chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was into clinic for dose 2 of moderna vaccine.  Patient reports allergies to Topamax, Macrobid, and gluten.  Patient states that after first vaccine she had tingling in the arm but desires to continue for dose 2.  Patient was given vaccine using aseptic technique to left deltoid at 2:27 pm.  Around 2:30 patient reports that was hard to swallow and tongue was beginning to feel thick.  Vitals signs 116/82, heart rate 100, sats 98% on room air. Around 2:43 vital signs 122/82, heart rate 91, and sats 98%. No shortness of breath noted.  Patient reports that was getting harder to swallow and that tongue was still feeling thick.  Epinephrine was given to left anterolateral thigh via EpiPen and 50 mg Benadryl to R arm.  EMS was activated.  At 2:48 vitals signs were: 128/74 108 98% on room air.  At 2:53 vitals 135/78, heart rate 99, sats 98% on room air; patient reports that "throat still feels fuzzy but tongue feel better".  At 2:54 EMS arrived.  Vital signs per EMS staff were 138/79, 101, and 93% on room air.  At 2:59 with assistance with EMS staff patient was stood up and vitals were 126/90, no hives were noted.  At 3:02 patient refused to be treated via ambulance to ER but will have friend who had accompanied patient to the appointment take her to ER.  It was stressed by all nursing staff and EMS that this is recommended.  Patient never lost consciousness.
The patient received her first COVID 19 vaccine, and was told to wait 15 minutes in the waiting area outside the pharmacy as with all vaccines. They pt then sat in the chair then proceeded to pass out and hit her head on the ground. By the time I paged for help and walked out of the pharmacy, she had come to. The patient slowly gained color back and slowed her breathing and was comfortably sitting up against the wall by the time EMS arrived. She was then evaluated by EMS in the ambulance due to hitting her head.
No AE; The patient states she was also administered an influenza vaccine on 04-NOV-2021, which the patient stated she thought was intramuscular and that it was the same location on her arm the VARIVAX was administered.; The patient states she was also administered an influenza vaccine on 04-NOV-2021, which the patient stated she thought was intramuscular and that it was the same location on her arm the VARIVAX was administered.; This spontaneous report was received from a 46-year-old female patient, who was referring to herself. There was no information regarding her medical history or concurrent conditions provided. Her concomitant vaccination included influenza vaccine.  On an unspecified date in September 2021, the patient received her initial dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, in the back of her upper arm (route of administration, lot # and expiration date were not provided) for prophylaxis. On 04-NOV-2021, she was vaccinated with the next dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, possibly intramuscularly in the deltoid (lot # and expiration date were not provided, the patient was not able to confirm exact location on the deltoid). The patient stated that the varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered in the same location on her arm as the influenza vaccine she received on the same day, and she thought influenza vaccine was administered intramuscularly (incorrect route of product administration, circumstance or information capable of leading to medication error). The patient was not able to confirm the needle size used to administer the vaccine. She stated she has not contacted her prescriber to discuss the situation at the time of the call. No adverse event (AE) was reported.
Immediately after injecting HPV, which was the  fourth injection, client began having jerking movement of upper extremities and was non-responsive for approximately 30 seconds.
Mom report 20sec of body shaking, eye rolling, tongue protrusions one hour after administration of vaccines. Admitted and observed without further events.
On 7/26/07 2-m-old infant received DTaP, IPV, HIB, Prevnar, and Rotateq (lot no. 0503U). On 7/30/07 Mom reported that he had 3 stools that contained blood-striated jelly like material. Was normal the next day.
Patient failed to advise they received a first dose of the Moderna Vaccine on 01/09/2021 at another facility and came into Pharmacy requesting a first dose of the Pfizer. After giving her the dose and submitting to the system we discovered the first dose.
Client presented to clinic on 12/13/21 for a 2nd dose of primary COVID vaccine series. Their CDC vaccination card indicated that she received a Moderna dose instead of the Pfizer pediatric (5-11 y) dose recommended on 11/22/21. As there was an error identified on 11/22/21 where a youth under the age of 12 received a Moderna booster dose (0.25ml) by the same vaccinator, the team concluded this was a similar error and informed the child's mother, that the child probably received the Moderna Booster on 11/22 instead of the age appropriate vaccine. As CDC recommends that a 2nd dose be administered at a minimum of 24 days past the last Moderna dose, the parent was advised to follow up at an alternate clinic for the age appropriate dose. The team assist parent in locating an alternate clinic. Parent reports that child did not have any adverse effects from the first dose administered.
Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who received 0.5 ml first dose of PENTACEL VACCINE (lot C5439AA, expiry date: 29-Oct-2018) once via intramuscular route in the right thigh on 27-Jun-2018 for which diluent used was sterile water. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that the patient was inadvertently injected with PENTACEL that had been improperly mixed with diluent from VARIVAX vaccine. It was reported that there were no signs or symptoms indicating an adverse reaction. 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. Documents held by sender: none.
pt recv vax 3SEP96 @ clinic & devel progressive pain in the proximal lt arm radiating to the neck;pt had pain, erythema & edema;
small hives on my left arm/I started to see them on my stomach, back, legs and my right arm as well; arm was hurting; I started to get itchy/itchy around my lips, my face, arms, belly and back/My whole body was itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 12:30 (Lot number: 331308A) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 21Dec2021 12:45, outcome "not recovered", described as "I started to get itchy/itchy around my lips, my face, arms, belly and back/My whole body was itchy"; URTICARIA (non-serious) with onset 25Dec2021, outcome "not recovered", described as "small hives on my left arm/I started to see them on my stomach, back, legs and my right arm as well"; PAIN IN EXTREMITY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "arm was hurting". The events "i started to get itchy/itchy around my lips, my face, arms, belly and back/my whole body was itchy", "small hives on my left arm/i started to see them on my stomach, back, legs and my right arm as well" and "arm was hurting" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pruritus, urticaria, pain in extremity.  Additional Information: The patient did not receive 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 has not been tested for COVID-19. After 15 minutes of getting the vaccine I started to get itchy. At home my arm was hurting and it was still very itchy. The next day, I was itchy around my lips, my face, arms, belly and back. On the forth day I noticed small hives on my left arm. I thought it was normal but then I started to see them on my stomach, back, legs and my right arm as well. My whole body was itchy, I decided to go to the urgent care (11Jan2022) and they gave me a steroid shot, cream and medicine. I went to see my doctor and he gave me medicine as well, but it work for a little bit. I still have hives on both of my arms, part of my back, stomach and legs. Ae treatment: Steroid shot, banophen, prednisone, hydroxyzine p.  No follow-up attempts are possible. No further information is expected.
Went to clinic at 17:00 on 12/30/00 with arm swollen and red, 4" below shot site, in left arm. Developed shortness of breath and swollen throat. Treated with 1 shot of Prednisone and po X 6 days and Benadryl X 2 days.
Never came back for 2nd dose, due to COVID pandemic; This case was reported by a pharmacist via and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never received 2nd dose of Shingrix due to COVID pandemic, which led to social problem. The reporter consented to follow up. This case was linked with case US2021AMR186082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186082:Same reporter.
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
I received my 1st dose on 02/12/2021. My adverse event started on 07/14/2021. at around 02:28PM. I was experiencing pains in joints and knuckles my right hand is worse than the left. I can't move them or use them. I had a regular check up and I told my doctor about what was happening to me. He did X-ray and told me that wasn't Arthritis. He advised me to take pain killers such as TYLENOL or aspirin. If it gets worse to contact him.
syncope, tingling in fingers. pt hit head when fainted. had dizziness and headache the next day. EMS was called due to hitting head and recommended she be taken in and evaluated, pt refused. next day phone call with pt recommended she be seen by provider due to possibility of concussion pt seemed unlikely to follow thru with that. stated she would rest
pain in kidneys; pain in lungs; body ache and annoyance; body ache and annoyance; fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B2IA) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ENALAPRIL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever). On 08-Apr-2021, RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Medication for the knee (meniscus).  Additional information:Second dose will be administered on 05May2021. Patient experienced fever, "calories", pain in kidneys and lungs. Body ache and annoyance were also mentioned. Patient took Tylenol to treat symptoms. Patient is feeling better now.
p/ being vax 3/98 pt approx 30 days later devel a rash consisting of 15 lesions that were vesicle-like in their appearance
Mother reported swelling and soreness at injection site, he was seen on 2/6/06, had swollen lymph node under R arm no erythema or warmth noted. Had 6 inch tender area on anterior and posterior shoulder. Treated with Motrin 800 mg for pain. Mother reported on 2/7/06 he felt worse and he was seen again. Still no erythema or warmth but TTP in R axilla pain 6/10 given Lortab 5/500 for pain and Prednisone taper.
Woke up with the right eye whiteness covered with blood.  10 days to heal.  This occurred the day after receiving the second dose - March 8.   On March 24, lost vision in the right eye for about a half an hour.
Red, swollen, hard, warm circular welt surrounding injection site.  Nearly 4 inches in diameter.  Did not appear until nearly 24-26 hours AFTER injection.  Nearly a week later, still present, but looks more like a bruise.  Benadryl given.
I have had floaters in my eyes since the vaccine. I started to use  refreshing eye drops on Saturday March 13. I am not sure if the acne cream got in my eye the night before the vaccine. it is called Retin A cream 0.025%. I have also been feeling very weak. I got a B12 injection on my butt for energy(Friday, march 12). My legs feel like they are in pain and the hurt when I walk. I also had a lot of pelvic pain after the vitamin injection. I drank ibuprofen March 14 at night. I woke up feeling very weak. Before going to bed on March 15 I drank Tylenol. I still feel pain in my legs today and now I have lower back pain.
53 yo M with multiple allergies and known "anaphylactic" reaction to the Covid19 vaccine was in clinic for his third dose COVID vaccine (Moderna) on 11/9/21 at 1033.  Per chart records, reaction following 2nd injection included nausea/vomiting, tachycardia, and chest pressure which started 15 seconds after getting the vaccine.  Symptoms required admission to the hospital for 2 days. Other symptoms included occasional chills, mild pruritic persistent rash.  Per patient, his MDs recommended he should get the 3rd dose.   Unknown if he was premedicated.   Approx 10 minutes after receiving the 3rd vaccine 0.5ml dose (lot # 032F21A) in the right deltoid, he developed hives that included intense generalized pruritis and erythematous patchy rash on his arms.  The patient was treated 25mg IM diphenhydramine with no improvement after 10 minutes.  Symptoms worsening and pruritis spreading to lower legs and plantar surfaces.  Additional 25mg IM diphenhydramine was given which totaled of 75 mg IM Benadryl. Patient was monitored for about 2 hours prior to being discharged. Transport called and taken to meet his wife at the front lobby.  At 1115, pruritis had subsided.  At 1140, the pruritis had returned.  Patient was given another 25 mg of IM diphenhydramine.  At 1215, pruritis had again resolved.  Patient feels drowsy, but is otherwise symptom free.  Remained symptom free and was discharged with wife to be driven home.
hives; itching; progressively worse and worse; I can't sleep; itch to the point of swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PREDNISONE. Vaccination history included: BNT162b2 (DOSE:3, lot 301308A), administration date: 08Sep2021, for Covid-19 immunization; BNT162b2 (DOSE:2), administration date: 09Feb2021, for Covid-19 immunization; BNT162b2 (DOSE:1, lot EL3247), administration date: 25Jan2021, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "itch to the point of swollen"; URTICARIA (non-serious), outcome "not recovered", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "itching"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "progressively worse and worse"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that after all the tests and everything, it was found that this is from a reaction from a booster shot. Caller was on prednisone for months, I had 150 allergy tests, the dermatologist did biopsies and came back that it is drug related". "Before and after my booster shot, any medicine that was on, was on years and nothing changed at all. Nothing changed with the allergy test as well and Caller concluded that it is Pfizer-related. reported her condition getting "progressively worse and worse and that the "itching is all over and is starting to affect her sleep. I can't sleep, the itching goes from here to there. "I itch to the point of swollen; they come and go to a different area". It is so bad on the outside, they start to itch and it is affecting my life. reporter added that nobody knows what to do" and asked what kind of doctor would help? My internist said that this is nothing except Pfizer booster-related. added that she read on internet people had this reaction but mine is not going away.  Follow-up attempts are completed. No further information is expected.
My son was given the H1N1 nasal mist on Oct. 14. On Nov. 3 he was diagnosed with H1N1 type A flu by his doctor.
PT REPORTED ARM SWELLING, REDNESS, TENDERNESS AFTER PNEUMOVAX. STARTED NIGHT OF VACCINE, HAS GOTTEN SOMEWHAT BETTER THE NEXT DAY, PT USING IBUPROFEN AND COLD COMPRESS. TOLD HER IF IT GETS WORSE AND NOT BETTER TO BE SEEN BY MD.
No adverse reactions reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State).
Patient reports that arm had red patch of erythema that evening from shoulder to elbow. Today (day 2) arm is swollen, red, warm to touch and painful.
TESTED + FOR COVID ON  11-4-21 AND 11-9-21 AND DECEASED ON 12-11-21 AT HOSPICE
Pt recv vax on 10/28/98; on same day pt exp itching at vax site, nausea,sinus swelling, hard to breath,eyes swelling, red rash on upper torso,achy,headache, fever &chills.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On 07-FEB-2017 the patient was vaccinated with an expired dose of VAQTA, intramuscular, (anatomical location, dose, frequency, and strength were not provided), lot# reported as L003196 and expiration date 06-FEB-2017 for prophylaxis. No adverse effects were reported and not product quality complaint was involved. Additional information has been requested.
fatigue; limb discomfort; pain in arm; pruritus; rash; urticaria; This case was reported by a consumer and described the occurrence of fatigue in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Twinrix. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria. On an unknown date, the outcome of the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria were unknown.   It was unknown if the reporter considered the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria to be related to Boostrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria after receiving a dose of Boostrix and a dose of Twinrix. No additional information was provided.
redness, heat, swelling at vaccination site, myalgias, objective fever, diaphoresis
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose improperly stored PROQUAD (lot # M001150 with expiration date 05-JUL-2017; recombinant human albumin (rHA), lot # M019233 with expiration date 17-OCT-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 5.5 degrees Fahrenheit for 4 hours and 45 minutes and 24.8 degrees Fahrenheit for 15 hours and 40 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2nd of 2 shots of shingles vaccine, recombinant zoster, RZV on the afternoon of August 5, 2019.   On the morning of August 6, 2019, chills,  fever and headaches started.  These continued through August 8th.  Site of injection, left arm, swelled and got very red and very hot and itchy.  Redness spread and covered upper arm.  Went to the doctor on August 8th in the afternoon.  Doctor examined and outlined the redness with a marker.  Still had a temperature.  He diagnosed Cellulitis and prescribed Keflex for 10 days.  He advised that if anything changed such as more fever or redness continued to grow even slightly, I was to go to the emergency room immediately.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 22Jan90 PT EXP PAIN AT SOI SIMILAR TO PRIOR INJECT.
On the evening of 04/01/2021 I noticed a sudden itching sensation in my right arm and when I scratched it discovered the area to be swollen.  Upon self examination I found the area be swollen in a disc shape approx 3 inches across and 1/2 to 3/4 inches deep. It is feverish to the touch.  This is a sudden presentation.  The area was not swollen or feverish earlier in the day.  An online searh found tht 'Covid arm' seems to describe the symptoms and I intend to take Tylenol if necessary.