chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & exp inj site rxn characterized by warmth, soreness, swelling, & redness; The reporter states that inj was given w/TB syring w/ 1/2in needle; MED Affairs com: TB syringes are typically used for SC inj-flu is labelled for IM
Soreness and pain in left leg in the area of glute, hamstring and calf. Pain is present when standing after 5-10 minutes and subsides with sitting or extended walking.
I had the vaccine on Thursday morning, and that night I started to feel really bad, I had COVID a month before after I go the vaccine I felt worse than I did when I had COVID, the COVID symptoms changed over time, I had chills all the time, when I got the vaccine I had a fever and it was so hot that I could not sleep, the next day I was very fatigued and just not feeling well at all. After the next day the fever did break and I was just fatigued for a few days. When I had COVID I had some chest pains after having COVID and it was like someone was sticking a needle through my chest, but they were getting better, but after the booster they came back on the 24th and  then on the 28th I went to the hospital to check to see what was going on and they said that this was something that they have seen with people get after they have had COVID. I just felt like my symptoms that I had for COVID just came back but worse. I had a physical exam and they did not give me any medications.
Approx 1 hour after injection, developed redness + swelling at injection site and approx 2" x 3"
Sudden total Hearing Loss in right ear.  Treated with Steroids (oral and injection into ear).  No recovery, deaf in right ear.
expired dose given; Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 5:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 5:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported.   Date the vial was moved from freezer to fridge is11apr2022. Vial punctured at 10:39 on 12apr2022 and stored at room temperature. Dose was given at 17:48 on 13apr2022. This was the patient's second booster dose.   No treatment information was reported.
Patient received Fluzone Influenza Vaccine on 9/25/2014 and 24 hours later developed progressive pain, stiffness and immobility in right arm including neuropathy described as tingling of entire right hand which is ongoing x 3 weeks.
I95.9 HYPOTENSION 11/12/2021 ANEMIA I95.9 HYPOTENSION 11/12/2021 ANEMIA I95.9 HYPOTENSION 11/12/2021 THROMBOCYTOPENIA, UNSPECIFIED.
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 15 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Sore throat, chills, joint aches swollen face and mouth (tongue), hives in mouth.
Patient reports on the 2nd day of training she complains of hands becoming numb.  She reports doing push-ups, sit-ups, and flutter kicks.  Nothing that seemed unusual for the patient.  She reports she has been an athlete her whole life.  She reports feeling like both of her hands were falling asleep a little.  Nothing in the wrist or arms at that time.  She reports it did not awaken her at night.  She reports having difficult feeling her hands at that time.  Then the following day she was vaccinated with TdaP.  She reports up until getting vaccinated she had a little numbness and then after getting vaccinated she loss strength in her hands.  She reports that after being vaccinated that her numbness progressed and then 4-5 days after being vaccinated she developed muscle weakness.  She complains of not being able to tie her shoes, she was not able to button clothes, she was not able to hold a pencil and she could not hold eating utensils.  The weakness in her hands were severe for about 3-4 weeks and then they started to slowly improve.  Currently she has 100% sensation in her right hand and about 50-70% in her left hand.  The strength is totally back for both hands.  No further episodes.  She has been followed by Orthopedics with no significant findings.  Neurology has not made a definitive diagnosis with EMG testing and etc.  She reports they have called it Neuropathy with no specific cause found.   ~  She denies any illness at the time of the event ~ No trauma to hands and arms except for holding in push-up position for a long time.  ~ Never had any thing like this before.  ~ No family history of problems similar to this ~  She reports problems with Tetanus vaccine given 2-3 years ago.  She reports having a fever and feeling sick after that vaccination.  She did not get a fever this time.  She does report that her arm was tender after this most recent vaccination with TdaP.   No back or neck injuries.
Received flu shot at about 10:22 a.m. Then around 6 pm she had arm pain and fever. The next day her arm was fine but the fever persisted feeling clammy & feverish. Patient has been taking MOTRIN for the fever with minor relief.
Was seen by Dr. at clinic 12/2/11. Started w/ hive-like rash night of 11/29/11. Took BENADRYL that night. Saw Dr. on 11/30/11 and gave PREDNISONE 50mg to take today for 6 days. On 12/1/11 - rash covering body and itching and burning. Joints very swollen and painful. Extreme body pain. BP elevated, HP up. Dx. w/ serum sickness. 12/2 Rash mostly cleared. Face bright red. Continues w/ joint pain and body hurts.
Information has been received from a physician concerning a 14 year old female who was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced tingling in her nose, passed out and little twitching.  Unspecified medical attention was sought.  It was reported that the patient recovered 2 minutes after the vaccine was administered.  There were no diagnostic or laboratory tests performed.  Additional information has been requested. This is in follow-up to reports previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female stundent with reaction to sulphite, milk allergy, sulfonamide allergy, drug hypersensitivity to CECLOR and polycystic ovarin syndrome who on 01-MAY-2007 was vaccinated, into left arm, with a second dose og GARDASIL. On 01-MAY-2007, within 1 minute, the patient recovered from all symptoms and her heart rate was 68. There were no diagnostic or laboratory test performed. No further information is available.
Intermittent sharp pains at injection site starting 2 days after dose. Numbness in left hand and arm starting 3 days after dose, continuing for a couple of hours
Patient states that rash (tiny dots) appeared today (0505/2020). Patient was counseled to contact MD as soon as possible.
Information has been received from a 41 year old female registered nurse with asthma, Fuch's dystrophy, and allergy to penicillin, tetracycline and bee stings. On 11/18/02, the nurse had administered a dose of MMR II, with a retractable syringe. It was reported that "the needle pulled out of the syringe and aerosolized into her left eye. She was wearing glasses but it enetered over the top of them. The nurse flushed her eye with tap water. She now has a sensation of dryness in her eye." It was noted that concomitant therapy included Flovent and albuterol. The pt sought unspecified medical treatment. Additional info has been requested.
Intense pain in arm, numbness and pain going down arm to fingers. Fingers felt detached and ached. Insomnia, stomach pain, fatigue and no appetite, diarrhea since she was given the shot all of these side effects have persisted. In addition her arm where the shot was given is extremely painful and she appears to be even more tired after a week from the date of shot.
Patient had seizure activity about 5 to 10 minutes post vaccination  (neck became stiff, bite down on tongue). Activity lasted about 10 minutes. She asked for help because felt it coming on and requested an ambulance. When ambulance arrived she was not experience any activity but stated 'felt out of it'.
Patient received TDaP on 2/7/17 for cut on left toe while trying pedicure on self. Two days after vaccine onset of extreme pain at site with induration, itching, burning and tenderness.
Fever to 100.9 on Saturday 1/16/2021 and 100.3 on Sunday 1/17/2021.   Right deltoid injection site swollen with a lump.  Warmth and itching also noted at site.  Motrin taken on Saturday and Sunday.  Cold compress to injection site.  Fever has resolved.  Cold compress will relieve injection site itching while being applied.
Body aches, headache, fatigue, nausea, low grade fever (99.8-100.0)
Getting it (vaccine administration)hurt; my arm was so bad I couldn't lift it / Whole forearm is still frozen / could not move her arm at all because it hurt so bad; Hand and fingers got stiff / forearm is still; Hand and fingers got swollen / pad under thumb is swollen; Hand and fingers got painful / pad under thumb is very painful / Severe arm pain; Huge lump in front of elbow where the flesh creases / Lump in her forearm joint; joints in her elbow and fingers also were swollen; joints in her elbow and fingers also were very painful; This case was reported by a consumer and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received Shingrix. On 28th February 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand. The patient was treated with ibuprofen (Advil) and naproxen. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand were unknown and the outcome of the limbs stiffness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, limbs stiffness, peripheral swelling, pain in extremity, upper extremity mass, joint swelling of hand and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The patient reported that even getting the vaccine hurts. The patient was in agony, her arm was so bad that she could not lift it then her hand and fingers got stiff swollen and painful. She had severe arm pain. The joints in her elbow and fingers also were swollen and very painful. The pad under thumb was swallow and very painful, huge lump in front of elbow were the flesh creases. she had a lump in her forearm joint. The patient's whole forearm was still frozen at the time of reporting. She also had been doing heat therapy with her physical therapist. She had notified her HCP and had a visit with them also. The reporter consented to follow up.
Chest pain, shortness of breath, heart hurt (about three weeks), fast heart beat (109 beats/min at the doctor?s office)
Patient received both vaccinations on 02/01/2020. He presented to the pharmacy today (5/12/2020) and claimed that he was hospitalized for septic bursitis. He claimed that he was on multiple IV antibiotics and treatments to treat the septic bursitis. He couldn't tell me exactly when he was hospitalized and the duration of stay because he stated that he thought he  was hospitalized in January and that he thought that he had received the vaccinations in December. In actuality, patient had received the vaccines on 02/01/2020.
New rash on trunk of body, about 20 bumps that look like pimples or bug bites.
Paraesthesia and paresis left hand and arm, erythema left arm. 3/23/06 soreness left upper arm. 3/24/06 soreness left arm. 3/25/06 less sore left upper arm but onset of odd sensation left arm. 3/26/06 onset of paraesthesias left upper arm and mild weakness left upper arm. 3/27/06 increased weakness esp left hand and increased numbness left arm, soreness left arm. 3/27/06 onset mild numbness left hand, sent to ER 3/27/06 about 8:45PM.
approx 4 wks p/vax pt devel flare of arthritis, shoulders, wrists, hands, rt knee; prior to that had only AM hand stiffness & minor pain;
Returned to clinic next day for us to observe the injection site to be red, swollen and hot to touch. Advised for cool compresses and OTC Benadryl cream
This spontaneous report as received from a pharmacist refers to an unknown number of patients. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patients might have been vaccinated with PROQUAD (Merck). Concomitant medications were not reported. The reporter mentioned that PROQUAD (Merck) might have been stored in the refrigerator for an indefinite amount of time. No adverse events were reported. This is one of the several reports of the same source. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thawdate). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thawdate), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date) and PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date).    No concomitant medications were reported. On 09-Aug-2022, the vial was thawed. Patient received vaccine after it had been stored more than 30 days past the initial thaw date.  Patient received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine(lot number AS1414B, expiration date unknown). All patients have not reported any symptoms.  Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-649988, MODERNATX, INC.-MOD-2022-650293 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-650293: MODERNATX, INC.-MOD-2022-649988:
1st seen 6-30-2000 "mild reaction to immunization myositis vs neuritis vs subacute infection Keflix Motrin & Tylenol. Flu diagnosed Adhesive capsulitis. Vioxx Tylenol Cortisone injection pt ortho consult.
During the night about 12-14 hours after receiving the vaccine, I work up dreaming of people who were complete strangers and I knew nothing about what they were doing in the dream or why I was there.  It made me wonder if the vaccine was having some effect on my brain.  I also woke up at least 8 times during the same night with my mouth so dry it almost had no feeling in it.   Neither of these events has ever happened to me before.  I don't dream about strangers and I don't wake up so frequently needing water.  So I don't know what to attribute it to except the vaccine since it was the only thing different.  I had a sore arm with the first dose but that was all that happened.
Client states has been feeling a "tightness" in her throat since 8am this morning & "an itchy rash on the under side of the left arm, the same area I got the shot in". Client was encouraged to follow up with her doctor immediately   11/13/2001-Client went to her doctor. He gave her Benadryl & a creme to lessen the urticaria
Flu like symptoms leading to disruption of work schedule. Treated with Tylenol, Excedrin.
No adverse event; an expired dose of ROTATEQ was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, once, lot #1821811 with expiration date: 27-JUL-2022, orally for prophylaxis (strength was not provided) (expired product administered). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had no history of temperature excursions. The patient had no adverse effects or symptoms from this dose (no adverse event).
Fever 104 about 2 hours after vaccination treated with TYLENOL & MOTRIN.  Then patient broke out in a rash with hives on the left leg.  Treated with BENADRYL.
Very sore arm, weakness and dizziness after an hour. Next day, feverish,  body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
After receiving all immunizations, Client was observed to slump to the side. He apparently fainted & was laid back on the table. He was given something to eat as he had reported not eating & his BP was monitored for approx. 30 min. He recovered & was going to leave when he again became dizzy & started to faint. 911 was called & he was transported to the ER.
arm was sore; arm had a rash was red and itchy; arm had a rash, was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was provided.     In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red). In 2021, PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Initial report received on 09 July 2008 from a health care professional.  A 15-year-old male patient, who had no concurrent illnesses, pre-existing medical conditions or use of other medications, had received on 07 July 2008 in the morning a right arm dose of MENACTRA (Lot # U2562AA, route not provided), and a dose of DTAP (trade name, manufacturer name, lot #, route and site of administration not provided).  Overnight, the patient developed "facial symptoms" and was subsequently evaluated by a physician two days later and was diagnosed with facial Bell's Palsy.  It was not reported whether the patient received any treatment, or if any diagnostic tests were performed.  At the time of this report, the patient had not recovered.
I am a 65 yr old post menopausal women  that is now having to deal with MS.  I have had two MS exasperation?s since getting the Moderna COVID 19 vaccination both requiring hospital stays  for a total of 12 days with treatment.
My Upper Respiratory infection started on 04/2023.  I had severe cough, fever, I felt like I was going to faint,  lack of appetite and tiredness. I went to the doctor's office and told him about the symptoms I was experiencing so , he prescribe me promethazine, and a capsule. They called me today 04/24/2023 and told me  that I tested negative for COVID-19 infection.
reaching to put a blanket over a bar to dry after being washed.  Could not reach up high enough as my arm hurt each time I tried, 3 attempts. The bar is in the bathroom over the tub, so needed to reach up over my head.  Could only reach as high as my head with my right arm.  I finally lifted to blanked with my left hand, using a step stool so I could use my right arm as well.    My are was very sore over the next three days and slightly red at the injection site.  Contact my doctor via text message through My Health app.  He said the redness is normal, and to let him know if I have this happen again with my right arm.  This heated once before, a week after my shot I went for my annual breast ultra sound.  My arm hurt as I had to raise it over my head for the ultrasound.  Didn't him much of it at the time as my arm was sightly still sore after the vaccine.  By the time of reporting that week, my arm was not hurting and hadn't thought if it until after I reported in.
In am 11/18/05 by 11 pm localized injection reaction possible allergic response to Fluzone 2" x 3" x 1 1/2 elevation, hard, red, swollen. Intensely itchy hot area around IM injection site. Resolving ecchymosis mild swelling persist.
The pt experienced swelling and redness at site. Swelling approximately 2 cm in diameter, redness was approximately 1 cm in diameter. Gait became abnormal, waddling.
Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.
I had very heavy bleeding approximately 2 weeks after I got the second dose of the vaccine. It was not a miscarriage, because I had my period right on time before and after the bleeding event.
The patient was given DTAP instead of Td as DTAP is inappropriate for her age.
the morning after immunizations was administration (only vaccine given at that time). Child awoke with hives over entire body and fever of 102. Hives and fever for 24 hours and lethargy 2-3 days.
Patient was administered Flublok vaccine instead of Fluvarix vaccine in right deltoid. No symptoms or reactions noted after administering vaccine.