chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore in and around immediate area of injection site of left arm. Was unable to put any pressure on the arm in that area the night of 4-21-2021 and 4-22-2021. Soreness subsided later in day on 4-22-2021 and was able to conduct normal activities without any pain/soreness.
Schedulers notified RN pt complaint of difficulty breathing. She had been sitting in waiting room for about 15 minutes post Pfizer COVID vaccine.  Upon assessment, pt stated difficulty breathing and "heaviness in chest." She stated this "felt different" from anxiety. She was taken to an exam room for further monitoring.  Pulse taken and WNL.  Clinic Response Team was called.  Pt was given water. She denied any other symptoms or worsening of current one.  After about 10 minutes, pt stated feeling better.  CRT arrival, EKG was performed and abnormal when compared to previous EKG from 5 years ago.  Recommendation was given for patient to have further evaluation in ER.
On 22 MAR 2007 we received from Vaccine information Service the following information: A male patient, born on 4 Oct 1962, was bitten by a dog and received therefore a post exposure regime of RabAvert (date and batch no. unknown). Later (interval?) he developed symptoms of ankylosing spondylitis, had increased RNP antibodies titre and his ANA was elevated. His blood sedimentation rate was elevated to 26. No further information available. Company assessment: Seriousness criterion: medically significant. Causality: not related.
Pt received Shingrix on 2/24/2023, woke up with fever and stayed in bed on 2/25/2023. fever subsided. pt presented to pharmacy on 3/2/2023 with injection site swelling, redness, heat and some slight swelling under the left arm. explained to pt these we most likely just typical injection site reactions
Racing heartbeat, chills, fever, joint pain, muscle pain, fatigue, weakness, nausea, headache.
1. Shot administered on Wed. 2. Thursday - dizzy - low fever by evening, very cold. 3. Friday am fever - dizzy - feeling faint. Friday by 12:00 very cold - lost use of right leg, use of leg did not fully recover until Sunday, still feel lightheaded.
Chills, muscle pain, headache, fatigue, dizziness, weakness 8 minutes after shot, anaphylaxis 1.5 hours after shot.
child received a dose of Pentacel without the DTaP IPV portion, and the Hib portion was reconstituted with sterile water, no AE; Initial information received on 17-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four month old female patient who received a 0.5 ml once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AAA and Exp. Date 22-Jan-2022) via an unknown route in an unknown administration site on 12-Jun-2020 for prophylactic vaccination, without the DTaP IPV portion, and the HIB portion was reconstituted with sterile water (ActHIB Lot number- UJ217AA, DTaP IPV Lot number- U6540AA,) (product preparation issue). The reporter also mentioned the child was a little behind schedule and was in for their month 4 immunizations.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ (PCV) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient states sharp pain in deltoid muscle that occurred 2 weeks post shot and is present when muscle is activated.
Anaphylactic reaction; Erythematous rash on her LEFT arm that extended to her finger tips; Erythematous rash / which was mildly painful; This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), red rash and painful rash. On an unknown date, the outcome of the anaphylactic reaction, red rash and painful rash were unknown.   It was unknown if the reporter considered the anaphylactic reaction, red rash and painful rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced a erythematous rash on her left arm that extended to her finger tips which was mildly painful. This occurred 3 days after receiving Shingrix in her right arm. She did not receive any other vaccines. It was unknown if she had other symptoms consistent with an anaphylactic reaction.
On 1/07/2022-1/09/2022 I had significant swelling in my left armpit and fatigue.  The fatigue remained for two weeks.  Then on 1/20/2022, I had swelling in my gums, which progressed to my ear.  I went to the dentist and then primary care on 1/25/2022 when I was diagnosed with shingles on the mandibular branch of the trigeminal nerve.  On 2/10/2022 I had to go the Emergency room as my right facial muscles were paralyzed.  I received a Bells Palsy diagnosis secondary to my shingles then.  On 3/3/2022 I had an MRI which confirmed the Bells Palsy is still present.
THAT NIGHT, STARTED FEELING: LIGHTHEADEDNESS WHEN WALKING AND STANDING UP, DIZZINESS AND GENERAL MALAISE. FOLLOWING DAY: FEVER OF 103.2, CHILLS, SEVERE HEADACHE, BODY ACHES AND INCREASED DIZZINESS AND LIGHTHEADEDNESS.  TWO DAYS AFTER IMMUNIZATION, HIVES AND RASH THROUGHOUT BODY, EYEBALLS WERE PAINFUL; FOLLOWING WEEK: INTENSE ITCHING ON THE SOLES OF FEET AND PALMS OF HANDS.
30 minutes after injection developed urticarial reaction to upper arms, chest, neck, ears, and legs. No angioedema or respiratory involvement. Treated in vaccine clinic with 50mg oral diphenhydramine and 40 minutes of additional observation. Symptoms began improving 20 minutes after diphenhydramine administration .
This may have already been reported by ER.   Patient went to ER 30 minutes after receiving her COVID vaccine due to a tightness in her neck.  Epi administered & patient received Rx for epi pen. No previous anaphylactic reactions.
Pt. had red, hot lump on L and R thigh where vaccines were administered. R side of face was red and swollen.
Pt called and complained of persistent arm pain - said she went to see provider in ER and he/she said it may be nerve related.
Swelling in arm moving to wrist then to the ankles with joint pain also nausea and vomiting.
Vaccination was given high in the deltoid muscle which resulted in left arm and shoulder pain with decreased range of motion for 2 weeks.
Case number PHEH2011US01891 is an initial spontaneous report received from a health care professional (medical assistant)on 17 Aug 2011. This report refers to a 12 year old male patient. He was vaccinated with MENVEO 0.5 ml, intramuscularly on 17 Aug 2011, which was stored out of range temperature during shipment on 17 Aug 2011. No adverse event was reported following the vaccination.
Not sure which influenza vaccine i received, but got it at same time as covid booster (previously vaccinated with J&J vaccine). Following day had body aches and chills. The day after that I had swollen lymph nodes under left arm and swelling in that armpit as well. Still painful and swollen today, but possibly decreasing in both pain and swelling.
This is a spontaneous report from a contactable other health professional (patient). A 24-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 10Jan2021 14:45 (at the age of 24-years) as 2nd dose, single for COVID-19 immunization. The patient previously took first dose BNT162B2 Lot Number: EJ1685 via intramuscular route, administered in arm left on 23Dec2020 10:30 as 1st dose, single for COVID-19 immunisation. Patient not pregnant at the time of vaccination. The patient medical history was not reported. The patient had allergic to augmentin. Concomitant medication(s) included Zyrtec, Vienva. The patient received the most recent COVID-19 vaccine at Hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Jan2021, the patient experienced fever of 102, body aches, chills, lymph node swelling under left arm and headache all lasted 24 hours. The patient did not received any treatment for the events. The outcome of the events was recovered on Jan2021. The patient underwent lab tests and procedures which included body temperature: 102 on 11Jan2021. Seriousness reported as non-serious. Follow-up attempts are completed. No further information is expected.
Post vax, the pt developed a fever of 103 for 5 days. Constant screaming, toe walking, finger flicking, biting hand, slapping head.
Muscle aches on and off all day the day after. Arm sore at sight of injection just the day after.
overnight - headache, joint pain (hip), occasional hot flashes following morning/afternoon - achy feeling, continued, headache, occasional chills, slight temp 100.2 for brief period Felt better by 5pm on 12/13
Pt reported rash on her left left arm within 24 hours of Fluzone HD administration (10/12). She took one dose of cetirizine for some improvement, but presented at pharmacy 10/14 with distinct erythematous patches on her left arm, near and below injection site. No reports of itching or pain. No chest tightness or wheezing according to patient. I encouraged her to monitor and continue cetirizine daily and I would follow up with her on the weekend. Left a message with her on Sunday to follow-up, she returned phone call today, 10/20/21. Redness is still there, but looks better than onset.  She mentioned she had a non-related PCP visit earlier this week, and PCP was not concerned.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable), PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis), FATIGUE (tiredness and fatigue) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. Concurrent medical conditions included Degenerative joint disease and Seizure. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis) and FATIGUE (tiredness and fatigue). On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable). On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (sore arm for a couple of days no other reaction it wasn't extremely sore nor unbearable), PAIN (has a degenerative joint disease and has pain in her neck and right shoulder), ARTHRALGIA (bad pain on her knee which has arthritis), FATIGUE (tiredness and fatigue) and FATIGUE (tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Events were resolved and consumer consented to follow up via phone.
Systemic: Allergic: Anaphylaxis-Mild, Additional Details: PATIENT EXPIRIENCED BRUSHING AND ITCHINESS NEAR THE INJECTION SITE AND ON FACE . PATIENT ALSO EXPIRIENCED NAUSEA. PATIENT SAID SYMPTOMS ARE GETTING BETTER. REFER TO SEE DOCTOR OR COME BACK TO PHARMACY IF ANY OF ABOVE MENTION SYMPTOMS GET WORSE
took to ER 11pm 12Sep94; could not comfort pt; no T; no s/c ER MD dx as rxn to vax; not to have any more pertussis
Racing heart, tingling around my mouth after about one hour of receiving the vaccination. Then felt light-headed. I actually prepared myself to advise a co-worker that I may need 911. About 4:00 PM, a hard, white, large mucous developed in the corners of my eyes and that continued for 24 hours. Achy muscles developed in the evening. Woke up in the middle of the night with pain in my head, pain in my mouth area/jaw and was very weak. I felt I may have had a fever but did not look for a thermometer to take my temperature. I stayed awake for several hours and during that time, the pain reduced tremendously. Fell back asleep and woke up at 6:30 AM feeling great except had the hard white large mucous in the corner of my eyes. The eye mucous reduced and disappeared about lunch time. I took no pain medication during that time. I hadn't received a flu vaccination in about 10 years previous to this vaccination. I'm thinking I will not get another vaccination. Thank you.
pericarditis; shortness of breath; heart palpitations; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included protein (whey protein isolate); multivitamin [vitamins nos]; vitamin d3. The patient experienced pericarditis, shortness of breath, heart palpitations, chest tightness on 16Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the adverse event included indomethacin and colchicine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) with Nasal Swab was negative on 17Apr2021; negative on 21Apr2021. The outcome of the event pericarditis was unknown, the outcome of the other events was not resolved.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Chills starting evening of 8/8  lasted for around 2 hours Nausea starting morning of 8/9 intermittent. Sore from shaking with chills.
Received first dose of Pfizer vaccine and began to feel flushed and light headed. had not eaten. Blood sugar 59- given snack and EKG completed- normal. B/P 169/106. Went to ED patient has a history of borderline hypertension. LIP discussed need to exercise, no salt diet, and recommended an antihypertensive medication to be discussed with PCP.  Patient remained asymptomatic during time in ED, discharged in stable condition.
Prolonged vaccine symptoms Received the J&J vaccine on the afternoon of 4/12/21 and by 6pm the same day, I started feeling dizzy/headache From 4/12/21 until midway through the following week I had a chain of symptoms starting with headache and fatigue and dizziness progressing to body aches, nausea, and continued fatigue through Wednesday the following week. Finally my symptoms let up after 1.5 weeks. I'm fine now, but my symptoms seemed to stay around a lot longer than the 1-3 days generally reported. I've never had any symptoms from the flu vaccine or any other vaccine I've ever received in my life.
Information has been received from a registered nurse concerning a 32 year old female who in September 1972, was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The patient was administered another dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live 29Sep1989. On 01JUN2003 the patient failed to seroconvert and the patient's immunoglobin G index was negative. Additional follow up information from the registered nurse stated that the patient "failed to seroconvert after two doses". Additional information is not expected.
Diagnosed with Guillain Barre Syndrome  Hospitalized from 1/21/2021 through 2/24, discharged to long term care facility 2/24
Rash, itching, hives, burning, soreness. Hives began 1/10/2000, no resp sx. Urticaria confirmed by allergist and dermatologist.
The morning after receiving vaccine I woke up & could not move my injection arm without extreme pain. The movement mostly returned after a week or so, but the pain continued. Made appointment with orthopedist on 7-28-11, started physical therapy 8-3-11.
Posterior neck & post head pain, generalized aches & rash on neck & face; completely resolved in a couple of days;
Body aches, low grade fever, swollen lymph nodes (neck and behind ears), joint pain/stiffness, followed by a generalized rash 2 days later.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. This case is for twenty-one patient out of 77 patients reported. No concomitant medication information provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Patient stated that on the day of the vaccine she notice that her left eye got heavy and started twitching. Patient went to the Dr. On 8/5/2021 and was Diagnosed with Cerapasly.  Patient is request a call back in regards to getting the second shot.
PATIENT IS 17 YEARS AND 5 MONTHS OLD WAS ACCIDENTALLY GIVE MODERNA COVID 19 VACCINE WHICH WAS INTENDED TO BE GIVEN TO 18 YEARS OLD OR OLDER DUE TO RUSH HOUR. PATIENT EXPERIENCED NO ADVERSE EVENTS DUE TO THIS ACCIDENT.
Mr arm And injection site hurt for a few days and then from that spot my arm got numb and the pain spread to my chest on the left side.  It felt like nerve damage and felt like when an arm falls asleep And starts to awake.  My family worried I was having chest issues and went to Urgent Care for a ekg which was fine.  I knew it was from the shoe because the pin spread from the injection site and my left arm and chest felt numb and like nerve issues.  It?s not a month later and I still can feel the nerve issues but not as bad.  Went to doctors and waiting on blood work .  Maybe an autoimmune Response since I have an auto immune condition?
BREATHING EFFECTED; LOW MIGRAINE; ARM EXTREMELY SORE; 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. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced breathing effected, low migraine, and arm extremely sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing effected, and low migraine, and had not recovered from arm extremely sore. This report was non-serious.; Sender's Comments: V0:As per protocol, MAC comment is not required for non-serious case
Flushing, flushed red hot face,  swollen red hot ears, fever, severe headache, gastrointestinal symptoms, brain fog, backache
Patient received Boostrix vaccine in left deltoid on 6/20. Administration was uneventful. Patient did not wince or complain of any pain during administration. Patient called pharmacy around 10:30 Sunday morning 6/25 saying that she received a shot on Tuesday, but this morning when she woke up, she stated that she could not move her left arm. She said she had to use her right arm to lift her left arm. She also stated she had a bad headache and the pharmacist on duty noticed that her speech was more slurred than usual. The patient was home alone. Pharmacist was concerned that patient may have been having a stroke. When patient didn't answer return phone call, pharmacist contacted someone for a wellness check. EMS went to the house and pt. refused medical care. Pt. called the pharmacy on 6/27 to request refills. When I asked how she was feeling, she said " I feel great". I specifically asked about her arm to which she said " I did a lot of housework yesterday and it worked the pain out",
I AM SUFFERING FROM UPPER ARM AND SHOULDER PAIN ALONG WITH LIMITED RANGE OF MOTION ON MY LEFT ARM WHERE THE VACCINE WAS ADMINISTERED . I CANNOT MOVE MY ARM IN CERTAIN POSITIONS. WHEN TRYING TO MOVE MY ARM IT SHAKES AND THE PAIN CAN BE INTENSE, ESPECIALLY IN THE MORNINGS . I HAVE TO NOW SLEEP WITH A PILLOW UNDER MY ARM .
Initial report received from a registered nurse on 26/Oct/2005. A nine month old female infant developed a red flat rash on her stomach that spread to both upper and lower extremities to below the elbow and knee, three to four hours after receiving the intramuscular injection of Fluzone, lot number U1743HA in the thigh on 14/Oct/2005. As per reporter the mom stated the rash lasted 24 hours and then disappeared. Mom denied fever or pruritis. Patient recovered. Follow up information received from a health care provider on 23/Nov/2005. The patient was not seen by a physician, and the patient did not require treatment. The rash was gone within 24 hours. Further information is not expected.