chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 7 months ago, not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 7 months and one week ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient reported that patient had not received second dose of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, fatigue and injection site joint pain. On an unknown date, the outcome of the muscle pain, fatigue and injection site joint pain were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and injection site joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient experienced the events the morning after getting the vaccination, his shoulder was sore at the injection site area and he felt tired. The events resolved within a day. The patient gave contact details of the physician.
Patient concerned about vaccine because sensitive to flu shot. Patient stayed for 15 min and reported to feel fine. Patient left and once in her car experienced throat swelling. SHe called Dr. and instructed to take benadryl. Patient went home and still experienced throat tightness and heavy arms. Patient took another dose. Patient finally felt relief saturday following vaccine.
Warm to touch; Arm broke into a rash; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), RASH (Arm broke into a rash) and VACCINATION SITE PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: TCR form received on 09-Aug-2021 and  events outcomes updated to recovered/resolved.
About 2 hrs after the vaccine, I had a sinus headache, loss of appetite,  fatigue, body aches, fever of 100 for two days, a sore throat but I'm not sure if the sore throat is related or not.
Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; Fever up to 102 degrees, chills, body aches, arm soreness near injection site, nausea when moving around; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 13May2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to food, medicine or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at 10:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 11:00, the patient experienced fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  The clinical outcome of the events fever up to 102 degrees (units unspecified), chills, body aches, arm soreness near injection site, nausea when moving around was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax 1OCT92 & w/in 3 hrs of receiving the vax pt exp a numbing effect along neck & jaw; also exp pain @ the inject site & numbness & tingling lt arm into shoulder & jaw;
CDC reports: 1 yo developed pain, swelling, & increased warmth @ inject site following DTP/OPV immunization, lasted 2 days.
Child was 10 yrs of age on day vaccine was given. Received the 12+ formulation.
soreness in the arm; This is a spontaneous report received from Pfizer-sponsored  Program. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 16Apr2021 05:20 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness in the arm in Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I am currently 8 weeks and 1 day pregnant. Wednesday evening after 24 hours after the vaccine i developed redness and swelling at th injection site. I developed a low fever of 101.1F and had chills. By the  next morning your symptoms were relieved.  I did get diagnosed last Tuesday with Covid which was one week after the Moderna vaccine. A few days after I got diagnosed with Covid, the swelling returned at the injection site.   As of today I have no redness or swelling anymore at the injection site.
desire to drink fluids; fever; massive headache; body aches; nausea; chills; lack of appetite and  desire to drink fluids; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking. On an unknown date, the outcome of the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking were unknown.   It was unknown if the reporter considered the fever, headache, general body pain, nausea, chills, appetite absent and excessive drinking to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had basically all the usual symptoms fever, massive headache and body aches, nausea, chills, lack of appetite and desire to drink fluids.
resembles a cellulitis to her/ red hot rash spreading on her left arm stated it was the same arm she got in injection; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration (left arm), on 28Dec2020, single dose, for COVID-19 immunization. Relevant medical history and concomitant medications was provided as none. After the patient received the COVID shot few days ago, the patient had a cellulitis reaction to it on 30Dec2020. It resembles a cellulitis to her, a red hot rash spreading on her left arm, stated it was the same arm she got in injection. Cellulitis was reported as worsened. The patient would like to know when she gets the next vaccine if she should alternate arms and get it in the other arm. Outcome of the event was not recovered. The event was assessed by the reporter as non-serious.
Shoulder was sore the day after injection. Instead of getting better shoulder became progressively more sore. It has now been 4 months since injection and shoulder is stiff and painful to the touch. Range of motion is decreased, particularly when attempting to reach upward with the arm.
hard spot that is sort red; sore arm/red spot hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/red spot hurts) and ERYTHEMA (hard spot that is sort red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm/red spot hurts). On 16-Apr-2021, the patient experienced ERYTHEMA (hard spot that is sort red). At the time of the report, PAIN IN EXTREMITY (sore arm/red spot hurts) and ERYTHEMA (hard spot that is sort red) outcome was unknown. Not Provided          No concomitant medication information was provided  No treatment product information was provided
On the morning of Dec 18th around 4am I woke up to feeling very itchy in a couple places. After coming in and out of sleep the rest of the morning the itches were still there. At first there were just some red spots from where I was itching, both nothing too major. I had some things to do in the morning and so I didn?t get back home until 12:30 PM. When I got home I realized I was very itchy in a few new spots from the night before. After checking it out in the mirror my groin and neck were the itchiest things and were very red.  I took a bath in baking soda to ease the redness/itchiness. I also started applying store brand cortisone cream to itchy areas which helped a little bit. But once one area was calm again it seemed another would start to itch. The rest of the night was filled with little bits of itches here and there, but nothing too bad until later in the night, about 10PM. I was really itchy on my lower back, head, rib cage, thighs, and neck. At that time it was more clear that it was hives as my lower back itch site swelled a little bit making what looked like little bubble in the areas. It?s now the morning of the 19th and I?m still here and there itchy as I was through the night.
Pt had localized redness, swelling, soreness to injection, low grade fever day of injection then on Sunday develop s/s of stroke, seizure acitivity, aphasia, Todds Paralysis
Tinnitus- increase in severity; Impacted ability to sleep; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 14:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and COVID-19. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient had increase in severity of tinnitus which caused patient to wake up at night and kept the patient from falling asleep, the patient had issues in the past but it never impacted the patient's ability to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events increase in severity of tinnitus and impacted ability to sleep were not resolved at the time of the report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Headache began at 3:00pm.  Woke up at 11:00 pm violently shaking all over.  I was not hot or cold.  Woke up several times after the 11:00 pm also violently shaking.  Seemed to have stopped by 3:00 am.
Periabrital edema, ud conjunctive, throat tightness, stating 3 hours after injection.  Prescribed Medimune H1 + H2
Rash/welts on upper left arm that started 24 hrs after vaccination close to vaccine site and disappeared about 8 hours later. Arm also very sore for 48 hrs that started in about 6-8 hours after shot
Blurred vision; vaginal bleeding; sharp, stabbing pain in right leg; muscle weakness (ongoing); numbness in limbs and right side of my face (off and on still); brain fog;   No treatment yet
Bilateral Facial Weakness., Difficulty Swallowing & Bilateral lower extremity Weakness
Felt initial pain at injection site (Left Deltoid) which persisted into night. Woke up at 3 am to get ready to go to work and had chills, body aching all over, increased pain in left upper arm with swelling in left upper arm and left hand/fingers (unable to remove ring). Took Tylenol followed by low dose ibuprofen. Called out of work. Had nausea, decreased appetite and headache all day on 10/3/19, had Fever 99.8 F, continued to take Tylenol. Had no cough, sore throat, shortness of breath or oral/facial angioedema.
Rashes: 1.) One rash on right arm was likely poison ivy -- blistery, oozy rash that itched like crazy (about October 21/22); 2.) The second rash appeared (Oct 23) was on right calf -- red spots that a couple days later developed into one red area about 3-5 inches wide/tall. Red skin was itchy and had a firmness to it. The leg rash developed on the opposite, left calf in the identical location. It progressed exactly like the right leg rash: first spots, then a big red area about the same size. 3.) the third rash looked like bites. They all appeared around the knee area and upper thigh on both legs (Oct 23) Some had an odd horseshoe shape with a "satellite" bite on the side; others just looked like regular spots/bites. All these oozed yellow-clear fluid, too like the rash #1. 4.) THE first rash on the right arm seemed to have turned into a classic case of contact dermatitis AFTER a six day Medrol Dosepack (4mg) course. The right arm rash worsen -- itchy welts and redness. The LEFT arm started looking the same: itchy welts and redness.
Within 5 minutes of administration, I experienced increased heart palpitations.  To be fair, I experienced random, infrequent heart palpitations before getting this vaccine.  When the vaccine was given, I noticed that they were more frequent, and lasted for about an hour, then stopped.  Each palpitation  only lasted a few seconds.
Chills, soreness at injection site, dehydrated and collapsed next AM 9-16-16 and went to ER.
Chills, fever of up to 102.9F, delirium, vomiting, aspiration, oxygen saturation was 85%. At 07:30 on 10/27/2021 paramedics were called and he was transported to Medical Center Hospital. He was admitted to the ICU and intubated when other measures to increase the oxygen levels failed. He tested negative for Covid.
07/10/2022 After 5PM I started to get a terrible headache and I thought at first it was due to being overheated. On the 11th the headache was gone and I had no symptoms. The lettuce that I ate for lunch was bothering my stomach and I began to feel extremely tired all of a sudden. And I had slept 5 hours throughout the afternoon. On the 12th my throat was extremely sore, congestion was extremely bad, I also had terrible sneezing as well, and I took a COVID-19 test it came back positive and then I took another one and it was again positive. I did call my doctor and they did a virtual visit and from there my doctor ordered a PCR test and on the 13th of July the PCR test came back positive. I continued to have these symptoms, my head felt extremely heavy, and I couldn't sleep very well at all due to waking up from having a sweaty head. Coughing became very bad as well. I never had a fever and I did receive a cough syrup and we discussed my symptoms and agreed not to take PAXLOVID since my symptoms were improving. I continued to take MUCINEX, SUDAFED afterwards, and cough syrup. The only symptom I have now is weak legs. Sore throat is gone, no coughing, a tiny bit of congestion, and no weighted head feeling.
Received Moderna vaccine 1/6/21 at 9:10 am.  Felt fine until approximately 4:00 pm when he noticed his left arm was very sore. At approximately 9:30 pm, the patient became cold with shivering.  Temp fluctuated during night between 99 - 103.8. During the night, he experienced nausea and vomiting, dizziness, body aches, and a weird taste in mouth. On 1/7/21, patient still complained of fever, headache, nausea, and the new symptom of diarrhea.  His neck was now very sore, with pain moving it right or left.  On 1/8/21, slight improvement of symptoms.  On 1/8/21 at 7:00 pm, he noticed a very itchy, red raised rash on torso, arms and legs.  He called his physician and was called in a prescription for steroids.  The pharmacy was closed and he picked the steroids up on the morning of 1/9/21.  He took the steroids on 1/9/21  and has noticed major improvements.  Rash still present, but not itching.  Temp currently 99.1, but all other symptoms improved.
localized redness & swelling @ inj site, h/a, cough, body aches, sl temp;
Left deltoid and edematous secondary to DtaP, no purulence or drainage noted.  Edema visible but non tender.  Approximately 2/3 deltoid affected.  BENADRYL and ice three times a day when needed to arm.
Instant funny taste in mouth.  tongue swelling, lymph nodes under chin swollen, top of mouth mucousy.  Swelling up to eyes.  dizzy.  dissipated within an hour.  Still has swollen arm at injection site. Hard, feels like a golf ball.  Headache.
Feel tired; Feel a bit feverish; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced tiredness and feeling hot. On an unknown date, the outcome of the tiredness and feeling hot were unknown.   It was unknown if the reporter considered the tiredness and feeling hot to be related to Shingrix.  Additional information received were as follows: The day before the reporting date, the patient received Shingrix. The patient experienced side effects which were not severe, but the patient definitely felt tired and a bit feverish. The patient asked whether Advil or Aleve be helpful.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (doses and routes were not reported) lot # K005180 expiration date 10-APR-2016, lot # K007972 expiration date 03-JUN-2016, lot # L001329 expiration date 13-JAN-2017, lot # L008272 expiration date 11-MAR-2017. No symptoms reported. This is one of several reports receive from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Patient 16 at time of vaccination. Moderna is only approved for those 18 years and older.
Pt returned to flu shot clinic just 45 minutes after receiving vaccination with c/o feeling dizzy & feeling heart beat fast. Employee taken to ED for eval. Pt's pulse - 226. Employee reports normal blood work & 3 EKG's, but did receive cardioversion in ED. Not admitted. Employee returned to work next day.
developed Guillan-Barre; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "developed Guillan-Barre".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201348576 same reporter/product/AE, different patient;
severe soreness in the arm vaccine was given, fatigue, dizziness, nausea, and fever and post nasal drip
G62.9 NEUROPATHY 12/13/2021 J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/13/2021 G62.9 NEUROPATHY 12/13/2021 J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/13/2021