chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection Jan 19 - Jan 29  two red itching circles, one at injection site and one below.  Grew together and formed large circle that was also slightly sore.  Upset stomach.  Both improving on Feb 5.
Sore arm; feeling cold; sweating; insomnia; headache; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 08-Sep-2020 to 15-Nov-2020 and Permanent cardiac pacemaker insertion. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING COLD (feeling cold), HYPERHIDROSIS (sweating), INSOMNIA (insomnia), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports contracting pneumonia post COVID-19 infection in September.Patient reports findings of a blood clot during his previous COVID-19 illness, and necessity to have a pacemaker inserted
Per hospital intake, the patient had ventricular fibrillation cardiac arrest in the field just a few hours after receiving his second Pfizer COVID 19 vaccination. EMS was called, and 20 minutes of CPR were administered, prior to achieving ROSC. Patient was sedated and intubated and taken into Hospital. Cooling protocol was initiated and CT angio did not show any evidence of pulmonary embolism. Patient also underwent cardiac catheterization, which was was negative for clear intracardiac or coronary abnormalities or stenoses. Ultimately, the patient was transferred to medical center for implantation of AICD device. No other obvious source or etiology of arrest, but did think worth reporting given temporal proximity to vaccination.
After the first shot on March 6 but much worse right after the second shot I developed hot feet, numb, and prickly sensation up the lower leg. the left arm also feels numb. It is worse at night. I did blood work, EKG and went to emergency room but all seems normal. Still suffering from the same issues.
Information has been received from a nurse and a medical assistant concerning a 44 month old female who on 03-MAY-2006 was vaccinated with her only dose of VARIVAX (Merck) (lot# not reported) 0.5ml SQ on the right thigh. On 01-JAN-2009 (also reported by the nurse as 06-JAN-2009) the patient experienced chickenpox and she had been on BENADRYL for it. The patient was seen in the office and was started on acyclovir. Lesions were on both sides of the cheek, on the lips, chin, part of the neck, and a couple on the legs. The patient's chickenpox persisted. Additional information has been requested.
HAD A PERIOD IN JAN AND AUGUST 2022; BODY GOES THROUGH EXCRUCIATING, UNBEARABLE SWELLING THAT MAKES ME FEEL LIKE I AM GOING TO SUFFOCATE; UNGODLY AND EXCRUCIATING BACK PAIN; BODY IS IN HORRIBLE PAIN EVERY MONTH; DID NOT HAVE A PERIOD FROM MARCH 2021 TO JAN 2022; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Before the vaccine, the patient had normal monthly periods. She never cramped, nor ever had the extensive swelling throughout her body. She had very mild periods. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced body is in horrible pain every month, and did not have a period from march 2021 to jan 2022. On 10-MAR-2021, the patient experienced body goes through excruciating, unbearable swelling that makes me feel like i am going to suffocate, and ungodly and excruciating back pain. On JAN-2022, the patient experienced had a period in jan and august 2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body goes through excruciating, unbearable swelling that makes me feel like i am going to suffocate, ungodly and excruciating back pain, body is in horrible pain every month, and did not have a period from march 2021 to jan 2022, and the outcome of had a period in jan and august 2022 was not reported. This report was non-serious.
About 8 months after vaccination I started to get this deep excruciating pain in my left arm pit. The pain would come and go sometimes worse than other times. After about 3 months the pain had gone from my left arm pit to my left leg behind the knee. The pain in my arm at this time still persisted but was mild. Yet the pain in my leg was now immense and on going. It was so bad I went to the emergency room expecting it to be a blood clot. During my visit to the E.R. I got no information. I was told it was not a blood clot and that there were no signs of anything to be alarmed about. I got nothing for pain and no follow up dates. About one month later the pain had receded almost entirely in my arm and the pain in my leg moved down to my left calf where it remains till this day. It has not got any better and I cannot function daily if I have to be standing up for any longer than maybe a half hour sometimes an hour.  I have been to the E.R. once more since the first visit.
constant headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date 24Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "constant headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9.5 x 7 cm area of erythema, firm induration, tenderness surrounding inject site accompanied by fever (Tmax 39); appeared w/in 24 hrs of inject; treated w/hot/cold packs lt thigh affected;
On 11/25/20 had a physical and they took him off of Atenolol, and put him on Metoprolol, one a day at bedtime.  He took those for almost 2 months without any problem until he got his shot.  He took his pill at 10:00 when he went to bed, woke him up around 12:30 AM and had severe itching all over his back, and his mouth, tooth area felt like they fell asleep.  Got some water and rinsed his mouth and felt that it was something he ate.  Again for the next 2 nights after taking his blood pressure medicine he was woken up with the same feeling (like it was asleep).  It did not affect his swallowing.  He then called his doctor and he put him back on his other medicine, and not having any trouble since switching back to Atenolol.  He is scheduled for the 2nd vaccine on 2/25/21.   Has an APT with his PCP 2/16/21.
Migraines followed by syncope. Has been occuring since 3 hours post vaccine. Still occuring as of 70 hours post vaccine
Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had frostbite/tingling on and off. This has reduced in effect over time.   I have developed strong chest discomfort and a cough exactly 48 hours after receiving my second dose.
angiodema eyes and lips  and itchy throat for about 12 hours extreme repetitive sneezing extreme runny noise  took benadryl. Only eye swelling left by following morning which resolved by noon that day.  I slept with an Epipen handy but did not need to use it.
The worst headache ever; nausea; chills; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. On 26th October 2022, 2 days after receiving Shingles vaccine, the patient experienced headache, nausea and chills. On 26th October 2022, the outcome of the headache, nausea and chills were recovered/resolved.   The reporter considered the headache, nausea and chills to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media The patient received her 2nd dose of Shingles vaccine 2 days prior to the reporting. The patient experienced worst headache, nausea, chills. The patient reported that she received text from her friend that she had shingles, she then described how painful and uncomfortable her experience was. The patient had read articles about shingles, learned about prevention and talked with doctor. After listening to her friend described what she was going through, she took action.  Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Initial misuse report received from a healthcare professional on 13 August 2013. A 70-year-old patient was administered a dose of DAPTACEL vaccine. No more information was provided. No adverse event was reported. Documents held by sender: none.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (Lot#, dose and route not reported). On an unknown date the patient experienced "flu like symptoms" after receiving vaccine. The patient saw the doctor for medical attention. No treatment was given. On an unknown date the patient recovered from "flu like symptoms". Additional information is not expected.
Headaches: Patient has a history of migraine headaches(first seen 2005 for recurrent HA), mother feels that intensity and frequency of headaches have increased since gardisil vaccine was given. Severe headache within 24 hours of 3rd dose.Patient was assymptomatic at time of visit.
Moderna COVID-19 Vaccine EUA NO ADVERSE EVENT at this time  Employee received full dose of 0.5ml instead of booster dose of 0.25ml
mom gives hx of pt high pitched screaming 2PM-5PM day of vax 4MAY93; no hx of fever; mom called MD;
first dose was on 2/7/2021 and his second dose was on 5/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd February 2021, batch number A955S and expiration date 22nd May 2022).   On 13th May 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   The reporter considered the drug dose administration interval too long to be unrelated to Twinrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient received his 2nd dose late by 3 months which led to drug dose administration interval too long. The reporter was looking for guidance, as patient received both vaccines have same lot number and expiration date. The reporter consented to follow up by Fax.
Cellulitis; Fever; Body aches; Chills; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading; have very sore arms; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: DF1306, NDC number: 0005-1971-02, Expiry Date: 31Aug2022), via an unspecified route of administration on 14Oct2020 at 0.5 ml, single in left deltoid for immunization, diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL, manufacturer: Sanofi, lot number: U6807BB, NDC number: 49281-400-20, Expiry Date: 10Sep2022) via an unspecified route of administration on 14Oct2020 in right deltoid at unknown dose for immunization, influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT, manufacturer: Sanofi, lot number: UJ497AA, NDC number: 49281-720-10, Expiry Date: 03May2021), via an unspecified route of administration on 14Oct2020 at 0.5 ml in left deltoid for immunization. Medical history included inflammatory arthritis, inflammatory bowel disease, arthritis, nasal allergy/nasal drip allergy, and anxiety. Concomitant medication included loratadine for nasal allergy, sertraline hcl for anxiety, tofacitinib citrate (XELJANZ), methotrexate, folic acid, celecoxib (CELEBREX) for arthritis. Patient received other concomitant therapy. Patient had 3 vaccines on this past Wednesday in Oct2020, and proceeded to get what may be cellulitis and patient was not self-diagnosing herself but she had fever and body aches and chills and had golf ball sized lumps in both arms and one of which was both hot and red and one was spreading. So, she marked off her arm with a sharpie and at present it was starting to get better. She marked it because it was just not looking good and then she woke up this morning and then the fever broke, she felt tremendously better than she did the night before, but still had very sore arms. She had what was no longer a golf ball size, may be just, actually it was probably still a golf ball sized lump in her right arm and two smaller lumps in her left arm. Those seemed to be doing fine other than mild to touch, soreness but the right arm just completely went, that was the wrong one. The left arm went down significantly but the right arm still had a pretty good sized hard lump. No treatment received in response to adverse events. The outcome of fever was recovered on 16Oct2020, outcome of the other events was unknown.
child received vaccines listed below, fainted approx 5 mins after his shots, head struck edge of exam table as he fell.
The next day ended up being sick with sweating,  dehydration,  cold, no appetite and slept all day,  The 2nd day felt a little better and started to have chest pains at night. 3rd day in Morning,  went to emergency room and they first described me as having a heart attack.  Was in hospital for (4) days and result is having takotsubo cardiomyopathy. Said my heart was only operating at 50%
neurological issues; uncontrollable shaking of her head; autoimmune disease; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 28-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neurological issues, uncontrollable shaking of her head and autoimmune disease. As a result of these symptoms, the patient was seen and treated by health care professional. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations that were not present prior to using zoster vaccine live (ZOSTAVAX), the patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Furthermore, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered as not recovered. Causality assessment was reported as related. At the reporting time, the patient was still under health professional care.  Upon internal review, the event of autoimmune disease was determined to be medically significant.
Information has been received from a consumer concerning her 17 year old daughter, who on 03-OCT-2008, was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscular. The patient was fine and had no pain and no side effect after receiving the first dose of GARDASIL on an unspecified date. By the evening of 03-OCT-2008, the patient experienced pain. The patient complained it hurt a lot. On 05-OCT-2008, the patient developed rash over forehead and spread into hairline to scalp. The mother would alert a physician to examine and assess the patient. This is one of two sibling reports from the same source. Additional information is not expected.
Projectile vomiting for 2 weeks, fever spikes on and off for 3 days, gastroenteritis diagnosed. Resulted in child having to be put back on formula for 3 months and wean solid foods back in.
Pt started to have swelling in throat, and swelling in hands complained of mouth dry at 15 mins after receiving flu shot. Pt was seen by nurse practitioner and given Epi Pen, Benadryl 25 mg IM, and non-rebreather was applied. V/S was monitored and EMS was intiated and arrived to pick up patient to take her to the ER.
Patient came in for Fluad vaccine around 430pm. Vaccine was dropped into system correctly however once vaccinating tech went out to vaccinate patient, Moderna was given instead of flu vaccine. RXM went out to apologize to patient and informed her that we will be informing her doctor on incident. Patient wanted to hold off on flu shot until further notice. RXM called patient at 7pm to check how patient was doing and she was fine. Will call patient again tomorrow to check on her. Spoke with PCP office, doctor is aware and will also reached out to patient who reported no effect. Moderna vaccine manually entered into STC to show on patients vaccination record that Moderna booster (0.25ml) was given on 11/9/2021.
Employee started exhibiting sx 10 minutes after vaccine administration.  She started having chest heaviness, difficulty breathing and became tachycardic.  Employee was sent to the emergency room.
Myalgia, Fever, Diarrhea, RUNNY NOSE Narrative:
red and raised area around the injection site; raised area around the injection site; red area around the injection site; itching area around the injection site; Initial information received on 27-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 34 years old female patient who experienced red and raised area around the injection site (vaccination site inflammation) with its symptom  raised area around the injection site (vaccination site swelling) and red area around the injection site (vaccination site erythema) and itching area around the injection site (vaccination site pruritus), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6539AA and expiry date: 13-Nov-2021) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious red and raised area around the injection site (vaccination site inflammation) with its symptom  raised area around the injection site (vaccination site swelling) and red area around the injection site (vaccination site erythema) and itching area around the injection site (vaccination site pruritus), (Unknown latency), following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that, patient last menstrual period was 13-Jan-2019.  No lab data was data.  Final diagnosis was vaccination site pruritus and vaccination site inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for vaccination site pruritus and vaccination site inflammation.
3-5 min post vax, devel erythema over entire body & face. Papules on arms. No resp problems or other symptoms. W/in 5 mins, erythema disappeared. No treatment needed. Immediate fu ordered at hosp.
Narrative:  COVID infection following COVID vaccine series 12/21/2020, Pfizer, dose #1 01/21/2021, Pfizer, dose #2 08/17 pt cc: chills, cough, fatigue, headache, myalgias, exposure: unknown 08/24 COVID swab, result: detected 08/24 SARS-COV-2 Variant Sequencing result: pending 08/26 clinically resolved