chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In patient's words, typed as written: Broke out in a rash with itching and dark spots all over my body, also had dark purple bruise from my ankle to the calf of my leg had to to go urgent care.
10/06/2007 2nd HPV; 11/26/2007-Left leg pain- no injury; 01/09/2008-shoulder pain; 01/30/2008 Ortho referral; 02/09/2008-3rd HPV vaccination; 04/11/2008 and 04/12/2008 -shoulder pain.  She has had MRI of shoulder pain. Normal injection and physical therapy.
woke up today had a headache just on the right side of her head and injection site is sore and a little knot at the site; woke up today had a headache just on the right side of her head and injection site is sore and a little knot at the site; woke up today had a headache just on the right side of her head and injection site is sore and a little knot at the site; This is a spontaneous report from a contactable nurse. A 60-year-old female patient started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on 16Dec2020 12:45 at SINGLE for immunization. The patient's medical history and concomitant medications were not reported. On 17Dec2020, it was reported that the patient woke had a headache just on the right side of her head and injection site is sore and a little knot at the site. Headache woke her up, no discoloration at injection site. The outcome of the events was unknown.   Information about Lot/Batch has been requested.
Erythematous, warm and tender area measuring 1 1/2 inch x 2 inch left upper arm below injection site
ERYTHEMA,SWELLING,TENDERNESS AT INJECTION SITE, FATIGUE, CHILLS Narrative:  Other Relevant History:
Muscle weakness, fever, chills for 4 hours Strong headache for 16 hours, completely resolved in 24 hours
Pt had vaccine around 11am. Pt returned to our clinic at 4:00PM with c/o swelling/redness/pain at injection site. Area had 10cm induration with redness and was hot to the touch.
Hospitalized 8/8/22-8/12/22 SOB, congestion, cough, dyspnea, fever, body aches,
Patient woke up last night (6/28/16) with a fever of 103 degrees F. MOC gave TYELONOL and MOTRIN which brought the fever down. Woke up at 10:00 am this morning (6/29/16) with fever of 102 degrees F. MOC gave TYLENOL and brought patient to the office.
near syncope. Vasovagal symptoms with pallor, diaphoresis, weakness. Patient was laid flat (supine) and rested for  15min and symptoms resolved except for a little fatigue. He was able to stand then walk out of clinic. States he felt a little tired but otherwise felt fine. He did not lose consciousness, did not vomit.
Flu s/s since 09/27/09 after receiving flu shot in 09/23/09.
Information has been received from a physician concerning a 14 year old female with no pertinent past medical history who on 20-JUL-2007 was vaccinated with 0.5 ml intramuscularly with a first dose of Gardasil (Lot # 658100/0525U). Concomitant therapy included ADACEL. On 20-JUL-2007 within minutes of receiving the injection the patient fainted onto the floor and was unconscious for a few seconds. The patient was sent to the emergency room. The patient developed a severe headache and amnesia and was hospitalized in the intensive care unit. The patient became combative and delirious and was given two unspecified sedatives and IV ZOFRAN. She was discharged from the hospital within a day or two. On 23-JUL-2007 the patient was seen in the physician's office and was fully recovered. She was referred to a neurologist. The physician considered the patient's fainting, unconsciousness, severe headache, amnesia, combativeness, and delirium to be life threatening and other important medical events. Additional information has been requested.10/03/07-records received-for DOS 7/20/07-Loss of consciousness, now asking repetitive questions, nauseous and seems disoriented. C/O right sided headache. PE oriented to person and time but not place. While in ER became combative uncooperative. DX AMS.
fever 103 F, pain, redness to site of injection, muscle pain, shivering. All these symptoms occurred for 2 days
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 62nd of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Extreme soreness in injection site starting at 8:30 P.m the night of injection.  Muscle aches and pains, low grade fever, chills, fatigue starting around 8:30 A.M  on 1/28/2021.  Has not resolved as of yet (4:05 P.M) 1/28/2021
Pt recvd MMR on 03JUL90; On 05OCT90 lab eval revealed negative titers for measles & mumps; Pt revaxed w/booster dose of MMR on 13NOV90; @ time of report lab results were pending; Pt has hx of lack of response to measles WAES90120615;
Approximately 2 -3 weeks after receiving my 2nd vaccination at the site, I experience two days (one day apart) of severe Vertigo.  I did not tie it to the Covid Shot at that time but immediately started using a cane. I had fallen twice on separate occasions a few months prior. It wasn't until August 25, 2021 that my friend called me and said the reason she hadn't called me the last week was that she suffered severe  Vertigo the last week. She had spoke to two other female friends who told her they had had the same experience. His friend has filed a report with VAERS.
day 1 - sore arm, red spit size of a quarter, chills, fever, fatigue day 2 - sore arm, red spot 2? round, fatigue, chills, arm numbness day 3-  sore arm, red spot 4? round, itchiness day 4 -  sore arm, red spot 4?, crazy itchy day 5 - soreness, red spot 4?, itchy, pain radiating day 6 - pain, red spot, very itchy,
Patient received vaccine at 12 pm, then eats large meal (after 24 hour fast) returns at 1 pm with N/V/HA. Negative lungs, negative hives. EMT evaluates pt vitals WNL, did relaxation techniques. Pt sent home from work with no further issues, ENT questions panic attack?
Facial flushing and "raccoon eyes" with some lump in her throat feeling. Mild cough, rash on upper chest with some itching around the face and neck and upper chest. Treatment = oral BENADRYL.
10 hours later. Fever, chills, throwing up, neck stiffness and pain, body aches
Sore arm-pain is getting worse, sometimes the pain goes into neck and across back and down arm. Unable to lay on side and limited range of motion.
30 to 60 seconds after the vaccine the patient fainted and was laid on the floor. The patient came to 5 seconds later. The patient laid down for 5 minutes and stated she felt better. The patient's skin was pink and dry. The patient had emesis and pale skin color. The patient laid down for 15 minutes and then had no problems. The patient was sent home with her mother.
No adverse event; Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown whether the patient had received any previous COVID-19 vaccination doses. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Diabetic.    On 06-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23).    No concomitant medication was reported. The expiry date was reported as 12-Jun-2023. No treatment medication was reported.
The patient and her husband came in for flu shots and Pfizer and Moderna booster, respectively. The patient requested to be vaccinated first. I had the flu and Pfizer doses ready on the preparation table. While I gave the flu shot, my assistant quickly retrieved a Moderna booster for the husband. Upon returning, my assistant placed the Moderna dose next to me on the table. After I gave the patient her flu shot, I reached for the Moderna dose, believing it was Pfizer neglecting to check the volume and label on the syringe. I immediately realized my mistake and notified the patient when I prepared to vaccinate the husband, only to see the Moderna dose was missing. The patient was upset and insistent on receiving Pfizer. She grew concerned of an allergic reaction to Moderna. I deeply apologized and assured her CDC has approved Pfizer and Moderna to be mixed, and due to her history of Pfizer doses with no reactions, it is unlikely she would react with Moderna. My assistant called my supervisor over, and she repeated to the patient CDC's approval as well as addressing the patient's safety concerns. We monitored the patient for over 15 minutes observing no reaction.
Vasovagal- Lightheaded, weakness with standing- patient said he was not dizzy.  Stood up/ sat down 3x.  Outcome: Rest, recovered.
Pain in injection site for three days - pain has decreased over the three day period Fatigue and body aches day after injection  Headaches for three days after injection. Mostly dull but consistent headaches those days except for the second evening after injection was sever headache on left side of head that felt like a migraine- I do not usually get headaches and never a migraine
Infant became more tired than usual evening after vaccines, then at 5 AM the day after vaccines, had blood in stool.   By 9 AM the day after vaccines, had normal stool, was feeding well, no pain or fever reported.   Then had 3 more stools with blood during day.   Ordered U/S to rule out, intussusception, since infant didn't have any more blood in stool after that point and was well, family did not go for U/S.  Remained well with no blood in stool the next few days.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 720 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
but is currently in the hospital for a femure fracture; supposed to get the 2nd dose/ likely miss the 2nd dose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FEMUR FRACTURE (but is currently in the hospital for a femure fracture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (supposed to get the 2nd dose/ likely miss the 2nd dose). In April 2021, the patient experienced FEMUR FRACTURE (but is currently in the hospital for a femure fracture) (seriousness criteria hospitalization and medically significant). At the time of the report, FEMUR FRACTURE (but is currently in the hospital for a femure fracture) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (supposed to get the 2nd dose/ likely miss the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported that her step father supposed to get the 2nd dose of Moderna Covid19 vaccine on Wednesday 14-APR-2021 but he will likely miss the second dose as he is currently in the hospital for a fracture femur. No treatment or concomitant medication were reported.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.; Sender's Comments: Based o current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
the patient was started on amoxicillin for otitis on 2/13. same day was given MMR. Fever 103 on 2/20. Rash began on 2/21/2020. DXerythemamultiforme
Pt received small pox vac 2 wks ago to L arm.  Yesterday he came to see me at ER b/c he had a disseminated erythema multiforme-like rash x 24hs (when he saw me.  He had no fever, no nausea, or weakness.  His only complaint was that his L arm was very, very sore.  The rash initially started on the opposite arm and moved very quickly to his left arm, neck, scalp, and forehead.  I called the CDC to see if VIG was necessary but they said that NSAIDs and Benadryl was warrented in this case as well as daily follow up to see if he develops any worsening events.
Patient received her first Covid vaccine 2/27/2021 and her second Covid vaccine March 20, 2021.  She had no symptoms with her first vaccine but the second 1 she developed chills, fever and body aches.  The body aches eventually went away but the chills and fever persisted.  She then developed loss of appetite and lack of energy and vomiting.  She was admitted to our hospital on 4/19/2021 with acute renal failure requiring dialysis.  She had no previous renal insufficiency
Approximately an 18 x 12 area on L upper deltoid. Arm very red and swollen. Non-tender.
Child was given 1st dose of Hepatitis A and HPV with dad present.  Dad and child remained in waiting area for 15 mins prior to leaving.  Child was eating ice cream and vomited one time and had lightheaded and dizziness.  Dad brought child back to LHD.  After lying down child felt that his stomach felt "a little better" and less lightheaded/dizziness.  BP 128/79 and then 118/68.  Dad declined to stay any longer at the LHD.  Child was assisted into the sitting position and then into the standing position.  Child felt that his stomach was feeling a little better and again less lightheadedness/dizziness.  Dad felt that his child would feel better if he ate something and took child home.
A report has been received from a Health Professional concerning a patient born on 30-Jun-1951, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 22-Oct-2014. It was reported that a FLUMIST vaccine was dispensed to the wrong patient population. The outcome of the event of ADMINISTRATION TO WRONG PATIENT POPULATION is unknown. The reporter's description of the event (s) was as follows: Not provided. The report was considered to be non-serious.
Soreness around injection site, muscle soreness, fever, cold sweat, and headache. Also, itchy eyes (both) redness and swollen. Doctor said rash in the eyes gave allergy medicine. Steroid drops.
Initial and follow-up information has been received from a registered pharmacist concerning a 75 year old male patient with no known drug reaction/allergies who on 04-JAN-2009 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Oka/Merck) (lot # 662856/1559X). The pharmacist reported that the patient developed a headache on 04-JAN-2009. The headache had not resolved at the time of the report. The pharmacist reported that she had not heard back from the patient as of today, so could not report if the headache still continues.  The patient sought medical attention by phone.
Fever, aches, headache, tiredness, very sore arm (which was expected)
Covid Dose 1- 3/31/21, Dose 2- 4/21/21.  Exact onset date unknown but sometime in late April, 2021  Spots/Lesions appeared on arms, hands & legs, mouth became "tight" with some sores.  Was later diagnosed by dermatologist and dentist as Lichen Planus.  Dermatologist treated with Triamcinoline dental paste, Clobetasol topical, Tacrolimus disolved in water and swished in mouth, Cellcept initially 2/day, increased to 4/day but I discontinued because the "cure" was worse than the disease.  2nd symptom was chest/lungs felt congested/tight.  Not bad but noticeable.  Over time it got worse and I went to see my GP.  Treated for Bronchitus with Azithromycin (no change).  Later treated with  Prednisone and Albuterol inhaler.  Better but still there.  All of this might be coincidental but my overall health is definitely worse now than before I received the Covid vaccines.  I have been tested for COVID several times and have never tested positive.  No Covid booster.
SCRATCHY THROAT; ABDOMINAL WALL PAINS; TIREDNESS; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced scratchy throat, abdominal wall pains, tiredness, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, nausea, headache, scratchy throat and abdominal wall pains was not reported. This report was non-serious.
Patient received the flu vaccine at an offsite clinic on 8/18. Patient stated that on 9/1 she still had residual pain in her arm that she believes is a vaccine-induced shoulder injury. She noticed the pain increasingly after attempting to lift her luggage on a trip in between these dates.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain, injection site tenderness, injection site swelling, tiredness and injection site erythema. The patient was treated with Diphenhydramine and TYLENOL. On an unknown date, the outcome of the pain, injection site tenderness, injection site swelling, tiredness and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, injection site tenderness, injection site swelling, tiredness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The healthcare professional (HCP) reported that the patient received a dose of SHINGRIX and within 1 to 2 days, experienced pain, tiredness, injection site redness (diameter of half of a grapefruit), swelling, and tender to the touch. The reaction started at 4 AM the following day of vaccination and took about 1 to 2 days to develop. The patient went to visit the doctor and the doctor recommended diphenhydramine 25 mg and TYLENOL 1000 mg three times daily.
The next day my arm was very sore and I felt somewhat lethargic. 48 hours later, red, itchy rash started appearing on left forearm, then right forearm with slight swelling.   It has not appeared at the vaccination site.   Additional breakouts occurred behind left knee, up right thigh, upper right arm,  and individual spots occurred on chest and back.  The worse spots look like welts, some of the individual spots were large some areas were just small red bumps.  At this point, the inflammation has gone down, and the redness is starting to fade, leaving very dry skin that still feels like very slight bumps.  Itching still occurs, particularly at night.  I have experienced more chills without fever daily  since the injection., longer lasting than before.   This quite resembles poison oak, which I was very allergic to when a child, it would go systemic and spread all over, requiring steroid injections.
pt recvd vax 10AM APAP was given 5PM mom says t103.5 ax & rising-sponged & wrapped in cool towels;pt noted to have labored resp prior to temp being taken-then resp were irregular;t101 @ 9:00PM & resp back to nl
TIRED (VACCINE FATIGUE OR LIFE FATIGUE); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced tired (vaccine fatigue or life fatigue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired (vaccine fatigue or life fatigue). This report was non-serious.