chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like sore throat; not able to swallow like normal; tongue feels fat; shortness of breath when laying down; This spontaneous case was reported by a non-health professional and describes the occurrence of OROPHARYNGEAL PAIN (Felt like sore throat), DYSPNOEA (shortness of breath when laying down), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (shortness of breath when laying down). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Felt like sore throat), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat). At the time of the report, OROPHARYNGEAL PAIN (Felt like sore throat), DYSPNOEA (shortness of breath when laying down), DYSPHAGIA (not able to swallow like normal) and PARAESTHESIA ORAL (tongue feels fat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Added reporter's information. On 21-Jul-2021: Follow up received contains no new information
Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up her muscles; Physical therapist told her she may have tendinitis in her head/brain; Pain in neck and shoulders; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Feb2021 (age at vaccination 77-year-old) as 2nd dose, single for covid-19 immunization. Medical history included fall. Patient stated that in the early 2000s she had a fall as a result of an allergic reaction to a prescription medication and hit her head on the kitchen floor and ended up in the hospital after fall, no further information provided by the caller about what prescription medication this was, allergic reaction to a prescription medication and pacemaker. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 for COVID-19 Immunization. Patient stated she had her second dose of the Pfizer Covid 19 Vaccine on 26Feb2021 and had some side effects and she assumes they were from the vaccine. On 27Feb2021, patient experienced head pain and pain on jawbone. Stated she continued to have pain in her head, neck, and shoulders. She went to her primary care and an ear, nose, and throat doctor. Says she had lots of sinus problems, lots of allergies, and was highly sensitive to medications. On an unspecified date in Feb2021, one night, all night, she had pain on both sides of her nose. States she continued to have serious head pain, pain in neck and shoulders, froze up her muscles, she stated the Covid Vaccine froze up her muscles. She said the physical therapist said she possibly has tendinitis in her head and said physical therapy has been helping, it was not just a minor, dull feeling in her head. Patient stated she was in Physical Therapy because they were working on her muscles and said she goes every Tuesday and Thursday. Said they were working on trying to unfreeze her muscles. Patient stated that she sees an allergist once a year. Patient said she wonders if she got an overdose of the vaccine due to her sensitivity, weight, and size. Patient stated she needs someone with technical expertise. Since she has a pacemaker she went and saw her cardiologist to see if there was any impact on her pacemaker. The cardiologist found no changes. She was concerned going forward how much of a risk was she at of getting Covid 19. Patient stated that the ear, nose, and throat doctor did a scan of her sinuses and an x-ray of her head. Patient stated she cannot have an MRI due to her pacemaker. The patient underwent lab tests and procedures which included scan of her sinuses: unknown, scratch test positive: unknown in an unspecified date in 2005, x-ray of her head: unknown. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
MY SPOUSE EXPERIENCED A GRAN MAL SEIZURE FOR THE FIRST TIME IN 14 YEARS.  HAS BEEN STABLE ON LAMOTRIGINE SINCE CIRCA 2007. CURRENT SEIZURE LASTED FOR MORE THAN 5 MINUTES, AND OCCURRED ABOUT 15 MINUTES INTO NIGHT TIME SLEEP.  AID WAS PROVIDE BY MEDFORD FIRE DEPT AND EMS.    MY SPOUSE HAS RECOVERED AND SEEMS TO BE BACK TO HER NORMAL SELF TODAY.
Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "reflux" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "sphincter of Oddi dysfunction" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OMEPRAZOLE. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (dose 3), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 01Aug2022, outcome "not recovered". The event "bell's palsy" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy.   Additional information: There was no other vaccine in four weeks. Antiviral medication, steroids were treatment for event. Patient did not have covid prior vaccination.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JAN-2017, the patient received a dose of improperly stored VARIVAX lot number M024683, expiration date 18-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. No further information was provided. Administered dose of VARIVAX was exposed to a temperature excursion of >5°F but <14°F for 10 minutes. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012278: US-009507513-1702USA001825: US-009507513-1702USA001826: US-009507513-1702USA001828.
Enlarged and painful lymph node on left armpit.  The size of a baseball on the second day after the 2nd dose of the COVID vaccine. The day after the vaccine I had Soreness to left neck, chest, arm and ribcage area. Chills and headache.
HCP reports no other AE's; Administration of proquad to 15-year-old female; This spontaneous report was received from a nurse referring to a 15-Year-old female patient. Patient's concurrent conditions,medical history and concomitant medications were not provided.     On 05-JAN-2022, the 15- year-old patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha) (PROQUAD) injection 0.5 milliliter one time with lot # U022729 and expiration date: 16-JAN-2023 for prophylaxis (Product administered to patient of inappropriate age). No other AEs, no PQC nor further information was reported.
Chills, nausea,  high heart rate 125 while at rest, general not felling well and flushed cheeks
Fever, Chills, Headache. No treatment. Symptoms abated after about 24 hours.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756499A, A0756501A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
I was extremely ill for 5 days.  Starting around 10pm on the day of my vaccination, my entire body was in severe pain - my joints and muscles all hurt (7 to 8 on a pain scale of 1-10).  My heart rate was elevated, and I was running a fever.  That lasted for about 24 hours.  For the next 4 days, I continued to ache, although not as severely.  I had trouble standing - I was light-headed and weak.  On the third day, I took a shower in the hopes that it would soothe the aching muscles, but by the end of the shower I was weak and shaky all over and my hands and arms were cramping.  The symptoms finally abated on the 5th day, although it was another 2-3 days before I could return to any semblance of normal activity.
DECOLORIZATION; COULDN'T WALK; RIGHT THIGH STARTED PAINING; This spontaneous report received from a patient 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 not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced decolorization. On JUN-2021, the subject experienced couldn't walk. On JUN-2021, the subject experienced right thigh started paining. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, C-reactive protein (NR: not provided) Normal, and X-ray (NR: not provided) Normal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right thigh started paining, and decolorization, and the outcome of couldn't walk was not reported. This report was non-serious.
Began feeling sick after injection. Low fever, fatigue for day of injection and day after. Day 3 felt normal, but day 4 began feeling sick again with no appetite, nausea and chills. At 5:30 I passed out and remained unconscious until my mother found me on the floor and then had a seizure lasting about 2 minutes. I was unconscious for at least 30 minutes. I have had seizures in the past, but never anything close to this.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced dermatitis, and eczema. On JUN-2021, the patient experienced inflammation of lymph nodes on the side of the vaccination. Laboratory data included: Mammogram (NR: not provided) Inflamed lymph nodes. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dermatitis, and eczema, and the outcome of inflammation of lymph nodes on the side of the vaccination was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000211236.
Armpit swelled up the size of a tennis ball and could not move my arm for 3 days.
In the area where the injection was administered was very red, itchy and warm. Also a little painful Where the injection was injected there was a bump raised up
Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11; A little more congested in her chest; it feels like a cold; muscle aches; Sore arm from needle stick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Lot number: FK5618), in arm and on 07Dec2021 as dose 2, single (Lot number: FK5127) at the age of 11 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC ALLERGY; MUCINEX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022 at 21:00, outcome "not recovered" and all described as "Tested positive for COVID after receiving COVID 19 Vaccine ages 5 to 11"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "A little more congested in her chest"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore arm from needle stick"; FEELING COLD (non-serious) with onset 2022, outcome "unknown", described as "it feels like a cold"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: He stated that his daughter tested positive on 16May2022 and it is ongoing. He stated she is very positive, she retested and still had two little red lines on the test kit. The caller stated that his daughters would have been vaccinated in afternoon on those days. He clarified to after school if he remembering correctly. He stated that they tested together when they were confirming if they had a false positive last night. He stated his daughter was trying to do school from home and he is getting complaints. States she had not received her booster as of yet. He stated that his daughter tested positive on 16May2022 and it was ongoing. He stated she was very positive, she retested and still had two little red lines on the test kit. He states his daughter was a little more congested in her chest. He clarified that it feels like a cold to her as well. He clarified that his daughters state has persisted. He stated she was doing pretty good either way. He clarified that she definitely has not gotten worse. She was doing well in general. He stated she has no tightness, nothing other than feeling like a cold, maybe muscle aches. The HCP told him to push water and make sure his daughter is comfortable and if she gets worse to let the HCP know. The events were not required Emergency Room or Physician Office visit.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L040458 with expiry date 04-FEB-2018, lot # M000442 with expiry date 31-MAR-2018 and lot # M013639 with expiry date 15-SEP-2017 (dose, route of administration and anatomical location were not specified). Administered doses of RECOMBIVAX HB underwent temperature excursion of 31 Fahrenheit degrees for 189 hours (2 cycles). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received first dose of Pfizer COVID Vaccine and second dose was Moderna.  No visible adverse events at this time.
This is ridiculous. Look, I signed up for daily Bd then weekly check ins after I received my 1st vaccine on April 5th. And indeed I was contacted by text everyday for a week, then weekly until my 2nd dose on May 3rd. After my 2nd dose, the only question I was ask was did I get my 2nd dose. Nothing about side effects. While I had no real side effects from the first shot, I did after the 2nd.  Started about 3am, 12 hours after the 2nd shot and continued for about 12 hours and then quickly disappeared within 2 hours. Pretty bad body aches, muscles and joints. Low grade headache. Extreme fatigue. Everything hurt, moving or sitting still. The only thing that remained normal was my appetite...I was hungry and was able to eat...no digestive problems.  Anyway, I was disappointed the system that had ask so often after my first dose, did not ask at all after my 2nd.
Developed Achiness, shakiness, low back pain, neck stiffness, headache, and some GI upset, Took 3 Aleve at 6:30 am.
Patient originally received the first COVID Dose with Pfitzer on 5/13/21, and got his second dose with Moderna on 5/25/21. So he got his second shot too early. Pt didn't report any adverse effects, and will continue to be monitored.
Swelling, inflammation, bruising, warm to touch.  Lt arm bruising/ pale halo ring around site - IM site 13 cm X 8.5 cm - Sub Q site.
Patient claims that the day after the administration of the FLUZONE HD, he woke up the next day with rash all over his back and feet. It was so itchy that he uses hydrocortisone cream, LOTRIMIN cream and toothpaste for relief of itching.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 20-JUL-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # 0385AE with expiration date of 08-NOV-2014, (dose, strength and route unknown). Concomitant medication was not reported. No symptom was reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt received Pfizer booster shot followed with Afluria then suddening started to fall over.  Grabbed on to pt's arm and stablized him on the chair.  He woke up in less than a minute.  Pt stated he was working all day and didn't eat.  Gave pt water and a candy bar and monitored him for 20min. Took his blood pressure, it was within normal range.  Pt left shortly
I felt okay after getting it and went to bed about 9:30pm. Then I woke up around 11pm so cold and shaking uncontrollably and my head was pounding and my whole body was uncomfortable like pins and needles with goosebumps and I was in so much pain with muscle aches and icy head was pounding and I couldn?t stay still I was like rocking in discomfort. And then I put on long sweat pants and socks and a sweater and got water. My throat was so dry and also hurt. A sore throat. And then I threw up a ton and it was awful me hard to clear and hard to breath and I had this pressure in my chest. My temp was 101.5F and I didn?t even have patients to let it keep going under my young so I think it was higher. And then I called my mom and tried to rest and tried hard to get comfy on my bed prolong myself up with pillows and I fell back asleep. Then woke up again at 2am and felt the same and rechecked my temp and it was 101.2F.  I took Tylenol. Then I fell back asleep until almost 7 but with lots of tossing and turning and lots of waking up uncomfortable again. Then in the morning I checked my temp again an fit was 99.2. And I still really hurt all over and my right eye is throbbing along with the headache and still gods bumps but not shaking anymore but still very uncomfortable. I took a warm shower and more Tylenol at 8:20. I didn?t retake my temp bc I didn?t want to move but I know it got really hot again with a fever. And I still feel really yucky.
4 hrs after receiving shot, heaviness spread from hips to knees to feet. Felt like extremities were swelling. Had feeling of heaviness in chest. Though would have to go to ER. I elevated my legs and used ice packs for swelling and just lay in bed waiting to see if it was going to get worse. Waited for approx. 1 hr. Symptoms did not get any worse, so I went on to sleep and decided to see Dr. the next day. The next day I felt much better. Also had red splotches around inj. site which lasted for 3 days. I work in health care & spoke with a Dr. informally. Did not require office visit. Dr. did suggest that I report this reaction to vaccine.
Patient was given 0.3ml instead of 0.2ml. Patient is doing fine, no negative effects.
I got my TDap shot on 10/25 it is 11/11/2022 and my left shoulder still hurts, its weak and when i move my shoulder i feel pain where I was given the TDap vaccine. I thought it would go away but it is still in pain. I feel the nurse that gave it to me put the shot way to far high on my arm.
Fever, redness,swelling, and pain at the injection site; left arm stiffnesss Narrative;low grade fever that she self-treated with acetaminophen; resolved within 24 hours redness, swelling, and pain at the injection site; pain and stiffnessresolved within 72 hours
See the vaccine history attached.   8 month old baby diagnosed with intussuscetion on April 11, 2007 had third rotavirus vax on March 15. DTaP-HBV-POL (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio) 3/15/2007, 1/2/2007, 10/31/2006  HBV adult (Hepatitis B) 9/1/2006  HIB PRP-OMP (Haemophilus influenzae b) 1/2/2007, 10/31/2006  PNUcn (Pneumococcal conjugate, pneumonia) 3/15/2007, 1/2/2007, 10/31/2006  ROT5 (Rotavirus live, pentavalent) 3/15/2007, 1/2/2007, 10/31/2006 6/26/07 Received hosp med recs which reveal on 4/10/07 pt experienced abdominal pain & wretching & seen in peds clinic.  Referred to ER for w/u.  Surg consult done. Pt d/c to home to be eval by PCP next day. FINAL DX: None provided, surgeon did not feel probable IS. 6/29/07 Received additional hospital medical records which reveal patient admitted 4/11-4/12/07 for continued fever, vomiting, irritability & abdominal pain.  Found to have heme (+) stool in ER.  Per MD notes, IS was reduced by barium enema but no radiology report included. FINAL DX: Intussusception, reduced by barium enema. 7/31/07 Received vax record from reporter.  VAERS database updated w/same.
Swollen 70cm and itching. Treated with clobetasol CL (0.09%); Benadryl 25mg po once or twice prn.
Fever(102) for 24 hours, 911 attendant told me to take Tylenol , my blood pressure got high .
Extreme pain -left arm, cannot move left arm, 100.9 temperature,chills, dizziness, headache