chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (100.8ºC/fever) and dizziness in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 vaccination. No reported medical history. On Jan 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On January 2021, patient experienced pyrexia (100.8ºC/fever) and dizziness. At the time of the report, pyrexia (100.8ºC/fever) and dizziness outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was unknown.
Fever; Chills; Bell's Palsy; Swelling and muscle weakness on the left side of the face; Swelling and muscle weakness on the left side of the face; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6198, first dose) solution for injection intramuscular in the left arm on 06Mar2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with Covid-19 on 26Jul2020 and penicillin allergy. Family medical history included diabetes. There were no concomitant medications. Past drug history included known allergies to codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced Bell's Palsy, swelling and muscle weakness on the left side of the face on 07Mar2021 at 05:00. It started with left arm swelling and muscle weakness on the left side of the face, left face pain diagnosed as Bell's palsy and developed headache (07Mar2021). The next day (08Mar2021) at 1pm started with fever and chills. The was no emergency room or physician office visit. No treatment was provided for the events Bell's Palsy, swelling and muscle weakness on the left side of the face. The outcome of the events Bell's Palsy, swelling and muscle weakness on the left side of the face was recovering. The outcome of the events headache, fever and chills was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Menquadfi and Bexsero were administered in the office at 1200 on 7/28. Father was present at time of injections and offered consent.  Patient left the office and drove himself home shortly after the vaccines were given.  3:15pm: Pt. called his mom c/o feeling tired and not well, and was going to take a nap.  3:29pm: Pt. called his mom stating he had just passed out, felt strange and needed help.  ~3:40pm: Mom arrived home and found pt., breathing, but not responding normally to verbal commands.  Mom drove pt. to the nearest ER, about 10 minutes drive.  During the drive, pt. experienced extreme neck pain, chills, headache and began convulsing.  Upon arriving at ER, pt. was moved to trauma bay where he received Ativan, Bendaryl, and steroids.  A CBC was drawn and WNL.  Pt. remained in ER for 3 hours under observation and was discharged home that evening feeling well and 'normal."  Pt. has no recall of these events after calling his mom at 3:15pm.
I woke up in the middle of the night with a sore throat that lasted a few days. I ended up taking a COVID-19 test a few times and it was negative. Once that had resolved I had developed more of mild congestion and a mild headache and then I tested positive once the sore throat had cleared up. On Tuesday which was day three I had a telehealth appointment, and they did not want to put me on a medication. By day five I was feeling really pretty good, and I was back at work wearing a mask and taking COVID precautions. That day however by about four or five in the afternoon I got a bad fever and chills and so I took ADVIL and that helped and then when that wore off, I was worse. I called my doctor back and they advised me to keep taking fever reducers. Anytime the medication would wear off I would feel horrible, and my fever would be up around 102. By Saturday night I had a cough that would not allow me to sleep. At this point I developed break through pneumonia. I was able to get on Wednesday that next week and they were able to do an x-ray and get me on an antibiotic. I don't have the fever or chills, but I am getting tired easily and I have shortness of breath as well.
Woke up today can hardly bend her knees; joints are painful: affecting ankles, knees and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Woke up today can hardly bend her knees) and ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN (ZOCOR) and POTASSIUM for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders). On 07-Apr-2021, the patient experienced ARTHRITIS (Woke up today can hardly bend her knees). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Woke up today can hardly bend her knees) and ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included bi-flex.  Treatment medication included half an aspirin at night.  Action taken with mRNA-1273 Moderna vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up information was received on 19-MAY-2021, additional information was updated.
This spontaneous report as received from the nurse practitioner refers to a patient of unknown demographics. on 21-NOV-2014 the patient was vaccinated with ROTATEQ (Dose, route not reported) for an unknown indication. On 21-NOV-2014, the patient received improperly stored ROTATEQ. The reporter stated that the dose which patient received was not the patient's first dose. Nurse did not provide the data when the patient first received ROTATEQ. No adverse symptoms reported. The temperature excursion for ROTATEQ was found to be supported with in-house stability data. No product quality complaint was involved. Additional information has been requested.
Experiencing upper respiratory infection. Struggled with asthma and poor breathing was sick for 7 days. Breathings was difficult to walk upstairs and walking to car until 2/21. Contacted doctor to see him, was put on low dose of 20 mil of steroids for a month. After I started taking nebulizer and still experienced coughing and issues with breathing, like a tightness in chest. Also started taking Xyzal for the past two weeks and fatigue because lack of oxygen.
Redness, itchy, heat, swelling at site and wrapping around left arm, Increased heart rate, Prescribed oral prednisone and Benadryl, currently taking medications, prescribed yesterday
Sore armpit, swollen lymph nodes in the arm pit on the injection site arm (right arm)
feels like I have a urinary tract infection; The night after receiving the booster I had urinary frequency. By the next night this increased; urinary burning; Dose Number: 3; This is a spontaneous report from a contactable other HCP (patient).   A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: FH8028) via an unspecified route of administration, administered in Arm Left on 01Nov2021 at 14:00 (age at the time of vaccination: 53 year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date. None medical history was reported. Concomitant medication included routine vitamins (unspecified) for unknown indication, start and stop dates not reported. She had no known allergies. The patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, she had not been tested for COVID-19. Prior to vaccination, She was diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 05Mar2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 26Mar2021 as dose 2, single for COVID-19 immunisation. On 01Nov2021 at 14:00 patient received dose 3 booster. The patient reported that the night after receiving the booster i had urinary frequency, by the next night this increased, urinary burning as well, she feels like she had a urinary tract infection on 01Nov2021 at 21:00. She did not experience this after the first two vaccines but did experience when she contracted COVID in Jan2021. She may go to urgent case later today if the symptoms remain. She did not receive any treatment for the adverse events. The seriousness of events was reported as non-serious. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Swelling at injection site and bleeding immediately after the injection. Patient iced arm daily and after 13 days swelling and pain had decreased slightly but was still there.
7 PM developed muscle pain  and could barley pick up the right arm, chills and fever, blood pressure was elevated, passed out
Patient was admitted for acute cystitis with gram negative rod and was found to be COVID-19 positive on 01/25/22. Patient is asymptomatic without hypoxemia, this is not considered a breakthrough case.
I have exercised on a continual basis for the last 40 years. I monitor my heart rate. 3 days a week I  do the same cardio workout. Normally it takes 12 minutes or so for my heart rate to get to 120 after starting at 80-90. After I had the booster, I was sick for 2 days. A week later I did cardio and after 5 minutes my heart rate shot up to 120, which is not normal for me. I tried 2 times over the next few days and the same thing happened. I went to the doctor. They are now doing testing and may have found something wrong with an echocardiogram. Plus my BP has gotten extremely high since the booster shot.
Neck pain; Headache; Redness at injection site; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and MYALGIA (Muscle pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NECK PAIN (Neck pain), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and MYALGIA (Muscle pain). At the time of the report, NECK PAIN (Neck pain), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and MYALGIA (Muscle pain) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DIZZY AND LIGHTHEADED POST VACCINE, WHICH PROGRESSED TO NAUSEA AND VOMITING. GIVEN P.O. BENADRYL @ 1444 WHICH WAS IMMEDIATELY THROWN UP. PT WITH STABLE VITAL SIGNS. PATIENT W/HISTORY OF POTS. SENT TO ED FOR FURTHER EVALUATION/TX.
Mom told office pt sleeping more - difficult to arouse - pale, awaken for several minutes & doze off, not drinking;
This spontaneous report as received from a medical assistant refers to unspecified number of patients. No information on patients' pertinent medical history, concomitant medications, drug reactions or allergies was reported. On unknown dates in 2016 (after 02-MAY-2016), the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L035129, expiration date: 14-SEP-2017, and lot # L046887, expiration date: 23-NOV-2017, subcutaneously. On 02-MAY-2016, administered doses of VARIVAX underwent temperature excursions prior to being administered. Maximum temperature was reported as 7.5 degrees Fahrenheit for 30 minutes, 14.2 degrees Fahrenheit for 20 hours and 7.3 degrees Fahrenheit for 30 minutes. About 15 patients received at least one of improperly stored vaccines: VARIVAX and PROQUAD (captured in MARRS# 1608USA000485). There was no known adverse effects. This is one of two reports from the same reporter source. Additional information has been requested.
Around injection site the arm was very sore and in the muscle it was also very sore. I went to the doctor on 09/22/2010 after realizing that it was more than normal pain. The doctor first thought that the injection site was infected. It was hard for me to move my arm in certain ways. She than gave me antibotics. While on the antibotics my arm got worse the pain went up into my shoulder and pain started to shot down into my forearm into my hand. It than became diffcult to sleep on, or do any repetitious activity. I than went back to the doctor on 9/28 and she had said that my nerve was probably hit and this was the result of the pain I was feeling. She gave me some steroids for 1 week, and if that does not help I will have to see a neurologist.
Felt tired, put down head, next I remember waking up in chair and feeling things were not right, took deep breath and got up and told pharmacist and sat right back down, felt light headed, started sweating a lot. drenched clothes in sweat, Had water sat for 30 minutes got better enough to go home. Asked store to not call 911,
Within 2 hours of receiving vaccine I experienced itchy eyes, lump in throat, difficulty in getting enough air, chills, and fever. All were gone within 6 hours.
3 inch red and 3 inch swollen injection site. Body aches everywhere, extreme fatigue and weakness, fever 99.5 and flu like symptoms. I have never had a reaction before to any vaccines in past. I'm still sick and it is 11/16/14.  Called MD and he RXed antibiotics.
Suspected vaccination failure; Shingles; dose on February 12 2018, March 20 2018, and November, 13, 2020; dose on February 12 2018, March 20, 2018; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chemotherapy. Concurrent medical conditions included blood dyscrasia and immunocompromised.   On 13th November 2020, the patient received the 3rd dose of Shingrix. On 20th March 2018, the patient received the 2nd dose of Shingrix. On 12th February 2018, the patient received the 1st dose of Shingrix. On 20th March 2018, not applicable after receiving Shingrix and Shingrix, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced drug dose administration interval too short. On 13th November 2020, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, drug dose administration interval too short and extra dose administered were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received first and second dose of Shingrix and experienced shingles. The pharmacist reported that his patient currently recovering from shingles and patient was taking Valtrex for treatment. The pharmacist also stated that there was another date recorded for a Shingrix vaccine for this patient on 13th November 2020, but the pharmacist questioned the accuracy of this latter date. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test and time to onset confirming shingles was unknown at the time of reporting. The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received a third dose of Shingrix, which led to extra dose administered.
Started with headache and tickle in throat. By the next day itch in ears, sore throat, cough, post nasal drip, sinus pain.
Shortness of breath; Redness all over his body; Hives; Fever; This spontaneous case from the United States was received on 17-May-2022 from other healthcare professional via Agency(reference number: SEQW22-01439) and concerned a 24-year-old, male patient. At the time of this report, the patient was 36-year-old.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date in Oct-2009, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration, anatomical location and dose: not reported) for influenza prevention. The batch number was not reported.   On an unspecified date in 2009, shortly after receiving Afluria Quadrivalent, the patient experienced shortness of breath, redness all over his body, hives and fever.    As reported, the patient had hives with his COVID vaccine, he was in the air force and was exempt from flu vaccines.  The outcome of all events was not reported.  The reporter did not provide causality assessment.  Company comment: A 24-year-old male patient experienced dyspnea, erythema, urticaria and pyrexia, shortly after receiving Afluria Quadrivalent vaccine. Information regarding medical history and concomitant medications was not provided. Reportedly, the patient had hives with COVID vaccine, also. Considering plausible temporal relationship causality is assessed as possibly related. Agency criteria for anaphylaxis could not be assessed due to insufficient information provided.; Sender's Comments: A 24-year-old male patient experienced dyspnea, erythema, urticaria and pyrexia, shortly after receiving Afluria Quadrivalent vaccine. Information regarding medical history and concomitant medications was not provided. Reportedly, the patient had hives with COVID vaccine, also. Considering plausible temporal relationship causality is assessed as possibly related. Agency criteria for anaphylaxis could not be assessed due to insufficient information provided.
TOOK FOUR DOSES OF VIVOTIF IN A ROW; This spontaneous case report (PVX2019-2401) was received from a nurse on 19-Sep-2019. It described a female consumer who "took four doses of Vivotif in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took all the four doses of Vivotif in a row instead of normal schedule in last month.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took four doses of Vivotif in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of Vivotif in a row" was considered as not applicable.
pt recv vax & 15-20min later, devel an inj site rxn characterized by splotches & itching;
The side effects I still have to this day are tingling in my left arm (it comes and goes but it is daily) and tinnitus.  I remember the tingling started a few days after the shot and I've had every day since, Tinnitus about the same.  I also have on and off loose bowels -- still. My diet and physical activity have been about the same long before and after I had the second shot, but my digestive system has been different.  I'll note the other side effects I had that went away -- just so you have all the information. 12 hours after I had the second shot I suddenly felt jittery and had a fever of 100.7. It was late so I took tylenol and went to bed. Woke up feeling fine. Was a little achy and tired later in the morning. I took tylenol and after that wore off I felt completely fine.  I also have felt I've had on and off brain fog. I can have that anyway but I would say it felt the worst 2 weeks ago.  Even though my ongoing side effects are not severe, it seems odd that I still have them over a month later so I thought I should report them.
After 6 days: armpit lymphadenopath  After 8 days:   skin rash on the arm where intramuscular injection was done
Redness and swelling (firm to touch) at injection site, increased in size over 2-3 days, mild discomfort/tenderness and warm to touch.
Half dollar size raised red mark that is swollen. Lump at injection site. Bruising at injection site.
Patient received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and PA DOH, decided to offer the patient an additional COVID-19 vaccine dose. Thanks.
Pfizer on 2/3 and 2/24. Positive on 9/13
I immediately had a pain in my chest that went into my stomach and I felt dizzy. My chest felt tight. I had a sun burn rash later that night the next day my eye lid swelled. That night I couldn't lift my arm.  My chest pain has been on and off since then. VERY Tired! Pain all over my body. BAD headache.
My arm is super sore; Had a little bit of fever; Made it difficult to sleep; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, fever and difficulty sleeping. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fever and difficulty sleeping were unknown.   The reporter considered the pain in arm, fever and difficulty sleeping to be possibly related to Shingrix.  Additional details were reported as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient stated that the social media informed him that the vaccine would be rough him up a little bit and they were not wrong. The patient reported that just 24 hours from the 1st of 2 shots, the patient had side effects were pretty, his arm was super sore and he event had a little bit of fever, both of which made it difficult to sleep. The patient took Tylenol as treatment medicine for fever, sore arm and difficult sleep. The information regarding consent to follow up was not reported.
Severe nausea and vomiting, diarrhea. Like getting a bad case of food poisoning. Lasted several hours, then subsided and then a headache next day. Seemed to be over by evening, felt very tired and had muscle aches, took Ibuprofen for headache and muscle aches.
102.8 fever, blurry vision, trouble walking, bladder and vaginal spasms night of shot     , severe back pain started day 3 to current  day 7 very high blood pressure day 1-day 5.  still experiencing side effects a week later