chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's wife called to report that her husband has been experiencing arm soreness, fever, and hallucinations following a Shingrix vaccine. Pt. received his vaccine on 2/1/2022. The next day he complained of significant arm pain at the injection site and subjective fever. He also had fatigue and was in bed for 2-3 days. Estimated date of 2/6/2022, pt. was described as having hallucinations during the night including getting out of bed "looking for something". His wife also stated that he was talking in his sleep. The patient saw his PCP the next day and was told to take benadryl that night. He was reported to have a slept very well with no issues that night (2/7/22) but the episodes recurred again last night, 2/8-2/9 and that he "seems to be getting worse".  I encouraged them to follow up with their PCP or seek emergency services, which she agreed.
a fever 100.7; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever 100.7) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included DULOXETINE, THYROID (ARMOUR THYROID), PANTOPRAZOLE and PRAVASTATIN for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (a fever 100.7). At the time of the report, PYREXIA (a fever 100.7) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient admitted to hospital as (inpatient) on (01/25/2022) due to alcohol dependence with withdrawal. Patient was tested for COVID-19 and was positive on (01/26/2022). 44 y.o. male with current COVID-19 infection, encephalopathy, alcohol use disorder with decompensated cirrhosis (MELD 22 on admission, MELD currently 28), who presented to the ED on 01/26/2022 with dizziness/malaise. On admission, reportedly also endorsed chills, poor appetite and cough. On initial workup, found to have significant lab abnormalities and felt to be undergoing acute alcohol withdrawal.  Over the course of the last several days, patient has has become increasingly tachycardic and encephalopathic with multiple MRTs called for seizures and SVT requiring multiple doses of adenosine.  Given his worsening clinical status, CT head obtained (no acute abnormalities) and abdominal duplex ultrasound obtained showing splenorenal varices and abnormal portal flow. Subsequent CT abdomen/pelvis obtained showing SMV thrombosis. During this time, patient has also increasing bilirubin, severe electrolyte abnormalities and a metabolic acidosis, although lactate has since normalized.  Given these findings and patient's challenging clinical course thus far, general surgery asked to evaluate.
PATIENT RECEIVED DOSE AT 11:11AM ON 8/31/19 BY EVENING TIME AROUND 9PM SHE STATES THAT SHE WAS VERY COLD AND GOT A BLANKET TO WARM UP. SHE HAD INVOLENTARY MOVENTS OF HER ARMS AND JERKING OF HER NECK/HEAD. SHE PROCEEDED TO GO TO SLEEP AND WOKE UP THE NEXT MORNING WITH FLU-LIKE SYMPTOMS FOR THE NEXT DAY AND IMPROVED ON DAY 2. **PATIENT ALSO REPORTED ON 1ST DOSE SHE HAD  NERVE PAIN DOWN HER ARM WITH FLU LIKE SYMPTOMS FOR 3 DAYS.
A friend received an unknown flu vaccine and experienced arm pain; This spontaneous case was received on 26-Apr-2021 from other non-health professional via Communications (reference number: SEQW21-01228) and concerned a patient of an unspecified age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced arm pain.   The outcome of the event 'pain in arm' was not reported.   The patient did not provide a causality assessment.   This case is linked to case 202102297 and 202102298 (the same reporter).  Company comment: A patient of an unspecified age and gender developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.; Sender's Comments: A patient of an unspecified age and gender developed pain in extremity after vaccination with the suspect product, influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Anatomical location of vaccination and event location was not clearly reported. Information regarding the underlying medical history, related diagnostic findings and concomitant medications has not been provided. Due to lack of information, causality for the reported event is unassessable.
VACCINE GIVEN AT LEAST 29 HOURS AFTER THE 6 HOUR PUNCTURE WINDOW; This spontaneous report received from a health care professional 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 ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced vaccine given at least 29 hours after the 6 hour puncture window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given at least 29 hours after the 6 hour puncture window was not reported. This report was non-serious. This case, from the same reporter is linked to 20220116755.
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA, start date: 04Jun2007; ZOLOFT, start date: 04Jun2007; TRAZODONE, start date: 04Jun2007; NUVIGIL, start date: 04Jun2007; METOPROLOL, start date: 04Jun2007; LISINOPRIL, start date: 04Jun2007. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Apr2023 to 24Apr2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173554 same reporter/patient, different product/AE;
HIVES ALL OVER BODY COMES AND GOES. MOTHER SAID HIVES DISAPPEAERED ON 01-01-2021
She states she started having itching on the left upper arm and the some redness the size of a quarter by 10:00 pm on 5/13/19.   She took a Benadryl to see if it would help.  On 5/14/19 she had redness that extended 2 cm x 2.5 cm on the left upper arm, raised and warm to the touch with severe itching.  She was advised to use a cool rag over the area,  continue taking Benadryl as needed and use an anti itch creme as needed.    As of 5/17/19 she stats the redness is getting better and the itching has subsided some.
she is not feeling well; she is really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well) and FATIGUE (she is really fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (she is not feeling well) and FATIGUE (she is really fatigued). At the time of the report, MALAISE (she is not feeling well) and FATIGUE (she is really fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
4 hours post-injection: soreness, heat at injection site 12 hours post-injection: continued soreness, heat at injection site; body aches; cold sweat/chills; fatigue 16 hours post-injection: continued soreness, heat at injection site; body aches; cold sweat/chills; fatigue; fever 101°; unable to go to work 24 hours post-injection: continued soreness, heat at injection site; body aches; cold sweat/chills; fatigue; fever 102°; unable to go to work 36 hours post-injection (following 800mg ibuprofen): continued soreness, heat at injection site; body aches; fatigue; fever gone; unable to go to work 48 hours post-injection: continued soreness, heat at injection site; body aches; fatigue; unable to go to work 72 hours post-injection: continued soreness at injection site; fatigue; able to work
Pt  stated that she developed a sore gland on armpit 01/08/2021 when she had woken up in the morning. Pt stated that on 01/10/2021 she had woken up in the morning with a hot and red arm, and that she had sought care from a physician and her physician had started her on antibiotics for an infection.
Moderate joint pain starting Tuesday afternoon, March 23, 2021, and still having as I fill this out on March 27, 2021. Most severe in the elbow of the left arm (injection arm) but felt in both elbows and knees.  Hands shaking/tremoring starting Thursday evening, March 25, 2021, resolved March 27, 2021.
Stiffness in joints (knees especially) back, swollen wrist, R knee swelling, Insomnia , migratory swelling, redness, Medical board pending. Sugery L knee 2001, R knee 2002, R wrist 2002
Patient states that she had redness and pain in her left arm, the day following the vaccination.  Patient states that she has gone to urgent care/ER and was diagnosed with cellulitis.  Not sure of the course of time, however as of today Aug 24th, the patient states that she is seeking additional medical help as the antibiotic she took, has not resolved the cellulitis.  Her symptoms were soreness, redness, heat, at the site and fever.
By the afternoon of the first dose, I was tired. At night in bed, I experienced dry mouth, brain fog, faint ringing in ear, tingling in hands and feet, dry eyes, some dizziness. Sensations in muscles, stomach, and bones. It felt like something is circulating around This continued each day 2-4 following this dose. I am concerned about the brain fog and tingling in hands and feet. I am on day 6, and I am experiencing more brain fog, inability to think or remember some things, pain in rib cage, collar bone, and sensitivity in lymph nodes in breasts and throat. I know experiencing longer than average side effects than others. I have seen my doctor on Monday and he is monitoring me for 2 weeks. I am a school teacher. I am concerned. I have had to take 3 consecutive days out this week and need to be at the school to administer state testing by next week. I don't understand why I was not given a good 2 weeks to overcome my effects of vaccination by the school dept. to protect myself, students, and my own family. I took the first dose because others had said that their side effects were minimal lasting only a few days. I had mine done last Thurs of the school vacation. I feel held back from doing my job as a teacher.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter called for the doctor looking for information on patients who might have developed a rash after getting the SHINGRIX vaccination. The patient was given the 1st dose on Sunday or Monday of the reporting week and within 48 hours developed an acute rash over her torso. No additional details were available.
Itching started 11-12 days after booster dose. Red viral looking rash first appeared in pubic and axillary areas after shower. Rash subsided after about an hour. Returned with itching on palm of hands and ankles later. This red, itchy rash continued to move around my body  from place to place including, inside ears, back, buttocks, legs, feet, abdomen, and areas mentioned above. If in scratched any area, a raised welt appeared. Took Benadryl at night to reduce itching and help with sleep. Consulted PCP on day 10 of rash. Changed to Zyrtec. This keeps the rash away until about an hour before dose is due. Ruled out any change in soaps, lotions, diet. Now on day 17 and one week on Zyrtec
Pt received Pfizer vaccines in January and February of 2021. On 08/30/21 pt presented to the ED with complaints of body aches, flulike symptoms, fevers, cough, and nausea for two weeks. Pt tested positive for COVID-19 and required supplemental oxygen.
A mild case of shingles. A shingles rash developed on my right shoulder/back. It resolved with medication.
Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.
Patient attended a walk-in vaccine pop-up event seeking vaccination.  He recalled receiving an unknown vaccine a month and a half prior at a location in the neighborhood, but had no knowledge or proof of what the vaccine was.  The patient was a poor historian, and had minimal recall regarding most events surrounding his vaccination history.  Patient did not appear to be under the influence of alcohol, and claimed to be feeling well the date of vaccination.  Other substance use and behavioral Hx are unknown related to patient recall.  Patient was vaccinated with dose one of Pfizer on 4/28/21.  Patient was later discovered in immunization information system as having received both doses of Moderna on 2/12/21 and 3/12/21 respectively.  Patient has been flagged in our electronic medical record to not be given a second dose of Pfizer. The street team will seek patient out to verify status, and will document outcome.  Patient does not own a phone.
Palpitations and elevated heart rate began evening of 3/29/2021. At 10:30 pm experiencing chills and took tylenol. By 3:30 am on 3/30/2021, weakness, chills with fever of 102-103 and heart rate of 132. Given fluids. At 6:30 am, fever still up and heart rate still high(120+). Took tylenol and went to ER.
"Had mild pain the day of shots. Then developed increasing pain, redness, swelling, stiffness. Yesterday had fever to 102. Sxs better with Tylenol. "  "Findings: Erythema and rash present.     Comments: 3 cm firm, erythematous, tender, warm circular region on right upper arm. Decreased ROM right shoulder and arm. No fluctuance. "
Narrative:  Patient received two doses of covid vaccine. Patient died three days after second dose. PMH includes T2DM (dx 1986), DM neuropathy, DM retinopathy, CKD stage 3, hx cervical spinal stenosis, hx recurrent UTIs, chronic PTSD and OSA (reports adherence w/ CPAP). Patient found deceased in home. No further reports of cause of death.
Client was inadvertently given both varicella and MMRV. No issues within 30 minutes. Mom alerted to keep eye out for increased pain at site, fever, and rash per recommendation from state vaccine consultant.
Isolated nausea about 8 minutes after her shot.   No emesis. No other symptoms to suggest a vasovagal reaction. No SOB, CP, dizziness, or sense of asthma attack.   No wheezing. Nausea spontaneous resolved within about 5 minutes. VSS throughout.  No orthostasis.   Initial BP- 110/81, Pulse - 68, O2 sat - 100%
I just wanted to report that I had a light case of shingles in Sept.   I had a shingles shot about 6 years ago. I just wanted to know if this could have been a side effect to the shot. I had treatment for them at the ER.  I know there are side effects to the vaccine but wanted you to know I'm healthy and never had a reaction to any vaccine before.
On day 0 of receiving the vaccine I experienced arm pain at the injection site and extreme fatigue. I went to sleep at 9pm and awoke at 1am with chills. My temperature was 99.5. Throughout day 1 after the injection, I experienced more fatigue, arm pain, chills, headache, and overall body aches.  I did not take any medication to relieve symptoms. On day 2 I awoke with just a minor headache. Arm pain improved significantly, but is still present.
Relatively mild but I don't have a cell phone that can use your smartphone app.  I had a mild headache on Saturday, the day after the vaccine, and some mild stomach upset.  On Sunday, I had a much more intense stomach upset with burping (which I never have) and a stomachache following dinner.  I took OTC medication for the stomachache and it went away in about 7 hours.  I never have a stomachache or burping.  I didn't have anything to eat that was unusual.  I did have 1 glass of red wine with my dinner.  The symptoms subsided overnight and I feel better today.
Approximately 24 hours after receiving lZ's mmr & Dtap in Rt arm, pt. mom noticed pt. arm red, warm to touch & swollen in area where lZ's were given.  12 cm X 12 cm are of redness/erythema.  Pt. seen here & told to use cool compresses & TYLENOL for releive.  Should resolve w/1 a week.
this was given to a pregnant person by mistake. she did not have any adverse reactions. just reporting that it was given in pregnancy.
Information has been received from a physician concerning a 19 weeks boy with a history or born premature and no drug reactions or allergies who on 26-APR-2011 was vaccinated orally with a dose of ROTATEQ (lot # 668908/1135Z). Secondary suspect therapy included a dose of RECOMBIVAX HB (dose, route and lot # not reported). Concomitant therapy included PENTACEL, PREVNAR, PREVACID and iron (unspecified) & vitamins (unspecified). On 26-APR-2011 the patient had a low-grade fever in the evening. The patient's parent spoke to physician on phone to seek medical attention. The patient was treated with TYLENOL. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. Follow-up information was received from the physician indicating that the 19 weeks boy with a history of Ex-preterm (27 weeks/745gm) who on 26-APR-2011 at 1:45 PM was vaccinated orally with the first dose of ROTATEQ (Lot # 668908/1135Z) at private doctor's office/hospital. At the time of the report, there was on adverse event reported. This is one of several reports concerning the sibling. No further information is available.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
11OCT92 pt eyes were fixed staring straight ahead-shaking all over, hot body was pale this lasted 5-7 minutes;  pt taken to hosp when sz occurred but taken to MD next day; dx w/ear infect, chest congestion & was put on ATB; rash; grumpy;
Extremely tired, headache, muscle aches (especially at night), joint pain in large and small joints, nausea, redness, swelling, and extreme pain at injection site.
Paraplegic received flu shot 10/18/11. Returned to Dr on 10/26 with c/o unable to use his hands. No grip.
outbreak of chickenpox-like lesions, initially on face, then trunk, arms, legs, as observed by refugee nurse during follow-up home visit;onset of lesions 8/16/99;nurse advised parent to seek medical attention;
arm itchy when recv vax on 8APR97 & t104;seen 7APR97 for bruise where vax given & non indurated red flush of about 3" around area & scattered hives around body;+demographism;no swelling or diff breathing;tx w/DPH;
Headache, Myalgia, Fever, SkinRash, Rash, swollen tongue, bruising Narrative: 1/8 and 1/9 sore arm treated at home with tylenol; 1/12 states she had bruising into axilla, rash, body aches, Shortness of air, swollen tongue, fever, and a headache. States she was admitted to the hospital but discharged the same day after receiving fluids, antibiotics and pain meds. She reports taking benadryl and tylenol at home before presenting to ER. States fever broke, she feels better after fluids; but still has post nasal drainage, congestion and cough. Of note, she tested for COVID on 1/5/21 PRIOR to getting the vaccine, test was negative.
10/3/11 FLUZONE 0.5cc IM. 10/5/11 c/o upper respiratory symptoms. 10/9/11 c/o double vision - MRI negative Tx. Prednisone 60mg x 5 days.
Overall soreness and lethargy. Headache. Very sore at injected site.  Took some Tylenol. It helped alleviate the symptoms.
Since date of injection 3/31/2021, patient has been experiencing extreme dizziness. She is 7 days post and currently still experiencing this symptom.
24 hours after Hep A number 2 pt had muscle weakness in lower extremities. C/o legs burning and feeling like rubber. No Temp, went to children's medical center. Had lab work- all normal.