chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I  have a history of acute and delayed allergic reactions to food and drugs.  I received Pfizer vaccine at approx. 12:00 Noon on 13MAR2021.  I experienced minor lower lip swelling at 9:30 PM (the lower lip, left side only).  Went to bed approx. 10:30 PM and experienced mild chills.  I woke up at ~3:30 AM with full facial swelling (forehead, brow, eyes, under eyes, facial lines, jowls and full lower lip only - now right side engaged and more pronounced than the left side) and mild full body hives.   I took a Zyrtec.  The itching of hives subsided in approx. 30 minutes.  The facial swelling and lower lip swelling subsided in approx. 12-hours.  I took and have photos of my face and lips.
NO ADVERSE EVENT --I DON'T KNOW HOW TO GET RID OF IT.
Initial report received from a healthcare professional on 09 SEPTEMBER 2013. A 27-year-old female patient had received an intramuscular first dose of ADACEL (lot number: U4612AA, anatomical site of vaccination was not reported) on 09 SEPTEMBER 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 04 FEBRUARY 2013 and the expected date of delivery was reported as 06 NOVEMBER 2013. The patient's health during pregnancy and risk factors (e.g. alcohol, tobacco or recreational drugs) were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: None
1st Day - Extremely tired, Nauseous 2nd Day - Fatigue, Nauseous, Ribs hurt, body hurt 3rd Day - same as day 2 4th Day - felt better 6th Day - Rapid heart rate / anxious 7th Day - Pain in my neck and found large Lymph Node in neck/clavicle 8th Day - Couldn't get out of bed, felt like a truck hit me, Lymph Node still enlarged in neck and also under left underarm.  Went to Doctor she confirmed it was Lymph Nodes - 5 CM in my neck with 4 -5 of them enlarged, and 3 - 4 under my left arm. Also behind my knee 9th Day - Lymph nodes still the same size and very painful, now in my groin area. Still exhausted. Went for Chest X-Ray, negative 10th Day - Still the same, trouble walking 11th Day (today)- Still the same, more pain
Large local reaction, tenderness at injection site, fever up to 101 degrees, malaise, bodyaches and fatigue. She will continue NSAID's, cold compresses, fluids and rest.
Tested COVID-19 positive, resulted in hospital admission. Symptoms included shortness of breath and diarrhea.
Patient reported dizziness, shallow breathing, fever 101 degree F, headache, nausea, severe left arm pain starting 3 hours after vaccine administration seen in ER 5/19/17 and treated for sickle cell crisis.
3 cm red wheal to (R) upper arm.  1 cm red nodule to (L) thigh.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the first of 4 reports. An adolescent patient of an unspecified race, ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 F and swelling all on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256875 same reporter/drug/event, different patient; US-PFIZER INC-2017256876 same reporter/drug/event, different patient; US-PFIZER INC-2017256877 same reporter/drug/event, different patient.
According to the patient, as soon as the needle went into her arm she felt a warm feeling go up her arm, into her neck and up into her head.  She felt dizzy and like her hands had pins and needles, only worse.  She stated that she has had tremors and some of the symptoms ever since.  She has seen a physician who would like to refer her to a neurologist, but she does not see the sense in it.  She stated she feels like the vaccine went into her blood stream.
There is a red rash around the injection site and it itches really bad. It started today on the 22nd of April
Chest pressure and tightening ( banding  around chest) Severe burning in hands and feet ( worsening neuropathy) Fever of 102 Severe aches; flu like symptoms
During vaccine administration pt became  rigid then non responsive, eyes fixed, increased saliva from mouth. Responsive after NH4 inhalant used for 45 seconds. Pt monitored for 1 and one half hrs. Pt complained of weakness-no dizziness. Intially slow in response to commands but gradually returned to normal response. Referred to primary care MD for evaluation.
Administered Infanrix after temperature excursion; Patient with , got Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug and inappropriate age at vaccine administration were 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: Receipt Date: 15-June-2022 Reporter's Comments: The medical assistant reported that a male patient was administered on 31st March 2022 the infanrix vaccine after a temperature excursion. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Infanrix at inappropriate age which led to inappropriate age at vaccine administration. The patient administered with Infanrix that underwent temperature excursions, which led to incorrect storage of drug. This is 1 of 12 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093597:Same reporter. US-GLAXOSMITHKLINE-US2022093600:Same reporter. US-GLAXOSMITHKLINE-US2022093643:Same reporter. US-GLAXOSMITHKLINE-US2022093637:Same reporter. US-GLAXOSMITHKLINE-US2022093638:Same reporter. US-GLAXOSMITHKLINE-US2022093640:Same reporter. US-GLAXOSMITHKLINE-US2022093642:Same reporter. US-GLAXOSMITHKLINE-US2022093644:Same reporter. US-GLAXOSMITHKLINE-US2022093645:Same reporter. US-GLAXOSMITHKLINE-US2022093646:Same reporter. US-GLAXOSMITHKLINE-US2022093647:Same reporter. US-GLAXOSMITHKLINE-US2022093648:Same reporter.
Gave patient a vaccination that expired on 03/15/2022 on 03/24/2022.
his big toe on right foot swelled; This is a spontaneous report from a contactable consumer or other non health care professional (Patient) from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Lot number was not reported ), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included limb injury wound in his leg from shrapnel, pieces of rock. The patient's concomitant medications were not reported.  The patient never had gout. On an unspecified date 3 to 4 days after vaccination, the patient experienced his big toe on right foot swelled. his feet was swollen and very painful, like needles.he never had gout.The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s)
due to lack of availability was unable to get a second dose within the 6 month period.; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix due to lack of availability, within the 6 month period, which led to product supply issue. The reporter enquired if she needed to start over.
Slight itching and discomfort first couple of days, so did not even examine site.  It was noticed a week later when a nurse started to give me my allergy injections in that arm.  There was an approximately 10 cm, slightly warm non-indurated area of left upper arm.
PT FAINTED AFTER COVID VACCINE. PT WAS FINE AFTER A FEW MINUTES AND DRINKING GATORADE. MOTHER WAS PRESENT.
Trumenba on 8/10/20 but they only have Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2020, the patient received the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 was provided as follows: The reporter was an office manager. The age at vaccination was not applicable for this report. The reporter stated that the patient was transferred to them and patient had a 1st dose of Trumenba, but they only had Bexsero on hand, which led to interchange of vaccine products and circumstance or information capable of leading to medication error. The reporter called to inquired about Trumenba and Bexsero series interchange and asked about how could they proceed with Bexsero series. The reporter did not consent to follow up.  GSK Receipt Date: 23-MAR-2021 Case update: The event circumstance or information capable of leading to medication error was deleted from case and narrative updated.
Patient presented to Clinic at 09:31 AM for possible allergic reaction to a TWINRIX vaccination that was administered on 05/23/2016.  Patient was seen by NP who noted the following symptoms: Itchy red raised rash to left (anterior and posterior) torso, and bilateral lip swelling with numbness, no fever, no chills, no recent weight loss, no HA, no chest pain or discomfort, no dyspnea and no cough, no tightness of throat, no SOB, No DOE or wheeze. Patient stated he received a TWINRIX vaccine on 05/23/16 at 15:03 PM and ate dinner that evening.  No other new known environmental contacts/exposures in past week.  Patient prescribed Methylprednisolne 4m dosepack 21 tabs - follow directions in package #21 RFO and Diphenhydramine 25mg oral cap - take 1 capsule by mouth every 6hrs as needed for allergy #28 RFO and to hydrate well (more than usual) and to seek immediate care for any airway/throat symptoms and to avoid scratching.  Patient diagnosis: Allergy, unspecified, initial encounter possible to TWINRIX injection (was paient's last), however could have other dietary or environmental component/etiology.
pt recv vax 28MAY92 & exp thimerosal sensitivity & serious, painful permanent personal injuries;no further details were provided;
Infant screamed uncontrollably for 4 to 5 hours.  03/15/2007 MR received from hospital visit for c/o crying spells following vax which have continued for 4-5 hours.  PE: WNL except for crying vigorously and irritability. Afebrile. Impression:  Crying reaction, likely to pertussis vaccine.  No cardiorespiratory compromise.  No apnea or fever.
Developed a marked rash with mottled skin pigment to left shoulder and pit of my left elbow joint, warm to touch and severe itching. The shoulder rash disappered after a few days, However, I still have the left elbow {pit of elbow joint} rash that disappers and reappears regularly. It is localized to this area and about silver dollar size, Hydrocortisone creams  do help manage the reoccuring rash, but it keeps returning and hasn't spread anywhere else. Humid environments really cause it to intensify. I have head aboutCOVID arm  and looked at online photo's, and the pictures of these reported COVID arm rashes looks exactly like mine. However, COVID arm is only suppose to last no more than a week or two after vaccinations - according to some websites. I have not had any medical testing as of yet, However I do wish to document this occurance should it become a problematic issue for myself or others.
Injection site has a large red rash (something like hives).  As of this date the site has the same rash and now itches.
August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
This could be coincidental to the vaccines, but I had blood work done on March 24 and am now anemic with elevated liver function.  More testing is scheduled.  I had no symptoms of anemia prior to the vaccines.
Approximately 2030 pt developed tingling and pain in her left arm, chills, became anxious and started to hyperventilate. Pt presented to ER with periorbital flushing and swelling and a lot of point tenderness to left lateral deltoid at the site of PNEUMOVAX vaccination. Pt given BENADRYL IM with excellent response.
I have been experiencing Tinnitus in my left ear (vaccination side) since the 9th day after vaccination. The mild ear pulsing feeling comes frequently in a day, and it may last a few seconds every time.
17 YEAR OLD RECEIVED COVID-19 MODERNA VACCINE DENIES ANY SYMPTOMS FOLLOWING COVID-19 MODERNA VACCINATION.  WILL SEE HER PRIMARY CARE PROVIDER, at medical facility TO DISCUSS FURTHER COVID-19 VACCINATION.  DENIES ANY SYMPTOMS FOLLOWING COVID-19 MODERNA VACCINATION.
Left Leg: Mother describes the rash as erythematous and inflamed. Denied aggravating factors. Symptoms were not relieved by antihistamines. Fever (not to exceed 102). Rash became worse "6/23/12 and 6/24/12".  On exam: First Lesion(s) appeared on left thigh pink in color. Approx 8cm. Shape was round "erythema". Mild clearing "less intense" with some bruising noted "at edge of rash".
PATIENT SAID SHE FELT DIZZY AND  HAD SHORTNESS OF  BREATH THE DAY AFTER SHE GOT THE FLU VACCINE. PT WAS ADVISED TO SEEK MEDICAL ATTENTION TO GET IT CHECKED OUT AND POSSIBLY GET MEDICATIONS TO HELP WITH THE SYMPTOMS, SHE SAID SHE WANTED TO WAIT IT OUT TO SEE IF HER SYMPTOMS IMPROVE.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (unspecified if ongoing). The patient took concomitant medications Birth Control (brand=Mylan) from Jan2019 to Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (17Nov2022) Positive, notes: Tested Positive for Covid again 4 days after finishing course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 09Nov2022 to 13Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of itchy, red, raised bumps over entire body except face 28 hr after Flu-Mist dose. Hives were relieved by single adult dose of Tylenol- Allergy medication but itchiness persisted x 1d until given 50mg. Benadryl. Patient denies any respiratory involvement. Hives recurred on 3rd and 4th day with decreasing intensity and released each time by 50mg. Benadryl. No incidence reported for days 5-10. No medical attention sought.
Patient was administered a vaccine of Tdap. Expiration 10/20/2013 and was administered on 11/19/2013.
Pt was administered Pediarix and a separate dose of Hepatitis B vaccine, he should of received Hib vaccine with Pediarix not Hep B.
undetermined/Category II SIDS. baby died in bed with parents. 6/7/06-physical in MD office-no problems noted
pulse low 60 to 80; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 12:30 (Lot number: ew0217) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEART RATE DECREASED (non-serious) with onset 01Jul2021, outcome "not recovered", described as "pulse low 60 to 80". The event "pulse low 60 to 80" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heart rate decreased.  Additional information: Patient not received any other vaccine in four weeks. Patient not had Covid prior vaccination. Patient not tested covid post vaccination. Patient not had known allergies. Patient received other vaccine, same date details included Pfizer, other vaccine same date lot number ew0186, other vaccine same date vaccine date 22Jun2021, other vaccine same date dose number 1, other vaccine same date vaccine location left arm.  No follow-up attempts are possible. No further information is expected.
The morning after the vaccination to the left deltoid, the lymph nodes in the left axilla were swollen and tender.
08/2/02 10:45 AM, mom called health department states child has a rash with little bubbles which appeared late yesterday. Started on both arms and later on legs. Child remains active. No breathing problems. Lives near a private clinic. Take child there if not better after pediatric dose of Benadryl. Has had reaction to vaccines in the past. The follow up received on 1/23/03 states 12/2/02 update mom took son to PMD following 8/1/02 Hib #2 because he had a few blisters around imm. site. Dr. felt they were water blister. His fever was controlled with Tylenol. No other treatment recommended. Blisters gradually went away. 8/2/02 10:45pm mo called H.D. states child has "rash with little buffles" which appeared later yesterday. Started on both arms and later on legs. No breathing problems. Has had reaction to vaccination in the past 3 and 5pm called and left message. 12/02/2002 Update: Mom took son to PMD following 08/01/2002 HiB #2 because he had a few blisters around immunization site. MD felt they were water blisters. His fever was controlled with Tylenol. No other treatment recommended.
Received the second dose of the Pfizer COVID-19 vaccine at 10:00 on 1/9/2021. Woke up that night at 23:30 with shaking, chills, and 104 F fever. Vomited approximately one hour later. Experienced extreme weakness, dizziness, nausea, headache, and mild fever (101-102 F) for 30-36 hours. Took acetaminophen every 6 hours and kept up fluids. Visited UTC on 1/10/2021. Was given stronger doses of acetaminophen and fluids by provider.
Information has been received from a registered nurse concerning a 6 month old male who on 17-NOV-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly.  The patient was supposed to receive PREVNAR.  The reporter stated that this was not a case of product confusion.  It was a mistake due to the fact that they had just received a shipment of Pneumovax 23, which was on the shelf, and during the course of the busy day the patients were mistakenly given PREVNAR.  Subsequently, the patient had not experienced any known symptoms.  Unspecified medical attention was sought.  Additional information has been requested.
Patient was 17 and given 1st dose of Moderna vaccine.  Moderna is not yet approved for patients under 18 years of age.  Therefore the vaccine was given in error.
Patient returned 1/18/2010 to report "allergic rxn to vaccine" administered 1/13/2010. She developed hives over her chest, abdomen, back and bilateral upper extremities on Saturday night, 1/16/2010. She notified her PCP who instructed her to take diphenhydramine as needed. This has helped reduce the rash and relieved the itching. She denies any wheezing, SOB or new onset edema. Today she presents with a moderate hive-like rash visible over her abdomen and arms. Resp exam- no s/s of wheezing, Bilat lungs CTA. Plan- Advised patient to continue diphenhydramine as needed and informed her of possible drowsiness from medication. Also advised to take loratadine 10 mg p.o. daily until hives resolve. Advised to f/u with PCP and to call 911 if s/s of anaphylaxis, including SOB, wheezing occur. Patient agreed with plan and will schedule to see her PCP 1/19/2010.
Case number PHEH2013US018851, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to an 11 years old male patient. Past medical history and concomitant medicaton were not reported. He was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 13 Jun 2013. No adverse reaction was reported following this administration error.