chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 minutes after injection, I saw white spots and felt dizzy.  The white spots in vision occurred  on and off for the following 24 hours.    Injection  site warm to touch (compared to other arm) but without redness.
Patient noticed 3 papular bumps around smallpox vaccination site that were intensely itchy. Bumps progressed into pustular lesions.
No other AE; The patient received her first dose of GARDASIL 9 and age 12 and didn't receive the second dose until the age of 25.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, when the patient was 12 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided). On 17-DEC-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, one time, lot # U007667, expiration date: 23-MAY-2023 (route of administration, anatomical location not provided), when she was 25 years old, as prophylaxis (inappropriate schedule of product administration).  No other adverse event (AE) was reported.
That night 10PM, I had body aches. The next day it was worst and I had a migraine. I was dizzy since I had the vaccine and I still sometimes feel lightheaded. I had a preexisting head injury and I sometimes I but it got got worse after this vaccine. I noticed that I had 9 inches by 4 inches rash on my left groin and under my breast not itchy, not raised just flat on the left side. My lower back, I had petechiae about 3 inches across. The next day I still had body aches and migraine, the rashes left went away but I had it on the right side of my groin. The next day I still had the migraine. The upper left arm was red, hot, a tiny bit raised and a little itchy - 9 by 4 inches. It keep going on for the rash on the left and today its better but still warm. I did not see a doctor. I had Pfizer for my other vaccines and I probably wont get Moderna again. My blood test taken in late Sep 22 showed that my antibodies were high. I think I had COVID-19. I don't know why my antibodies were high but I don't have anything that I could identify that I was sick.
Pt developed a significant maculopapular rash all over body. There was a similar rash in twin and another patient from same lot of MMR and Varivax.
This case was reported by a healthcare professional and described the occurrence of injection site bleeding in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ENGERIX B (1 ml, unknown route). On 27 July 2011, less than one day after vaccination with ENGERIX B, the subject experienced injection site bleeding. On 28 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported 3 incidences of subjects experiencing bleeding at the injection site with ENGERIX B. This is case 3 of 3 (see case IDs A0939441A and A0939443A for details of the other reports). Follow-up information received on 22 September 2011 indicated that no further information was available for this adverse event.
Patient indicated on consent form that he had never had a reaction after receiving a vaccine before. Pharmacist on duty administered vaccine to patient. Patient walked from the vaccine administration location to the waiting area and sat down. Pharmacist heard a loud thud, and customer yelled "call 911" 911 was called, and patient was given a pillow under his head, and a blanket covering his body. He was unconscious for about 5 seconds, then came to. He was able to answer questions correctly like his name, and what year it is. Management came to help and take care of patient also. EMT arrived and took patient's BP and blood glucose levels. EMT recommended a snack because patient had not eaten yet today. Patient was given cheetos and water. EMT stayed to monitor patient until his vitals returned to normal. Patient told EMT that he has fainted about 8 times previously after giving blood, but never after receiving a vaccine. Came to pick him up so he did not have to drive home. Patient stated he had chipped his tooth  when he fell from the chair.
100.5F Fever for 24 hours, initially met with vomiting. All over body aches and headache. Chills. All continued the entire time outside the vomiting which was controlled by keeping cooler.
Janssen COVID-19 Vaccine EUA: Vaccine recipient experienced overheating and syncope.  Vaccine recipient was monitored by EMS.
Information has been received from a college health registered nurse concerning a female who was vaccinated with either a second or third dose of GARDASIL (lot #659962/1740U). Subsequently the patient developed pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad." The patient was weak and "felt like fainting." The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check.  This is in follow-up to report(s) previously submitted on 3/14/2008; 7/8/2008; 1/7/2009. Initial and follow-up information has been received from a college health registered nurse concerning an approximately 20 year old female who was vaccinated with either a second or third dose of GARADASIL (lot #659962/1740U). Subsequently the patient developed excruciating pain at the injection site. It was reported that it was the worst shot she ever had. The patient had to lie down because "the shot hurt so bad". The patient was weak and "felt like fainting". The patient sought medical attention in the office. At the time of the report, the patient's outcome was unknown. The registered nurse is requesting a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number 659962/1740U was satisfactory. The lot # 659962/1740U met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check was performed. All in-process quality checks for the lot number 659962/1740U in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot number 659962/1740U met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several reports received from the same sourced. Additional information is not expected.
occasional flares of Rheumatoid arthritis; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4351745-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "occasional flares of Rheumatoid arthritis"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The action taken for upadacitinib was dosage permanently withdrawn.  Clinical course: It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's assessment of the causal relationship of "occasional flares of rheumatoid arthritis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "sore arm" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
No tx.  Left arm pain; slight fever and severe muscles aches lasted TWO DAYS after injection.
Still feeling the effects of the alcohol today; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic hangover (The patient consumed alcohol 14-APR-2021 night and was still feeling the effects of the alcohol.) on 14-Apr-2021.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today). At the time of the report, ALCOHOLIC HANGOVER (Still feeling the effects of the alcohol today) outcome was unknown. Not Provided          No concomitant medications reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No treatment medication details were provided.
On Sunday April 4th I came home from church and the injection site was all red.  The night of March 3rd my entire body was really itchy.  I let my doctor know and showed her a picture.  She told me to take Benadryl and that did help the rash.  This morning April 6th, I noticed a lump below the injection site.  I have started to massage the lump and that has seemed to go away.
Patient reported "shooting pain" from where she got the KENALOG shot 2 month ago to her fingers. She started getting the symptoms 2 hrs after the flu shot. Also felt "funny on her throat".
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date unknown) for prophylaxis. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The pharmacist stated that the patient experienced sore arm with first dose of the SHINGRIX. No further details were provided. This case was linked with US2018144799, reported for same patient.
Expressed thanks to Moderna that her breathing has been easier; she just had some allergies growing up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07F21A) for COVID-19 vaccination.     The patient's past medical history included Respiratory disorder NOS.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) had resolved and HYPERSENSITIVITY (she just had some allergies growing up) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-404862, MOD-2021-404866 (Patient Link).
Neck  and upper  arm stiffness on right side. Throbbing and shooting pain in head, neck and arm.
Information has been received from a registered nurse concerning a currently 46 years old female patient. There was no information about concurrent condition, medical  history or concomitant medication. On 08-SEP-2014 and 07-OCT-2014, the patient was vaccinated with the first and second dose of GARDASIL (lot # J002641, Expiration Date: 12-OCT0-2015) (strength, dose and route unknown) (inappropriate schedule of drug administration). On 11-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (lot # K008931, Expiration Date 04-MAR-2017) (strength, dose and route unknown) (inappropriate schedule of drug administration). NO adverse effects reported. Additional information has been requested.
SHINGRIX is the shingle shot if got (0.5 mg) I or 2. I got the shot at 2 PM started feeling fever at 4 PM which was told to take Tylenol. The welts started at the same time on my face in my eyes, on my arms and chest. told by pharmacist to take Benadryl two every 4 hours. For three weeks put up with it then went to the doctor. 10/2/18 went to Dr's. nurse she gave me a shot cortisone next day had an appointment with Dr. he said it was an allergic reaction to the Shingles shot he prescribed Dexamethasone 1mg 7 days. helped with the pain not swelling. Here I am still with the swelling and itching not going out because fabric touching it hurts and makes it worse.  I would rather have the shingles then this!
First just arm pain then a few days later hot red and swollen at injection site. It is 2 weeks today and it has not gone away
COVID MRNA VACCINE INDUCED THYROIDITIS; This is a literature report.  While cases of Thyroiditis after COVID mRNA vaccination are reported, the recovery duration is not yet determined. Therefore, the authors present the time course of two healthy middle-aged patients who developed symptomatic, biochemical, and radiological evidence of Thyroiditis following COVID 19(mRNA) vaccine administration. Despite being more than six months post-vaccination, both are still hypothyroid, requiring levothyroxine replacement.  Case Description: Case 1: A 35-year-old male presented with palpitations and neck pain ten days after receiving the first dose of the Pfizer-BioNTech vaccine, initial labs showing biochemical hyperthyroidism TSH -0.07uIU/mL (0.450-4.50uIU/mL), Free T 4 (0.82-1.77ng/dL4) -3.04ng/dl, TotalT3 (71-80ng/dl) -200ng/dl. He was started on propranolol and ibuprofen for symptom control. During four months of follow up, he was euthyroid with TSH -2.060 uIU/mL Free T4 1.04ng/dl, Total T3 122ng/dl, and five months of follow up showed hypothyroidism with TSH -5.730uIU/mL, Free T4 -1.00ng/dl, Total T3 109ng/dl. Due to fatigue and weight gain symptoms, he was started on Levothyroxine 25mcg daily. Discussion: Thyroiditis is an inflammatory disorder diagnosed based on clinical and laboratory findings. While there have been cases reports of Subacute Thyroiditis following immunizations, such as the influenza vaccine, the mechanism of thyroiditis after the COVID mRNA vaccine remains unclear. Subacute Thyroiditis typically manifests as a triphasic clinical course of thyrotoxicosis, followed by hypothyroidism and a return to the euthyroid state; however, mRNA vaccine-induced Thyroiditis seems to have a different disease course. In the observation of these case series, both patients remained in the hypothyroid state requiring Levothyroxine replacement eight-and twelve-months post-vaccination, respectively. Whether they developed permanent thyroid damage or are able to recover with prolonged recovery time is still unclear, which needs further follow-up in the future.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Thyroiditis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201282091 Same article/drug/event, different patients;
Recurrent hive like reaction post AVA and spv.  Recurred 01 Apr and treated and cleared within a couple of days with ZYRTEC, BENADRYL and ZANTAC.  Had AVA #2 without recurrence.  Symptoms: Urticaria.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M024677, expiry date 18-MAY-2018; dose and route were not reported). The dose was stored under temperature of -11 Celsius degrees for 8 hours and 30 minutes. The previous temperature excursion was -9.3 Celsius degrees for 8 hours and 30 minutes and -10.6 Celsius degrees for 4 hours. The call was because of a data logger. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008781.
Information has been received from a certified medical assistant (CMA) concerning a 70 year old patient who on 28-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experienced pain at injection site, hot skin to touch, swelling, achiness all over, and red and warm to touch at injection site.  The outcome of the events was not reported.  Follow up information has been received from a physician concerning the 70 year old female restaurant owner with hypertension, diabetes mellitus, hypothyroidism, anemia and allergies to clarithromycin (BIAXIN) and codeine who on 28-OCT-2005 was vaccinated in the right arm with her second dose (first dose in 2000) of pneumococcal 23v polysaccharide vaccine. lot number ( confirmed certified medical assistant stated when patient's chart was pulled the lot number was not the lot originally reported).  The patient was vaccinated with influenza virus vaccine in the left arm on the same day.  On 28-OCT-2005 the patient developed "right arm red, hot swollen, hard lump, feels flu like symptoms".  The patient required unspecified oral antibiotics and recovered on approximately 30-NOV-2005.  Additional information is not expected.
Developed tinnitus symptoms within 6 months after 1st vaccination (in between 1st and 2nd booster dose). Symptoms are now permanent with no abatement after two years after 1st vaccine administration.  Booster shots provided in 2021, with no adverse or pro-verse change in tinnitus symptoms.
Erythema, edema, mild tenderness and mild itching to (R) anterior thigh/knee; afebrile; treated with BENADRYL and ZYRTEC.
PATIENT RECEIVED SECOND DOSE OF PFIZER AT 59TH DAY AFTER FIRST DOSE
Patient arrived early for his scheduled afternoon appointment. I took him back and stated that he was receiving 2nd dose of pfizer vaccine. I administered the pfizer dose and documented on his vaccine card. I then went to document the injection into the computer and noticed that his first dose given was Moderna.
Got 2 shots in right arm.  Next day, right upper arm became swollen, red, tender, second day, swelling worse.  Also, complained of itching.  Treated with Benadryl/Atarax, cold compress.
Fever, chills, headache, stomach cramps, insomnia  Started at 11:00 pm and is still happening at 4:30 am
This study case was received from the investigator on 27 September 2012. A 29 year-old male subject with a history of no reported medical history was found to have "Other, chest pain" 13 days after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 May 2012. The following laboratory data was not available: Troponin I, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Information has been received from a registered nurse (RN) concerning an elementary aged child was vaccinated with a dose of Varivax. The RN reported that in February 2006, the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
underdose/received half of dose/other half went on to the table; luer lock device leaked; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a male patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero (unknown arm) .5 ml. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: underdose/received half of dose/other half went on to the table), syringe leak (Verbatim: luer lock device leaked) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint 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: GSK receipt date: 8-Jun-2023 The nurse reported Bexsero product quality complaint. The vaccine leaked at the luer lock device.  No at the back through the stopper, no the blister and/or carton was damaged, no the luer lock was damaged and there was damage/breakage on the syringe barrel. The reporter reported that the syringe was pre-assembled with needle sometime before administration (30 second so for long). The size of gauge needle used was 25 G. The needle which was used was available, the reporter asked if so return of this needle was also required. The reporter stated that yes leaking from plunger stopper, there were liquid traces observed on the plunger stopper rings. The replacement was pending. The reporter needs to determine if they want a credit for one Bexsero vaccine. If yes, please obtain all wholesale information. Please verify if the reporter was returning suspect vaccine. The reporter consented to follow-up. The nurse reports the luer lock device leaked as she was injecting the vaccine to the patient and the patient received half of dose, which led to incomplete dose administered and syringe leak.