and slummped in chair, eyes rolled back and began to have a seizure lasting about 30 sec. Noted arms tightening and legs moving during seizure. Client awoke but very pale laid on cot and rested for 15 minutes MD called and reported blood pressure of 102/60. Client after 15 min sat up for 10 minutes then walked outside. MD advised if episode happens again to take to ER. No history of seizures or medical problems. Client was showing no signs of nervousness when she came into room even joking with nurse.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Electroencephalogram, Febrile convulsion, Pyrexia
Clinical narrative: Developed fever and complex febrile seizures.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Paraesthesia
Clinical narrative: About 12 hours after the vaccine (vaccine 3pm Friday night, first onset of symptoms 3am Saturday morning), I developed a tingling in one particular nerve in my left leg culminating with extreme sharp pain at one particular part of my foot (intermediate dorsal cutaneous nerve).  The pain was like being stabbed in the foot by an ice pick.  The tingling/pain repeated with a period of 15-30 seconds.  After talking to a doctor Saturday afternoon, I applied ice to the location and elevated the foot.  This provided some relief from the stabbing pain.  However as I slept that next night (Saturday night), the pain returned.  I got very little sleep both Friday night and Saturday night.  On Sunday, I tried lidocaine patches directly on the foot.  These patches were left over from some back pain I had last year.  The patches provided essentially complete relief from the stabbing pain throughout Sunday and Sunday night.  By Monday afternoon, the pain was gone without using the patches.  As I write this today, Tuesday, there is still a little minor tingling, but no stabbing pain.  Both my father and my grandmother had shingles at various times.  I was with them when they had it.  The pain they described from their cases of shingles matches exactly with what I felt, except their pain was not localized to just one place as mine was, but over a larger area.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fever, shivering, muscle pain, headache, tired and nauseous.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, shivering, muscle pain, headache, tired and nauseous.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Neuralgia
Clinical narrative: Diarrhea and sever onset neuropathic pain.  Pain was severe enough the pt. considered emergency room services.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Influenza, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain at injection site Flu symptoms Nausea Sore swollen  lymph glands left underarm which resulted in bruising
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pain at injection site Flu symptoms Nausea Sore swollen  lymph glands left underarm which resulted in bruising
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Crying, Decreased appetite, Hypersomnia, Injection site erythema
Clinical narrative: Spoke with patient's mother at approximately 2:30pm the following day after the immunizations. Mom reports that the patient screamed as she was getting the vaccines and didn't stop crying for hours, and this is not typical at all for the patient with vaccines. Mom reports that last evening she had a low grade fever (did not have specific #), and kept complaining of pain in the site of the MMRV. Mom reports localized 2 inch area of redness around the MMRV injection site. More concerning patient slept until 1pm today, only urinated once in almost 18 hr period. Patient has fever of 104.5F, reduced with Tylenol 1 hr after administration and currently at 100F. Patient also complaining of neck pain. Hurts to tilt neck back to drink small dose cup of Tylenol. No appetite, not wanting to drink. Low energy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Neck pain, Pain, Pyrexia, Screaming
Clinical narrative: Spoke with patient's mother at approximately 2:30pm the following day after the immunizations. Mom reports that the patient screamed as she was getting the vaccines and didn't stop crying for hours, and this is not typical at all for the patient with vaccines. Mom reports that last evening she had a low grade fever (did not have specific #), and kept complaining of pain in the site of the MMRV. Mom reports localized 2 inch area of redness around the MMRV injection site. More concerning patient slept until 1pm today, only urinated once in almost 18 hr period. Patient has fever of 104.5F, reduced with Tylenol 1 hr after administration and currently at 100F. Patient also complaining of neck pain. Hurts to tilt neck back to drink small dose cup of Tylenol. No appetite, not wanting to drink. Low energy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Thirst decreased, Urine output decreased
Clinical narrative: Spoke with patient's mother at approximately 2:30pm the following day after the immunizations. Mom reports that the patient screamed as she was getting the vaccines and didn't stop crying for hours, and this is not typical at all for the patient with vaccines. Mom reports that last evening she had a low grade fever (did not have specific #), and kept complaining of pain in the site of the MMRV. Mom reports localized 2 inch area of redness around the MMRV injection site. More concerning patient slept until 1pm today, only urinated once in almost 18 hr period. Patient has fever of 104.5F, reduced with Tylenol 1 hr after administration and currently at 100F. Patient also complaining of neck pain. Hurts to tilt neck back to drink small dose cup of Tylenol. No appetite, not wanting to drink. Low energy.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, headache, chills, nausea for roughly 24 hours beginning nearly 12 hours after administered vaccine
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, headache, chills, nausea for roughly 24 hours beginning nearly 12 hours after administered vaccine
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Nausea, Pyrexia, Tremor
Clinical narrative: Fever,  shaking,  nausea, headache
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: local reaction, redness and itching  treatment Medrol dose pack and cold compresses
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Upon review of immunization record client received MCV4 #3 when client was compliant with doses 1 and 2. Mother and client notified. No adverse reaction or concerns voiced per mother.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Cold sweat, Cyanosis, Respiratory rate decreased, Syncope
Clinical narrative: patient fainted for a few minutes. developed blue tinged lips, clamy, slow breathing had to be given epinephrine 0.3mg IM
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Blood uric acid increased, Gout, Joint swelling, Limb discomfort
Clinical narrative: Swelling of right foot big toe joint and ankle. Subsequent swelling of right knee. Orthopedic doctor gave shot of novocaine and cortisone in right knee. Knee swelling went down after 3 days. Foot problems continued. Gout was suspected. Primary care doctor ordered blo0d tests. Gout was confirmed.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Confusional state, Erythema, Lethargy
Clinical narrative: pain, swelling, rednes, 101 fever, muscle aches, joint pain, lathargy, confusion & weakness. Took ibupropin.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: pain, swelling, rednes, 101 fever, muscle aches, joint pain, lathargy, confusion & weakness. Took ibupropin.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Pain in extremity
Clinical narrative: Patient had pain at injection site for 3 days after the vaccine, then had a migratory pain that began in his upper back and migrated to his his left toes over the 2 weeks after the vaccine administration and is now resolved
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient called 6 days after the shot complaining her arm was still very sore and swollen in certain parts.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: patient called 6 days after the shot complaining her arm was still very sore and swollen in certain parts.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: patient called 6 days after the shot complaining her arm was still very sore and swollen in certain parts.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, SARS-CoV-2 test
Clinical narrative: nausea, vomiting and diarrhea, left arm pain at site of injection, headache
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: nausea, vomiting and diarrhea, left arm pain at site of injection, headache
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left Deltoid area, local swelling and very painful
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Cardiovascular evaluation, Loss of consciousness, Syncope, Vaccination complication
Clinical narrative: Vasovagal, no treatment. From the time I got the 4 vaccines, I have passed out over 100 times through out my life. Most of the time, it has happened at doctors offices. It has also happened at home and in the car. Many doctors can vouch for this.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Herpes zoster, Lymphadenopathy, Rash erythematous
Clinical narrative: 1 week after administration, patient developed red, itching rash with pain in middle of back and under arms. patient did not develop any blistering. patient say her family physician and was diagnosed with shingles but was not treated with medication. physician wanted to watch patient and ride out the adverse reaction. 2 weeks after administration on 8/14/20, patient developed enlarged lymph node under her left arm. physician still did not treat and wanted patient to ride out reaction. patient said md was to report adverse reaction but wanted pharmacy to report also.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: 1 week after administration, patient developed red, itching rash with pain in middle of back and under arms. patient did not develop any blistering. patient say her family physician and was diagnosed with shingles but was not treated with medication. physician wanted to watch patient and ride out the adverse reaction. 2 weeks after administration on 8/14/20, patient developed enlarged lymph node under her left arm. physician still did not treat and wanted patient to ride out reaction. patient said md was to report adverse reaction but wanted pharmacy to report also.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Dizzy, Sweating, loss of consciousness
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: Nausea evening after injection. Headache  Very tired  Strange dreams Feeling warm (no fever) Site soreness
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea evening after injection. Headache  Very tired  Strange dreams Feeling warm (no fever) Site soreness
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Feeling hot, Injection site rash, Injection site swelling
Clinical narrative: patient had rashes and huge bump in the injection area, got allergic to it, was very hot after 1 day of administration
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eye movement disorder, Fall, Head injury, Seizure
Clinical narrative: Patient got flu shot. After about 1-2 minutes she fell down and hit her head. Father stated daughter looked lightheaded, rolled her eyes back, and fell and hit her head. Stated she had a seizure. I did not notice a seizure.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: warm bump and itching
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Rash
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Bedridden, Dizziness, Fatigue, Head discomfort
Clinical narrative: Skin burning and tingling, itching (like a bad sunburn). At night - body ache started (especially feet) . Next day, skin issue continue. Then weakness started and lightheadedness. Friday morning not able to walk unassisted. Went to ER and tested for covid( results negative) - 2 days bed ridden(thurs night - sunday morning). Head felt heavy. Sunday was able to stay out of bed, still very tired. Sunday afternoon , rash develop on abdomen, spread to thigh. Rash is now gone.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Paraesthesia, Pruritus, Rash, SARS-CoV-2 test negative
Clinical narrative: Skin burning and tingling, itching (like a bad sunburn). At night - body ache started (especially feet) . Next day, skin issue continue. Then weakness started and lightheadedness. Friday morning not able to walk unassisted. Went to ER and tested for covid( results negative) - 2 days bed ridden(thurs night - sunday morning). Head felt heavy. Sunday was able to stay out of bed, still very tired. Sunday afternoon , rash develop on abdomen, spread to thigh. Rash is now gone.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Skin burning sensation, Walking aid user
Clinical narrative: Skin burning and tingling, itching (like a bad sunburn). At night - body ache started (especially feet) . Next day, skin issue continue. Then weakness started and lightheadedness. Friday morning not able to walk unassisted. Went to ER and tested for covid( results negative) - 2 days bed ridden(thurs night - sunday morning). Head felt heavy. Sunday was able to stay out of bed, still very tired. Sunday afternoon , rash develop on abdomen, spread to thigh. Rash is now gone.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING AND ITCHING AT INJECTION SITE
Age: 67.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Back pain, Chest pain, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: PATIENT WAS FINE AFTER THE VACCINATION, STOOD UP WALKED AROUND THE STORE FOR A FEW MINUTES AND CAME BACK WITH FACE AND ARMS FLUSHED RED. PATIENT ALSO REPORTED CHEST PAIN AND DIFFICULTY BREATHING. AFTER LOWERING PATIENT TO SEATING POSITION SHE REPORTED SEVERE SHARP PAIN IN LOWER BACK AREA. I INSTRUCTED PATIENT TO TAKE DEEP BREATHS (WHILE HAVING EPIPEN READY AND AMBULANCE WAS CALLED AT THIS POINT) PATIENT PALOR RETURNED TO A MORE NORMAL COMPLEXION BEFORE PARAMEDICS ARRIVED AND THE CHEST PAIN AND BREATHING WAS ALSO RESOLVED BUT THE SHARP LOWER BACK PAIN REMAINED . PATIENT WAS TAKING BY PARAMEDICS TO EMERGENCY CENTER WHERE AN EKG WAS COLLECTED. PATIENT LATER CALLED THE PHARMACY AND REPORTED THAT INITIALLY THERE WAS NAUSEA AS WELL FOR WHICH SHE WAS PRESCRIBED MEDICINE (NAME NOT PROVIDED). SHE ALSO REPORTS NO OTHER SYMPTOMS AND EVERYTHING WAS RESOLVED WITHIN HOURS OF ADMINISTRATION
Age: 67.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Flushing, Nausea, Pallor
Clinical narrative: PATIENT WAS FINE AFTER THE VACCINATION, STOOD UP WALKED AROUND THE STORE FOR A FEW MINUTES AND CAME BACK WITH FACE AND ARMS FLUSHED RED. PATIENT ALSO REPORTED CHEST PAIN AND DIFFICULTY BREATHING. AFTER LOWERING PATIENT TO SEATING POSITION SHE REPORTED SEVERE SHARP PAIN IN LOWER BACK AREA. I INSTRUCTED PATIENT TO TAKE DEEP BREATHS (WHILE HAVING EPIPEN READY AND AMBULANCE WAS CALLED AT THIS POINT) PATIENT PALOR RETURNED TO A MORE NORMAL COMPLEXION BEFORE PARAMEDICS ARRIVED AND THE CHEST PAIN AND BREATHING WAS ALSO RESOLVED BUT THE SHARP LOWER BACK PAIN REMAINED . PATIENT WAS TAKING BY PARAMEDICS TO EMERGENCY CENTER WHERE AN EKG WAS COLLECTED. PATIENT LATER CALLED THE PHARMACY AND REPORTED THAT INITIALLY THERE WAS NAUSEA AS WELL FOR WHICH SHE WAS PRESCRIBED MEDICINE (NAME NOT PROVIDED). SHE ALSO REPORTS NO OTHER SYMPTOMS AND EVERYTHING WAS RESOLVED WITHIN HOURS OF ADMINISTRATION
Age: 67.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Symptoms developed on 8/25/20 on the left arm. Symptoms include redness covering about a 4 inch area below injection site. Area is hot and tender to touch.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Pt reporting "avocado size" welt at injection site, significant soreness, itchiness, swelling from shoulder to elbow
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: Patient states that he started experiencing small bumps that were painful across both shoulders within 72 hours of receiving the vaccine. The bumps were not a visible rash but could be felt by the patient and was very painful. The reaction has improved daily per the patient
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: -Joint pain all over her body, with excessive in wrists, knuckles, and elbows -Naproxen- did not help
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: inflamed and painful at injection site
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site swelling, Rash, Urticaria
Clinical narrative: swelling at the injections site, rash (hives) on the arm and face.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Fatigue, Mass
Clinical narrative: Patient was given shingles #2 approx 1 wk ago.  No rxn to 1st immunization.  With this 2nd immunization, patient noted increased fatigue, tiredness, low-grade fever, and chills.  Patient slept for about 1 to 2 days and was very fatigued.  Patient notes 48 hrs after injxn, noted square patch like hive on R upper arm but below the injxn site.  Also notes lump/swelling in R dorsal hand and hurt to stretch her fingers out.  Patient did note some redness over this area.  Swelling spread thru hand.  Now right hand appears bruised swollen and hurts to make a fist.  Notes mild pain over wrist.   Tx: supportive care.  Pt went to hand specialist
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient was given shingles #2 approx 1 wk ago.  No rxn to 1st immunization.  With this 2nd immunization, patient noted increased fatigue, tiredness, low-grade fever, and chills.  Patient slept for about 1 to 2 days and was very fatigued.  Patient notes 48 hrs after injxn, noted square patch like hive on R upper arm but below the injxn site.  Also notes lump/swelling in R dorsal hand and hurt to stretch her fingers out.  Patient did note some redness over this area.  Swelling spread thru hand.  Now right hand appears bruised swollen and hurts to make a fist.  Notes mild pain over wrist.   Tx: supportive care.  Pt went to hand specialist
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Chills, Cold sweat, Dizziness
Clinical narrative: At around 12:00 pm I noticed my fingers felt numb, then I felt very cold. I went to the bathroom and had a bowel movement but felt faint and laid on the floor. I then broke out in a cold sweat and was nauseated. After getting assistance to get off the floor I laid down for 2 hours while drinking water. I had chills and my arm was swollen. I slept very little last night. Woke up with a pulsating headache and feeling fatigued, I then went to the urgent care for further evaluation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram, Fatigue, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: At around 12:00 pm I noticed my fingers felt numb, then I felt very cold. I went to the bathroom and had a bowel movement but felt faint and laid on the floor. I then broke out in a cold sweat and was nauseated. After getting assistance to get off the floor I laid down for 2 hours while drinking water. I had chills and my arm was swollen. I slept very little last night. Woke up with a pulsating headache and feeling fatigued, I then went to the urgent care for further evaluation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Nausea, Peripheral swelling
Clinical narrative: At around 12:00 pm I noticed my fingers felt numb, then I felt very cold. I went to the bathroom and had a bowel movement but felt faint and laid on the floor. I then broke out in a cold sweat and was nauseated. After getting assistance to get off the floor I laid down for 2 hours while drinking water. I had chills and my arm was swollen. I slept very little last night. Woke up with a pulsating headache and feeling fatigued, I then went to the urgent care for further evaluation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain arm at injection site  cannot lift arm entirely  slight itching in region  hot spreading
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Middle insomnia, Pain in extremity, Vomiting
Clinical narrative: Patient woke up at 1am on 8/25, the day after getting The shot. Threw up once with a temperature of 103'F, with a second reading of 102'F. Patient has not thrown up since the first time. No apparent problems with injection site, but Patient did complain about pain in the arm. No Dr visit as of now.
Age: 49.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Rash
Clinical narrative: Rash on both arms (inside forearms) and both legs
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 7/16/2020 that evening arm felt "a little itchy" 7/17/202 In the AM noticed arm was very itchy, painful, red, raised and firm at the vaccine site.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: 7/16/2020 that evening arm felt "a little itchy" 7/17/202 In the AM noticed arm was very itchy, painful, red, raised and firm at the vaccine site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Arm pain (R)  muscle pain, weakness (R) chills redness at site shoulder pain (R)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain (R)  muscle pain, weakness (R) chills redness at site shoulder pain (R)
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Pyrexia, Swelling
Clinical narrative: Patient reported fever greater than 102, swollen, bruising.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Started with redness and itching at injection site. Redness and swelling moved down her arm into the medial arm near her elbow. She developed a fever of 100.7 degrees F. She went to an urgent care, who prescribed her cephalexin.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Ligament injury, Pain in extremity, Skeletal injury, Weight bearing difficulty
Clinical narrative: Shingrix vaccination was administered to left shoulder. Pain a 6/10 requiring NSAIDs unable to bear weiht on left arm. Patient stated needle hit bone in arm and feels instead of the deltoid it may have hit the ligament.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: arm red swollen/hot to touch, body aches, chills, fever, headache. All day after shot and slightly the day after that.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: arm red swollen/hot to touch, body aches, chills, fever, headache. All day after shot and slightly the day after that.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives approximately 2.5 HRS after receiving vaccines; when she got up from her nap
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Reaction
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Headache, Injection site reaction, Migraine
Clinical narrative: Patient woke up on Sat with severe headache/migraine, nausea, and chills (didn't take temperature). Around 7 pm a red rash appeared at and around the injection site. She experienced extreme fatigue also. On Sunday she still had a rash that extended down to about the elbow and still had headache and fatigue. On Monday she was feeling 90% better but still had nausea, headache and pink rash.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Rash erythematous
Clinical narrative: Patient woke up on Sat with severe headache/migraine, nausea, and chills (didn't take temperature). Around 7 pm a red rash appeared at and around the injection site. She experienced extreme fatigue also. On Sunday she still had a rash that extended down to about the elbow and still had headache and fatigue. On Monday she was feeling 90% better but still had nausea, headache and pink rash.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Injection site pain, Syncope
Clinical narrative: Patient Fainted; pain form injection/needle; Information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 825168).  This spontaneous report was received from a health professional referring to a 14 year old patient with an allergy to penicillin. The patient's medical history, and concomitant medications were not reported.  On 24-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, and frequency were unknown) intramuscular in the left arm with lot # reported as"R009615" for prophylaxis.    On the same date after vaccination, the patient patient fainted (syncope).   At the time of the report, the outcome of syncope was reported as resolved. The reporter did not mention the causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.  Lot number R009615 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), but upon internal validation it was established that Lot number R009615 has been verified to be a valid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine.  Follow up information has been received from health professional on 24-AUG-2020, and referring to currently 15 year old male patient. On 24-JUL-2019, the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose were unknown), and had a brief episode of syncope (also reported as he fainted) and experienced pain from injection/needle, while in office as vaccine being administered. After 1 minute, the patient fully recovered and had no residue side effects from vaccination. The vaccine was purchased from private funds. There was no temperature excursion involved.   The reporter considered the events to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon interval review, the event of syncope was considered to be medically significant.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Unevaluable event
Clinical narrative: Intense crying for multiple hours at a time.  Her body was very stiff and it was hard to hold or cradle her.  She was obviously in pain and only stopped with she physically could not cry any more.  This lasted about 2 months.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Crying, Musculoskeletal stiffness, Pain
Clinical narrative: Intense crying for multiple hours at a time.  Her body was very stiff and it was hard to hold or cradle her.  She was obviously in pain and only stopped with she physically could not cry any more.  This lasted about 2 months.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and aches
Age: 17.0
Sex: F
Vaccine: HEP, HEP, HPV9
Symptoms: Injury associated with device
Clinical narrative: While administering Immunizations, used finger instead of table to put safety guard on the needle. Needle stuck left pointer finger. Unsure of  which vaccination was given during incident. I listed them both.; This report was identified from a line listing obtained on request by the Company from the Food And Drug Administration (FDA) under the Act.  This spontaneous report was received from a health professional referring to a 17-year-old female patient. It was unknown if she had previous allergies to medications, food, and it was not reported if she had other Illnesses at the time of vaccination or if she had chronic or longstanding health conditions. Her concomitant medications included drospirenone, ethinyl estradiol (YAZ) as birth control, diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), poliovirus vaccine inactivated (vero) (IPOL), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX).         On 23-MAY-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number R021633, expiration date not reported, but upon internal validation established as 08-MAY-2021) and second dose hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot number R007212, expiration date not reported, but upon internal validation established as 04-NOV-2020) both by intramuscular route in the right arm as prophylaxis (concentrations were not reported)  On 23-MAY-2019, while administered Immunizations, used the finger instead of table to put safety guard on the needle. Needle stuck left pointer finger. It was unknown  which vaccination was given during incident (injury associated with device). The patient had a blood drawn, however the results were not provided.  At the time of this report, the outcome of injury associated with device was reported as recovered.    The causality assessment between the suspect therapies and the aforementioned event was not reported.  As of 21-AUG-2020, an inbound call was received from a nurse, who stated that she was unable to identify the patient and therefor was unable to answer the questions on the form.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion for GARDASIL 9 that was administered; This spontaneous report was received from a nurse practitioner, concerning a 13-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 06-AUG-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, as prophylaxis (frequency, route of administration, and anatomical location were not reported; lot number S020254 has been verified to be a valid lot number with expiration date reported and validated as 09-DEC-2021) which experienced a temperature excursion (product storage error).  On 12-AUG-2020, it was noted that the administered dose of vaccine experienced temperature of 11.2 degrees Celsius for 75 hours and 17 minutes on an unknown date. It was not reported if data logger was involved. No additional adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); devicelotnumber: S020254; expirationdate: 09-DEC-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