chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre Syndrome. Onset on symptoms 1/23/05. Increased CSF protein. Progressed to respiratory failure - BIPAP 1/31. Currently in ICU; quadriplegic.  4/25/05 Progress note from Neuro states confirmation of GBS based on unfinished EMG report. An earlier evaluation discusses pt's condition in the earlier stages of the syndrome, physical findings and suggests a course of diagnostic testing to better establish complete Dx.   Additional records include Progress noted documentation of respiratory failure, intubation & mechanical ventilation.  Consults relating to evaluating GI hemorrhage, evaluation of respiratory failure, Evaluation of possible radiation damage causing neurologic changes(negative). Multiple lab values tracking glucose, H&H levels primarly, chemistries and on pg 48, report of CSF with protein elevated at 68. Other documents include GI evaluations and initial EMG report.  Exam revealed areflexia & subacute quadriparesis.  Tx w/plasmapheresis.     From Neuro office; 04/26/05 Followup note from Neurologist stating confirmed GBS Dx; discusses course of pt care at Hospital and Rehab Center and addresses other medical conditions included in the pt's diagnosis.  Pt  has had barium swallow studies more associated w throat CA and continues on PEG tube feeding; swallowing continues poor dispite all manuvers.
Anxious, mouth numb, cough - asked for inhaler, 25 mg po bendaryl given. Tongue becomes numb. Difficulty breathing. Called ambulance.
Shingles after 1st dose; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, 1 month 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 Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The patient came down with Shingles one month after receiving the Shingrix vaccine.  The patient did not get the second dose of Shingrix. The reporter would like to know how long she should wait until she was able to vaccinate the patient. The reporter agreed to follow up from GlaxoSmithKline.
Bedtime: Fever of 100.3   Chills, Body aches, headache. 11:30 temp higher, but thermometer not used. 1:30 felt better, but sl. headache and weakness.
Pt states he started having small purple spots that evening, that progress the next day, to large bruises, Parents called office 18:00 05/10/13, Pt was seen at a local urgent care and started on po steroids, pt followed up with PCP 05/14/13, CBC shoed platellet count of 2,000, pt was seen in local ER, repeat plt count was less than 5,000. Pt was admitted to the hospital and is currently under the care of a hematologist, he recieved  IVIG and po steroids to this point. Pt is currently still hospitalized.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that 2.5 weeks after receiving the vaccine, she had a bad reaction. The patient did not leave any additional details. Outbound call placed to obtain additional information, however, contact was unsuccessful.
Fever, chills, very large lymph node swelling and fever in left arm pit.  Bruising in left arm pit after lymph node swelling gone (about 5 days later).  Bruise was about the size of a phone.
Post vax, the pt died. No further information was available at the date of this report. The reporter indicated that 9 pts experienced this event, however, they are not presently identifiable. 15 day follow-up states that the pt experienced flu-like symptoms as did a total of 9 pts.
Lymph nodes on Left side of neck and armpit are swollen and painful to touch. Left and right side parotid gland swollen and painful to touch. Can barely raise left arm.
A 2 year old child received an injection of Prevnar in March, 2001. Forty-eight hours post-immunization, the child developed a fever and swollen lips. A diagnosis of herpes simplex virus gingivostomatitis was made; however the child's symptoms resolved within 36 hours. The child was well for approximately 1 or 2 days, then presented with swollen lips, red oral pharynx, palmar erythema and swelling, and fever then was hospitalized. The child had a positive throat culture for a group A streptococcus. The differential diagnoses on admission were atypical Kawasaki syndrome, group A Streptococcus syndrome, or reaction to Prevnar. The reporter noted that the child's older sibling had a recent history of a streptococcal throat infection.
Pt given monovalent dose of Covid 19 after when we should have started bivalent stock. No adverse symptoms.
Eczema reaction than a rash on her face, primarily on her cheeks; Severe digestive issues, kind of like gastritis; Severe tenderness; She couldn't eat much of anything; Her stomach hurt when she was standing up or walking; Flu-like symptoms; Intestinal pain; Fever around 99 to just under 101F; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything) and ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F). The patient was treated with PANTOPRAZOLE at an unspecified dose and frequency and IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. On 28-Jan-2021, ECZEMA (Eczema reaction than a rash on her face, primarily on her cheeks), GASTRITIS (Severe digestive issues, kind of like gastritis), TENDERNESS (Severe tenderness), EATING DISORDER (She couldn't eat much of anything), ABDOMINAL PAIN UPPER (Her stomach hurt when she was standing up or walking), INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Intestinal pain) and PYREXIA (Fever around 99 to just under 101F) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up received on 06-Apr-2021 reported minimal side effects from the second shot as well, not otherwise specified. On 08-Jun-2021: FU NNI : Reporter said: No need for additional follow up she is fine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Itchy throat, sinus congestion, fever around 100, chronic coughing, wheezing, short of breath
Injection was ordered as subcutaneous injection but given as intramuscular injection by error. No treatment necessary. Provider and patient were informed.
(+) 8.5X5cm indurated erythematous nodule left thigh slightly tender.
Patient is afraid of shots so she was feeling dizzy after the shot was given to her. She has phobia to needles.
ARTHRALGIA; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced arthralgia. On 09-MAR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arthralgia, and lethargic on 10-MAR-2021. This report was non-serious.
I woke up with a deep throbbing pain in my left arm on 3/30/21 (5 days after injection). Swollen lymph nodes under the armpit, and general sensitivity/difficulty moving that arm. It caused a lot of pain when attempting to lift anything. A rash formed around the injection site on 4/1. As of today, 4/2, the swelling and pain is slowly reducing.
I have myalgia and vomitting. I am currently pregnant but am due to take medication this weekend to stimulate cramping. I have had 4 healthy pregnancies without complications.
Stated that it started hurting approx. 1 hour after injection. Then the evening of 10/18 and into 10/19- (24 hours after) c/o of pain into forearm and stated pain was "throbbing". She stated that she took ADVIL and has been placing ice on the shoulder. She also stated that it has gotten better-now approx. 1 week after injection, the shoulder still is sore-she also stated that she is "babying" the arm. Denies any problem with movement and states she has full range of motion.
Pimple-like bumps on both sides of the face and on chin, consistent dull pain on exactly the same spot the shot was given.
FELT LIKE ATTACKING IMMUNE SYSTEM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-SEP-2021 18:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-SEP-2021, the patient experienced felt like attacking immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like attacking immune system. This report was non-serious.
Received the injection on 4/7 at the top of my shoulder. It felt odd going in this time.  Arm was fairly normal, just a little sore. At around 4:30 pm that same day, could not lift arm straight out, to the side, or  back.  The ache starts at top of my shoulder and runs down the inside of my arm. It is a significant ache that gets worse with movement. When at rest, it also aches but not as bad as when I move it. It hasn't gotten better and it had been almost 2 weeks.   When at rest,
Period type bleeding in between cycles lasts for days. No warning when it comes and is not normal for me
Accidentally administering only the diluent portion; Accidentally administering only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA639A, expiry date 31st May 2023) for prophylaxis.   On 19th April 2022, the patient received Menveo. On 19th April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments:  The healthcare professional did not have any of patient's demographic.   Pharmacist reported that the nurse accidentally administered only the diluent portion of Menveo, did not reconstitute the vaccine. The consent to follow up was given. Additional Supportive Information: The patient received Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
About 5 mins after vaccine administration at 1135 am, the individual complained of R side of head numbness, "feels like a balloon".  Also experiencing pain at same site and spreading to the nasal area and R side of face and also the forehead. No other sxs. Provided some juice since she did not eat this am per client. Pulse ox 96-97%. HR rate within acceptable ranges, 60-74/min.  Continue to assess sxs and monitor for any other issues.  No facial swelling, or any type of asymmetry is absent. Alert and oriented to name, address and place.  The symptoms of the numbness feeling and pain is still the same after 40 mins. Pt instructed to call physician but declined. Instructed that we will call 911 and educate her the reason.  At 1220, 911 was called. EMT arrived at 1228. the client refused to go to the hospital for further assessment.  The client remains stable and felt a little better. Ambulatory and d/c in stable status, accompanied with staff member.
people had side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (people had side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (people had side effects). At the time of the report, ADVERSE DRUG REACTION (people had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patients post temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot number AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided. This case contains information for the 3rd of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Woke up chills, temp 101, headache, nausea, went to work took ASA at 11:00 AM started "chest burning" cough stated taking inhalers Proair 5:00 PM starting to get hoarse voice got home still chest burning and tightness  took Advair inhaler went to bed 12/2/20012 6:00 AM woke still cough, hoarse headache went to work {ICU NURSE} arrived at 6:45 started coughing very hoarse now difficulty breathing especially exhaling rushed to Emergency room on arrival at 6:55 AM given DuoNeb, Benadryl IV, Pepcid IV, dexamethasone IV breathing improved still hoarse then 15 mins later had acute shortness of breath again and stridorous placed on 100% oxygen and given epinephrine sq breathing improved dramatically off oxygen breathing not burning but remained hoarse adm to hospital over night getting steroids and Benadryl of note I HAVE NEVER HAD AN ASTHMA ATTACK IN MY LIFE I have reactive airways last had used inhaler about one year ago. Discharged on Epi Pen.
Initial unsolicited report received from a healthcare professional on 19 October 2015. This case involves a 2-month-old female patient who was vaccinated with a dose of PENTACEL (batch number, dose, dose in series were not reported) intramuscularly on thigh and also received a dose of ROTATEQ (batch number, route and site of administration were not reported), a dose of Hep B (batch number, route and site of administration were not reported) and a dose of PREVNAR (batch number, route and site of administration were not reported) on 12 August 2015. The patient's medical history of pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were reported as none and concomitant medications were not reported. On 12 August 2015, few hours following the vaccination at 9:00 pm , the patient started crying and became very agitated she began throwing her head back and forth in a flexion extension motion but, the patient was conscious and afebrile. This episode had lasted for 10 minutes. Laboratory data was reported as none and corrective treatment were not reported. The patient was recovered from the events. List of documents held by sender: none.
Pt  started with enlarged lymph nodes 2 weeks after second dose.  19 days after that she began with rapid hair loss which wishing in 4 -6 weeks progressed to total scalp hair loss that then progress to Alopecia Universalis  within 3 months
On 4/13/2022 I had a headache about 09:00AM. I took 2 Advil at work and then started noticing other body aches. The head ache did not go away. I finished up a meeting and went home. I did not feel like staying at work. When I got home, I was extremely tired. I had trouble staying awake. It was worse than the head ache and body aches. By about 5:00 PM I started feeling better. The headache went away and body aches were better. I could tell I was getting past it. I also had a sore arm, but not any more sore than a normal vaccination. I feel like I have recovered. I do not feel sleepy, no pains and my arm is slightly sore, much better than yesterday.
Pruritis around chest/throat occurred within 10 minutes of injection; migrated to scalp; resolved 30 minutes after recieving  diphenhydramine 25 mg orally.  **Also got flu vaccination (Fluzone lot #UT7058LA) but has not had reaction to flu vaccinations in the past**
Moderna COVID-19 Vaccine EUA  2 pm day of first injection chills for 4 hours 4 days later- pain behind left knee when bent. As the time went on, about a week later, both legs started to be sore from the knee down. It felt like i worked out when i did not. The soreness did not prevent me from doing anything until Saturday 3/27/21. I walked 9 holes on the golf course when all of a sudden, my legs hurt very badly and they felt weak. I could no long walk the remaining 9 holes. I could still stand but it hurt at a rate of 9 on a scale of 1-10. Today they are still sore but at a 2. I did experience light light headedness 3/29 in the evening. I thought it was my glasses
Not adverse- but possible side effect? She was nursing and her last period was in Feb2019, She started my mensural cycle the day of her vaccine.; She was nursing and her last period was in Feb2019; She was nursing and her last period was in Feb2019; This is a spontaneous report from a contactable other Health Professional (patient). This reporter reported information for both mother and baby. This is the maternal report. A 32-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 06Jan2021 13:30 at single dose in left arm for covid-19 immunization. Medical history included the patient had COVID prior vaccination. The patient's concomitant medications were not reported. Post vaccination, the patient had no COVID tested. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that it was not adverse, but possible side effect. She was nursing and her last period was in Feb2019, she started her mensural cycle the day of her vaccine (on 06Jan2021). No treatment was received for event "her last period was in Feb2019, she started her mensural cycle the day of her vaccine". The outcome of the event "her last period was in Feb2019, she started her mensural cycle the day of her vaccine" was recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046112 Baby case
This case meets criteria for vaccine breakthrough review.  SxS for 11-13 days PTA include fatigue, myalgias, headache, cough, sore throat, congestion, SOB, nausea, abnormal taste and smell, and diarrhea.  Admitted after syncopal episode.
an hour and a half after shot, rapid heart beat 101 hard to breathe like just after doing yard work, Took several slow breaths drank lots of water and rested. By 8 pm was back to normal.
Was monitored for approx 15 min, and released. Returned to vaccine clinic approx 15 mins later with bumps on tongue, and swelling. 50 mg Benadryl given. BP 115/95, however pt stated she takes lisinopril at home
pain in lt eye 3wk p/vax;seen by MD & dx w/retinal edema & multiple white dot synd;