chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Influenza vaccine. Previously administered products included Influenza vaccine with an associated reaction of influenza (please refer case US2018GSK037537 for a case of a dose which was administered 5 years ago.). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: The patient reported that, after taking the flu vaccine this year, she experienced the flu at the time of reporting. The patient did not report any hospitalization. At the time of this report, the patient had recovered from flu episode. The patient clarified, of all the times she had taken the vaccine, she twice got the flu anyway. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule and lab test confirmation for targeted disease was unknown. This case has been linked with US2018GSK037537, reported by the same reporter.
A patient indicated that she has should pain and was wondering if it might be related to the Prevnar 13  shot she received on (10/10/2019). She also said that it hurts when her Celebrex medicine wears off.  Since it?s been three weeks since the shot, I advised her to follow up with her doctor.  She indicated that she?ll wait few more days to see if the pain goes away before visiting her doctor.  I told her to provide an update to us after visiting her doctor.
BURNING IN ARM IMMEDIATELY AT TIME OF  SHINGRIX INJECTION.  SWOLLEN AT INJECTION SITE. PAIN RADIATING FROM SHOULDER TO HAND. PATIENT WENT TO DOCTOR AND DOCTOR PRESCRIBED AN ANTIBIOTIC AND A STEROID.
48 hours after vaccinations, pt developed splotchy red rashes beginning under armpits, thighs (at injection area), on the face, and back of his neck. At noon we visited the pediatrician whom suggested it could be a coincidental viral rash, food allergy (exclusively breastfed), or unlikely reaction to the vaccination. Three hours later the rash continues to spread and causes purple discoloration of hands and feet. We take pt to the ER and though his vitals seem fine, the rash has spread all over his body. We are sent home with an ointment. The next day, splotches turn into rings and pediatrician gives the diagnosis as erythema multiforme, pt continues to have purplish hands and feet intermittently. The rashes seem to subside thereafter with occasional hives to a lesser degree throughout the next month. His skin clears up completely in May.
Per family, male didn't feel well since receiving the vaccine on April 14, 2022. Male passed away on April 24, 2022.  Manner of Death-Natural
Pt recvd Tetramune at the ages of 2,4 & 6 mon. At 18 mon pt recvd inj of Acel-Immune. 12/12/97 pt dx w/pertussis. No further info.
First Moderna vaccine given 3/21/23, second Moderna vaccine given 3/24/23.
Swelling in both hands, Right Knee, Both Ankles, Top of both Feet, pain in calve muscles, Joint pain in Knees, ankles, feet, Shoulders and hands. Development of left knee grinding when going to sit. Swelling sights are hot. Tested positive for ANA but unknown which one. High Cholesterol level, and Hypoththroidism to date.
This spontaneous report as received from a pharmacist refers to a 28 year old female patient with no drug reactions or allergies and with no medical history. No concomitant medications were reported. On 09-APR-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneous, lot number: J003790, expiration date 28-MAR-2015, dose 0.5 ml (injection site was not reported). Other suspect therapies included ENGERIX-B, intramuscular, (dose, lot number, expiration date and injection site not reported). On 09-APR-2015, the patient experienced a little bit of pain around injection site. The patient did not seek medical attention. No lab diagnostic studies were performed. The reporting pharmacist believed that the pain reported was mostly due to intramuscular administration of ENGERIX-B. The outcome of the pain around injection site was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Hives on face began on 6/20/18 around 7:00 AM. Patient took BENADRYL. Hives not itchy. Patient did not have this reaction with previous doses of HPV.
03/26/2021 - We decided to sit for 30 minutes after the injection and were fine.  We got home and had lunch and then just took it easy the rest of the afternoon.  Around 2pm I took a couple of Tylenol because a headache was forming and my left arm was aching at the injection site.  I also noticed a tenderness in the lymph nodes in my groin.  I slept mostly well.  I did wake up in the middle of the night with the 2 bones in my left foot were throbbing where the screws are.  It feels like anywhere I had severe inflammation or surgery, there were intense feelings of burning pain.
Delayed rash at the injection site; Arm is warm at injection site area; Itching near the injection site; Tender arm  after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is warm at injection site area), VACCINATION SITE PRURITUS (Itching near the injection site), VACCINATION SITE PAIN (Tender arm  after injection) and VACCINATION SITE RASH (Delayed rash at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tender arm  after injection). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm is warm at injection site area) and VACCINATION SITE PRURITUS (Itching near the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (Delayed rash at the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is warm at injection site area), VACCINATION SITE PAIN (Tender arm  after injection) and VACCINATION SITE RASH (Delayed rash at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching near the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received their first dose of the vaccine and after the injection, their arm was a little tender. On 15-Apr-2021, the patient's arm began to itch near the injection site. The patient reported that the area was warm and was still itching as of 19-Apr-2021. The patient has applied hydrocortisone cream which has helped with the itching. The patient also reported that they read about delayed rash at the injection site in an AARP article.  No Concomitant product use was reported.  Treatment medication included hydrocortisone cream which has helped with the itching.
Moderna COVID-19 Vaccine EAU. Itching at injection site,  approximately 3 inch diameter red patch at injection site, and hardness around injection site in the arm muscle.
I had chest discomfort. Went to the ER. I lost consciousness and went into cardiac arrest briefly. I continued to have trouble regulating heart rate. It was determined that I needed a pace maker to keep my heart rate from bottoming out.
generalized seizure with fever 102, lasting 7-10 minutes, brought to er at st vincent's hospital. was diagnosed with otitis and sent home on amoxicillin.
Swelling of eyes, lip numbness, tingling and dryness. Dizzy and weak. Client received Benadryl and was transported to hospital via EMS.
The pt complained of swelling of hands with itching, an itchy red rash on arms, welts the size of quarters.
I am internal medicine physician.   This vaccine reaction was unacceptible.   Within 3 hours and had 4/10 pain in my lower deltoid and by that night there was redness that was 10cm and lasted 4 days - slowly subsiding.   But worst symtpoms were onset of fatigue, diffuse aching and a sense of fever but T 99-100 and that lasted 36 hours requiring Tylenol every eight hours to manage the symptoms.    This vaccine side effect is just unacceptable.      I read that the GSK liposome with SA21 is likely cause of the reactiveness of this vaccine and this was moderately severe  reaction to me.  I will not take this vaccine again and you should consider suspending this until modifications in the SA21 are made.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 17-MAY-2012, the patient was vaccinated with the first dose of improperly stored VARIVAX, dose, route and frequency unknown, lot#671861//1907AA. On 21-JUN-2012, the patient was vaccinated with second dose of improperly stored VARIVAX lot # 671861/1907AA. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
After the vaccination, on Saturday morning, I woke up with an arm, that I could not use. It stayed sore until about mid afternoon, and it still hurts today. I am going to call the doctor to see if its something they can do. I have not been to the doctor yet.
Information has been received from a physician concerning a 36 month old male who on 01/11/01 was vaccinated with a dose of varicella virus vaccine live. The pt developed "breakthrough varicella". There was no concomitant therapy. There was no prescription drug treatment required. Subsequently, the pt recovered. Additional information is expected.
hot and cold alternating chills and sweats over night 6 days after the vaccine no fever
Slept from 6;30 p.m to 7:30a.m., 13 hours after getting shot at 10a.m. Went back to sleep about 10a.m. and slept  till about 4p.m. Then went to sleep about 7p.m. and woke up at 3a.m.. and went back to sleep till 7a.m. It is now 9:30 a.m. and I think I will be able to stay awake the rest of the day. I had my usual aches and pains that first night but none after that. I slept much more then I usually do after these shots Usually I sleep the next day but not this much.
Received Modern vaccine in am on 01/03/2022 and in am on 01/04/2022 left arm became sore in area where shot was given.  Arm sore x 1 week.   Patient noted immobility with arm and continued for 2 months.  Now arm has limited ROM.  Reports shoveling a truck load of dirt at the beginning of December and felt like it had not recovered from that.  Today she is able to demonstrate limited ROM.  Encourage her to seek doctors advice.  States she will eventually follow up with me.
Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site.  I left work early and went home to lay down.  I took 2 aspirin.  I slept for 20 minutes and woke up feeling better.  My doctors office was closed since this happened on a Friday.  I consulted with a friend that is a RN and she advised going to emergency room.  I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.
My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
After the second dose had fever and chills for a day and a half; After the second dose had fever and chills for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (drug that was no longer in the Market). Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In March 2021, the patient experienced PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half). In March 2021, PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half) had resolved.            No treatment information was provided.  After the second dose, patient had fever and chills for a day and a half.   This case was linked to MOD-2022-474179 (Patient Link).
My son has been running a temp after rabies vaccination. The first shot was given on 12/31/2003 and he is still with temp every day is currently seeing an infectious disease doctor to find out what is going on. His first 2 vaccines were involved in the recall. Doctors cannot find out what is causing the temps. He also has had a sore throat off and on along with stomach pains that come and go but there is an every day temp.
Within 24 hrs, (R) upper arm became itchy and within 36 hrs redness, firmness (induration?), swelling. No neuropathy. No fever. Red and firmness 13x14 cm. (R) upper arm circumference 34.5 cm; (L) upper arm circumference 31 cm. Full range of motion.
On  Tues.7th my 5 week old daughter was given a Hepatitis A vaccine by a medical assistant in my doctors office. She was supposed to get the second round of her Hepatitis B vaccine and the person that I was told was a nurse giving her the shot gave the wrong one. I notified the doctors office as soon as I realized their mistake. As I said my daughter is 5weeks old and the Hep. A immunization is not supposed to be given until 12 to 23 months. I was told by my doctor that the vaccination would not harm her and would have no lasting side effects.
5/21 flu-like symptoms 5/24, still felt run-down 5/26, flushed and restless during the night with urination multiple times per hour, dehydration and dizziness in the morning. 5/27, flushed and restless again, no other problems 5/28, same 5/29, constant sensation of drowning during the night. Arose at 4 am, went to the 24/7 clinic where they said I have AFIB with congestive heart failure, and sent me by ambulance to Hosp. 6/3, released.
First, she did feel faint after getting the injection, and also shock symptoms (pale, clammy, nausea). She sat/laid down for 20-30 minutes and seemed fine after that. When she received her 2016 flu vaccine, she had similar symptoms but actually did faint that time. She did have a small reaction to that 2016 flu vaccine (a few hives/itching/redness around injection site). Anyway, the first adverse symptom happened around 10:30 p.m. on 10/07/17, patient had some redness and itching on one of her thighs. Sometime in the night it spread to most of her body. She had been itchy through the night and didn't sleep very well because of it. She awoke around 7:00 AM on 10/08/17 and showed me what was wrong. Most of her body was covered in itchy, red, raised hives. I immediately gave her 1 tsp. BENADRYL, which helped relieve the itching a little, but the hives continued to spread and worsen throughout the day. Continued giving her 1 tsp. BENADRYL every 4 hours that day (and through the night). By mid-day the hives had spread to her face, scalp, lower legs, back of hands and tops of feet. Around 7:00 PM she reported it felt like her throat was swelling a little (like it does when she eats watermelon--which she had not by the way). We continued monitoring her to make sure she could breathe fine, which she could. We also noticed that evening (even took pictures) that there were many more hives on her left arm (injection arm) than her right arm. By the morning of 10/09/17 the hives were redder, itchier, more numerous, and had spread to the bottom of feet, palms of hands, ears....pretty much everywhere. She was seen by a pediatrician that afternoon around 4:00 PM and prednisolone was prescribed (2x day for 5 days). The hives were much better after the 5 days and haven't flared up again yet (which the Dr. said could happen up to 4 weeks after). She still has markings on her skin where the worst hives were, but they are slowly healing.
Headache, Myalgia, Fever, NauseaVomiting, Chills, fatigue,  Narrative:
High blood pressure; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 at 08:00 (Batch/Lot number: unknown)at the age of 61 Year(s) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; Anatomical location: Left Arm; Administration time: 08:00), administration date: 19Jan2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious) with onset an unknown date in Aug2021, outcome "not recovered", described as "High blood pressure". The event "High blood pressure" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment taken as a result of hypertension included lisinopril 10 mg. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 14Oct2021 at 14:45 (Lot number: unknown) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Moderna arm; lot of pain; can't rest the arm/"affecting her daily living; pain from the neck; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 039b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant product use was not provided by the reporter.
1.  (Day of injection) minor headache, pain at injection site; confusion/wooziness 2.  (Following day) 30 minutes severe shaking of right hand followed by 30 minutes minor shaking; headache; fatigue, sense of a sharp instrument like an ice pick being pressed hard into the inner surface of my ankles and my lower thighs - but only felt this in one location at a time as it there was a ghost poking me in those locations intermittently with just one ice pick; wooziness; pain at injection site 3.  (2 days after injection) morning still had wooziness but subsided by evening.
This spontaneous report as received from a nurse refers to a patient of unknown age. It was reported that the patient administered the first and second doses in the GARDASIL vaccination (dose and lot# not reported) series intramuscularly on 31-DEC-2007 and 05-JUN-2008, respectively and administered the third dose in the GARDASIL vaccination series on 30-OCT-2013. There was no adverse effect. Additional information has been requested.
Staff member reporting "itchiness" after vaccine administration. Resident had raised, red rash on LUA following administration. As of 2/8/21 area's redness has diminished.
This is a spontaneous report from a contactable consumer (patient) or other non-HCP, from a Pfizer-sponsored program. A female patient, of an unspecified age, received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 11, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Reportedly, patient had the vaccine on Thursday, Mar 11, 2021. 2 days later, Saturday, Mar 13, 2021 she had a rash. She also asked if it was a normal reaction. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
SHINGRIX VACCINE (LOT Z4359 EXP 09/19/2020) WAS GIVEN TO PATIENT LEFT ARM DELTOID MUSCLE(IM) ON 11/20/2019 IN THE EVENING 4 PM. REPORTED TO ME AT 9:10AM(11/21/2019) THAT PATIENT WAS TAKEN TO HOSPITAL VIA AMBULANCE. NURSE FROM GROUP HOME STATED THAT 5;30AM THAT MORNING PATIENT HAD DIFFICULTY BEATHING( O2 SATURATION DONE TO 82%) RESTLESS THEN HAD A SEIZURE. LAST SEIZURE WAS IN 2012 AS STATED BY NURSE WORKING AT GROUP HOME WERE PATIENT RESIDES.