chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse effects came from the vaccine it was given in error as it had expired on 2/28/2022 and it was given at 3/2/2022. 20 year old client came into the clinic in need of Polio, TD, Hep A, and Hep B vaccines to finish her catch up schedule.  The vaccines were taken from the fridge and they were prepared and administered to the client. It was found after that the Hep B vaccine expired at the end of February and that it had been missed and administered to the client in error. The manufacturer was called and they stated that it is up to the health care provider to decide if the dose counted. Health Officer of clinic was called and he stated that we should offer to vaccinate the client if they would prefer to be revaccinated. The nurse spoke to the client and explained the error and client verbalized understanding and stated she had no concerns at this time. Client was informed that the nurse will call her when new Hep B vaccine is in clinic to get the vaccine in so she can come get revaccinated. Client left the clinic without issue or incident.
75-year-old male with history of PE, multiple chronic medical problems who presents with acute respiratory failure. On initial examination, heart rate in the 60s, patient is in shock, agonal breathing, unable to ascertain oxygen saturation. Death imminent which was discussed with the wife at bedside. Wife confirmed DNR status and advanced directives. Per EMS, Patient reportedly from COVID-19 unit at nursing home, currently infected with COVID-19. Patient was not Intubated, CPR not initiated per discussion with the wife. Patient appeared comfortable with non-rebreather. Answered questions. Time of death 9/28/21 @1655.
Pt received vaccine, and after a few minutes, he said he started feeling dizzy, lightheaded, chills, ringing in the ear, and vision changes. He was taken to the vaccine room where he fainted. He regained consciousness within a few seconds. He felt better after a few minutes, firemen came and evaluated him. They did not find anything wrong with him. His blood pressure was also checked.
Following Vaccines I experienced AFib when exercising with heart palpitations and beats over 300 bpm.  Every weekend when cycling this would happen after 30 years of riding 3000-5000 miles per year without issue.  Had ablation surgery 4-Jan-2023 to correct Afib but it has now gotten worse showing up daily.
Information has been received from a registered nurse (R.N.) concerning a female who on 30-JUL-2007 was vaccinated intramuscularly with a 0.5 milliliter dose of Zostavax (Oka/Merck) (MSD) instead of Varivax.  It was unspecified if medical attention was sought.  The outcome is not reported.  No product quality complaint was involved.  Follow-up information received on 10-Aug-2007 indicates that all follow-up attempts have been unsuccessful.  No more information is expected.
Patient was receiving her teen immunizations, received the TDap and started to faint 5 minutes after. She was caught by mother and assisted to the ground, no injury, LOC and no disorientation. She was transferred to bed and monitored
Received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. Unable to reach pt to f/u after several attempts.
Had a mild headache before going to bed. Woke up at midnight with a fever, body aches, and chills. Took ibuprofen and it did not break the fever until 4:30 AM. Around 11:45 AM same day fever spiked again up to 102.3 highest tempt. Immediately took ibuprofen and still has not fully broken fever and it is 2:19 PM
Pt received Pneumovax 8/24/06 per pt report: developed pain and swelling, redness below the injection site, then developed hives on trunk of her body.
Vomiting Diarrhea chills severe stomach cramps nauseous and aches and pains  lasting 24 to 48 hours a week later ringing I'm the ear
Experienced truncal maculopapular rash, followed by arthritis in small joints of hand & feet, wrists & ankles; Also experienced vertigo, sensorineural hearing loss of approx 70% in lt ear;
No adverse effects but patient was not supposed to receive a 5th dose as it has not been approved yet.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2019SA056122 and 2019SA055109. This case involves a eight months old female patient who was vaccinated with 0.5 ml FLUZONE QUADRIVALENT (lot: LB549), expiry date- 30-Jun-2019 via intramuscular route in the left thigh which was on temperature excursion, on 11-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Injection site pain; Injection site swelling; nausea; fever; chills; headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2019 17:00, the patient received Shingrix. In January 2019, 7 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue. The patient was treated with ibuprofen (Advil) and ondansetron (Zofran). On an unknown date, the outcome of the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, nausea, fever, chills, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. Approximately 7 hours later, increasing over next 9 hours, the patient experienced pain at injection site, swelling, nausea, fever, chills, headache, fatigue. The events were continued 10 hours later. The patient was treated with Advil and Zofran. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Patient received Adacel vaccine on 01-09-08 due to dog bite. On 01-10-08 patient developed fever 101 orally with vomiting. Patient complained of redness and pain at injection site right deltoid that interfered with routine activities and had to leave school. Patient returned to office today temperature was 98.1 at 11:30 am stating temperature was 100 this AM. Patient was given Ibuprofen by father this Am. Redness, pain, and swelling still present at injection site.
Patient received his first vaccine from the manufacturer Pfizer and then was incorrectly given moderna for the second dose. The patient did not have any kind of reaction. The patient contacted the pharmacy and was instructed not to receive any other vaccine doses at this time based on CDC recommendations.
Pharyngitis, Enlarged Sub mandibular Salivary Glands, Rhinorrhea, Cough, Generalized Fatigue and Malaise
About 15-20 minutes after vaccine patient experienced nausea and diarrhea on second day. Fever occurred in the first couple of days. Patient also had weakness and these lasted for 5 weeks.
pt came into office w/rash dx w/varicella on 28JUL97;
pt recv vax 9DEC96 3-4PM aorund 8-9PM started w/t013 ax sponge bath & APAP given;10DEC96 rash & temp inc to 102 ax;mon cont to treat w/APAP;11DEC96 temp around 99-100 & rash begining to fade;rash still present 12DEC96;red raised bumps;
Patient states she started feeling sore, tired, light-headed, dizzy, and nausea within minutes of the injection. Went home and slept from 7:30 PM that night till 5 AM next morning. She reports that her arm pain went down to her hand and on the inside to her arm up to her right breast including lymph node. All symptoms started same day and have continually gotten better each day.
Initially normal soreness after influenza shot but then instead of getting better it got worse and worse. I was unable to sleep because the pain was so bad when I moved my arm it would wake me up. My shoulder joint was extremely painful and started cracking everytime I moved it.  My deltoid was so painful I was unable to use it to move a chair or pick up kids or put my weight on my elbow.  I start naproxen scheduled for 6 days and pain went away but it came back after stopping the naproxen.  I went on/off Naproxen depending on how much pain there was.  Eventually about 3-4 weeks after the vaccine I went to the doctor to get a prednisone bolus and taper to help with the pain.  The pain was better after the prednisone bolus but it still hurts 1.5 months later. I am unable to sleep on the left side due to pain.
12:30am severe pain at injection site throughout the night.  Severe exhaustion set in around 6am and went till about 11am. Started having body aches that feel like flu symptoms around 1pm on and off till about 5:30pm. From 5:30pm till now I am having severe body aches, upset stomach, headache. Burning sensation in face and neck but no fever. I have taken a round of dual action advil that seemed to help earlier today. But nothing else has helped.
Nausea, sinus pressure/pain, body chills, NO fever, Frontal HA, loss of energy all x2 weeks
3" red hot circle at the injection site; left elbow started bothering her; left arm started itching/more left arm itching; hard lump at the injection site; warm left arm; tender left arm; mild soreness in her left arm; little fogginess; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild soreness in her left arm), FEELING ABNORMAL (little fogginess), INJECTION SITE MASS (hard lump at the injection site), INJECTION SITE WARMTH (warm left arm) and TENDERNESS (tender left arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Drug allergy (Levaquin and cipro.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (mild soreness in her left arm), FEELING ABNORMAL (little fogginess) and HEADACHE (headaches). On 26-Feb-2021, the patient experienced INJECTION SITE MASS (hard lump at the injection site), INJECTION SITE WARMTH (warm left arm) and TENDERNESS (tender left arm). On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (left elbow started bothering her) and VACCINATION SITE PRURITUS (left arm started itching/more left arm itching). On 01-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (3" red hot circle at the injection site). On 21-Feb-2021, PAIN IN EXTREMITY (mild soreness in her left arm), FEELING ABNORMAL (little fogginess) and HEADACHE (headaches) had resolved. At the time of the report, INJECTION SITE MASS (hard lump at the injection site), INJECTION SITE WARMTH (warm left arm), TENDERNESS (tender left arm), VACCINATION SITE REACTION (left elbow started bothering her), VACCINATION SITE PRURITUS (left arm started itching/more left arm itching) and VACCINATION SITE ERYTHEMA (3" red hot circle at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided
I got the SHINGRIX vaccine and the next day it was like I had a severe illness. I was so out of it every time I thought about getting out of the bed before I managed to get out I fell back to asleep. I had to get my daughter to physically drag me out so I did not lie in bed all day (or I would have been in physical pain from that plus not been able to sleep that night) The second day after I Really should have stayed home from work but had to go in due to meetings I could not miss. Bottom line: SHINGRIX kicked my butt for two days. I was completely nonfunctional for one day and virtually nonfunctional for the second day. Now, granted I was given information AFTER I got my shot that I did not get a chance to read that day. When I finally read it I saw that the above are known side effects, especially in younger people. I am on the younger end of people getting that vaccine. I also have alpha-gal allergy and had to talk to my doctor about getting the vaccine at all due to it being made from Hamster Ovaries. It was decided that the risk of getting it now was better than the long term risk, but that may have made my reaction worse. THE ISSUE: If this is such a well known side effect (that a large percentage of younger people may not be able to perform their daily functions for 2-3 days' then people need to be seriously warned about this IN ADVANCE, not in arrears. After having gotten the shot it's too late. What if I had had to be at work the next day? What if my job was not as sedentary as it is? If I was a waitress I would have been out of work for two full days, and I am probably the exact person who could not afford to be out of work for two full days!! THE SOLUTION: people should be seriously warned about possible side effects such as this so that they can PLAN when to get a shot like this. Had I known I could have made a special trip in on Friday night so I could have been laid up for the weekend instead of this bleeding into the workweek. It is a joke to provided this type information after the shot is given. With such a large percent of people having this side effect I believe there should be a simple pre-screen question "Are you willing and able to take the next 2-3 days off to potentially be in bed 'sick' while you recover from this vaccination?" While not life threatening this is a very serious issue. I have offered one solution, I am sure you can come up with others, but something needs to be done ASAP. PS: and if you think you might scare people off getting the vaccine if you were honest up front, believe me I have scared a number of people off by talking about the unexpected, unplanned for, hassle I had to go through. Even my GP said she was probably not going to get it after listening to me! SO, bad advertising by putting people in this situation is not helping your case either.
This case was reported by a pharmacist via call center representative and described the occurrence of chest heaviness in a 68-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced chest heaviness. On an unknown date, the outcome of the chest heaviness was unknown. It was unknown if the reporter considered the chest heaviness to be related to SHINGRIX. Additional information was reported as follows: At an unknown time, the patient experienced heaviness in his chest after vaccination with SHINGRIX. The reporting pharmacy intern reported that the patient called the pharmacy on 20th July 2018 to report symptoms. At the reporting time, it was unknown if the symptoms had resolved.
2 areas of redness, firmness and heat 2 1/2-3 cm on right thigh.
Immediately felt pain and itch. Within 30 minutes, injection site had severe swelling and itching on (L) arm. At hospital was given BENADRYL and TORADOL injections. Kept getting worse. Back to hospital, given prescriptions.
1 day post vaccinations: Fever started and lasted for 4 days intermittently. Patient was overly tired, loss of appetite, fussy, clingy, drowsy (eyes glazed throughout the day) and off balance.  Approximately 10 days post nap: Patient woke up crying from his nap. When I went to get him out of his crib, he was not moving and just stared into space and would not move or make eye contact with me. It took about 5 mins to get him to move and respond. This had never occurred before and was extremely concerning.
The pt developed hives, erythema and itching within 30 minutes of receiving MMR. He was given Benadryl 12.5mg and symptoms improved.
Client called the Health Department reporting an adverse reaction to her COVID-19 bivalent booster. Client reports receiving her booster at the Pharmacy on 10/31/2022. Client request PHN to submit a report on her behalf. On Monday, October 31, 2022 client received her Moderna Booster and reports that, that evening, she was up in the night with a cough and dry heaves. Client reports that she went on to develop extreme diarrhea, exhaustion, pain everywhere including her breast plate, ears, nipples, and back, as well as a fever. Client reports calling and notifying the nurse with her primary care provider, NP, of the reaction. The nurse at the provider?s office encouraged fluids and rest for client. Client reports that she then developed a back spasm and severe pain in her leg on the Thursday following vaccination. On the Friday following vaccination, client reports that she developed ?sweats? and that her leg was ?useless.? By Sunday, her fever had finally passed. Client reports seeing person with Dr. office on 11/08/2022. Client received an XRAY at this appointment for the ?back spasm? and ?leg pain.? Client was unsure of what the XRAY showed, but client reports having an upcoming procedure with Dr. in radiology. Client reports that her provider told her that the COVID vaccines can cause autoimmune illnesses to flare. Client feels that her autoimmune illnesses such as osteoporosis and glaucoma are flaring due to the vaccine. At time of PHN speaking with client, client reports some symptoms have improved/resolved, but client is still having great difficulty with walking due to ?back cramp? and pain, needing two canes to walk, weakness, and a puffy eye. Client reports she has a follow up appointment for her eye. It is unclear when the client developed a puffy eye.
Developed an allergic reaction at the injection site 8 days after vaccination.  It was a red, swollen welt.  It was hard, itchy, and warm.
pt called 12/13/07 to report feeling a hard bump at injection site and also had some small bumps and itching.  the site has cleared up but the bumps moved up his arm to his bicep area.  pt given triamcinolone acetanide cream and advised to call if any further problems come up.
Per notes, Probable Guillain-Barré syndrome/CIDP related to Covid vaccination.  Patient came in with tingling and numbness, weakness in arms and legs, some difficulty swallowing
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 an unknown ate, unspecified number of patients were administered doses of PNEUMOVAX 23 injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Area around her mouth is a little red and it felt itchy; Area around her mouth is a little red and it felt itchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 18Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. Yesterday morning (18Jan2021) at 9:15, the patient got her vaccine, and around 04:00 PM (also reported as 04:30 PM), yesterday afternoon, the patient started to rub the area around her mouth. And when she looked it in the mirror, it was a little red and it felt itchy. The patient took diphenhydramine hydrochloride (BENADRYL) which helped a little, just one. And the patient put some diphenhydramine hydrochloride topical cream on it also. The patient was able to sleep last night and woke up this morning and the redness is gone. It's not itchy. The patient seemed to be fine, but she doesn't know if it's from the vaccine or not. It's not one of the typical side effects. The patient asked if it is safe for her to get the vaccine (second dose) or if she needs to ask them. The patient's second dose of vaccine is scheduled on 08Feb2021. The patient recovered from the events on 19Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Mom reports patient intermittently fussy, irritable, no fevers, eating well and slept overnight.  On 12/9/14, mom has noticed that patient seemed unsteady on his feet at times.  She noticed he would be standing and lose balance quicker than usual, take a few steps back and fall over.  Gait seems to be largely normal, although his age makes it difficult to assess.  Started walking at 10.5 months, walking well at 11 months although did have a slight regression 2 weeks ago when he learned to crawl but has been walking well again for about 1.5 weeks prior to appointment on 12/9.
7 DAYS AFTER THE VACCINES WERE GIVEN PATIENT HAD A FEVER OF 104. TOOK HIM TO THE ED WHERE IT SPIKED TO 107 AND OVER THE COURSE OF 30-45 MINUTES HAD 3 FEBRILE SEIZURES. LUMBAR PUNCTURE AS WELL AS BLOOD TESTS CAME BACK NORMAL
Patient had redness of the arm and warmth in the arm. He had a very swollen lymph node about the size of a baseball. He had no pain, but it was uncomfortable. The swollen gland never went down so he went to the doctor's on 6/18/2021 and they prescribed 2 antibiotics and an ultrasound.
Within 5 minutes of receiving the injection I started feeling dizzy and lightheaded. 10 minutes post injection I started having a rash on my arms and chest. I reported it immediately and 15 minutes post injection Benedryl was taken. 30 minutes post injection the rash started to itch. One hour post injection symptoms were managed and starting to subside. At no time did I experience breathing issues.
Dermatological ulceration  Lichen Planus  -arm, mouth and genital parts.
Very fatigued; Threw up; Headache; Couldn't get out of bed; Severe chills; Chattering teeth; Body aches; Pain on joints of her hands; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches) and ARTHRALGIA (Pain on joints of her hands) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced FATIGUE (Very fatigued). On 01-Apr-2021, ASTHENIA (Couldn't get out of bed), CHILLS (Severe chills), CHILLS (Chattering teeth), MYALGIA (Body aches), ARTHRALGIA (Pain on joints of her hands), VOMITING (Threw up) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Very fatigued) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included ibuprofen.