chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on arm my for 4 days; arm was achy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was achy at the injection site) and RASH (rash on arm my for 4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 VACCINATION SITE PRURITUS (arm was achy at the injection site). On 09-Feb-2021, the patient experienced RASH (rash on arm my for 4 days). At the time of the report, VACCINATION SITE PRURITUS (arm was achy at the injection site) and RASH (rash on arm my for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT 048C21A.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
UNCONTROLLABLE TREMORS; LOST ABILITY TO OPEN OR CLOSE HAND; ACHY(FLU-LIKE SYMPTOMS); SEVERE JOINT PAIN THROUGHOUT THE BODY; MINOR HEAVINESS IN THE ARM; FEVERISH; INTENSE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bullous pemphigoid. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced uncontrollable tremors. On 17-SEP-2021, the patient experienced lost ability to open or close hand. On 17-SEP-2021, the patient experienced achy (flu-like symptoms). On 17-SEP-2021, the patient experienced severe joint pain throughout the body. On 17-SEP-2021, the patient experienced minor heaviness in the arm. On 17-SEP-2021, the patient experienced feverish. On 17-SEP-2021, the patient experienced intense headache. Laboratory data included: Body temperature (NR: not provided) 103.5, 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from minor heaviness in the arm, feverish, achy(flu-like symptoms), uncontrollable tremors, severe joint pain throughout the body, intense headache, and lost ability to open or close hand. This report was non-serious.
Synptoms: patient experienced itchiness after Moderna injection. Her Oxygen saturation was 98% and HR 89.  BP 134/83.  Then she experienced swollen tongue and itchy tongue and dizziness.
Pt exp negative lab test p/ 3 dose series of hep B vax.Pt recvd addt'l hep B doses.
During patients 15 minute wait he had a syncopal episode and fell out of his chair. Once I got to the patient he had come to, mom said he was out for about 10-15 seconds max and patient says he did hit his head. Oxygen saturation was 99% on RA, heart rate was 62bpm. BP 110/78. Patient was alert and oriented once I was assessing him. He was able to sit up in the floor about 5 minutes after coming to. He was able to drink water and the PCT had placed cool wet paper towels on his head and neck area. We provided the patient crackers and the management team was available. The patient said he felt like his stomach was upset and did not want the crackers. I suggested he go to the ER and mom said she would drive him and asked if this was caused by the vaccine itself. I explained what could have occurred and educated them on where he hit his head he needs to go to the ER to be assessed. Mom agreed and the manager got a wheelchair from the front of the store and mom drove him to the ER. I called report to ER.
On 11-4, 8 days after vaccine, pt noticed decreased sesation/numbness during bowel movement. The following day, pt noticed decreased sensation/numbness advanced to entire perineal area.  11-15 pt noticed numbness in posterior of right buttocks. On 11-16, pt called neurologists office and spoke with nurse. Told by drs. office to call back on Tuesday if not better.  On Tues. 11-19, pt called (the neurologist- see details in 19.) 11-21, pt noticed numbness in lateral aspect of right calf and bottom of heel. Symptoms have not progressed further since that date. 1/2/08-records received-DOS 11/29/07-on 11/2/07-middle two toes of right foot numb times 1 hour then on 11/14/07 noticed difference in sensation right buttock and loss of sensation right perineal area, difference in sensation had spread down right leg, right leg feels weaker, upper thigh. Right side of abdomen sensation is different. Feels urge to have bowel movement but feels does not have control during bowel movements. PE: Romberg negative. Intact thermal, intact vibratory. Impression: possible MS.
Not feeling good; Headache; Fever; Tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19), MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19). On an unknown date, the patient experienced MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID 19), MALAISE (Not feeling good), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received half dose. They administered the vaccine to 346 patients after the 30 days by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
The patient recieved her pneumococcal vaccine for the first time on Friday 10/02/2009 in her right arm. She received her seasonal influenza vaccine in her left arm on the same day. She noteded redness at the injection site following administration of the pneumococcal vaccine. The redness worsed over the next few days. The site became swollen and warm to touch with some discomnfort with movement. She presented to the Emergency Department on Tuesday 10/6/2009 following a motor vehicle accident. She complained of itching around the injection site. The swelling extended to just above her elbow. There was no redness, swelling, or discomfort in her left arm (site of influenza injection)
During vaccine administration, the patient and administering nurse noted that the some vaccine leaked out as the connection between the needle and syringe was not secure.  The provider on site was advised immediately.  At which time, due to uncertain amount of vaccine administered, the nurse was ordered to administer an  additional full dose.  The patient tolerated the second dose without incident and completed a 15 minute observation period before being released home.  The CDC was contacted via telephone to ask for additional guidance and Dr. confirmed guidance to administer the additional dose with instructions to also submit a report to VAERS and state vaccine agency.  The patient was instructed to contact the clinic call center or VAERS for any adverse symptom.
Exactly a week after I received my first dose of the Moderna Vaccine, which was on 03/19/21, the injection site became swollen, red, hot, and itchy. Although itchiness and swelling came down in the following days, my upper left arm is currently experiencing red patches, and almost like it is creating a ring of redness  on my tricep. It feels slightly warm, but it is not as itchy as it was when it first happened. I have been using a homeopathic salve called Puremedy for baby skin in the meantime.
104 fever. Nausea. Body aches. Uncontrollable shaking. Diarrhea. Headache.
Patient presented for scheduled WATCHMAN placement.  Successful placement of a 31 mm WATCHMAN FLX device was performed on 12/2/21. Access for left atrial appendage closure was obtained via transseptal puncture. Hemostasis was adequately achieved postoperatively. Patient discharge to home after hospital recovery.
Stomach discomfort a few days, ,, sharp  short pain in stomach one day, Spit up blood 2x one morning, bloated 1 day
This spontaneous report as received from a consumer refers to a 47 years old female patient with prevent shingles. The patient was vaccinated with ZOSTAVAX on SEP-2011. No other co-suspects were reported. No concomitant medications were reported. On NOV-2011 the patient experienced shingles outbreaks 6 times since being vaccinated. The patient reported each time it is progressively more painful. The patient reported that before the outbreaks she had cold type symptoms, ran a fever, and got a feeling similar to burning in her legs. The patient also experienced eyesight is diminished and she wears sunglasses due to the sensitivity to light. Treatment information was with antivirals. The outcome of shingles outbreaks, sensitivity to light and eyesight diminished is unknown. The relatedness for shingles outbreaks, sensitivity to light and eyesight diminish is unknown for ZOSTAVAX. Additional information has been requested.
Narrative:  PATIENT WAS VACCINATED IN TIMELY MANNER FEB 1, AND FEB 22, 2021. PATIENT TESTED POSITIVE FOR COVID 8-30-21 AFTER PRESENTING IN ED WITH GENERALIZED WEAKNESS. PATIENT WAS HOSPITALIZED AND IMPROVED, LATER DISCHARGED TO HOME.
received  vaccine to left arm and felt pain and tingling afterward - cont. to have pain 11/09/2022
Child was undervaccinated.  He was given 0.25 mL of 2009 H1N1 influenza vaccine.  On 11-30-09, he was revaccinated with 0.5 mL of 2009 H1N1 Influenza vaccine.  No adverse events noted or reported.
1 day p/vax pt devel an inj site rxn characterized by erythema, pain & warmth;went to ER & was treated w/ATB;
Mild nausea, mild mild headache about 12 hours after injection. Debilitating headache about 20 hours after injection, lasting for 5 or six hours.  (All will now, about 32 hours after injection).
The patient woke up Saturday (1/23/21)  with a sore arm and also woke up a little late (for her) with a headache. The patient also felt like she wanted to throw up. The patient went to the bathroom, then started seeing light spots. Shortly after the patient  went to the floor. Her husband said that she had a seizure. Said she went stiff, arms were pinned down, eyes open and fixed for 20-30 seconds. and then went limp and sweaty. When she came to, she was nauseated and weak. She took Zofran and slept most of the day. She woke up Sunday and felt fine.
Immediate: headache on left side of forehead and nausea Within 4 hours: nausea, chills, fatigue Within 8 hours: severe chills and uncontrollable shivering, nausea and vomiting, fatigue, body aches, headache...these symptoms lasted about 8 hours more After 16 hours: fatigue, mild nausea, mild headache, poor appetite
5/3/2018 pt notified office very sick the following day tired, nauseated, just felt sick - then noticed increasing redness and swelling at injection site. States site is golf ball sized today, and very red, sore to touch. Acetaminophen.
Asthma symptoms escalated and maintenance medications did not relieve symptoms.  I was unable to rest at night, felt terrible, and became weaker while awaiting next Dr. appointment.
He had a fever for 3 days, runny nose, cough, and a headache. I took him to the doctor, and he was diagnosed with an ear infection. They prescribed amoxicillin and told us to give him TYLENOL as well. He got better and then this happened again in January 2023. He tested positive for Flu as well. He was prescribed amoxiclav, TAMIFLU, and we have been giving TYLENOL. He is still coughing and has a runny nose, but no fever.
NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer concerned a male 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, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210637243.
09/06/16 - fever 09/07/16 - fever 09/08/16 - fever 09/09/16 - 1st seizure at 4:30pm 09/10/16 - 10 seizures 09/11/16 - 4 seizures 09/12/16 - 2 seizures 09/13/16 - 8 seizures 09/14-17 - 8 seizures 09/18/16 - 30 seizures 09/19-20/16 - 10 seizures. Pt's eye roll upward, eyelids almost close, mouth shifts to side and freezes cannot move.
BRUISING; BLOOD IN URINE; HEAVY BREATHING; DIZZY AND LIGHT HEADED; FLARED ECZEMA ON SIDE OF THUMB, FORE FINGER AND MIDDLE FINGER OF RIGHT HAND; RASH LIKE MOSQUITO BITES; NEUROPATHY IN FEET,NECK AND HIP; FALL; This spontaneous report received from a patient concerned a 62 year old Aboriginal and African American male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker (2-3 cigarettes per day), marijuana abuse, street drugs abuse, diabetic, hypertension, memory issues, cirrhosis of liver, acid reflux, neuropathy, arthritis, and pain in ankle and legs and eczema.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, 1 total, administered on 29-JUL-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, after the vaccination patient laid down, half asleep and half awake and fell down. Patient nose, mouth, face, neck and shoulder hits on the floor. Patient experienced the neuropathy in feet. Patient reported that, he had the more pain in feet after the vaccination. On an unspecified date, patient experienced the bruising, rash like mosquito bite randomly on body, blood in urine, heavy breathing, dizzy and light headed. Patient had the asthma pump to use when he felt like short of breath. Patient reported that, he experienced the pain in left side of hip and not able to move. Patient did some stretching to lower the pain. He also experienced the neuropathy in hip, sharp pain in neck like sticking an ice pick and flared eczema on side of thumb, fore finger and middle finger of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, had not recovered from bruising, rash like mosquito bites, heavy breathing, dizzy and light headed, neuropathy in feet, neck and hip, and flared eczema on side of thumb, fore finger and middle finger of right hand, and the outcome of fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210808496-covid-19 vaccine ad26.cov2.s-Neuropathy.Peripheral This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Patient is a 15 y.o. male presenting for 5 days of symptoms following his second dose of Pfizer SARS CoV 2 vaccine culminating in an urticarial rash which prompted him to present to emergency department.  Patient received the second dose of the Pfizer vaccine on June 8 (first dose was administered on may 17 without symptoms). The next day (June 9) he complained of nausea and subjective fever. On June 10 he complained of chest "weakness" and shortness of breath intermittently. He had also mild light headedness but no syncope or palpitations. All those symptoms resolved by June 11. However, he had a diffuse rash on extremities, pruritic, and non-exudative.
Right arm at vaccine site, became swollen and indurated. Fever of 102F, 3 days later. Resolving to small area of hardness at site.
Patient is a 14 year old minor who was accompanied (presumed) by his father and brother for a "first dose" of COVID19 (Pfizer-BioNTech) vaccine.  They arrived with their paperwork in hand, and filled out.  The COVID-19 Vaccination Affidavit was signed and the eligibility type that was checked off :"I am eliebible for the vaccination.  I am 16 years old or older with at least one chronic medical condition." There is a written statement by one of the nurses that she asked the father of the patient how old his son was and he stated, "Fifteen, I mean sixteen..."
Malaise; short lasting fever & chills; short lasting headaches; nausea w/o vomiting; loss of appetite; sleepy; upper body aches; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 11 Feb 2021 at 01:30 PM (at the age of 66-years), as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot# unknown) via an unspecified route of administration, administered in left arm on 19 Jan 2021 at 02:30 PM, as a single dose for Covid-19 immunization. Medical history included polymyalgia rheumatica. Patient was allergic to ibuprofen and opiates. Concomitant medication was not reported. On 11 Feb 2021 at 01:00 AM, patient experienced short lasting fever & chills, malaise, sharp but short-lasting headaches, nausea w/o vomiting, very sleepy, loss of appetite and upper body aches. The events were long term side effects which were from 2-9 days post second dose of vaccination. Patient did not receive treatment for events. Patient did not receive any other vaccine in four weeks prior vaccination. Patient does not have Covid prior to vaccination and was not tested for it post vaccination. The outcome of all the events of was not recovered.   Information on the lot/ batch number has been requested.
This spontaneous report was received from a physician via a company representative and refers to a patient of unspecified age and gender. No information regarding patient's pertinent medical history or concomitant medications was provided. On an unspecified date in May 2016, patient received a dose of GARDASIL 9 and after that he/she received another dose in June 2017 and another on 23-AUG-2017 (exact dose, route of administration, anatomical location, lot# and expiration date were not provided for any dose). No adverse effects were reported.
Information has been received from a physician concerning a currently 7 year old male patient who on 25-FEB-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). On 17-SEP-2010 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR vaccine. Other concomitant therapy included DTaP and poliovirus vaccine. Subsequently the patient developed severe chickenpox. He also developed "strep" throat along with chickenpox lesions all over his scalp. The patient has no fever and was prescribed with AUGMENTIN and BACTROBAN. There were no diagnostic laboratory studies performed. At the time of this report, the patient was recovering. Additional information has been requested.
Developed hives and severe swelling leading to anaphylaxis. No known anaphylactic allergies prior. Gives and swelling subsided. Second episode 8 hours after epinephrine injection. Returned to ER and was given steroid shot. Followed up with allergist, and blood allergy test was negative for all tree nuts.
I took my first dose of the Covid vaccine on Thursday, 01/28/2021 a 6:05 pm. Then on Friday afternoon, my temperature was around 100. I had chills, a sore arm, and weakness. It continued on Saturday as well. On Sunday morning, I woke up with chills on my chest, shoulders, and back. The rash was pink colored and it was itchy.  Around Sunday afternoon, the color turned to bright red and spread to my belly and arms. Then I took a shower and Benadryl. Monday morning, it is still itchy and fades away. I contacted my primary physician. They told me to take another Benadryl.
HYPOTENSION 2/22/2023 CKD STAGE 3B (GFR 30-44)