chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Notice reaction redness/swollen on 01/26/2010. (L) Deltoid (KINRIX). Today notice 43mm x 43 mm rashes. Advised to apply ice and BENADRYL to reduce swelling.
This case was reported by a healthcare professional (also the subject), via a GSK representative and described the occurrence of injection site redness in an adult female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  No information was available regarding concomitant medications, medical history or any adverse events following previous vaccinations.  Concurrent vaccination included TWINRIX, (GlaxoSmithKline) given in August 2009.  On either 24 August 2009 or 25 August 2009 the subject received one and only dose of BOOSTRIX (unknown route, left arm).  In August 2009, less than one week after vaccination with BOOSTRIX, the subject experienced injection site redness and swelling injection site.  It was described as a "fairly large" diameter around the injection site.  At the time of reporting the outcome of the events were was unspecified.
Since the first shot, I haven't had a regular or normal period. I've had 3 maybe since the first shot almost 2 years ago. They were so light they were mostly just spotting lasting only 2 days. I haven't had anything now in almost 6 months.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
In addition to the expected flu-like and ISR in the R arm,  L arm painful, very itchy, scaly rash noticed on day 2--still persisting with cracking and peeling on day 5; fatigue still requiring daytime sleeping after a few hours of being up; R arm rash was a very faint pink but swelling and pain is persisting Symptoms that resolved by day 3 are sharp toe pain, flank pain, and pain with deep breathing
This was patient's first time receiving the flu vaccine. Pharmacist asked patient to stay for 15 after shot to make sure patient did not have an allergic reaction. Patient states several hours after getting the flu shot she experienced hives all over body and face was warm to touch. Patient was told to take BENADRYL which help alleviate symptoms but not completely. The following patient still had hives and was told to take ZYTREC. Patient stated did not have any trouble breathing.
After receiving the vaccine with in minutes the patients left arm began to swell and bruise.  He began to become pale and his eyes rolled back into his head and passed out.  He woke up a min later and had SOB.  Very pale and almost threw up.  Paramedics and Firefighters were called.  The eveulated the patients and gave him a liter of sodium choride.  His Heart Rate was in the 30's.  After several min and a liter of fluid, patient was alert.  Once stable he was transported to Hospital.
Per hospital report "Administered live vaccine, MMR, two weeks after pt received live vaccine, (varicella vaccine). It should have been a minimum of 28 days between administration of two live vaccines."
"Covid arm". Swollen, red, hard, hot and itchy at injection site 9 days after vaccination. Applied hydrocortisone and took benadryl before bed. As of today only symptom remaining is itching.
Severe allergic reaction with redness, severe itching, and soreness of left arm from elbow to injection site in upper arm. Lasted for about 5-6 days. Took Allegra per doctor's advise.
got GBS; Near death experience; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria disability and GSK medically significant) and near death experience (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and near death experience were unknown.   It was unknown if the reporter considered the guillain barre syndrome and near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that 5 years ago from flu shot, the patient was permanently disabled as the patient also got guillain barre syndrome and nearly died. The patient had been having vaccine for many years as was in food industry and was the law.
Information has been received from a registered nurse concerning a 5 year old female who on 06/04/2001 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 06/05/2004 the patient developed 3-4 hives on her leg near the injection site.  On approximately the 6th or 7th of June the parent called the doctor's office and was advised to give the child Benadryl.  Subsequently, the patient recovered from the hives on her leg.  No further information is available.
Initial information received from consumer on 17 AUGUST 2012. A 31-year-old female patient, whose medical history and concomitant medication was not reported received dose of ADACEL (batch lot number and dose not reported) intramuscularly on 27 JULY 2012. The patient stated that she was pregnant at the time of vaccination with date of last menstrual period 29 JUNE 2012 and estimated date of delivery 05 APRIL 2013. Also the patient experienced low grade fever and small lump  under the skin on upper left arm which was hot to touch for a week on unspecified date. Laboratory details and corrective treatment was not reported. Outcome of the event was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 28 JANUARY 2013. The patient had no illness at the time of vaccination. The patient had received ADACEL (lot number: C3828AA) in left deltoid on 27 JULY 2012. "The patient thought that she was not pregnant at the time of vaccination".
3/7/13 - developed bloody stool, U/S negative, bloody stool increased, air enema diagnosis of intussusception but not successfully reduced. 3/8/13 - Brought to OR for reduction.
Adverse event: PT abruptly felt lightheaded approximately 14 minutes after receiving Moderna COVID vaccine at 1235. PT lowered herself to the floor to lay on her left side. PT presented with pallor and diaphoresis. RN responding called for aid at 1249, aid arrived at 1251. SPO2 was 97% on RA. PT reported a history of syncope, especially after injections, denies significant medical history and was unsure of baseline BP. EMTs prompted PT to sit in chair, PT was able to rise without difficulty, but continued to c/o 'lightheadedness'. EMTs provided education on vaso-vagal response, provided juice and water to PT. PT reported feeling "stable, but a little warm" and then reported increasing nausea. PT provided emesis bag and chose to lay down once again, reporting that she felt better laying down. At 1304,  PT reported that her nausea was resolved, and that she felt 'normal'. Denied vision changes, vertigo when moving head side to side. Color improved. EMTs medically cleared PT at 1313 to be driven home by husband.  Treatment: Juice and water were provided, EMTs assessed/treated (Vitals at 1250: Bp 100/P laying, HR 106, SPO2 97% RA. 1255: BP 100/P sitting, HR 92, SPO2 99% RA. 1303: BP 96/52 laying. 1308: BP 102/60 sitting). Pupil check at 1300 WNL, PT declined CBG check. Education provided on s/s to watch for, when to seek medical care provided by RN. Outcome: PT was medically cleared by EMTs at 1313, driven home in private vehicle by husband. HCP Responding: RN, EMT, EMT, RN
This spontaneous report as received from a physician via a field employee refers to a 68 year old male patient. On 06-FEB-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported). On 11-NOV-2014, patient sought medical attention at the office of the physician for a unilateral rash on his right side that started at his back "sort of midline" and came around the front, "consistent with shingle". Unspecified antivirals were given for the adverse event. No lab diagnostics studies performed. The outcome of the event was unknown. Additional information is not expected since the reporter refused to be contacted.
Breakthrough COVID case: sore throat, no fever, mild head cold symptoms. Tested positive on 06/13/2022. Administered PAXLOVID on Monday, 06/13/2022. Tested negative on 06/17/2022 using antigen self test.
Hubby and I got a sore arm; Hubby and I got / some tiredness for a couple of day; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and experienced sore arm and some tiredness for a couple of days. At the time of reporting, the patient was fine and it was a time for patient's second shot. The reporter stated that they do not want to get shingles. No other information was reported. This case is linked to case US2021AMR151468, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151468:Same reporter
Severe skin rash, started evening of vaccination, first on my back, then arms and legs, lasted 6 weeks
Fever, headache, severe chills, whole-body fatigue--24 hours painful, red area at site of injection, measuring approx. 6"x8", hot, tender and swollen--2 weeks
Pt recvd HIB/DTP & devel irritibility, fever to 100.8R, uncontrollable screaming x 1 1/2hs;
Mom called us to report that child had both feet swollen and red from the toes to above the ankles. Child also complained of his feet itching. This was on 01-11-2018. This nurse suggested BENADRYL and TYLENOL. The morning of 01-12-2018, the swelling was down and the redness was decreased. The itching went away with one dose of BENADRYL.
25SEP98 child had sz in family care EMT's notified & transported to hosp;on admission T103.3;all lab test negative UA negative;no signs of infect released to parents a few hr later;
Pt recvd vax & pt eye was not normal; rx'd w/erythromycin ointment for poss conjunctivitis; 6APR office visit, lt eye swollen, pupils equalized & reactive; no nodes; dx ptosis; 29APR parent states dx encephalitis; 3rd nerve cranial palsy;
Left deltoid about 5x4" erythema, induration at site of DTap immunization.
body aches; Fever; A lot of Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (Fever) and CHILLS (A lot of Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (body aches), PYREXIA (Fever) and CHILLS (A lot of Chills). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), PYREXIA (Fever) and CHILLS (A lot of Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
approx 15days p/vax pt exp general rash w/26 lesions on chest & back. treated w/valtrex.
On 06-24-15 when patient woke up she had a 6 inch red swollen area at the injection site. Throughout the day she developed fatigue with body aches in her left arm, left shoulder, back of head, neck, and down her back. The body aches developed into a burning sensation like a sunburn. The body aches and burning sensation has worsened each day and remains present today. The local reaction at the injection site was gone by 06-27-2015.
Patient said she had a severe migraine headache so intense that she could not get out of bed. She tried her migraine medications (imitres and buprenorphine-( not filled here). She also had arm swelling and redness.
Reddened area about 2 inches in diameter at injection site.  This occurred almost 2 weeks following immunization.  Site was itchy and slightly warm.
pt recvd 1 dose of vax & 23 hrs later exp vomiting which lasted approx 6 hrs;
Flush, malaise, fatigue, slurred speech, insomnia, slowing of cognition and arm soreness approximately 1 hour, post vax. Symptoms worsened and pt returned to ER approximately 24 hours , post vax. Symptoms cleared over dates 5/4/00 to 5/11/00. Released on 5/5/00 (same day) from ER. Vital signs stable and afebrile.
upper arm area oval shaped about 3 inches..(area of vacc) firm, red, very itchy, slightly warm to touch... using topical Calagel or Caldryl with relief... Zostavax (merc)
Symptoms of bilateral buttocks pain with sitting started December 10-11, although the left seemed worse at times. Muscular pain/soreness. Within a few days bilateral legs, predominately the thighs became sore, painful, and easily fatigued. Over the next few weeks this worsened to the point where I sought medical care from my physician. I felt unsafe going up down stairs and standing prolonged periods of time as well as sitting (particularly in the car was hard, although sitting in general was difficult). I am a home care physical therapist so my occupation involves sitting in the car driving to patient homes, standing/walking providing treatment and performance of steps within patients homes or to get inside. I was taken out of work due to this issue. I saw my primary care 1/5/22, saw neurologist the next day on 1/6/22. I have not yet returned to work.
Member received Moderna vaccine x2 as well as a Moderna Booster 6 Dec 2021.  Noted dermatographic, intensely pruritic rash throughout the body starting 10 days after vaccination.  Also noted occasional angioedema of L hand.   Patient states he has had two separate reactions to the Moderna Covid-19 Vaccination.  The first occurring after his second dose and the next occurring after his booster.    Patient was seen 22 Dec 2021 in clinc  and later that night, after eating chili at home, he noticed swelling of the lips and cheeks.  Patient visiting the ER again where a new set of steroids was prescribed and a EPI Pen was prescribed as well. Patient denies ever having dyspnea or problems swallowing, never used epi pen.
Case number PHEH2014S013548, is an initial spontaneous report received from a nurse on 02 Jul 2014 with a follow up report received from the nurse on 04 Aug 2014. This report refers to a patient of unknown age and gender. The patient was administered only the Men CYW-135 liquid component of MENVEO (batch number: A12027) intramuscular on an unknown date during the last year fall. No adverse event was reported. No further information was provided. Follow up report received from the nurse on 04 Aug 2014: The patient received the vaccine during last year fall season.
1/27/21: went to bed very tired... 1/28/21: fatigue, body aches, pronounced shortness of breath... 1/29/21: shortness of breath continues resulting in minor cough; fatigue and body aches abated... 1/30/21: shortness of breath and minor cough continues; developed mild GI symptoms (loose stools and nausea); developed mild raw throat and congestion... 1/31/21: mild shortness of breath (beginning to abate), continuing GI symptoms, raw throat, congestion; brief area-specific headaches; nausea abated. Temperature was not taken the first two days as I was already taking Tylenol (fever reducer) for other symptoms; temperature taken final two days, no fever recorded. 2/1/21: symptoms seem to have cleared up, continuation of very mild dry throat, a little coughing.
On 4/4/22 it was discovered that the patient received pneumovax 23 twice. The first time was at her pcp on 2/5/20 and then again on 10/08/20 at Pharmacy. I spoke with the patient about this and she reported no adverse events and did not have any further questions. I left a message with her pcp also.
Racing heart beat that awoke the patient during the night; Headache identical to the one had four hours after 2nd dose; Had a headache four hours after receiving 2nd dose.; Dizzy; Getting winded more easily; Lightheaded; Intermittent palpitations; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8233) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, four hours after vaccination the patient had headache. On 08Apr2021 at 1:00, the patient had a racing heart beat that awoke the patient during the night. On 08Apr2021, in the morning, the patient had a headache identical to the one the patient had four hours after receiving second dose. In addition, on an unknown date in Apr2021, the patient continued to be lightheaded and dizzy (not constant, but several times/day). The patient also noticed that she getting winded more easily, which was not occurred before the second dose. It was difficult for the patient to pick things up, that the patient had picked up in the past with ease and not became winded. The patient had intermittent palpitations, but nothing like the racing feeling from the other night. It was reported that, she was a healthy individual who has not been ill and was not on medications for anything and if the symptoms continue, the patient would make an appointment with the doctor. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache (which occurred on08Apr2021) and included treatment with an unspecified OTC but headache did not go away. No therapeutic measures were taken for other events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache four hours after second dose (which occurred on 02Apr2021) was recovered on an unknown date in Apr2021 ; while that of lightheaded and dizzy, getting winded more easily, intermittent palpitations, had a headache identical to the one had four hours after receiving second dose (on 08Apr2021) and racing heart beat that awoke the patient during the night was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient states after about 1 and one-half hours after she left the store she started feeling odd, neck swelling trouble breathing.  She thought her diabetes might be the problem but soon ruled that out.  She was in her car and pulled over and called 911 and was transported to the hospital where she states she was given "shots".
Swollen red arm at injection site 10/30/2003.  Resolved 10/31/2003.  Urticaria started 11/05/2003.
Mother states child had redness& swelling in left arm at injection site on 2/21/05. On 2/22/05 mother states swelling increased, patient complained of itching in left arm and child vomited.
I did wait more than the recommended time for each shot; arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 14th November 2022, the patient received the 2nd dose of Shingles vaccine. On 14th November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. In November 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had his/her second shot yesterday (on the day before reporting) and his/her arm was still sore but getting better. The patient did wait more than the recommended between time for each shot, but it was done. The patient stated that now to not be sore and then get his/her Flu and COVID booster. Additional supportive information: The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
child was given 3 doses of Rotarix /Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 20-JUN-2023, the patient received the 3rd dose of Rotarix lyophilized formulation. On 20-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix /Extra Dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Pt received flu vaccine at Elementary School 11-2-05. 11-5-05 Developed arthralgia, fatigue, temp. 11-8-05 Generalized rash.
I had been having shingles 4 and 5 times a year. In Nov. 2008 I received the vaccine ZOSTAVAX. In October 2009 I broke out with shingles and they lasted 6 wks.
A week later I felt tenderness on my clavicle and discovered a swollen left supraclavicular lymph node still there and tender a week later