chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Musculoskeletal disorder
Clinical narrative: Flu vaccine left my left arm weak for about 6 months... I had no strength to pick anything up it was as if my arm was only working 40 percent. I luckily regain strength but was very limited for months. I didn't bother going to the doctor just hoped whatever nerve affected would heal.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Chest X-ray abnormal, Human rhinovirus test positive, Malaise, Pneumonia, Respiration abnormal
Clinical narrative: On Friday August 9th patient had her vaccines done. I was against the vaccines but my husband and I had decided to change our minds, and lean towards getting them for her. On 8/12 I took my daughter back to the doctor because she had started wheezing and seemed sick. The NP prescribed a steroid called predinose that I know my child will refuse to take and will literally spit it out because it is so disgusting. I asked NP to prescribe her the disintegrating tabs but my insurance wouldn't pay for it. Patient had seemed to be getting better on her own, so I left it alone and did not give her any medicine. I was thinking she is just having a minor cold and will clear up on her own as she has before. On 8/27 I put her to bed, but at about 5:30 am on 8/28 I rushed her to the hospital as I could tell her breathing was getting worse and she was not responding to breathing treatments. She was admitted  for 3 days and two nights. The did an x-ray and said she had pneumonia in her right lung, which I recall being one of the possible side effects of the MMRV vaccine. She had a nose swab done and it came back positive for rhinovirus. I do not know if the vaccine caused this to happen, but I believe that it did since she was a healthy child before the vaccines.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: On Friday August 9th patient had her vaccines done. I was against the vaccines but my husband and I had decided to change our minds, and lean towards getting them for her. On 8/12 I took my daughter back to the doctor because she had started wheezing and seemed sick. The NP prescribed a steroid called predinose that I know my child will refuse to take and will literally spit it out because it is so disgusting. I asked NP to prescribe her the disintegrating tabs but my insurance wouldn't pay for it. Patient had seemed to be getting better on her own, so I left it alone and did not give her any medicine. I was thinking she is just having a minor cold and will clear up on her own as she has before. On 8/27 I put her to bed, but at about 5:30 am on 8/28 I rushed her to the hospital as I could tell her breathing was getting worse and she was not responding to breathing treatments. She was admitted  for 3 days and two nights. The did an x-ray and said she had pneumonia in her right lung, which I recall being one of the possible side effects of the MMRV vaccine. She had a nose swab done and it came back positive for rhinovirus. I do not know if the vaccine caused this to happen, but I believe that it did since she was a healthy child before the vaccines.
Age: 40.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: Fever temp 102, chills, diaphoresis, fatigue, decreased appetite, polydipsia
Age: 40.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Polydipsia, Pyrexia
Clinical narrative: Fever temp 102, chills, diaphoresis, fatigue, decreased appetite, polydipsia
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Chills, Headache, Vomiting
Clinical narrative: Began with a bad stomach ache, four hours after flu shot was given, followed by vomiting eight times, headache, chills. No treatment other than going to bed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Insomnia, Mobility decreased
Clinical narrative: Vaccine given on a Friday. Pt reports that evening started having headache, back/neck pain, fever and chills and that she stayed in bed Saturday and Sunday with these symptoms. She also had arm swelling which started "that day" of the injection and by the next morning was the entire upper arm down to her elbow, couldn't sleep in that side, limited use of arm due to pain for next 2 days.  She took ibuprofen for this. Reported it to office on 7/15/19 at 835 am and said "most of it is over, the swelling has gone down, just wanted us to know"
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Peripheral swelling, Pyrexia
Clinical narrative: Vaccine given on a Friday. Pt reports that evening started having headache, back/neck pain, fever and chills and that she stayed in bed Saturday and Sunday with these symptoms. She also had arm swelling which started "that day" of the injection and by the next morning was the entire upper arm down to her elbow, couldn't sleep in that side, limited use of arm due to pain for next 2 days.  She took ibuprofen for this. Reported it to office on 7/15/19 at 835 am and said "most of it is over, the swelling has gone down, just wanted us to know"
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Varicella virus test negative
Clinical narrative: titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; titers were negative fot measles, mumps, rubella and varicella; This spontaneous report as received from a nurse refers to a 21-year-old female patient. The patient had no pertinent medical history, no concomitant medications and no drug reactions or allergies.     On unknown dateS, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date and dose were not provided) subcutaneously and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date and dose were not provided) subcutaneously, both for prophylaxis. The nurse reported that the patient finished the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) series on an unspecified date, 16 years ago. It was unspecified how many doses of suspect vaccines were administered to the patient.  On 12-AUG-2019, the patient had titers drawn and it showed that titers were negative for measles, mumps, rubella and varicella. No treatment was given for the event. The patient did not seek medical attention. The outcome of the event was reported as recovered/resolved on an unspecified date in August 2019.  The relatedness between the event and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccines was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events reported; one dose of improperly stored vaccine, Gardasil 9, was administered to one patient; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported.  On 28-AUG-2019, the patient was vaccinated with one dose of an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection 0.5 milliliter, one time for prophylaxis (lot # R017624, expiration date17-MAR-2021; strength, route of administration were not reported).  The dose of varicella hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced a temperature excursion of -5.57 degrees Celsius for 10 hours and 30 minutes. There were no previous temperature excursions. The temperature excursion was detected by a data logger. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: Peripheral neuropathy of feet and hands; flulike symptoms; Post Herpetic Neuralgia; pain in joints of toes; This case was reported by a physician via call center representative and described the occurrence of peripheral neuropathy in a elderly female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 20th July 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (for tolerance of 1st dose, refer case US2019153184).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), influenza-like symptoms, post herpetic neuralgia and joint pain. On an unknown date, the outcome of the peripheral neuropathy, influenza-like symptoms, post herpetic neuralgia and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, influenza-like symptoms, post herpetic neuralgia and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician called regarding adverse events experienced by his wife after receivng Shingrix.  The patient had peripheral neuropathy feet and hands, post herpatic neuralgia, flu like symptoms. The patient had also experienced pain in joints of toes. The symptoms were getting progressively a little worse. Peripheral neuropathy was severe. These symptoms had been persisting for almost 3 weeks now. The reporter consented to follow up. The batch number of Shingrix was reported as M9512, which was corrected to M95T2 as per sales data sheet.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: Off label use; Rationale: The case is considered as invalid in the system core due to lack of valid adverse event. Based on reported information, it seems that the patient has shingles before receiving Shingrix. Also, symptoms persisted after Shingrix administration and diagnosed at the time of enquiry. Since Shingrix is intended for protection of Shingles and not as treatment, in this case the patient had no event but a current condition.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: pain in arm; Vaccine Administered at Inappropriate Site; Circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the pain in arm, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix about 5 months ago, exact date unknown and experienced pain in her arm during injection. To lessen the pain she was considering having the 2nd dose injected into her hip or thigh, vaccine administered at inappropriate site and circumstance or information capable of leading to medication error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site erythema, Injection site reaction, Injection site swelling, Oedema
Clinical narrative: Pain, swelling, edema, rapid heartbeat, fever. A very large red welt from injection site to elbow. The vaccine was given on 9/2/2019 and today's date is 9/4/2019 and the site is still red and swollen. When I had my first vaccine over a year ago all I had was a sore arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling, Urticaria
Clinical narrative: Pain, swelling, edema, rapid heartbeat, fever. A very large red welt from injection site to elbow. The vaccine was given on 9/2/2019 and today's date is 9/4/2019 and the site is still red and swollen. When I had my first vaccine over a year ago all I had was a sore arm.
Age: 32.0
Sex: F
Vaccine: TYP, YF
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Client called on August 28, 2019 to state that she had done a home pregnancy test and it was positive.  She stated she was going to call and get an appointment with her physician to verify pregnancy and inform them of the vaccines she received while not knowing she was pregnant.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blister, Rash erythematous
Clinical narrative: Vessicles and pink dots all over.  Various stages of healing and new vessicles forming while in the room.  Arms, legs, face, abdm, back
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of smell and taste beginning 48 hours after vaccine
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Rash pruritic, Varicella post vaccine
Clinical narrative: Pt came to our office on 9/3/2019 because his dad said he had come down with a rash the night before that was "very itchy". No other symptoms. No fever. Child did have the Varicella vaccine on 8/20/2019. Dr confirmed that it was chickenpox, probably from the vaccination on 8/20/2019.
Age: 63.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site discharge, Injection site induration, Injection site infection, Injection site nodule, Injection site pain
Clinical narrative: Approximately 5 days (08/12/19) after injection, patient stated she noticed a painful knot at injection site on right arm. Then by day 7 (08/14/19), the knot got harder and developed a blood blister at surface. Patient did not pop or open blister, but it opened and drained on its own during the night while sleeping on day 11. Patient went to provider's office and was seen on day 27 (09/03/19) and told the area was infected. She was prescribed oral cephalexin for 7 days and mupirocin oint for 5 days. Patient will start antibiotic therapy today (09/04/19) and follow up with provider in 7 days if no improvement.
Age: 63.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Approximately 5 days (08/12/19) after injection, patient stated she noticed a painful knot at injection site on right arm. Then by day 7 (08/14/19), the knot got harder and developed a blood blister at surface. Patient did not pop or open blister, but it opened and drained on its own during the night while sleeping on day 11. Patient went to provider's office and was seen on day 27 (09/03/19) and told the area was infected. She was prescribed oral cephalexin for 7 days and mupirocin oint for 5 days. Patient will start antibiotic therapy today (09/04/19) and follow up with provider in 7 days if no improvement.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Discovered today at patients appointment that on 7/2/19 that LPN gave her a 3rd Menveo (only 2 doses in this series, not 3) instead of giving the MenB #1. No harm done to patient. MenB given at todays appointment.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: patient given extra dose of Dtap and Polio
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Gastrooesophageal reflux disease, Headache, Nausea
Clinical narrative: Chills, nausea, headache, GERD chest pain
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: patient was accidentally given a dose of gardasil, even though series has been completed.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Joint range of motion decreased, Magnetic resonance imaging, Musculoskeletal pain, X-ray limb normal
Clinical narrative: Shoulder pain and reduced range of motion occurring over several days consistent with shoulder bursitis
Sex: F
Vaccine: HEP
Symptoms: Dermatitis allergic, Ear infection, Ear operation, Gastrointestinal disorder, Intensive care
Clinical narrative: Child was given the Hep B at birth.  Child was born healthy and  other had zero pain meds or delivery assistance from medication.  Natural healthy vaginal delivery.  After being administered the Hep B vaccine, baby began projectile vomiting with such force it appeared she would aspirate.  Child was immediately placed in the NICU for five days.  Child was chronically ill following this and has a neurodevelopmental delay, chronic ear infections, bowel issues and skin allergies.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Neurodevelopmental disorder, Vomiting projectile
Clinical narrative: Child was given the Hep B at birth.  Child was born healthy and  other had zero pain meds or delivery assistance from medication.  Natural healthy vaginal delivery.  After being administered the Hep B vaccine, baby began projectile vomiting with such force it appeared she would aspirate.  Child was immediately placed in the NICU for five days.  Child was chronically ill following this and has a neurodevelopmental delay, chronic ear infections, bowel issues and skin allergies.
Age: 1.58
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Developmental regression, Pneumonia, Pyrexia, Rash
Clinical narrative: reoccurring lung infections, on going fevers, joint pain, skin rashes, developmental regression all following the immunization. Still under care at hospital for each symptom.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Day following vaccine, patient experienced generally feeling ill as well as arm swelling, turning red, and being itchy and painful.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site reaction, Neuralgia, Pain in extremity
Clinical narrative: I initially developed a fever the night of the vaccination followed by chills and shivers.  This lasted about a day and a half.  Soon after the fever my arm started to ache and then it became almost immobile.  I could not initiate movement in that arm for about two days and the nerves were painful in that arm near where the shot was given for about four days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I initially developed a fever the night of the vaccination followed by chills and shivers.  This lasted about a day and a half.  Soon after the fever my arm started to ache and then it became almost immobile.  I could not initiate movement in that arm for about two days and the nerves were painful in that arm near where the shot was given for about four days.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Feeling hot, Headache, Lip swelling, Nausea
Clinical narrative: Around 7:30 pm, arm started hurting.  started having itching of neck and face.  Took Benadryl around that time. felt hot.  patient would get a cold rag.  developed a headache and had some nausea.  around 12:30 am, vomited 3x and then at 5am vomited again.  noticed swelling around her eyes and lip.  noticed a red rash on her arms. came to the the office today with her daughter.  and decided to be seen.  has had Benadryl again.  on exam now.  no swelling of lips noted.  reddish rash on arms.  slight swelling around left eye lid.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pruritus, Rash erythematous, Swelling of eyelid, Vomiting
Clinical narrative: Around 7:30 pm, arm started hurting.  started having itching of neck and face.  Took Benadryl around that time. felt hot.  patient would get a cold rag.  developed a headache and had some nausea.  around 12:30 am, vomited 3x and then at 5am vomited again.  noticed swelling around her eyes and lip.  noticed a red rash on her arms. came to the the office today with her daughter.  and decided to be seen.  has had Benadryl again.  on exam now.  no swelling of lips noted.  reddish rash on arms.  slight swelling around left eye lid.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Aggression, Aphasia, Crying, Ear infection, Insomnia
Clinical narrative: Unconsolable crying, sleeplessness, loss of speech 2 weeks after injection, recurrent ear infections with ruptured eardrum. Tantrums that lasted over an hour.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Tympanic membrane perforation
Clinical narrative: Unconsolable crying, sleeplessness, loss of speech 2 weeks after injection, recurrent ear infections with ruptured eardrum. Tantrums that lasted over an hour.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Client presented to Health Department with guardian. Reviewed 2 record for client, 1 electronic and 1 paper copy. Reviewed the date incorrectly for next V2V dose, and administered VZV dose too early. 2nd dose due 11/1/2019. Monitored client for approximately 20 minutes in clinic without any adverse reaction noted. Discussed with guardian that dose was given too early. Guardian was understanding about the incident. Called guardian to check on client; left voicemail to please return call.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Inflammation, Pain, Skin warm
Clinical narrative: Pain started day of shot....lasted 1 week Left arm hot. Inflamed area grew to 6" down and almost totally surrounding
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site pruritus, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever; Weakness; Pain at injection site; Injection site Stiffness; Itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever, weakness, injection site pain, stiffness and injection site itching. On an unknown date, the outcome of the fever, weakness, injection site pain, stiffness and injection site itching were recovered/resolved.   It was unknown if the reporter considered the fever, weakness, injection site pain, stiffness and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 50 or 51 years. The patient received the first dose of the Shingrix vaccine on a Wednesday. The patient had pain, stiffness and itching at the injection site. He also experienced a fever, and weakness. All symptoms resolved by either the following Saturday or Sunday. The patient would not provide any additional information.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Periorbital swelling, Rash, Skin ulcer
Clinical narrative: Swelling of face, chills, puffy eyes, rash to face and sores to left forearm (after 2 days), pain to left arm (no swelling or redness)
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of face, chills, puffy eyes, rash to face and sores to left forearm (after 2 days), pain to left arm (no swelling or redness)
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Induration, Pain in extremity, Pruritus
Clinical narrative: Vaccine given on Thursday.  Within an hour of receiving it I started with severe burning then induration, increased warmth, pain, redness, pain and warmth started spreading over my upper arm, lasted until Monday and my skin was left with a yellow discoloration as you might see with a bruise resolving.  Also severe itching present.     I have pictures of the progression.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Yellow skin
Clinical narrative: Vaccine given on Thursday.  Within an hour of receiving it I started with severe burning then induration, increased warmth, pain, redness, pain and warmth started spreading over my upper arm, lasted until Monday and my skin was left with a yellow discoloration as you might see with a bruise resolving.  Also severe itching present.     I have pictures of the progression.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Gastrointestinal motility disorder, Vomiting projectile
Clinical narrative: Projectile vomiting after nursing for 3 weeks post vaccination, pediatric progress note states post viral dysmotility
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Activated partial thromboplastin time shortened, C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Injection site erythema
Clinical narrative: child developed a petechial rash that extended from the right thigh at injection site up the right side of her body, including her face and chest on the right side only. She also had a local reaction, with erythema and tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site rash, Laboratory test, Local reaction, Petechiae
Clinical narrative: child developed a petechial rash that extended from the right thigh at injection site up the right side of her body, including her face and chest on the right side only. She also had a local reaction, with erythema and tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Prothrombin time normal, Streptococcus test negative, Urine analysis normal, White blood cell count increased
Clinical narrative: child developed a petechial rash that extended from the right thigh at injection site up the right side of her body, including her face and chest on the right side only. She also had a local reaction, with erythema and tenderness at injection site.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Flushing, Pruritus generalised
Clinical narrative: Patient is having flushing of the face and itching all over her body.  She has taken benadryl without any relief.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Generalized papular pruritic rash started 2 days after receiving the vaccine.  Started on buttocks and spread to back, legs, arms, neck, scalp.  On exam rash is somewhat concerning for varicella but without pustules or vesicles.  Recommend use of loratadine for pruritus.  Pt to follow up in 2 days to see if develops pustules/vesicles which would be more c/w varicella.  Advised pt avoid physical contact with immunocompromised family members (wife is pregnant).
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure, evaluated in ED.  No labs or tests performed.  No treatments given.  Seizure resolved and he returned to baseline.
Age: 2.42
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Client accidentally administered DTaP too early. Parents notified of mistake and that injection will not be considered valid and will need repeating later. No adverse reaction at time of report.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Papilloedema
Clinical narrative: Papilledema
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Incontinence, Loss of consciousness, Nausea, Syncope
Clinical narrative: her arm is feeling sore where she got the vaccine administered; because of the syncope she experienced yesterday / passed out; experienced some incontinence; became dizzy; felt nauseous; This spontaneous report was received from a 15-year-old female patient, who referred to herself. Her pertinent medical history included asthma. The patient's concomitant medications included unspecified multi-vitamins. She did not have any drug reactions or allergies. On 28-AUG-2019, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On that same day, approximately 10 - 15 minutes after the vaccination, while the patient was a passenger in the car, she became dizzy, felt nauseous, passed out and experienced some incontinence. The patient informed that she recovered form the events about 10 minutes later. Subsequently, she went back to her pediatrician's office where "they said she was fine".  On 29-AUG-2019 (reported as today), the patient's arm felt sore at the vaccine administration site. On that same day, the patient went to an unspecified hospital, because of the syncope she experienced a day before, however she did not received any treatment.  The patient had no lab diagnostics or studies performed.  The outcome for the event vaccination site pain was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event of the syncope was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain
Clinical narrative: her arm is feeling sore where she got the vaccine administered; because of the syncope she experienced yesterday / passed out; experienced some incontinence; became dizzy; felt nauseous; This spontaneous report was received from a 15-year-old female patient, who referred to herself. Her pertinent medical history included asthma. The patient's concomitant medications included unspecified multi-vitamins. She did not have any drug reactions or allergies. On 28-AUG-2019, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, lot # and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On that same day, approximately 10 - 15 minutes after the vaccination, while the patient was a passenger in the car, she became dizzy, felt nauseous, passed out and experienced some incontinence. The patient informed that she recovered form the events about 10 minutes later. Subsequently, she went back to her pediatrician's office where "they said she was fine".  On 29-AUG-2019 (reported as today), the patient's arm felt sore at the vaccine administration site. On that same day, the patient went to an unspecified hospital, because of the syncope she experienced a day before, however she did not received any treatment.  The patient had no lab diagnostics or studies performed.  The outcome for the event vaccination site pain was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event of the syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Headache, Injected limb mobility decreased, Muscle spasms, Muscle twitching
Clinical narrative: Headache; Severe muscle spasms while the pharmacist was injecting the serum; I couldn't raise my arm at all; Flushed; Nausea; Pain in arm; Muscles in that arm hurt when I move my arm; Muscle throb; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching. The patient was treated with ibuprofen (Advil) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the headache, muscle spasm, flushing, nausea, muscle pain and muscle twitching were unknown and the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving.   It was unknown if the reporter considered the headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix a week ago from the date of reporting. The patient had severe muscle spasms while the pharmacist was injecting the serum. The patient reported her shot took much longer to give than her husband's. Several hours after vaccination, the patient could not raise her arm at all. The patient was flushed. The patient stated she expected to be sore, but an arm that she could not lift up, was a surprise. This pain lasted 5 days. On the sixth day, the patient began to be able to lift her arm higher up, but with pain. That still was where she was on the seventh day. The patient had tried Advil and ice, as directed by a doctor, but she had received little relief. The patient's muscles in that arm hurt when she move her arm, and sometimes they throb without movement. The patient asked if the anyone heard of this happening. The patient asked if she inoculated incorrectly.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Headache; Severe muscle spasms while the pharmacist was injecting the serum; I couldn't raise my arm at all; Flushed; Nausea; Pain in arm; Muscles in that arm hurt when I move my arm; Muscle throb; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching. The patient was treated with ibuprofen (Advil) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the headache, muscle spasm, flushing, nausea, muscle pain and muscle twitching were unknown and the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving.   It was unknown if the reporter considered the headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix a week ago from the date of reporting. The patient had severe muscle spasms while the pharmacist was injecting the serum. The patient reported her shot took much longer to give than her husband's. Several hours after vaccination, the patient could not raise her arm at all. The patient was flushed. The patient stated she expected to be sore, but an arm that she could not lift up, was a surprise. This pain lasted 5 days. On the sixth day, the patient began to be able to lift her arm higher up, but with pain. That still was where she was on the seventh day. The patient had tried Advil and ice, as directed by a doctor, but she had received little relief. The patient's muscles in that arm hurt when she move her arm, and sometimes they throb without movement. The patient asked if the anyone heard of this happening. The patient asked if she inoculated incorrectly.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Headache; Severe muscle spasms while the pharmacist was injecting the serum; I couldn't raise my arm at all; Flushed; Nausea; Pain in arm; Muscles in that arm hurt when I move my arm; Muscle throb; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching. The patient was treated with ibuprofen (Advil) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the headache, muscle spasm, flushing, nausea, muscle pain and muscle twitching were unknown and the outcome of the injected limb mobility decreased and pain in arm were recovering/resolving.   It was unknown if the reporter considered the headache, muscle spasm, injected limb mobility decreased, flushing, nausea, pain in arm, muscle pain and muscle twitching to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix a week ago from the date of reporting. The patient had severe muscle spasms while the pharmacist was injecting the serum. The patient reported her shot took much longer to give than her husband's. Several hours after vaccination, the patient could not raise her arm at all. The patient was flushed. The patient stated she expected to be sore, but an arm that she could not lift up, was a surprise. This pain lasted 5 days. On the sixth day, the patient began to be able to lift her arm higher up, but with pain. That still was where she was on the seventh day. The patient had tried Advil and ice, as directed by a doctor, but she had received little relief. The patient's muscles in that arm hurt when she move her arm, and sometimes they throb without movement. The patient asked if the anyone heard of this happening. The patient asked if she inoculated incorrectly.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. During the call the patient stated, he had both doses of Shingrix, and on the second dose he experienced tiredness such that he left work and went home and slept and then it resolved. The reporter did not consent to follow up. This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: UTI; This case was reported by a pharmacist via call center representative and described the occurrence of recurrent urinary tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced recurrent urinary tract infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the recurrent urinary tract infection was unknown.   The reporter considered the recurrent urinary tract infection to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had experienced recurrent urinary tract infection and had been off and on antibiotics, so she had not yet received the 2nd dose of the Shingrix series. The pharmacist stated that the urinary tract infection was unrelated to the Shingrix vaccine. The reporter consented to follow up. No further patient details were provided by pharmacist on the call, though she did grant permission to follow up. She reiterated the urinary tract infection was not related to the Shingrix.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: swelling and redness at the injection site; swelling and redness at the injection site; fever; This is a spontaneous report from a contactable other health professional (medical assistant) on behalf of physician. A 11- year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, Lot Number: T66104, Expiry date: 31Dec2019, NDC number: 000510001), via an unspecified route of administration on an unspecified date at single dose in deltoid right for immunization at age of 11 years old, hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9, Lot Number: R029117, Expiry Date: 10Jul2021, NDC number: 0006412101), intramuscularly on the same day at unknown dose in deltoid left for immunization. The patient medical history was not reported. Concomitant medication included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Lot Number: U6153AA, Expiry Date: 21Mar2020, NDC number: 4928158958), intramuscularly on an unspecified date (within 4 weeks prior to the first administration date of the suspect vaccine) at unknown dose in deltoid right for immunization. The patient previously took amoxicillin and experienced amoxicillin allergy. The patient experienced swelling and redness at the injection site and fever on 02Aug2019. The doctor advised the patient's mother to administer Motrin and Tylenol as needed for fever, lots of liquids, and an ice pack. The outcome of the events was not resolved. Causality between events and suspect vaccine meningococcal group b rlp2086 was reported as yes (related).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: maculopapular exanthema concentrated on L thigh and around L eye and scattered elsewhere.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Decreased appetite, Fatigue
Clinical narrative: About 5pm started to feel bad.  By 10pm had headache, chills, weakness, muscle aches, difficulty with moving, keeping balance and heart palpitations.   Patient slept very poorly.   Patient woke up feeling better but arm was quite sore.  After 3 hours, patient overcome with weakness and fatigue; had to sleep for 30 minutes.  Seemed to be getting tired and tired as the day went on.  On Friday, was still feeling poorly, had chills and totally without energy.   On Saturday noticed redness around injection site 2x3 inch; arm was tender.  All day just felt like lying down and sleeping.  Noticed that there was increased flatulence, had trouble making decisions, chills like hot flashes, decrease in appetite and intermittent nausea.  On Saturday, called the pharmacy around noon about the arm redness since it was odd that it appeared days later.   On Sunday woke up with a moderate headache and about 3 hours later food did not taste goodthings that she loves to eat tasted terrible.  Patient had lack of energy and fatigue.  More bowel movements that are frequent started Saturday and continued to Sunday.  Redness in arm was gone when woke up but came back after shower.   Sunday morning had to lie down again because felt so tired and had no appetite.    On Monday morning felt well when woke up and by afternoon felt like mostly okstill does not feel back to normal.   The fatigue is much better; it comes in waves and not as frequent.   Food taste ok now.   Patient did not call the doctor at any time.  Patient has received the Flu High Dose vaccine for several years prior with no problems.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Flatulence, Frequent bowel movements, Headache, Hot flush
Clinical narrative: About 5pm started to feel bad.  By 10pm had headache, chills, weakness, muscle aches, difficulty with moving, keeping balance and heart palpitations.   Patient slept very poorly.   Patient woke up feeling better but arm was quite sore.  After 3 hours, patient overcome with weakness and fatigue; had to sleep for 30 minutes.  Seemed to be getting tired and tired as the day went on.  On Friday, was still feeling poorly, had chills and totally without energy.   On Saturday noticed redness around injection site 2x3 inch; arm was tender.  All day just felt like lying down and sleeping.  Noticed that there was increased flatulence, had trouble making decisions, chills like hot flashes, decrease in appetite and intermittent nausea.  On Saturday, called the pharmacy around noon about the arm redness since it was odd that it appeared days later.   On Sunday woke up with a moderate headache and about 3 hours later food did not taste goodthings that she loves to eat tasted terrible.  Patient had lack of energy and fatigue.  More bowel movements that are frequent started Saturday and continued to Sunday.  Redness in arm was gone when woke up but came back after shower.   Sunday morning had to lie down again because felt so tired and had no appetite.    On Monday morning felt well when woke up and by afternoon felt like mostly okstill does not feel back to normal.   The fatigue is much better; it comes in waves and not as frequent.   Food taste ok now.   Patient did not call the doctor at any time.  Patient has received the Flu High Dose vaccine for several years prior with no problems.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Mental impairment, Mobility decreased, Myalgia, Nausea
Clinical narrative: About 5pm started to feel bad.  By 10pm had headache, chills, weakness, muscle aches, difficulty with moving, keeping balance and heart palpitations.   Patient slept very poorly.   Patient woke up feeling better but arm was quite sore.  After 3 hours, patient overcome with weakness and fatigue; had to sleep for 30 minutes.  Seemed to be getting tired and tired as the day went on.  On Friday, was still feeling poorly, had chills and totally without energy.   On Saturday noticed redness around injection site 2x3 inch; arm was tender.  All day just felt like lying down and sleeping.  Noticed that there was increased flatulence, had trouble making decisions, chills like hot flashes, decrease in appetite and intermittent nausea.  On Saturday, called the pharmacy around noon about the arm redness since it was odd that it appeared days later.   On Sunday woke up with a moderate headache and about 3 hours later food did not taste goodthings that she loves to eat tasted terrible.  Patient had lack of energy and fatigue.  More bowel movements that are frequent started Saturday and continued to Sunday.  Redness in arm was gone when woke up but came back after shower.   Sunday morning had to lie down again because felt so tired and had no appetite.    On Monday morning felt well when woke up and by afternoon felt like mostly okstill does not feel back to normal.   The fatigue is much better; it comes in waves and not as frequent.   Food taste ok now.   Patient did not call the doctor at any time.  Patient has received the Flu High Dose vaccine for several years prior with no problems.