chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness and pain in arm. On an unknown date, the outcome of the weakness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the weakness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on unknown arm. The patient stated last time patient got the shot it knocked patient down.  The patient felt very weak.  The patient also reported that he had arm pain after the injection. The outcome reported for all adverse events in the structured field of database is " RECOVERED/RESOLVED WITH SEQUEL" instead of " Recovered/Resolved" (outcome uploaded in database)
Headache, NauseaVomiting, 1/9fatigue, cough, rhinorrhea, congestion 1/7 felt faint, tongue was numb Narrative:
sore arm,arm is also sore again; Injection site has redness, knot (hardness) and tenderness; Injection site has redness; Injection site has redness, knot (hardness) and tenderness; injection site has developed a rash and is spreading as the day progresses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), PAIN IN EXTREMITY (sore arm,arm is also sore again), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and EZETIMIBE (ZETIA) for Cholesterol, TELMISARTAN for Hypertension, VITAMINS NOS for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm,arm is also sore again). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), PAIN IN EXTREMITY (sore arm,arm is also sore again), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: new events are updated.
left eye was red; increased tearing; after first dose / developed shingles in her left eye; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye red and lacrimation increased. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, eye red and lacrimation increased were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, eye red and lacrimation increased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. Around 5 months back, the patient received 1st dose of Shingrix and about 2 to 3 months after the 1st dose of Shingrix, she developed shingles in her left eye and the symptoms were her left eye was red with increased tearing. The patient stated there was no blister in the eye. The physician started her on eye drops, the patient did not remember the names. After about 2 weeks the shingles in her eye resolved. The patient stated she had not had shingles before, and she was shortly due for the 2nd dose. The reporter consented to follow-up. For 2nd and 3rd outbreak refer case US2021AMR078994 and US2021AMR078995 respectively, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078994:same reporter (2nd outbreak) US-GLAXOSMITHKLINE-US2021AMR078995:same reporter (3rd outbreak)
Symptoms started about 12 hours after injection. Fever 101-102 for about 24 hours, periods of uncontrollable shaking, body aches, sore arm with intermittent spikes of shooting pain from injection site to fingers. About 48 hours in, extreme arm soreness accompanied by red/splotchy rash and swelling along with swelling of lymph nodes in underarm and breast lasting about 3 days. Much better now  on day 5 but continuing to experience intense, sudden  headaches and fasciculations in injection arm, particularly around the elbow.
Patient says about 5 days after imz she started to get itchy and bumps on injected shoulder. Over the next two days the shoulder got redder and splotchy. The splotchiness is slowly spreading down her arm but it's difficult for her to gauge how much due to her skin imperfections. She says she has no fever and feels fine other wise. She also started using diclofec gel but I did not ask her where she is using it.
I started having a rash under my injection site two days after I got the vaccine. The rash was itchy and burning. My arm was stiff for the next two days.
Patient reports hives on bilateral arms, neck and some on torso.  Some localized erythema and swelling, but hives were more bothersome.  Alleviated by Benadryl.
A non-serious spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier.  Medical history and concomitant medication were not reported.  On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers.  The medic removed the cap and attached a needle to the end of the FLUMIST syringe.  There was no adverse event  associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
swelling @ inj site, no appetite crying over 4hr-not able to console baby;no fever, onset 4hr p/shot given;
No second dose of the Pfizer vaccine for COVID-19 received at 3 weeks after the first dose.; pains; couldn't lift her arms; extreme lethargy; body aches/tremendously achy; This is a spontaneous report from a contactable consumer or other non hcp. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 16:00 (about 4:00 in the afternoon) as DOSE 1, SINGLE for covid-19 immunisation. She has not taken her second dose yet and she wants to know if it is ok to take it now, 3.5 months after the first dose. caller says her mother was not sick at the time of vaccination, no allergies and no surgeries. She is as healthy as a horse. Medical history included ongoing rheumatoid arthritis probably about 10 years. Concomitant medications included methotrexate taken for rheumatoid arthritis, start and stop date were not reported; has been taking this a long time, like 10 years. She got the first COVID shot and the side effects she suffered they believe was due to the fact that she was on Methotrexate. She was lethargic and achy for about 10 days after she got the shot. She says they went to her doctor and rheumatologist and they heard of 2 other patients on methotrexate to treat rheumatoid arthritis that have experienced side effects. She got the first shot back in Feb2021 so can she go back and get the second shot as long as she's off the methotrexate before she goes. The patient experienced no second dose of the pfizer vaccine for covid-19 received at 3 weeks after the first dose, On 04Feb2021, extreme lethargy on 04Feb2021, body aches/tremendously achy (pain), pains, couldn't lift her arms (limb deformity) (non-serious) on an unspecified date. Her MD stated he felt it was because she was on Methotrexate and he advised her to stop taking this medication before resuming the vaccine series. She says they were going to go back to get the second shot, but her mother did not want the second shot because of the side effects. The caller says her mother didn't tell her about the side effects at first. She says they lasted 10 days, later confirmed it ended 13Feb2021. All the events started at the same time: first thing in the morning the next day. The outcome of the event (lethargy, pain) was recovered on 13Feb2021 and remaining events were unknown.
High fever beginning approx. 8 hours after receiving the vaccine and lasted for about 6 hours.  A low-grade fever lasted another 24 hours.  Developed a quarter-size blistery rash on the left cheekbone on the next day after the shot was administered.  Area is still red but nearly healed up.
Erythematous 2.5 cm area of induration on posterior right arm (deltoid). Treatment plan: ibuprofen and ice pack.
Had vaccination on Friday morning.  The following Monday morning I woke up feeling fine but by 9:00 AM started having stomach pain and back pain.  As day progressed I developed diarrhea and a fever which reached 101.7 in the evening. By Tuesday morning the stomach and back pain were gone, but had a headache and 100.0 fever all day, and frequent diarrhea all day.  By 8pm I am feeling much better and am able to bring the fever down with acetaminophen.
Approximately 2 minutes after receiving vaccine, patient exhibited a numbness in the tongue and deeper areas of the mouth.  BP 134/80  HR 78.  Slight numbness has remained fairly constant at 11:55am.  Patient reported symptoms subsiding (or less worrisome).  Patient clinically stable.  Patient released at 12:10pm.
Had ache and pain that usually goes with fever; Nausea; Throwing up; Had a fever of 101.5 F for 3 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea), VOMITING (Throwing up) and PYREXIA (Had a fever of 101.5 F for 3 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Had a fever of 101.5 F for 3 days). On an unknown date, the patient experienced PAIN (Had ache and pain that usually goes with fever), NAUSEA (Nausea) and VOMITING (Throwing up). On 28-Feb-2021, PYREXIA (Had a fever of 101.5 F for 3 days) had resolved. At the time of the report, PAIN (Had ache and pain that usually goes with fever) had resolved and NAUSEA (Nausea) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101.5 f (High) 101.5 F. Patient was on some medications. No treatment medications was reported.   This case was linked to MOD-2022-589356, MOD-2022-589308 (Patient Link).
On 6/18/22 Client had increased fatigue, increased urinary incontinence, increased weakness (had 3 falls in 24 hour period first starting at 9:00am.) Client had new right sided weakness and wasn't able to use right arm or right leg. Staff have to completely assist client with eating.
Insomnia, Anemia, dizziness, imbalance, nervousness, reflux, depression, anxiety, pain and abdominal cramps, arthritis, erectile dysfunction, loss of memory, pain and swelling on both knees and back, difficulty breathing, skin eruptions/rash, fungal infection on skin and feet. Medical records received from VA which reveal patient w/hx of low back pain, depression, anemia, left knee joint effusion, IBS, patellar tendinitis, left toen medial meniscus, GERD, overweight.  Received multiple rounds of PT w/o relief for back pain.  Old MRI showed L5-S1 degenerative disc disease w/bulging disc w/o radiculopathy.  Epidural blocks in 2004 provided temporary relief.  Has antalgic gait & uses single point cane.  Muscle spasms of the LS & TL spine regions.  Also being w/u for anemia to r/o hemoglobinopathy./ss
I have pain in my knees, hips and shoulders. I also have pain in my legs and some time have cramping. I usually walk 2-3 miles per day and my legs never relax. They remain tight at all times. I have pain in my legs when sitting and arising from a chair. The aforementioned joints ache in bed to the point that I have to roll over constantly because of pain caused by pressure. I have tried to stretch daily to loosen the muscles and joints to no avail. I never had any of these problems before. I recognize that the symptoms arose a month after my 2nd shot. After the first dose, 2/8/2021, i had leg fatigue on the forth day only. The next day I had no symptoms and none until 4/10/2021.
diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spontaneous report from a contactable consumer (patient's stepbrother). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Arm Right on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunisation. The patient was feeling very weak and has fallen twice and no fever or flu like symptoms. He ended up going to the hospital where they did a blood test which came back showing he had very high glucose levels and he was now convinced that the vaccine has given him diabetes. The patient experienced Patient says he is feeling very weak and has fallen twice but no fever or flu like symptoms on 24Feb2021, high glucose levels and diabetes on an unspecified date. The patient underwent lab tests and procedures which included blood glucose increased: high glucose levels on an unspecified date.The patient was not tested for COVID-19 since the vaccination. Outcome of the events patient says he is feeling very weak and has fallen twice was not recovered and unknown for other events.  Follow-up attempts are completed. No further information is expected.
neuropathy; muscle weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness".  Clinical course: Patient had enquiry that patient wanted to know what to do about the neuropathy and muscle weakness as well as other complications that patient had from COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
DPT given 1030AM 5AUG92 1130AM c/o h/a; 3PM c/o stomachache; 1030PM vomiting, t104.2;
This spontaneous report was received from registered nurse regarding a currently 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient's vaccination history included TDaP and unspecified flu vaccine. The patient's immunization records showed date in 1997, the patient received vaccination with first dose of PNEUMOVAX 23 from lot # 0906E (expiry date: 02-APR-1999), he received his second dose of vaccination from lot # 0691P (expiry date unknown) on an unknown date in 2005, and he received his third dose of vaccination from lot # 0895AA (expiry date unknown) in approximately 2012 (extra dose administered), (dose, and route unknown). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
10 days after 1st dose, started with severe itching burning tingling on left flank early morning.  For a few days prior had headaches as well that would keep coming back.  Was able to get into see primary next morning,  confirmed shingles, prescribed valacyclovir 7 day course. As days progressed red rash appeared, also along that and up left back flank greenish yellow bruising as well.  Meds help stop progression of blistering, blisters did not appear. It has been about seven days now.  Today, Sunday 4/18/21, I went to ER for mid upper thoracic spine pain discomfort and into chest, weird heavy inflamed feeling in chest, little shortness of breath. This pain and feeling been going on for few days or more. ER Doc did not do xray of lungs. Jist prescribed 5 day course of prednisone.  Said neuralgia shingles and fatigue malaise.  No fever.  Blood pressure was 146/69. Pulse 90 at time of ER visit.  Normal BP for me is 70-80/60 approx. Said to take Ibuprofen on schedule to keep in system and help with inflammation. CBC done on Fri 4/17 , showed normal values, same with PTT  PT.  I am to followup with primary Dr on Tuesday. Still in a lot of discomfort,  neuralgia I assume. Hoping meds start working to help.  Not going into work tomorrow per doc recommendation.
Vaccine was administered on 4/3/12... pt presented to hospital on 4/12/12. Initially treated for TMJ... pain worsened and lesions appeared on eye/jaw area on 4/16/12... MD diagnosed with shingles and treated by primary MD.
Pt recvd 2-1cc injections of Recombivax 1DEC90 & 1JAN91; 13JUN91 recvd Engerix-B; pt "did not develp immunity";
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6203), in right arm, on 08Apr2021 as dose 2, single (Lot number: EL9266), in right arm and on 06Nov2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Reactive Hypoglycemia" (unspecified if ongoing); "Symptoms of Sjogrens" (unspecified if ongoing); "Hashimoto's Disease" (unspecified if ongoing); "Obese" (unspecified if ongoing). Concomitant medication(s) included: ACARBOSE, start date: Jan2018; WOMENS MULTI ONE A DAY; RESTASIS; ALLERGAN, start date: Mar2011; VIRTUS, start date: Jan2018. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies Ibuprofen.  The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient did take other medications in two weeks. It was reported that patient was recovering from Paxlovid Rebound. CDC Health Advisory (CDCHAN-0467) directed patient to this website to report the Paxlovid Rebound.
Rapid onset of flu symptoms that lasted for 4 days, lingering cough for 4 weeks, recurring illnesses in February, March and April including sinus infection most recently starting on 4/12/17.
Dark red throat and sinus, bad headache. In bed for a week with flu, 102.2 temp. spike for 1 1/2 days, severe dizzy, seizure like movements, trouble breathing, no bath, swelling.
Increased erythema/swelling right upper arm, significant pain, treated initially cold compresses, Tylenol and Benadryl
Lymph nodes under arms swollen. Injection side arm pit swelled to the size of my fist?right side swelled to half that size. Swelling is going down but have under arm pain and soreness.
Information has been received from a Licensed Vocational Nurse concerning unspecified number of patients of unknown demographics. On unspecified dates since 05-FEB-2015, unspecified patients were vaccinated with VARIVAX (1. lot number: K003412, expire date: 06-MAR-2016; 2. lot number: K005427, expire date: 15-APR-2016; 3. lot number: K006138, expire date: 29-APR-2016; 4. Lot number: K007981, expire date: 03-JUN-2016; 5. Lot number: K010440, expire date: 22-JUL-2016; 6. Lot number: K015971, expire date: 23-SEP-2016; 7. Lot number: K021484, expire date: 03-NOV-2016; 8. Lot number: K026387, expire date: 15-DEC-2016; 9. lot number: L001335, expire date: 13-JNA-2017, dose and route unspecified), which were previously exposed to temperatures outside of the recommended range. No adverse effect had been observed or reported. Additional information has been requested.