chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gen urticaria noted 45-60min p/vax;gen inspiratory/expiratory wheezing as well w/resp of 36;epi given w/improvement of urticaria;T97.2;P150, R36;
Headache Hemibody sensory deficits Narrative: Patient presented to Employee Health Clinic on morning of 4/16/2021 with report of headache and numbness on left side of face, left upper extremity, left lower extremity. Immediately taken to on-site ED for further eval. Evaluated in ED with concern for stroke. Unremarkable head CT. Etiology of headache and hemibody sensory deficits unknown at this time, though stroke unlikely per Neuro consult in ED. Admitted to hospital 4/16/2021 for further assessment and observation.  Other Relevant History:
Caller's entire arm from shoulder to hand started to swell and there were lymph node swelling.; lymph node swelling; has a pinkish-reddish color on his arm as well; He was just very quickly flushed; freezing feet; arm is tight; tight skin; his left arm started to swell. It was not just at the injection site but it was his entire arm and hand; This is a spontaneous report from a contactable consumer (Patient). This male consumer of an unspecified age reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC Number: not reported), via an unspecified route of administration, administered in left arm on 05Mar2021 (Friday) at 10:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Within the first 24 hours he had a very low grade reaction. He was just very quickly flushed and he had freezing feet (on an unspecified date in Mar2021). He didn't have anything really until Sunday evening when his left arm started to swell. It was not just at the injection site but it was his entire arm and hand (on an unspecified date in Mar2021). It went from his shoulder down to his hand. The lymph nodes under his arm and against his chest also started to swell (on an unspecified date in Mar2021).. It had continued to do so and his arm was tight (on an unspecified date in Mar2021). Other than that, he had no real pain, other than tight skin. He had a pinkish-reddish color on his arm as well (on an unspecified date in Mar2021). His left arm was very swollen compared to his other arm. He asked could anybody tell him if that was a usual side effect or could they tell him what to do about it. When asked if caller had time to complete a safety report today prior to being transferred to medical information he said that he would rather get his question answered since he waited 90 minutes for someone to answer. Caller's wife mentioned that Pfizer needs to up their game, need to get medical doctors on the phones. Caller asked what he should do regarding these possible side effect. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt states she developed a severe headache.  She is dizzy, nauseated, vomiting, has sore throat, trouble swallowing, and has some fatigue.  Pt has had some tele visits w/ her PCP due to her headache.  She requested he prescribe Topamax which she is currently taking but does not seem to help with the pain.  Pt will be seeing her PCP again for a head scan.
VACCINE EXPOSED TO TEMP. OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
Pregnancy history: 7 months pregnant, EDD 6/14/23  Adverse event: developed trauma to oral gum tissue, lower left side, bone actually broke off from inner gum jaw area and worked its way out, severe gum and tooth pain. As of June, still struggling, another loose piece of bone working it?s way to surface. Been closely following with dentist and Endodontics. They were concerned of a vertical root fracture and possibly needing extraction. Previously I have had very healthy gums and teeth, never had a cavity, short dental visits, no root canals or crowns, no previous dental work. No smoking or chewing tobacco.
Large raised red painful injection site. Ice to the area, Tylenol or ibuprofen prn
Felt burning in back of left hand in the first 15 minutes. Once released and able to drive off, began to feel 'off' on the 15 minute drive home. Hive-like reaction on skin, wheezing that required inhaler and overall terrible feeling. Did not abate until 10 PM that night.
After eight days I experienced a very itchy, enlarging red area at the injection site, which was warm to the touch.  Today is day ten and the itching is less but the red area is still present and warm.
Patient developed a localized, itchy rash around the injection site minutes after vaccination.  Patient did not show any other symptoms of respiratory compromise, hypotension, angioedema, or spreading of rash.  Patient was consulted to go to the Emergency room if the child developed any worsening of the rash or the aforementioned symptoms.  Attempted to follow up with patient's parents 2 hours after administration and 9:00AM the next day but was directed to voicemail each time.
Information has been received from a medical assistant concerning a female who in December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported).  Concomitant therapy included hormonal contraceptives (unspecified).  In February 2008, the patient was vaccinated with her second dose of GARDASIL (lot# not reported).  Subsequently, the patient experienced a fever of 101F and body aches.  The patient recovered from a fever of 101F and body aches after 2-3 days.  Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Information and follow up has been received from a registered nurse concerning a 20 year old female who is allergic to codeine and CECLOR and has asthma who in December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 28-FEB-2008, the patient was vaccinated intramuscularly in the right deltoid with her second dose of GARDASIL (lot# 659435/1265U). Subsequently, the patient experienced a fever of 101F eight hours post injection lasting 24 hours accompanied by generalized malaise and myalgia. The fever, generalized malaise and myalgia spontaneously resolved with no further problems. Additional information has been requested.
Received DPT (Adacel), developed pain (unk) at site, fever and generalized arthrolyse within 6-10 hours.
Pfizer vial that was left out from last evening (around 4PM) was administered to the patient by student, which was~12 hr expired. Pharmacist noticed the mistake and addressed it to me. I contacted clinical team for advise which is to repeat dose ASAP
Client received the 1st COVID vaccine Janssen (Lot #1822809 exp 03/07/2022) at 3:01PM and the Fluarix Quadrivalent vaccine (Lot # 3NA4M exp 06/3/2022) at 3:07PM. After receiving both vaccines, the client disclosed to RN that he had received a Moderna COVID vaccine about 2 weeks ago. The client stated he received the 1st dose of COVID vaccine Moderna "about two weeks ago." The client stated that he did not have any documentation of the Moderna COVID vaccine and was unsure what location he received the vaccine. Prior to receiving the COVID vaccine Janssen RN had asked the client if he had received any other COVID vaccines. The client denied having received any previous COVID vaccine.  The client denied any s/s of anaphylaxis. RN recommended the client wait 30 minutes in the observation area. The client voiced understanding of this education. RN  checked in with database representative, who stated no records appeared when they searched the client in database prior to receiving the COVID vaccine Janssen. Representative again searched the client in database and RN verified no records appeared. RN returned to the client. The client denied any current symptoms. The client stated that his 30 minutes had elapsed since he received the COVID vaccine Janssen. The client stood up unassisted and left the vaccination site at 3:20PM. After the client left the vaccination site, Representative noted a record matching client information received the 1st COVID vaccine Moderna (Lot#058E21A exp 01/10/2022).
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
LISPING OR SLIGHT LOSS OF CONTROL OF lips ,sunday evening the 24th into monday afternoon 25th on and off slight loss of control of lips ,sunday evening the 24th into monday evening the 25th heavy perspiration almost all day every day from monday the 25th burred vision from time to time ,sunday evening the 24th to monday morning the 25th traveling pain in the back of my legs,monday night the 25th and tuesday night the 26th pain in the lower back tuesday night 26th. pts description
2 days post vax, the pt presented with little bumps which itch all over her extremities, a fever of 103F which lasted one day and a runny nose which was clear and turned to green. The pt was diagnosed with Gianotti-Crosti syndrome of typical of viral exanthum.
Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined MD assessment (and states this resolved within hours.  Day after shot (1/9), she states she noted redness/tenderness at site, fatigue, body aches, fever to 103 (responsive to tylenol; reduced to 99.4 after 8hrs).  She presents to AOH 01/12/21 for assessment of L deltoid: 8x8.5cm injection site erythema/tenderness/very mild induration. States fever has resolved; neck/back aches continue; tenderness at site continues. Possible cellulitis? Advised to seek PCP counsel as soon as possible.
Chilling, unable to get warm, shivering. This started after going to bed, about 12 hours after administration, and lasted for apporx 4 hours.  Additionally had headache (wicked) when I woke with symptoms. It is now about 24 hours post admin and i still have the headache.
Fatigue, extreme. Treating with rest, diet, exercise, vitamins. I have not visited a physician yet for this but I plan to as appointments become available in my area.
This report described cutaneous leukocytoplastic vasculitis in a vaccinee of unspecified age and gender who received Hep-A vaccine, inactivated (Havrix). Allergies, medical history and concomitant medications were not specified. On an unspecified date, the pt received the 1st dose of Havrix. Two weeks, post vax, he experienced cutaneous leukocytoplastic vasculitis. This report is considered to be "Medically Serious". As of 6/16/01, the outcome of the event was unknown. Additional information has been requested.
pt recv vax; pt appeared pale, "sleepy glazed look"; purple around lips,lasted 1-1/2 mins; no abnl movements;no LOC;
The recipient booked the first dose of Moderna knowing that he received an Astrazeneca vaccine from fourteen days ago. When he was asked if he had received any other Covid 19 vaccine in the past he denied it. Thus, proceeding through the process of getting his first dose of Moderna. However, he confessed that he received an Astrazeneca vaccine after he received his Moderna shot to the vaccinator. Which lead her to notify her chain of command.   Please see the following notes from the appointment verifier and vaccinator:  Appointment verifier: The patient came in with an appointment to check in, he was asked if this vaccine was his first dose he said answered yes, he was also asked if he had any other vaccines in the last 14 days and he answered no, we checked him in and proceeded to the vaccination tent. Vaccinator: As the patient came in I verified he was receiving the 1st dose of his vaccine, I state it was a modern first dose .5 ml he ok to continue with his vaccination, ipader gave me his ok as well and I proceed to vaccinated on the left side.
I woke up around 1am after feeling fine all evening and was shaking uncontrollably with chills. Finally around 2am I started vomiting. This went on for half an hour before it stopped but the chills and aches continued. I woke up again at 6:30am and have had chills, severe body aches, fatigue, and nausea all day. I have treated it with fluids and some food as I?m able and rest.
Subacute fevers, cough, dyspnea for 2-3 weeks, found to be hypoxemic requiring up to max 5L nasal cannula, not responsive to coverage of community acquired pneumonia with 2 courses antibiotics. No bronch performed based on goals of care, empirically trialed on high dose steroids (soluemdrol 1000mg x3 days, then 500mg x1 day, transition to PO prednisone) as well as cefepime x7 days. Improvement to room air while continuing on steroids currently.
Mother reports that she removed bandaid today and noticed a red bump with smaller raised bumps, about the size of a quarter, on the child's left upper arm (vaccine site).
Syncope 5 minutes after dose. Vasovagal response to pain at injection site. Carpopedal spasms. Patient requested to be transported to hospital via ambulance. Patient evaluated and released from hospital same day
Tired and not feeling well 101318 - by Monday, 101518, started feeling tingling in hands, progressed and was out of work few days between 101518 and 110218. Sunday, 110418 was walking very wobbly and unstable and hands and feet were numbing more. By Monday, 110518 - no longer able to walk or stand. Admitted to via ER visit.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Nov-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Patient allergic to medications, food and other product was unknown at the time of reporting. It was unknown that the patient had ever been diagnosed or tested positive for COVID-19.  The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Excursion duration was reported as 1 month and on 19NOV2021 vials went from the super cold freezer to the refrigerator. At the time of reporting, 70 vials were still in ultra cold freezer and 8 vials were stored in refrigerator. No vaccine state changes were noticed and the vaccine was never refrozen. Number of vials/doses 78 vials were impacted. No previous temperature excursions were noticed.  No treatment drugs were reported.   This case was linked to MOD-2021-402935.
Right lower eye lid started to itch and then formed a bubble under eyelid. Swelling then extended to upper eyelid and approximately 1 in in diameter in the lower lid. Swelling has lasted for 72 hours.
diarrhea; pain / ran like a band to the upper back / back pain; and upper abdominal pain; arm pain; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   The patient's past medical history included tick bite, rheumatoid arthritis, connective tissue disorder, colitis (colon inflammation) and diverticulosis. Concomitant products included hydroxychloroquine and doxycycline.   On 21st October 2020, the patient received the 1st dose of Shingrix and FLUAD. On 23rd October 2020, 2 days after receiving Shingrix, the patient experienced diarrhea, upper back pain, upper abdominal pain and pain in arm. The patient was treated with loperamide hydrochloride (Imodium), ibuprofen (Advil) and steroids nos (Steroids). On an unknown date, the outcome of the diarrhea, upper back pain and upper abdominal pain were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the diarrhea, upper back pain, upper abdominal pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix vaccine in her left deltoid. She also received the flu vaccine, Fluad in the other arm on that same day.  The reporter stated she had left arm pain, for about 2.5 days and then it resolved. Two days after receiving the Shingrix vaccine, she had diarrhea and upper abdominal pain which ran like a band to the upper back.  The patient taken Immodium the 22nd October 2020, and also stopped taking meat products and then the diarrhea resolved, but she continues to have the upper abdominal and back pain.  The patient stated has a past medical history of rheumatoid arthritis, connective tissue disorder, with colitis, diverticulosis and colon inflammation. She also has a history of tick bite and thus has alpha-gal allergy.  The patient was currently taking Advil and steroid to treat the abdominal and back pain. The reporter did not consent to follow up
36-40hrs after immunization he started having poor feeding and lethargy. He was taken to ER-CT and blood work. He then went apneic and was intubated. Since then it has been determined that he had botulism. He continues to be on the ventilator and is receiving supportive care. The 60 day follow-up states that the pt is still hospitalized in rehab unit. Slight improvement but probable continued rehab unit for few more months. Botulism, non-infantile. The follow up received on 7/17/03 states botulism, non-infantile type.
NONE  We became aware yesterday (07/20/2021) of this error in vaccine administration. The patient doesn't have the age allowed.
Information has been received from a registered nurse concerning a 15 year old male patient with no pertinent medical history and no drug reaction/allergies who on 14-JUL-2001, was vaccinated with the first dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown, could not be ruled out) (lot# not reported). On 31-AUG-2001, the patient was vaccinated with the second dose of hepatitis B virus vaccine rHBsAg (lot# not reported) and on 22-JAN-2002, was vaccinated with the third dose of hepatitis B virus vaccine rHBsAg (lot# not reported). The nurse reported that the patient's titer was too low. The patient received 3 doses at another provider's office. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Follow-up information has been received from a medical assistant who stated she would need to retrieve the patient's chart from storage and then forward the chart and WAES letter to the physician if provided her the patient's birth date. Follow-up information received from the physician revealed that the patient did not received hepatitis B virus vaccine rHBsAg (manufacturer unknown) in their office. Additional information is not expected.
16 days post vaccination, diffused raised rash, started on hands, progressed to trunk and lower and upper extremities.  Does not itch, but blisters are tender.  Senior Medical Officer awaiting response from Infectious Disease for plan of care.
Pt received first Moderna dose in on 3/25/21 at age 16 years old. Physician spoke to Moderna regarding if patient should receive second dose due to age; was advised that patient should receive second dose. .
received /on June 30th, 2021/ expired on June 8th, 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 8th June 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Boostrix on 30th June 2021, which was expired on 8th June 2021 and led to expired vaccine used. The reporter consented to follow up.
No reaction to shot until later  Sunday 5/2/21 whe left shoulder developed sharp breath taking pain, tried rolling it out but the pain was too intense, Did not sleep.  IT was the most excursiating pain were it brought me to cry. PT said it was probably due to shot, Later that week because I was still in pain she thought it was excerisers I did. Went to PCP he said it was a pinched nerve. put me in prednisone. took pain away but my arm has been weak and heavy feeling. Can't lift 3 corella dishes to put away in cupboard. Arm freezes.
Patient received vaccine on 2-6-21.  We made a follow up call on 2-8-21 and at that time pt. reported some soreness at the injection site, but otherwise felt fine. On Feb. 17th at 10:30, pt. called to report that 3 days ago (on 2-14-21) that the pt. noticed an area approximately 3" x  3" that looked to have a rash, as well as extreme itching, redness, warmth to the touch, and "slightly puffy".  Symptoms continue today, but pt. advises that area is getting better other than the itching.
Immediately after Tdap injection by staff, noted swelling and induration at site. Area was 4 x 5 cm on (L) upper arm with slight violaceous discoloration at site.