chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I came and got my shot I waited 15 min. but it didn't kick in until that night and I could not lay on it and just kept getting worse then my skin started peeling, now it just feels like there is a knot and a burn mark. Not treated. It still kind of hurts and the skin is still burnt.
Arm a little bit sore; Red rash; A little bit itchy; Bumpy rash all over the trunk of her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little bit sore), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (A little bit itchy) and RASH (Bumpy rash all over the trunk of her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Pain and Shingles (patient thought she had a shingles episode). Concomitant products included SIMVASTATIN for Cholesterol, GABAPENTIN for Pain, VALACYCLOVIR [VALACICLOVIR] for Shingles, LEVOTHYROXINE and TRAMADOL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm a little bit sore), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (A little bit itchy) and RASH (Bumpy rash all over the trunk of her body). On 19-Mar-2021, PAIN IN EXTREMITY (Arm a little bit sore) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (A little bit itchy) and RASH (Bumpy rash all over the trunk of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided for events.
L arm swollen 3 inches above elbow. Blister area about size of 50 cent. Instructed cold/warm compresses. Benadry prn
Infant is 8 months old. Infant is on a modified vaccine schedule as mother has opted out of the HiB, Influenza, and PCV 13 vaccines. Mother wanted only the DTaP, IPV, and Hep B vaccines administered. PHN administered Kinrix as a combo vaccine. Kinrix is not recommended for the infant's age group, however, according to Dr. at the Immunization Branch, the doses of DTaP and IPV count as valid. The infant had no adverse reaction during the 20 minute observation period following the vaccine administration, Mother was called at approximately 3:00pm for notification, however, there was no answer. Left message to return call.
This spontaneous report as received from a medical assistant refers to a 4 year old female patient. On 13-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT) (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010458:
fever, throbbing sensation, redness, hot to the touch, demarkations, swelling
Approximately seven hours after administration, I began to experience muscle and joint pain, as well as approximately six hours of involuntary shivering from feeling so cold (though I was not).
Information has been received from a 62-year-old male consumer with "heart problems" who on Thursday or Friday of last week (20-MAR-2008 or 21-MAR-2008) was vaccinated SQ with a first 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included "heart medication." The patient also reported he received a cortisone injection a couple of days prior to receiving the vaccination. Subsequently, "this weekend" on approximately 29-MAR-2008 the patient reported having a rapid heart beat. Unspecified medical attention was sought. There were no lab studies performed. The patient recovered "this morning" on 31-MAR-2008. There was no product quality complaint involved. Additional information has been requested.
Person is under the age 18 years of age for Moderna, but they were provided the first dose by accident.  Second dose was provided as an using the CDC guidance as an off-label.
Pharmacy Intern gave a second dose of the Pfizer vaccine to a patient. Patient had indicated no issues on her about having any reactions to any vaccines she's had in the past. During her 15 minute observation period, she came up to the counter and complained about feeling nauseous and about to faint. I advised her to lay on the floor and we put her legs up resting on a chair. We put an instant cold pack on the back of her neck and gave her some water. She then felt as if she needed to throw up so we put a trash can next to her and she threw up and instantly felt better. She just wanted to wait out another 5 minutes and then left.
THERE WAS NO ADVERSE EVENT-THE CLIENT WAS DOSED WITH A PEDIATRIC PFIZER DOSE RATHER THAN THE FULL DOSE A 12 YEAR OLD SHOULD HAVE BEEN GIVEN.
Medical alert called. arrived to patient on floor unconscious. LVN who first visualized stated patient fainted. Aroused after 1-2minutes. vitals taken 1025 92/56 73 bpm 99%O2sat FSBG 105 MD present assessing pt.  1030 vitals repeated 119/72 82bpm 99% O2Sat patient Alert and oriented, stated dizziness.  after initial eval, seated patient upright, provided water and juice. then moved patient to chair. cracker provided. pt states dizziness resolved.  vitals 1040 108/72 78bpm 100%O2 saturation.  pt states she feels stable. refuses wheelchair to car. stable to walk, accompanied by mother. reviewed vaccination patient instructions. advised to call 911 if symptoms worsen or any of the listed severe reactions occur. mother of pt stated understanding. pt stable and stated she feels much better. released.
Patient received dose 1 and 2 of COVID vaccine on 2/6/21 and 2/27/21, respectively.  On 8/4/21 the patient presented from home after progressive upper respiratory symptoms that began on 7/28/21.  She states that about a week prior to admission she started having some generalized fatigue with progressively worsening shortness of breath to the point where it is difficult for her to ambulate.  She checked her oxygen levels at home and they were low hence she presented to the ED today for further evaluation.  On arrival she was found to be 82% on room air oxygen saturation.  She had no recent nausea, vomiting or diarrhea.  She stated that she has been occasionally seeing blood in her stools.  She had an EGD April 2021 which showed some gastritis and Schatzki's ring.  She also stated that she had a colonoscopy 2 weeks prior to admission which according to the patient showed some hemorrhoids. Patient was started on remdesivir, Lovenox for prophylaxis of DVT, continued home blood pressure medications, as well as vitamins.  Her inflammatory markers were trended.  Since oxygen saturation deteriorated rapidly, patient was upgraded  and was placed on Vapotherm 40 L 100% with as needed BiPAP.  Patient was continued on IV steroids and remdesivir.  Patient continued to decompensate while on Vapotherm, patient was requiring continuous BiPAP for several days and was unable to be weaned off of it.  Patient's mental status deteriorated as well.  All attempts were made to reach family but had difficulty, supportive care medicine was involved as well.  Her mentation began to further deteriorate and patient began to desaturate on BiPAP, necessitating intubation as per family's wishes.  Further goals of care discussion guarded family patient was made DNR.  Patient's family members came to hospital to see her, noted her again deconditioning discussed poor prognosis.  Patient is then made comfort care as per family.  Patient expired on 8/13/2021 at 4:18 AM.
No additional AEs were reported.  No further information provided.; Nurse called and reported that a patient received an expired PNEUMOVAX 23 today 7/29/2022.; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 29-JUL-2022, the patient received an expired Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# T032761, expiration date: 30-MAY-2022; 1 dose, strength and route were not provided) for prophylaxis (expired product administered). No additional adverse events were reported.
Patient experienced a burning sensation during the injection and 1 month later is still experiencing muscle soreness around the injection site. Has difficulty lifting her arm still. Recommended contacting her primary MD as well as OTC NSAIDs and rest. No swelling or redness around the injection site that she notices.
Fatigue. Onset a few hours after the second shot and  lasted about 36 hours.  The fatigue was similar to that experienced when I had covid19 in March of 2020, but not as intense. Other information After the first shot I only experienced arm soreness in the arm that was injected.  I was donating antibodies to the through about September/October 2020.  I stopped donating for personal reasons, .
Within 24 hours patient developed high fever and loose/diarrhea stools.  Elevated temp and diarrhea continued for four days.  Temps usually at 102.  Tylenol and Ibuprofen alternated every 4 hours to keep temp. down.  Refused to breast feed for first 24 hours.  Infant had similar symptoms after 2nd dose of Rotavirus was administered at 4 monthes.  Symptoms were not as severe and did not last as long.
Pt recvd 1st dose of Hep B vax on 27NOV90 & on 5DEC90 the pt devel a red rash on inner arms, legs, & abdo;
Intermittent Dizziness and vertigo since the day of. Today is the second day.
extra dose of both HAVRIX and BOOSTRIX; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28th February 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th November 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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 details were provided as follows: The reporter stated that, their office had administered an extra dose of both Havrix and Boostrix to the same patient, which led to extra dose administered. No additional symptoms reported. The reporter consented to follow up.
Cellulitis, 6 in x 5 in area of redness, tenderness to touch, warmth on thigh around injection sites. Antibiotics.
EXPIRED VACCINE ADMINISTERED TO FIVE PATIENTS; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered to five subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to five patients was not reported. This report was non-serious.
Contracted COVID-19 within 3 days of vaccine. Doctor prescribed Paxlovid and steroids.
Significant shortness of breath and stridor moderate distress and wheezing. Xopenex 0.63 mg nebulizer was administered which improved pts condition stridor resolved completely.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
45 minutes after injection I felt very strange, this increased to a point where I felt as if I were on drugs. I never take drugs, I was fortunate that my boyfriend had driven me there as I was really out of it. I felt like my brain was disconnected and expanded at the same time. This unconnected sensation went on for hours. I had to stay home as I was so spaced out. At night I lay in bed singing songs that had no meaning and then laughing!  What!  The next day I was still not properly connected and spaced out. I could work instinctively but the more rational part of my brain was not working. A week on I still feel a disconnection in the center of my brain.  The second day I had a slight fever, and by the 4 th day I had diarreha.  I am still not properly 'right'.  I am deeply concerned about getting a second shot, I don't want some kind of permanent brain disfunction.  I want you to know that this is not in any way normal for me. I don;t take hallucinogens, a barely even take aspirin.  My boyfriend thought it was hysterical because he had never seen me like that before. I was babbling on about my internal (now its going into my brain, now its in my feet) and external (look at the river, oh its a house, we're on the road)experiences not able to connect to him at all.   So as you can imagine I am in a quandary about the second shot. I just don't know what to do, and if I have the never to get it. I'm schedule for April 14th.
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog.   2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog.  2:30 thru evening  Face and neck puffy, red, hives & fatigue.
Headache 20/30 minutes after vaccination, continues next day.  Tiredness about 3 hours after vaccination.  Fever, body aches approx 8 hours after vaccination.  Day after vaccination tingling/itching in left hand and foot.   Numbness in left side of face with itching.
This spontaneous case reported by a consumer, describes the occurrence of headache in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 004M21A) for COVID-19 immunization. No medical history reported. On Jan 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient had a headache. Patient treated with Tylenol (paracetamol) on Jan 27, 2021 for headache, at an unspecified dose and frequency. On Jan 28, 2021, headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medication. This case linked to MOD-2021-396060, MOD-2021-396061 (patient link). Most recent follow-up information incorporated: On Nov 26, 2021: Follow-up received contained non-significant information.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210958321, 20210958525 and 20210958993.
Gave a 17 year-old Kinrix instead of boostrix; Gave a 17 year-old Kinrix instead of boostrix; This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 17-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered 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 details were provided as follows: The reporter informed that one of the employees in clinic gave a 17-year-old patient a dose of Kinrix instead of boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case has been linked to US2021AMR262202, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR262202:Same reporter. Pt 1 - 16y/o
Approximately 2 hours later, tachycardia 120-130 bpm for 3 hours. Also, when checked BP 80-90/ 40-50 running concurrently with the tachycardia.
Large, localized reaction 3-4" diameter; red, swollen and warm to touch.
patient was vaccinated on 11/24/06 and later on that day injection site became swollen and red. Over the weekend the redness and swelling increased and patient felt feverish, achy, tired and experienced chills. Patient saw doctor on 11/27/06 and reaction site measured 6 cm. Doctor prescribed the patient antibiotics and antihistamine, gave patient an ice pack, told her to take Motrin, and send her for blood work, which turned out to be fine, no infection was detected. Doctor also forwarded patient to an infectious disease specialist, who said that the patient does not have an infection and experienced an adverse reaction to the Td vaccination. Reaction cleared up in 5-6 days after Td injection and patient completely recovered.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included mycophenolate (ongoing). The following information was reported: immune system disorder/immune compromised, with outcome of unknown. Additional information: Patient is immunocompromised. She is on mycophenolate, and has taken both Pfizer COVID-19 shots. Patient not enrolled in a clinical trial. No follow-up attempts possible. No further information expected.
fatigue, nausea, loss of appetite, on side of shot pain on right side of neck all the way down to elbow.  Lasted for 3 days.  arm pain went away and returned 7 days later at the injection site and lasted for 3 days.  arm pain started same evening as shot.  Also had chills that evening only.  Had itching inside right ear and right ear ringing.  Fatigue, loss of appetite and nausea was present for 2 full days after the shot.
A report has been received from a Pharmacist concerning a 11 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. It was reported that the consumer was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Spiked a temperature of 102 degrees 4 hours after getting the shot.  Had severe chills where my body was shaking.  Next day was down to 99.7 but had to stay on the couch all day due to body aches, head ache, etc.  On Monday (Got the shot on that Saturday) I felt like myself around 10am.
Pain, redress, swelling at injection site. Fatigue, muscle, and joint aches for 2 days afterwards. Swollen lymph nodes in left armpit. Prescribed medrol steroids, ibuprofen and acetaminophen.
2-9-07 Varicella vaccine given. 2-11-07 Temperature 100. 2-14-07 Clear fluid filled blisters on abdomen, back and hands. 2-15-07 Pruritic lesions > 300 (according to mother) from head to feet.
I am sure the staff of the hospital where he received both doses (this was his second dose) do not see a connection between receiving this dose and his death, about 12 hours or less later. I am sure this has not been reported. I am not positive of the time of injection, nor the exact time of death, but it is roughly about 9-11 hours apart. I am not sure he got the right medicine. After the first dose, he complained seriously for a week of arm pain and injection site redness. This dose was easy! according to him. My brother spoke with him about 6 or 7pm that evening. No pain at all, but it had only been a few hours. He collapsed with sudden death at home that evening and was found dead the following day. It was clearly sudden (and unexpected); he had his gym bag packed and ready to go the next morning by the kitchen door. Even at 94, he still went to an exercise class three times a week and was very active. I had seen him exactly one week prior and he was totally fine. I will always be suspicious of this dose of SHINGRIX.
several hrs p/receiving vax c/o chills & fever (temp not taken) today; c/o numbness & tingling in lt arm; no redness or induration noted; equal grip both hands; now has URI-nasal congestion;
Golf ball sized knot under the skin. Painful to the touch, red and purple coloring around the knot. Fever and excessive crying for days following vaccination.
This spontaneous report was received from a Registered Nurse (RN) referring to a 34 year old tobacco user, non pregnant female patient with hypothyroidism, and drug reaction/allergy to codeine. On 26-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R009408, expiring on 07-MAR-2020, intramuscularly, in the right deltoid for prophylaxis (dosage schedule was not reported). Concomitant therapies included levothyroxine sodium, CHANTIX and ORTHO-CYCLEN. On 26-SEP-2018, at the evening, the patient developed pain and swelling at the area of the injection site. The RN stated that the symptoms became worse over the next couple of days and the swelling and pain spread from the injection site down to the elbow. On 27-SEP-2018, the patient experienced a low grade fever. On 28-SEP-2018, the patient was seen in the RN's office. No treatment was given for the adverse events.  No lab diagnostic tests were performed. The outcome of the aforementioned events was reported as recovering. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.
gradual onset of ataxia progressing to encephalitis & sz w/in one month;Annual follow-up dated 10/04/00 states unclear if related to vaccine. Child with encepahlitis is now improving but has developmental delay, has hx of seizure disorder but now off of all meds and no recent seizures.