chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local swelling in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   The reporter considered the local swelling to be unlikely related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and another vaccine in the same arm on the same day and experienced localized swelling which did not think was related directly to the vaccinations, but more related to patient receiving them in the same arm.  The reporter did not had any patient details available at the time of this call and was not the one who administered the vaccines and did not take the patient's follow up phone call to the office.  However, stated if safety wanted to follow up would likely be able to gather the patient details if needed. The reporter consented to follow up. This case linked with US2020AMR203680, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR203680:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: diagnosed with Cancer after receiving the first dose; received the first dose of Shingrix about 2 years ago / now received the second dose on 10 Oct2020; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KY5T4, expiry date 27th May 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On 10th October 2020, the patient received the 2nd dose of Shingrix. On 10th October 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were as follows: The reported batch number KY5P4 for Shingrix did not exist and was updated to KY5T4 as per the sales database. After receiving 1st dose of Shingrix, the patient experienced cancer. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not know the exact date. The reporter did not know which type of cancer patient had. The reporter consent to follow up. The case was considered as medication error with harm.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: first Shingrix injection on 13 SEP 2020 / second Shingrix injection on 12 OCT 2020; tired; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 93FR9, expiry date 29th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: On 12th October 2020, the patient received the 2nd dose of Shingrix vaccine, shorter than the recommended schedule, which led to shorting of vaccination schedule. The pharmacist stated that the patient was tired. The reporter consented to follow up. For tolerance of 1st dose refer cases US2020AMR206754.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206754:Same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Low grade fever; Diarrhea; Soreness; nausea; lethargy.; Dry heaves; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 1st dose of Influenza vaccine Quadrivalent unspecified season .5 ml. On 13th October 2020, less than 3 weeks after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced dry heaves. On an unknown date, the patient experienced fever, diarrhea, pain, nausea and lethargy. On an unknown date, the outcome of the fever, diarrhea, pain, nausea and lethargy were not recovered/not resolved and the outcome of the dry heaves was unknown.   The reporter considered the fever, diarrhea, pain, nausea and lethargy to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the dry heaves to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received both the Shingrix and the Flu vaccine the last week of September in left arm and about 4 hours after the injections, she began to experience low grade fever, diarrhea, soreness, nausea and lethargy.   The reporter reported symptoms had gotten worse over past 3 weeks.  The patient experienced dry heaves.  The reporter provided medical disclaimer and advised her to follow up with her physician and copy of PI sent via email.  The reporter also informed could HCP follow up with GSK Medical Information department for any further questions. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Low grade fever; Diarrhea; Soreness; nausea; lethargy.; Dry heaves; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 1st dose of Influenza vaccine Quadrivalent unspecified season .5 ml. On 13th October 2020, less than 3 weeks after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced dry heaves. On an unknown date, the patient experienced fever, diarrhea, pain, nausea and lethargy. On an unknown date, the outcome of the fever, diarrhea, pain, nausea and lethargy were not recovered/not resolved and the outcome of the dry heaves was unknown.   The reporter considered the fever, diarrhea, pain, nausea and lethargy to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the dry heaves to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received both the Shingrix and the Flu vaccine the last week of September in left arm and about 4 hours after the injections, she began to experience low grade fever, diarrhea, soreness, nausea and lethargy.   The reporter reported symptoms had gotten worse over past 3 weeks.  The patient experienced dry heaves.  The reporter provided medical disclaimer and advised her to follow up with her physician and copy of PI sent via email.  The reporter also informed could HCP follow up with GSK Medical Information department for any further questions. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed an episode of shingles in the same area as before / leg; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles on leg in August 2019).   On 5th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient had experienced shingles in her leg. The patient received the dose of Shingrix and later developed an episode of shingles in the same area as before. The episode was not an open rash situation. The reporter did not clarify when the patient started having the episode. The reporter consented to follow up. The reporter did not provide details of 1st dose because it was not administered as his pharmacy but agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness, Malaise
Clinical narrative: got sick / didn't feel good; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced sickness. The patient was treated with methylprednisolone (Medrol Dosepak). On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient got sick and did not feel good right after receiving the first dose of Shingrix. The patient was given Medrol Dosepak. No additional details were available. The reporter did not consent to follow up. The reporter could not clarify further what got sick entailed and did not remember any further details. The reporter does not wish to be contacted because she had nothing more to provide.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site urticaria
Clinical narrative: erythema on upper forearm; urticaria lesions around site of injection; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a child patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date unknown) for prophylaxis.   On 30th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 1st October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced erythema of extremities and injection site urticaria. On an unknown date, the outcome of the erythema of extremities and injection site urticaria were unknown.   It was unknown if the reporter considered the erythema of extremities and injection site urticaria to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a later response. The patient experienced local erythema on upper forearm and urticaria lesions around site of injection. The reporter consented to follow up. The reporter found suspicious that same lot number was involved in many adverse event in the clinic. The reporter could not find expiration date from this Flulaval shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202326:same reporter US-GLAXOSMITHKLINE-US2020202330:same reporter US-GLAXOSMITHKLINE-US2020204774:same reporter US-GLAXOSMITHKLINE-US2020204778:same reporter
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: red blotch on left arm; This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 30th November 2021) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th October 2020, 1 days after receiving Shingrix, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on left arm. After vaccination patient developed a red blotch near the injection site on her left arm. Red blotch was described as 2 inches wide by 6 inches long. The reporter consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Barre syndrome; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from non health care professional via social media.  This case involves patient (unknown demoghraphics) who experienced barre syndrome (Guillain-Barre syndrome) while received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious barre syndrome (Guillain-Barre syndrome) (GBS), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case details- Patient had Barre syndrome that's why avoided the shot.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for guillain-barre syndrome.  Information on batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed."
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hot flush, Myalgia, Pain, Sleep disorder
Clinical narrative: Muscle pain that began bilateral back around the shoulders and just below the should blades and that extended down to my back and into the abdomen approximately 6 hours after receiving the vaccine. Difficulty sleeping when turning in bed and pain severe with movement. Took Advil and it helped a lot. Also had chills and hot flashes.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Full blood count, Malaise, Metabolic function test
Clinical narrative: Approximately 5 minutes after receiving vaccine felt dizzy, did not feel well. Vomited multiple times and had diarrhea, developed hives on chest and face. I spoke with father at 1PM, no face or lip swelling, no drooling or wheezing, no difficulty breathing. Instructed them to go immediately to the ED. In the ED received Epinephrine, zofran, IVF and benadryl, observed for 5+ hours.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Vomiting
Clinical narrative: Approximately 5 minutes after receiving vaccine felt dizzy, did not feel well. Vomited multiple times and had diarrhea, developed hives on chest and face. I spoke with father at 1PM, no face or lip swelling, no drooling or wheezing, no difficulty breathing. Instructed them to go immediately to the ED. In the ED received Epinephrine, zofran, IVF and benadryl, observed for 5+ hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Headache, Nausea, Pallor
Clinical narrative: Patient received vaccines, 5 minutes later he was noted to be pale, complained of headache and nausea. Was laid down on exam table, BP 96/60, assessed by MD. Still pale but talkative. Fully recovered and was discharged from office approx 30 mins after vaccine administration.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site pain, Pain
Clinical narrative: Patient states approximately one week after her influenza vaccine, she woke up and noticed numbness in her left arm where the injection was given. The numb area was approximately "softball-sized" per her.  This has been continuous and has not improved. She then adds that she developed pain around the numb area and directly in the center--this began "a few days ago"--roughly around 10/16/20. She notices the pain with gripping, pushing, and pulling with her left arm.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt presented 10-18-20 covered in hives. upon questioning no other new exposures pt could identify, Counseled signs if severe reaction/breathing issues and got pt benadryl and hydrocortisone cream.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling & erythema  noted 9/9/2020. Next day erythema resolved and swelling better.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cough, Dysphonia, Dyspnoea, Electrocardiogram
Clinical narrative: Obtained seasonal flu shot at Pharmacy located at the store location at approx. 4PM on Friday, October 16, 2020. Injected in left upper shoulder. At approx. 7:30pm the same evening, I began having problems breathing and my neck and chest were blotchy red with what looked like hives, but not itchy just hot to the touch. My throat tightened, and my voice became very raspy, and my lips began to tingle but were not swollen. I began coughing to clear my throat, and drinking cold water, but the odd feeling continued to progress. I took my temperature at approx 8:15pm on the same evening and did not have any noticeable change, but my heart rate was increasing. By 8:30pm I called an urgent care facility to obtain their advice, as my primary physician's office was closed. The admin nurse listened as I recounted my situation of getting a flu shot earlier in the afternoon. She suggested I immediately go to the Emergency Room and if I had a Benadryl tablet, to take that immediately before leaving for the ER. I did take one 25mg Benadryl. I arrived at the ER approx 8:50pm, and was immediately triaged. I was admitted by 9:15pm, after having an IV line placed in my left arm. The attending nurse placed EKG leads on my chest to monitor my heart rate and pulse oxygen rate. By approx. 10:34pm the decision was made to give me (all via IV): diphenhydramine, famotidine, and methylprednisolone sodium succinate. The ER doctor on duty, visited with me at approx 11:15pm, at which time I was improving and the most alarming of the symptoms were regressing. I was discharged at approx. 11:45pm and was given a prescription of Prednisone (pill form) to take over the next 5 days to ensure the anaphylaxis symptoms stayed in check. As of Saturday,  October 17th, I was feeling much better and back to normal.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Heart rate increased, Paraesthesia oral, Rash macular, Skin warm
Clinical narrative: Obtained seasonal flu shot at Pharmacy located at the store location at approx. 4PM on Friday, October 16, 2020. Injected in left upper shoulder. At approx. 7:30pm the same evening, I began having problems breathing and my neck and chest were blotchy red with what looked like hives, but not itchy just hot to the touch. My throat tightened, and my voice became very raspy, and my lips began to tingle but were not swollen. I began coughing to clear my throat, and drinking cold water, but the odd feeling continued to progress. I took my temperature at approx 8:15pm on the same evening and did not have any noticeable change, but my heart rate was increasing. By 8:30pm I called an urgent care facility to obtain their advice, as my primary physician's office was closed. The admin nurse listened as I recounted my situation of getting a flu shot earlier in the afternoon. She suggested I immediately go to the Emergency Room and if I had a Benadryl tablet, to take that immediately before leaving for the ER. I did take one 25mg Benadryl. I arrived at the ER approx 8:50pm, and was immediately triaged. I was admitted by 9:15pm, after having an IV line placed in my left arm. The attending nurse placed EKG leads on my chest to monitor my heart rate and pulse oxygen rate. By approx. 10:34pm the decision was made to give me (all via IV): diphenhydramine, famotidine, and methylprednisolone sodium succinate. The ER doctor on duty, visited with me at approx 11:15pm, at which time I was improving and the most alarming of the symptoms were regressing. I was discharged at approx. 11:45pm and was given a prescription of Prednisone (pill form) to take over the next 5 days to ensure the anaphylaxis symptoms stayed in check. As of Saturday,  October 17th, I was feeling much better and back to normal.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria
Clinical narrative: Obtained seasonal flu shot at Pharmacy located at the store location at approx. 4PM on Friday, October 16, 2020. Injected in left upper shoulder. At approx. 7:30pm the same evening, I began having problems breathing and my neck and chest were blotchy red with what looked like hives, but not itchy just hot to the touch. My throat tightened, and my voice became very raspy, and my lips began to tingle but were not swollen. I began coughing to clear my throat, and drinking cold water, but the odd feeling continued to progress. I took my temperature at approx 8:15pm on the same evening and did not have any noticeable change, but my heart rate was increasing. By 8:30pm I called an urgent care facility to obtain their advice, as my primary physician's office was closed. The admin nurse listened as I recounted my situation of getting a flu shot earlier in the afternoon. She suggested I immediately go to the Emergency Room and if I had a Benadryl tablet, to take that immediately before leaving for the ER. I did take one 25mg Benadryl. I arrived at the ER approx 8:50pm, and was immediately triaged. I was admitted by 9:15pm, after having an IV line placed in my left arm. The attending nurse placed EKG leads on my chest to monitor my heart rate and pulse oxygen rate. By approx. 10:34pm the decision was made to give me (all via IV): diphenhydramine, famotidine, and methylprednisolone sodium succinate. The ER doctor on duty, visited with me at approx 11:15pm, at which time I was improving and the most alarming of the symptoms were regressing. I was discharged at approx. 11:45pm and was given a prescription of Prednisone (pill form) to take over the next 5 days to ensure the anaphylaxis symptoms stayed in check. As of Saturday,  October 17th, I was feeling much better and back to normal.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Severe swelling extending from the top of the shoulder to the elbow, area hot puffy and red for 5 days.  Site still painful and patient is running a fever and has a runny nose.  Mother consulted physician and has been treating with acetaminophen and drinking more water.  While still painful at day 5 the swelling has gone down.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Rhinorrhoea
Clinical narrative: Severe swelling extending from the top of the shoulder to the elbow, area hot puffy and red for 5 days.  Site still painful and patient is running a fever and has a runny nose.  Mother consulted physician and has been treating with acetaminophen and drinking more water.  While still painful at day 5 the swelling has gone down.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Left arm numbness and tingling, headaches, redness and swelling about 2 inches in diameter around site of injection.
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: by the evening of the immunization c/o + fever ; + chills; + nasal congestion; + runny nose; + fatigue; + headache
Age: 21.0
Sex: M
Vaccine: FLUC4
Symptoms: Rhinorrhoea
Clinical narrative: by the evening of the immunization c/o + fever ; + chills; + nasal congestion; + runny nose; + fatigue; + headache
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Mom called stating that pt started with barky cough on 10/16/2020.  Congestion/ runny nose, lots of sneezing.  Temp no higher than 99.  Mom wanted to call in as last year he rec'd flu shot as well and ended up with fever and vomiting a couple days later and thought it might be due to flu vaccine.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye swelling, Lip swelling, Swollen tongue, Wheezing
Clinical narrative: Coughing, wheezing within 4 hours of vaccine.  Another 4 hours later, tongue, eyes and lips swollen.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Suicidal ideation
Clinical narrative: Following receiving the vaccine I began to experience thoughts of "what if I were to commit suicide."  No thoughts to act, just "what ifs."  This has been occurring randomly since in varying frequencies.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Musculoskeletal stiffness, Pain
Clinical narrative: Upper back pain, stiff neck, body aches
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: I started getting very sore in my left arm about an hour after the shot.  By 7 PM, I developed a 101 fever, chills, body aches throughout and a very bad headache.  I started taking Tylenol at 9:30 and by 6:30 the next morning, the fever was down to 99 but aches and headache still present.  Went to local clinic thinking could potentially be covid.  Was tested negative for Covid.  Asked doctor there if this could be reaction to flu shot and she said no, only if it was an aerosol.  Continued to take tylenon for next day to deal with aches and headache.  Fever was back to normal by Friday morning.  Friday morning I reached out to my doctor, explained symptoms and they said it was most likely a reaction to the shot.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I started getting very sore in my left arm about an hour after the shot.  By 7 PM, I developed a 101 fever, chills, body aches throughout and a very bad headache.  I started taking Tylenol at 9:30 and by 6:30 the next morning, the fever was down to 99 but aches and headache still present.  Went to local clinic thinking could potentially be covid.  Was tested negative for Covid.  Asked doctor there if this could be reaction to flu shot and she said no, only if it was an aerosol.  Continued to take tylenon for next day to deal with aches and headache.  Fever was back to normal by Friday morning.  Friday morning I reached out to my doctor, explained symptoms and they said it was most likely a reaction to the shot.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Muscle spasms, Myalgia, Tenderness
Clinical narrative: Patient has extreme cramping in calves and feet. Patients forarm and trapezius muscle are painful to touch.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, COVID-19, Chills, Headache, Hypoaesthesia
Clinical narrative: ER documentation:From RN:  Attempted to return phone call to patient.  Left a voice mail message.  Will try to reach pt one more time.   Returned phone call to 39 year old patient.  Pt states she has a history of multiple sclerosis.  Pt states she received the DTP vaccine 10/15/20, and has been experiencing several side effects.  Pt states her temp was 103 ( TA ) this morning, and is currently 99.4.  States she is experiencing slight body aches, and a persistent frontal headache.  Rates headache 2/10 currently, but states ibuprofen is not helping.  Pt states her fingers and toes were feeling numb and tingling earlier, but that has ceased.  Denies weakness on one side of the body.  Denies blurred, or double vision.  Denies a rash, or vomiting.  States headache is interfering with her normal activities.  Denies difficulty breathing, or swallowing.  Denies chest pain, or fainting.  Denies swelling in back of throat, or tongue.  Denies palpitations.  Reviewed immunization, tetanus and headache, disposition seek medical care within 24 hours.  I advised pt to go to urgent care to be assessed.  Pt verbalizes understanding, but wants to speak with the on call provider.  I instructed pt to call back if no response from on call within 30 minutes.  Pt verbalizes understanding.   From MD Spoke to patient yesterday.  Already feeling better by time of call and temp around 99 degrees.  Taking Advil helps with chills and aches.  She has NO respiratory symptoms and Tmax of about 103 was transient (resolved without meds it seems).  I think very unlikely to be flu or COVID and given the timing of symptoms, most likely a vaccine reaction.  Will add Tdap to her chart and have office file a report.  She agreed to call back immediately with any worsening symptoms, fever that goes back up or if symptoms haven't resolved by Monday.  She's in agreement with plan.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Loss of personal independence in daily activities, Pain, Paraesthesia, Reaction to preservatives
Clinical narrative: ER documentation:From RN:  Attempted to return phone call to patient.  Left a voice mail message.  Will try to reach pt one more time.   Returned phone call to 39 year old patient.  Pt states she has a history of multiple sclerosis.  Pt states she received the DTP vaccine 10/15/20, and has been experiencing several side effects.  Pt states her temp was 103 ( TA ) this morning, and is currently 99.4.  States she is experiencing slight body aches, and a persistent frontal headache.  Rates headache 2/10 currently, but states ibuprofen is not helping.  Pt states her fingers and toes were feeling numb and tingling earlier, but that has ceased.  Denies weakness on one side of the body.  Denies blurred, or double vision.  Denies a rash, or vomiting.  States headache is interfering with her normal activities.  Denies difficulty breathing, or swallowing.  Denies chest pain, or fainting.  Denies swelling in back of throat, or tongue.  Denies palpitations.  Reviewed immunization, tetanus and headache, disposition seek medical care within 24 hours.  I advised pt to go to urgent care to be assessed.  Pt verbalizes understanding, but wants to speak with the on call provider.  I instructed pt to call back if no response from on call within 30 minutes.  Pt verbalizes understanding.   From MD Spoke to patient yesterday.  Already feeling better by time of call and temp around 99 degrees.  Taking Advil helps with chills and aches.  She has NO respiratory symptoms and Tmax of about 103 was transient (resolved without meds it seems).  I think very unlikely to be flu or COVID and given the timing of symptoms, most likely a vaccine reaction.  Will add Tdap to her chart and have office file a report.  She agreed to call back immediately with any worsening symptoms, fever that goes back up or if symptoms haven't resolved by Monday.  She's in agreement with plan.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Ear swelling, Erythema, Lip swelling, Pruritus, Swelling
Clinical narrative: "Itching, redness, welts, and swelling around lips, neck, and ears" went to ER was given steroids and BENADRYL.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: "Itching, redness, welts, and swelling around lips, neck, and ears" went to ER was given steroids and BENADRYL.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: numbness and pain in arm
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Ocular hyperaemia, Throat irritation
Clinical narrative: scratchy  red eyes, scratchy throat
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoacusis, Injection site haemorrhage, Injection site swelling
Clinical narrative: After administering vaccine, site was a little puffy/swollen. Did bleed more than usual, enough to prompt me to ask if patient was on blood thinners, which she said no to. Patient then said she felt dizzy, but no pain or soreness in arm above the usual for a vaccine. Patient complained of voices sounding muffled as if listening to radio and static was coming through when others were talking. Patient asked for water. Water given. Temperature was 97.2 F when checked. No pain or trouble moving, flexing arm, puffiness/swelling went down a little. Called mom to come over and pick her up and drive her back to be on the safe side.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site, route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced a temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter