chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes under right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes under right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes under right arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes under right arm) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-089075 (Patient Link).   Reporter did not allow further contact
Caller reported an improperly stored and administered GARDASIL 9.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, route, frequency, and anatomical location were unknown) with   lot # 1637642, and expiration date on 28-MAY-2022 for prophylaxis.  The administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced the temperature excursion of 2°C to 8°C (8.4°C)  Celsius degrees for 34 hours and 41 minutes, above 9°C (10.5°C) Celsius degrees for 6 hours. There was a digital data logger invloved, but there was no previous temperature excursion.
Patient received 2 doses of Moderna COVID vaccine on 2/5/21 and 3/5/21 at an outside facility. Patient was admitted to our facility from 7/26/21-7/28/21 for acute GI bleed with anemia due to blood loss (most likely related to COVID-19) in a sickle cell anemia patient, and COVID pneumonia (cough, but never hypoxic).
Pt had red swollen upper thighs and warm to touch. Was told to put warm compresses to affected area.
No adverse effects have been reported.  Immunization given was incorrect, GARDASIL 9 was given instead of KINRIX.
I have injection site tenderness that began in the evening after receiving the second dose. Woke up the next day with a headache, joint pain; and a general feeling of confusion and malaise. By 5 pm, I had a 101 degree (Fahrenheit) temperature. Today, Friday May 7, 2021, I woke up without the symptoms above except for slight injection site tenderness. I also have hives over my body, neck and arms.
Patient experienced a vasovagal response 5-10 minutes after receiving their first dose of the Moderna vaccine on their left arm. After receiving their dose, patient felt dizzy and lightheaded and passed out. During period of syncope, patient hit their head and reported to have woken up crying on the ground. Medics was informed, vitals taken, and neurological exam was performed. Everything WNL, no abnormal findings, and patient advised to stay another 15 minutes and to request a ride home from a family member. Patient expressed that this is a common occurrence after receiving vaccines, shots, and blood draws.
fatigue; a little headache; chills; muscle pain; joint pain; a little bit of fever; This spontaneous report was received from a male consumer who was participating in mRNA-1273 and experienced the events, fatigue, a little headache, chills, muscle pains, joint pain, a little bit of fever.  The patient's medical history and concomitant medications were not provided.  On 23-Dec-2020 the patient received the first of the two planned doses of mRNA-1273 for the prophylaxis of COVID-19.  On an unspecified date, the patient experienced fatigue, a little headache, chills, muscle pains, joint pain after receiving the mRNA-1273 vaccine. He did not experience any nausea, vomiting or intestinal distress. The patient thought of experiencing a little bit of fever based on the way he feels, but temperature was not confirmed.  No medication was taken by the patient for the events.  Action taken with mRNA-1273 vaccine in relation to events was not provided.  The outcome of the events fatigue, chills, little headache, muscle pain, joint pain, a little bit of fever was not provided.; Reporter's Comments: This case concerns a male subject of unknown age, who experienced a non-serious expected event of fatigue, headache, chills, myalgia, arthralgia and fever. All events occurred at unspecified time after the first dose of mRNA-1273 vaccine. Treatment for reported, as well as outcome were not reported. All events were assessed as possibly related to mRNA-1273 vaccine; however additional information has been requested.
Information has been received from a physician concerning a 15 year old male who on 20-SEP-1995 and 17-NOV-1999 was vaccinated with the first and the second dose of MMR II. On 13-NOV-2009, the patient was diagnosed and the patient was afebrile. The patient had right parotitis. The parotitis count was 97. On 13-NOV-2009, the first blood work revealed that serum immunoglobulin M was negative, serum immunoglobulin G 5.59 and serum amylase 43. On 26-DEC-2009 the patient experienced mumps. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a physician reported that on 19-JAN-2010 the patient experienced mumps. On 20-JAN-2010 (also reported as 13-NOV-2009) the patient was diagnosed. The patient had left parotitis and left facial swelling. It was also reported that the patient was 13 years old at the time of onset. The patient did not receive the third dose of MMR II. It was unknown if the patient experienced orchitis, sequelae or was exposed to others with mumps of if there were other cases of mumps in the same household. This is one of several reports from the same source. Additional information has been requested.
Patient 54 years old who is requesting an exemption from AVA re-vaccination, due to h/o chronic, intermittent pruritus/non-specific dermatitis vaccination, s/p receipt of AVA's (#1- 05-Nov-99; #2- 16-Nov-99l #3- 22Feb-2000). Denies any difficulty breathing, swallowing, wheezing, angioedema or urticaria immediately following receipt of AVA vaccinations. Two to three weeks after receipt of AVA #2 / AVA #3, upon deployment, the SM began to experience intense itching around his lower abdomen, extending to suprapubic area, base of genitalia, inner aspect of thighs, calves & underneath forearms, bilaterally. The itching which was intense during the day, but intolerable at night "it would itch till driving me crazy - felt like something was crawling under my skin. Denies dx of scabies or STD's or h/o high risk sexual behavior. The SM would unconsciously scratch affected areas at night, while sleeping, without relief of pruritus. Given OTC hydrocortisone cream by medic and military docs rx'd with topical triamcinalone & antifungals, po antibiotics & Allegra for relief of relief of itching. SM would experience recurrent episodes of similar symptoms, but stopped seeking medical care, as nothing was helping. Per AHLTA medical record review, SM's sx worsened considerably in August 2007, upon return from deployment. In Nov of 2007, SM was seen by dermatology x 3 (27-Nov-07, 14-Dec-07, 17-Dec-07) with documentation of "elongated excoriated patterns and inflamed papules with white cloudy fluid over lower abdomen & sparsely scattered on chest/shoulders. "Rx'd for FOLLICULITIS with KEFLEX 250  mg, 2 caps po gid x 10 days & ATARAX 10 mg po ghs, with excellent response. However, several days later, after participating in filed exercise competitions, the SM noticed new red, tender papules on his thigh and scrotal area. Culture of drainage from papules + for MRSA / Rx'd with Septra DS po BID # 14 (17-Dec-07). F/U nasal swab neg for MRSA. SM's Pruritic outbreaks not only associated with periods of deployment in warm, tropical climates. Most recent episodes of intense pruritus of abdomen and things was Dec 2009, while at Fort Bragg, but SM did not consult with a provider. Some relief with home remedies (olive oil and water spray). Never has seen Allergist. No skin testing. SM is scared that another dose of AVA will make his sx flare during his deployment leaving 02-Apr-10.
had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type2 diabeties" (unspecified if ongoing), notes: I am a Type2 diabetic on Metformin, Trulicity and Insulin. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; TRULICITY taken for diabetes mellitus; INSULIN taken for diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had Covid". It was reported that patient recently had Covid after a trip to (Place name withheld). Prior to this experience, patient received vaccines and both boosters. Patient's doctors at (Care name) prescribed the 5 day Paxlovid. Patient's symptoms were fatigue and a cough, no fever. The medication worked great. Patient was a Type2 diabetic on Metformin, Trulicity and Insulin. Prior to Covid patient daily numbers were 140 and above. After taking Paxlovid patient numbers are 95 to 110. A big difference observed and patient wanted to report the positive effect. The patient underwent the following laboratory tests and procedures: daily numbers: 140, notes: I am a Type2 diabetic on Metformin, Trulicity and Insulin. Prior to Covid my daily numbers were 140 and above; 95 to 110, notes: After taking Paxlovid my numbers are 95 to 110. Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
There was about a 1.5cm circle shaped red spot on the arm that received the first dose of Moderna vaccine.  On Feb 5th (9 days after) the red shaped spot started to get very big, warm, and also with a bump. It got even bigger the next day (10 cm). It also had the feeling of irritation a lot.
Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter, different patient US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter
Pt had routine Td immunization. Four days later had 18x10cm area of cellulitis. Immunization given correctly by experienced RN.
Chest tightness, tight jaw, nausea, dizziness, and feeling of full ears
pt recv vax 1OCT96 & by evening 2OCT lt arm (upper) was sore & warm;3OCT whole lt arm painful-couldn't wear watch;ROM limited;upper arm reddened & edematous;tx meds, dx cellulitis;
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
Fever, Chills, Body Aches, Dizzy, Tired, follow up with severe stomach and back pain.
Pt recv vax on 2/3/99; 5 min post vax pt exp agitation, holding breath, cyanotic face, fainting, seizure-eyes upward, jerking, irregular respiration, limp
Information has been received from a physician concerning a 60 year old female who on 21-SEP-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  On 23-SEP-2007 the patient developed injection site redness and vesicular lesions at the injection site.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Presents for evaluation of swelling in the right arm following administration of a PNEUMOVAX Vaccine two days ago. Of note he also received the SHINGRIX vaccine on 9/14 in the left deltoid however he has no reactions in that arm. After the vaccine on Friday night he reported some joint aching and frequent urination, then those symptoms resolved by the next day. Then on Saturday he developed swelling without redness in the left deltoid area where he received his PNEUMOVAX vaccine. Then this morning he developed redness, warmth and swelling in the deltoid and down the arm toward the elbow. He also reports some swelling developing in the forearm. No warmth or tenderness at time of exam. No erythema or warmth at the left deltoid or right deltoid but erythema present on the medial aspect of the right upper arm and down to the elbow with some swelling, no pitting. Also erythema at the site of the SHINGRIX vaccine in a small dependent semicircle at the base of the left deltoid.
Two wks. following H1N1 shot student broke out in hives. "Her mother reported, "Her doctor believes it is her body's immune system adjusting to the shot." Taking BENADRYL.
Seizure with fever of 39.7C; self resolved. Seen at ER.
Covid #2 booster was given on July 5, 2022. The day after I had the booster I felt weak with a headache and slept for 5 hours. - A little over two weeks later around July 23rd, I noticed I was scratching my head a lot, especially around my ears. At the time I thought I had dry scalp. Itching continued. I noticed on Aug. 13, 2022, I had hives where clothing fit tightly or at pressure points, and I still had the itching on my scalp. It all made sense that the itching was hives all along in my scalp, I just couldn't see them there with my hair. I saw a derm/MD twice to treat the hives on 9-15-22 and on 10-13-22. She treated it with Prednisolone and Zyrtec. If I stop the pills I get hives again. It's an ongoing problem.
redness, soreness, inflammation; patient applied cool compressors to the left lateral arm injection site.
Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia.  The patients medical history was not provided.No relevant Concomitant medications were reported.   On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection.  On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Painful where they put it, hurts for days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-FEB-2023  Reporter's comment: The case  was received from the patient via interactive digital media. The reporter reported that he/she got the Shingles vaccine for prevention and arm was painful where they put the vaccine. The reporter reported that pain hurted for several days. The reporter said that there were two injections and the second was six months later. The reporter stated that he/she hoped that you were better. As per reported verbatim, outcome was captured conservatively.
Pt presented with swollen, red, bruised, hot to touch upper arm. Pt saw primary care dr and was administered a steroid injection and prescribed KEFLEX.
Patient states he has a sore arm a month after the shot was given especially when he gets out of a chair.
Patient came 03/30/31 to receive Covid 19 vaccine.  Patient came for 2nd dose, and didn't have CDC card from 1st dose. She also didn't make clinic staff award that she had received a previous dose of Covid-19 dose from Pfizer.
Information has been received from a pharmacist who reported that a 62 year old male consumer who on 04-NOV-2014 received a dose of ZOSTAVAX (lot number K012921, expiry 29-NOV-2015) 0.65 ml subcutaneously (location not specified). Concomitant medications included lisinopril (manufacturer unknown) 20 mg. The pharmacist reported that the patient contacted him on 24-NOV-2014 and reported that he had developed a rash with lesions that started on his left leg on 24-NOV-2014 and then spread to his right leg and up his trunk on an unspecified date after receiving a dose of ZOSTAVAX. The pharmacist stated that the "lesions" that are on both of the patient's legs and up his trunk are "about an inch long and a half and an inch wide". The pharmacist also stated that the patient reported that the lesions are painful (unspecified date of when the pain started). The pharmacist reported that the patient also received AFLURIA on the same day he received a dose of ZOSTAVAX. As of the time of reporting, the patient had not yet recovered. Additional information has been requested.
Starting on Sunday her left arm where she got the shot was hot.  The right was unusually cool.  She got up and had trouble walking.  She has pain in the bend of her left knee that radiates down through the calf of her leg.  When she gets up from sitting it hurts, and having to use two canes to walk and it still hurts.  The pain has not gone away from the day of vaccine, but the persistence has continued since Sunday.   The arm is okay, but the leg that is on the same side.  She did not have any problems with walking prior to the vaccine.
Unexpected headaches, temporary blindness, vomiting, nausea, resulted in IIH
breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single  for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.
Breakthrough case admission after 4 vaccines  Moderna 1/21/21 Lot# 032H20A;  Unknown type or lot# 2/18/21;  Moderna 11/3/21 Lot# 053E21A;  Moderna 7/13/22 Lot# 014B22A
2 TO 3 MINUTES AFTER THE SHOT ADMINISTRATION. PT WAS SITTING FOR OBSERVATION AND SUDDENLY EXPERIENCED EPISODE OF SEVERE DIZZINESS.  SHE WAS TOLD TO REMAIN  SEATED. PT WAS ALERT AND RESPONSE AT ALL TIME. RPH CHECKED HER BLOOD PRESSURE IN 3 OCCASION 5-10 MINUTES APART . THE RESULT WAS AS FOLLOWED: 93/56, 115/76, AND 98/72 RESPECTIVELY.   PT ATTESTED TO HAVE BEEN SUFFERED FROM LOW BLOOD PRESSURE.  SHE SUFFERED FROM POSTURAL ORTHOSTATIC HYPOTENSION.   . EMS WAS NOT CALLED BECAUSE PT WAS SEATED AND TALKING LIKE EVERYTHING WAS NORMAL. AFTER 40 MINUTES, PT LEFT SHE PHARMACY
Swollen and painful left axillary lymph node that has been present for about 2 days.   This morning I developed a significant raised bright red rash at the site of injection that itches.
Moderna booster. Had Pfizer for first two shots. Entire body aches, some feels skeletal
This spontaneous report was received from a medical assistant and refers to 5 unspecified patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M024702, expiration date 18-MAY-2018, subcutaneously; site and doses were not provided), reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 6 to 14 Fahrenheit degrees (-14 to -10 Celsius degrees) for 14 days before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007889:
Pt's left arm where PNEUMOVAX was injected was red & swollen & felt warm to touch. Pt went to Dr & was prescribed MEDROL pack and CLARITIN.
four hours after receiving the shot I experienced severe dizziness mild headache, Blurry eyes, passing out, disoriented, severe pain in the top mussel of my left shoulder  that traveled up into my neck on my left side.