chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 2nd dose of SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and drug dose administration interval too long. On 15th March 2019, the patient experienced enlargement of lymph nodes and pain localized. On an unknown date, the outcome of the injection site pain, enlargement of lymph nodes, pain localized and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain, enlargement of lymph nodes and pain localized to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported this case for his wife. The patient received 2nd dose of SHINGRIX at greater than 6 month interval, which led to lengthening of the vaccination schedule. Three days after receiving SHINGRIX, the patient experienced Swollen lymph nodes and pain under right mandible.
No adverse event. Wrong formulation of vaccine given. Patient got a KINRIX instead of a PEDIARIX.
Large red rash at the injection site exactly one week after getting the vaccine. Slightly itchy but not painful.
Patient received FLUVIRIN MDV on 10/21/15. She called on 10/28/15 reporting hives, redness, and warmth in left arm on the day of immunization. Those symptoms subsided, then on 10/27/15 redness and rash on right hand appeared. That also subsided.
My shoulder on the side of injection is swollen, visible bump that hurts. Along with pain in back of  left shoulder area.
Mom sts" her arm is red and swollen where the shot was given extending down to the elbow.  I've been putting cool compresses on it since it was given." Mom asked if she has massaged the area sts "no." Mom was informed if feels uncomfortable, can follow up with doctor.
Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 (Lot number: 30125BA) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epileptic seizure" (unspecified if ongoing); "Disabled" (unspecified if ongoing); "Traumatic brain injury" (unspecified if ongoing), notes: Epileptic seizure due to traumatic brain injury. Concomitant medication(s) included: VIMPAT taken for epilepsy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: 30125BA, Dosage text: unable to provide, administered to right arm), administration date: 14Sep2021, when the patient was 26 years old, for COVID-19 Immunization, reaction(s): "Erythema", "Hot to touch".  The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovering", described as "Headache".  Additional information: The patient had no other vaccines the same day and no problem with vaccines in past. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect. Went for the second vaccine on 05Oct2021 and had a headache for a couple of days, 2-3 days, and it was better. Caller states she had questioned if it could have been a reaction because of his medication, Vimpact. No further details provided.  No follow-up attempts are possible. No further information is expected.
red spot at at injection spot; injection site sore and itchy; right arm at injection site swollen; right arm at injection site sore; covid arm; good size patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot) and VACCINATION SITE SWELLING (right arm at injection site swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (injection site sore and itchy). On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at at injection spot). In August 2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore). At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received contains. New event of injection site sore was added. Coding was corrected for the events injection site itching and redness
Two months after I received to vaccine I began experiencing ringing in my left ear which is now in both ears.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unknown date, patient administered a full, undiluted COVID-19 vaccine, with outcome of unknown. The patient asked for medical advice. No follow-up attempts possible. Information about batch/lot  number cannot be obtained. No further information expected.
Dizzy/disoriented, joint pain, sharp pain in lungs, headaches. Went to emergency room due to temp of 101.5 degrees F and pulse 121. Received IV fluids and MOTRIN.
Rash on forearms, worse on left side - Hives, spread to head, scalp, back, face - patient still showing some signs 10/2/10 - took BENADRYL.
This spontaneous report was received from a physician, via a company representative, concerning 1 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (doses, lot number, expiration date, strength and route were not reported) in the leg. Concomitant therapies included VAQTA and PREVENAR 13. The reporter stated an patient received (Oka/Merck) VARIVAX on an unspecified date, and experienced a lump at the injection site on her leg immediately following. At the time of the report the outcome was reported as recovered. Additional information is not expected.
Rash on both thighs starting 5/3/14, day after vaccine anterior thighs. Rash more raised on (R) thigh than (L). Had similar rash both anterior thighs after 2 mth shots though fewer bump than currently. Had fever 2 days ago (5-3) fussy (5-4) happy today 5-5-14. Not scratching thighs today.
Information has been received from a physician concerning a female patient who in approximately August 2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). Concomitant therapy included 3 other vaccines (therapy unspecified). The physician reported that the patient received the first dose of GARDASIL vaccine (yeast) and experienced syncope within a few minutes. She hit "here" head and lost consciousness for a few minutes. At a later date she had a computed axial tomography (CT scan) of her head which was negative. The patient sought medical attention in the doctor's office. No additional information at this time. She recovered. Additional information has been requested.
C/o lt sided weakness became weak, lost strength; BP 190/100, t103.5 treated & released @ ER 28SEP; hospitalized 4 days later w/pneumonia ? sl stroke;
Information has been received from a physician concerning a female with history of chemotherapy who was vaccinated with ZOSTAVAX. Subsequently the patient experienced zoster on the face. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician concerning a 60 year old female with a history of chemotherapy and breast cancer who on 22-JAN-2007 was vaccinated SC in the right arm with a 0.65 ml first dose of ZOSTAVAX (Oka/Merck) (Lot#652935/0621F). There was no illness at the time of vaccination. On 14-AUG-2007 the patient developed zoster on the face approximatly 10 lesions at the right trigeminal nerve. There was no rash at the injection site or elsewhere within 42 days of vaccination. The patient had pain which was a level 4 on a scale of 0 (least) to 10 (most). The patient had no other systemic symptoms. There was no recent exposure to chicken pox or herpes zoster. A DFA was not done. A specimen was not collected for PCR. A photo was not taken. On 29-AUG-2007 the patient recovered. No further information was provided. There was no product quality complaint involved. The patient had no adverse events following prior vaccination. Additional information is not expected.
Within 10 minutes, my chest got extremely tight. I was prepared for an anaphylactic episode, with my EpiPen in pocket, but not this. My chest hurt so bad I was trying to grab my heart with my hand. But very calmly because I didn't want to cause a scene. They called the ambulance that arrived from the fire dept. When it arrived, they hooked me up to an EKG, which showed my heart stopped and started again. I want to add they advised me not to get the second shot until cleared by my cardiologist. I have no health insurance, so that is not possible. I have not gotten 2nd shot either nor do I intend to. My pain went away completely after about a week or so. But after hearing of the inflamed heart and my experience, I thought I should share my story. Perhaps mine was as well. They wanted to transport me but again I have no insurance. I can't afford any insurance. I refused service but still have heart palpitations. Thank you and hope this helps somewhere down the line.
Father informed Dr. that shortly after MENACTRA and BEXSERO were given in the office 8/19/2016, Pt. experienced some very bad abd. pain which lasted 10-15 mins. Followed by diaphoresis, hyperventilation, and then carpopedal spasm - Received IV flds in ER and then sent home - Symptoms had resolved when arrived in ER.  8/20/16
Need vax on Monday IIA. Injection site is now red and itchy and getting worse instead of better. She is going to call her Dr.
13 minutes after injection- tongue tingling and numbness  for 3 hours. Hot flashes,  feeling hot, headache, and extreme fatigue.
Chest pain ( Heart) with any sort of stimulation. Causes great delay to my routine.
pre-syncopal, anxious, throat feeling congested/heavy, resolved, pt. left site.
01/15/2022 presented to ED for fatigue, loss of appetite, cough, non-bloody diarrhea and nausea.
Pt vaccinated with ENGERIX-B developed headache, anxious, rash, episodes of twitching, swollen eyes.
Lump 4 days Site rash  4 days Chills 2 days Aches 2 days Fever 2 days
ear infection; flu; high fever which reached 104.3 F; Initial information was received on 25-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 3 years old female patient who experienced ear infection(ear infection), flu(influenza) and high fever which reached 104.3 F (pyrexia) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   On 19-Dec-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via unknown an route in her left thigh for prophylactic vaccination.  On 25-JAN-2020, the patient developed non-serious ear infection(ear infection) ,flu (influenza) and high fever which reached 104.3 f (pyrexia)1 month 6 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date:  [104.3F]  Final diagnosis were influenza and ear infection.  The patient was treated with OSELTAMIVIR (OSELTAMIVIR) 60 ml BID and CEFDINIR (CEFDINIR) 60 ml 1xday.  At the time of reporting patient was recovering from all the events.  Information on the batch number was requested.
No adverse effects reported; an improperly stored dose of VARIVAX was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 22-JUL-2019, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route and anatomical location were not reported), lot # R020672 with expiration date 18-JUL-2020 and lot # S005084 with expiration date 19-FEB-2021, for prophylaxis. The doses of the vaccines were reconstituted with properly stored sterile diluent. The doses of varicella virus vaccine live (oka/merck) (VARIVAX) were exposed to a temperature excursion of 6 Fahrenheit degrees (°F) to 14°F (6.4 °F) during a timeframe of 15 minutes, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.
I had surgery 3 weeks after moderna #1. Surgery was 6/2/2021. On 6/11/21 I started developed symptoms of a PE (pulmonary embolism). On 6/14/21 I was officially diagnosed with a right lower lobe pulmonary embolism via CT scan. I have had 3 GYN surgeries in the past without any complications. Factor V Leiden negative. I wonder if the PE is related to the covid vaccine.
Three days after receiving shot, left elbow started swelling and a bruise appeared on same elbow. Could not move arm or hand. Had to bend arm in a 90 degree angle. Couldn't make a fist, everytime I tried to move a finger, I felt a sharp pain moving up to elbow. Lost use of left arm, needed help to get dressed and do other personal things. On Sunday June 8, left hand started swelling and pain was unbearable, went to work and manager sent me to hospital.
I had pain at the injection site which started after injection and increased in intensity from tenderness to pain around 5pm the day I received the vaccine (3/24). The pain has not yet resolved. I developed a fever of 101.2 degrees in the middle of the night, I estimate around 2am on 3/25. At this time I also developed chills and muscle aches.  I experienced high levels of fatigue all of 3/25. These symptoms have resolved as of 8am 3/26.
Fever of 99 degrees, terrible joint pain through out my body (unable to sleep due to pain), slight nausea, dizziness, pain at injection site, swollen lymph nodes on left side, painful headaches.
patient was not acutely ill but was found dead in her chair within 24 hours of flu vaccine.   1/15/08 Death certificate states COD as acute myocardial infarction w/chronic ischemic heart disease as contributing factor.
24 hours after injection: sharp stomach pain that roamed around the abdomen,  27 hours after injection: fever and chills, abdominal pain did not go away by night so I went to the ER 35 hours after injection.  I had a urinalysis, blood test, and an ultrasound to find the site of pain.  The ultrasound showed appendicitis.  41 hours after injection I had an appendectomy
Evening of 10/29/02 client with fever, chills, body aches, neck ache. Also noted redness and some swelling below site of injections Wed am symptoms continued with increased swelling/redness from injection site to elbow. Thurs am noted redness/swelling spread. Red and swollen ~ 4" band circling arm below injection site and ~ 2" above elbow. Tricep area only area not involved. Advised to see physician. Client state latex allergy. 11/1/02 spoke with client who saw MD 10/31/02 started on Keflex and steroid on arm. Redness decreased intensity but swelling same.
01/15/22 presents to Birth Center Triage for "contractions".  PMHx of "Anemia"
I had diarrhea, chills, headache, nausea, joint pain, and fever. I went to the doctor, and I tested positive for COVID-19. They told me if I wasn't feeling better to come back in. I wasn't feeling better, so I went back to the doctor. They gave me fluids because I was dehydrated. They checked my lungs, and they were clear. Now I feel so much better, but I am tired
FEVER; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on left arm on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
First throat felt tight & heart sped up. Then felt dizzy & weak. Returned to clinic for evaluation, felt like passing out, dizzy again. Symptoms came and went - dizzy, weakness, tightness in chest. Went to ER for evaluation. No treatment. (All within 3 hours of vaccination).
Second dose not given in over 1 year; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if 2nd dose of Shingrix not given in over 1 year, then was it okay to complete the series or need to start over. The follow-up could not be possible as no contact details were available.
I woke up by 9am with a headache, dizziness, chills, low grade fever, arm pain, and muscle pain. I was not able to work so I went to sleep for many hours. When I woke up my heart pulse was accelerated. I took paracetamol and chlorfenamine after talking with a friend who is a doctor and that helped me to feel better. Now it?s almost 10pm and it looks like the symptoms have stopped.
Patient is an 86-year-old woman with a history of T2DM, bicuspid aortic valve s/p AVR, CHF (EF 70%), HTN, and CKD stage 3 who presents with altered mental status including expressive aphasia with the last known normal of 7:30 a.m.. Per daughter, patient developed URI like symptoms on August 18th.  Chest x-ray was obtained at that time which did not show any evidence of pneumonia.  Her COVID test at that time was negative.  However, she was started on Augmentin, prednisone, and Tessalon Perles.  This Friday she noted worsening URI like symptoms and again returned to the doctor and was tested for COVID which came back positive on Saturday.  They had transitioned her to Levaquin and started a 2nd prednisone burst out of concern for COPD exacerbation and pneumonia.  Daughter did speak with her this morning and noted she was conversant answering questions appropriately and texting appropriately at approximately 7:30 a.m..  Throughout the day she stopped responding to text messages. the facility contacted the daughter to notify her that she was altered.  Per report, she is confused using inappropriate words and has word-finding difficulty.  There is no weakness in the upper or lower extremities other than left arm weakness from a known previous injury.
swelling around where shot was given, red, itchy, grew to approximate of size of baseball under skin, hard to the touch, sore and kinda numb at the same time.  Swelling, redness and itching first noticed Thursday, 1/28.  Today, Saturday the swelling appears to be going down a bit, still sore and numb and itchy.  I applied anti-itch cream and took Tylenol.
After first dose I had fever, chills and achiness the first night the it went away with 800mg of ibuprofen.  9 days later I woke up to a very swollen shoulder a red rash and itchiness. That lasted approximately one week.  I read that there are a few number of people with this delayed site reaction. It was the second does that I'm most concerned with.  After having fever, chills and aches the first night again I took 800 mg of ibuprofen again and was fine.  This time, however, approximately 8 days later I started feeling sick again. by the 9th day my neck was stiff, I had a fever and my muscles and joints were extremely painful. On the third day I went to the doctors and he ran a serious of tests on me including Covid, Type A flu and type B.  All were negative.  The doctor also requested a chest x-ray that came back fine and a series of bloodwork tests.  Nothing unusual came back so I am writing this response to see if anyone else has had this delayed reaction.  My fever went away this morning after 3 days but I can still hardly move around without pain.