chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In May 2019, the patient received Boostrix. On 20th May 2019, less than a month after receiving Boostrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Boostrix.  Additional details were provided as follows: The healthcare professional stated that the patient was vaccinated with Boostrix 2 weeks ago, from the date of reporting and was experiencing pain in the arm. There was no redness or swelling. There was not red to the touch. There was only pain around the injection site.
Feb 8 started having severe abdominal pain intermittently, continue Feb 20th when I went to doctor, received cat scan, diagnosed with diverticulitis.
This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect". A non-contactable consumer reported for a female patient (daughter). A female patient of an unspecified age and race received, on an unknown date, TRUMENBA single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced nausea. Clinical outcome of the event was unknown at time of this report. No follow-up attempts possible. No further information expected.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 9 years old female patient who experienced inflammation, induration and flushing, while she received vaccine influenza vaccine. The patient had past vaccination with flu shot and experienced same reaction (inflammation, induration and flushing). On 04-Oct-2018 (07:00 PM thursday), the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date (Friday AM), the patient developed a non-serious arms swollen and arm to touch (inflammation) (Unknown latency), hard to touch (induration) (Unknown latency) and arms swollen (flushing) (Unknown latency) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was arms swollen, hard to touch and arms swollen and arm to touch. Doctor recommended cool compresses, zyrtec or Claritin/ Benadryl if needed. The event outcome was reported as Recovered / Resolved (on Sunday PM) for inflammation, induration and flushing. List of documents held by sender: none.
Patient felt "a rush" come over him & becamed faint & fell to floor as was being assisted to bed. Pale. BP108/84, P75. States he has anxiety to new things, especially shots,  & also had not eaten since 5pm yesterday.  Drank 2 juices & rested.  Reported feeling better.  Accompanied via wheelchair to pick-up ride.
I forgot to get my second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I forgot to get my second vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I forgot to get my second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I forgot to get my second vaccine) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Dime sized knots under my skin .. I still have some of them, especially on my right leg and left arm pit. I have constant pain that can radiate to my neck or hands. Usually  it starts in my back but sometimes it?s my whole body. My body feels like a bag of concrete at times.. I feel stiff and heavy when the pain is bad. I?m in constant pain and have to take Advil or ibuprofen every day. When the pain is really bad my whole body throbs. I also take flexeril and hydrocodone as needed when the pain is really bad. My left side also twitches but you can?t see it, I just feel the twitches. I have lost 2 jobs due to my pain and having to take hydrocodone.
ELEVATED IMMUNE RESPONSE; EXTREME EXHAUSTION; 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, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the subject experienced Extreme exhaustion. On an unspecified date, the subject experienced Elevated immune response. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme exhaustion and elevated immune response was not reported. This report was non-serious.
Arm Pain that moved to the underside today Fever of 101.9  abdominal and rib pain Chills Achy all over
pt recvd 1st dose of vax 22JUN92 w/no noted problem; JUL92 pt was vaxed w/2nd dose of vax & on 23JUL92 pt devel a limp feeling from shoulder to elbow; By that evening exp total body listlessness; over the following 3 days, devel itchy;
Redness, swelling, itching at site w/in 15 min. of receiving shot. Itching on entire (R) arm and both hands. Took ZYRTEC at home. Offered EPI, but pt. decided on no treatment. Refused.
Information has been received from a health care professional concerning a 19 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL. It was reported that after the second dose of GARDASIL she developed lymphoma. It was reported that the parents were trying to associate it with GARDASIL. The patient was no longer a patient with this practice due to her age. It was reported that she was going to an Obstetrician/Gynecologist practice. The outcome of the patient was not reported. Upon internal review lymphoma was determined to be an other important medical event. Additional information has been requested.
Chills, Fever, headache, Body aches, loss of appetite, dizziness,
Petechial rash on full left upper extremity in patches which then appeared on left upper extremity in patches the following morning.  It then spread down her arm. She was seen in the office on 5/30 for this and followed up on 5/31. On 5/31 she presented with similar rash to right arm.  She has a history of epistaxis and severe menstrual bleeding. Spoke with hematology and infectious disease, no treatment advised at this time.
Restless sleep, sweating, chills, fever, extreme fatigue, pain to injection site
9:40 AM TDAP, MMR ADM.  FEW SECONDS LATER CLIENT HAD FAINTING EPISODE MILD SEIZURE LIKE ACTIVITY LASTING 20 SECONDS.  NO INJURY OCCURRED.  JUST LEANED AGAINST MOTHER AFTERWARDS WAS ORIENTED TO DOB, TIME AND PLACE.  REFERRED TO PHYSICIAN DID NOT GO,  MONITORED 30 MINUTES.  PHONE AT 1:30PM AT HOME.  EATING AND DOING WELL. NO FURTHER PROBLEMS
Patient called at 11:00 am on 10/24/06. Received flu vaccine on 10/23/06 around 1:00 pm. Approximately 1 1/2 hours after injection patient complained bitter taste in mouth which she still had as of this next day conversation. Patient denies any SBO, swelling in mouth, SOB, urticaria. Advised to go to PCP or local ER and notify me of results. I called patient on 2 separate dates to checkon her but she would not speak to me. She did call in & talk to another nurse & she said her son was a physician & she was returing ho,e to be checked by him. No further correspondence with her.
mom noticed rt leg swollen & red from knee thigh & pt was reluctant to move leg this AM; noticed fever; took to hosp;
Patient received the vaccine (dose 2) on Thursday, woke up early Saturday morning with hives all over body - no history of reaction to anything. Did not take anything. Went back to sleep. Reaction resolved within 4 hours. No other identifiable changes in diet or detergents.
Immediately after the vaccines the patient was crying, turned blue, stopped crying and slumped over on to mom's chest. This was brief and only a few seconds.  This happened again while mom was driving the patient home and took longer to get the patient to respond.  She pulled over and felt like the patient was OK, so she did not take him to the emergency room as advised.  So far after this he has been OK and without any odd episodes.
pt recv vax 10JUL97 & 11JUL97 pt exp rash around mouth;
Severe back spasms and back pain, leading patient to be immobilized for 2 1/2 days.
Enlarged lymph node under right arm pit.  Currently on antibiotics and steroids for it.  Not sure outcome quite yet.
SWELLING AND REDNESS APPROX 7 CM IN SIZE. CHILD C/O ITCHING.
EXTREMELY HIGH FEVER; This spontaneous report received from a health care professional concerned an adult male. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced extremely high fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely high fever was not reported. This report was non-serious.
8 days post smallpox vaccination fever, myalgia, fatigue, nausea; 10 days post vaccine, shortness of breath with exertion, fatigue.  After 2 days of rest, shortness of breath resolved
Within hours of initial injection, area swelled to golf ball size, red, warm and very tender to touch. Worse on day two but gradually got better by day 5, treated with MOTRIN and TYLENOL and 4mg of prednisone in 3 doses.
1st dose in November 2019 but not the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   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 as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter inquired, if the patient should restart the series. No additional patient or vaccine information was provided by the healthcare professional.  Follow up left blank as this was a webform request.  No address provided but email address was provided.
15-month-old female who is admitted to the PICU from emergency department with a concern of status epilepticus. The child was found by the mother early morning on the day of presentation with generalized tonic-clonic seizure and head deviation. EMS were called and they administered 1 mg of ATIVAN upon transporting the patient to the emergency department. Upon arrival to the ED, child received subsequent doses of ATIVAN due to continued seizure activity in total of 6 mg. This resulted in respiratory depression and RSI was done. Head CT was performed and was negative. She was loaded with KEPPRA and fosphenytoin then she was started on ATIVAN drip and transported to another Hospital. Patient had low-grade fever for the last 2-3 days. No history of trauma. There is negative family history of epilepsy. She has also had regression of motor and language milestones over the past months.
Patient sitting for prescribed observation time.  I noticed her blinking rapidly and stepped out to ask if she was ok, she stated her vision was blurred and then proceeded to have what appeared to be a very brief seizure (5-10 seconds in length) then passed out briefly (10-15 seconds) when she came to she seemed completely normal again.  We had her lie down on the bench and she drank some water, she was sweating more than normal.  After 30 minutes or so she sat up for 5 minutes or so then stood and walked with mom out of store.  Mom called pediatrician to see if they could have her seen.
Systemic: Flushed / Sweating-Mild, Additional Details: She said probably triggered are anxiety
Patient is a 67y.o. female very pleasant with PMHx HTN, COPD on 3L home oxygen, CAD/Stent, Hypothyroidism, Chronic Non suicidal Depression presents with cough, nasal congestion and shortness of breath for the past 2 to 3 days. Patient apparently; lives with her Daughter who has been sick and was diagnosed with COVID-19 yesterday and she believes that she got it from her but she is vaccinated. She denies chest pain, palpitation, fever, nausea, vomiting but had diarrhea the first day and she had to increase her oxygen to need to 4 L with increased clear mucous producing cough. She has not been able to take care of herself due to feeling weak and low energy. Denies recent travel and no new medication but she was in our facility from 12/3 to 12/7 post MVA secondary to syncope of unclear etiology.
Rash- redness- on the side of ---------- about 6 cm in diameter erythmatous rash. Rx benadryl
c/o feeling flushed and heart racing after vaccination. Vitals stable. P 134/87, HR 86, RR 16, Sats 94%. No CO, no SOB. Recovered and discharged home.
7 days post vax pt experienced a fever of 102F axillary. Pt was treated with Tylenol and fever decreased somewhat. Pt remained feverish for 5 days.
HEART ATTACK - 100% Blockage in Left Artery - STENT INSTALLED
BRIEF OVERVIEW: Admission Date: 8/9/2023 Discharge Date: Aug 19, 2023 Discharge Disposition:  skilled nursing facility      Active Issues Requiring Follow-up: PCP ?  No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Fall, initial encounter [W19.XXXA] COVID [U07.1] COVID-19 virus infection [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 93-year-old female with a past medical history of chronic thrombocytopenia, diabetes mellitus type 2, hypertension, hyperlipidemia and dementia who presents with a chief complaint of fall.  Patient's daughter tested positive for COVID-19 a week prior to admission.  She tested positive at home on 08/08/2023 for COVID.  Family noted she had progressive weakness over the last week.  She had an unwitnessed fall.  Her daughter did not believe she hit her head.  She also was noted to be increasingly confused for the last few days prior to admission.  In the emergency department, she was hemodynamically stable.  She was afebrile.  She was not hypoxic.  Her she was noted to have pancytopenia which was acute on chronic in terms of her platelet level.  CT head and CT C-spine were unremarkable for acute injury, though there was questionable findings that could be consistent with compression fractures in her cervical spine.  Chest x-ray showed bilateral opacities.   She was admitted under observation to the hospitalist service for COVID-19 pneumonia.  She was treated with IV remdesivir.   PT/OT recommended SAR.  The patient was discharged to subacute rehab 8/19. at the time of discharge patient was in good spirits and eager to leave. all questions and concerns addressed, all meds and follow-ups reviewed. advised to follow-up with PCP after rehab.
Sensation of heart rate increase but blood pressure machine sensed absolutely nothing, very nervous and paranoid, biting my finger nails until they bleed, difficulty sleeping that night and the following night. Wouldn't get again for my second shot. Pfizer manufacturer should be in trouble because this is also on the streets. It tends to make people dye their hair red and become bossy/hotheaded.
Approximately 10 minutes after vaccination, patient told mom that she felt like she had to vomit.  Nurse placed a waste basket in front of patient, but no vomiting occurred.  Her face appeared pale, and she began breathing rapidly.  While sitting in chair, patient was encouraged by nurse to lean forward and put her head between her legs but did not comply.   She became diaphoretic and cool moist compresses were applied to her head and neck area.  Assisted by nurse and her mom, patient moved slowly to exam table and lied on her left side.  Vital signs taken?128/82, P-103, Pulse Ox-98, and she agreed to place her mouth around a paper bag to breathe.  nurse was present for translation purposes at this time.  Her breathing rate became less rapid at this point. Vital signs taken again were 95/61, P-85.    She complained of numbness in her hands and feet, which appeared rigid.  When asked to move her hands and feet, she did so minimally and slowly.  EMS was called and arrived promptly.  It was noted that her respirations increased when EMTs arrived.  She was transported to Emergency Department for evaluation and discharged to home same day. The nurse spoke with the patient?s mother, through translation services, later that same day.  Mom said that her child was home now and doing very well.  Mom told the nurse that the emergency department doctor said that her condition was caused by nervousness and her rapid breathing.  In addition, the doctor did not believe that she was having an allergic reaction to the vaccinations.  No bloodwork/labs/x-rays were ordered or performed.  Mom denied that any referrals were given.
Injection was given 05/30/2018. Patient came in 06/01/2018 to show reaction. The reaction was approximately 5 inches in diameter, redness, and blistering area 1.5 inches in diameter near a small BANDAID covering the injection site. Patient's daughter reported the reaction began 05/31/2018 and her mother was in the hospital on that day with fever when she noticed the reacton.
fever 103-104 & vomit approx 3 hrs p/vax; vomited 3-4 times that day; some diarhea, but no vomiting; shen seen the next day in the office;
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: cellulitis, growing erythema, swelling, heat.  Given ATB-Medium, Additional Details: Pt given ATB for increased swelling, erythema, heat.  Pt has daily tracked progression.  Site circled, currently 14 cm today in L detoid. Lot number of COVID-19 immunization not available to NP in Clinic.
Pt. given Hep A #2 in (L) deltoid IM. Within 3 min., pt. had redness at site and developed raised rash around site, up over shoulder and near armpit. Also had two small areas on (R) side of neck. Cold compress applied. Breathing normal, no distress. Child said arm felt "funny" but moved it with assistance. After 20 min of cold, rash was less and not raised. Instructed mom to monitor carefully and I keep cold on it during trip home.
This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat tightness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included METFORMIN and GLIBENCLAMIDE (GLYBURIDE) for Diabetes, ATORVASTATIN for High cholesterol. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat tightness). At the time of the report, THROAT TIGHTNESS (Throat tightness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medicines were not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-149672 (E2B Linked Report). This case was linked to MOD-2021-149408 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149672:Crosslink case for family member.
This case was reported by a other health professional via sales rep and described the occurrence of injection site warmth in a 64-year-old male patient who received SHINGRIX. Co-suspect products included SHINGRIX. On 4th May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) 1 ml and SHINGRIX (intramuscular) 1 ml. On 4th May 2018, not applicable after receiving SHINGRIX and less than a day after receiving SHINGRIX, the patient experienced injection site warmth, injection site erythema, injection site wheal, injection site swelling, inappropriate route of vaccination and accidental overdose. In May 2018, the patient experienced erection failure. On an unknown date the outcome of the injection site warmth, injection site erythema, injection site wheal, injection site swelling, erection failure, inappropriate route of vaccination and accidental overdose were unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site wheal, injection site swelling and erection failure to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical assistant. The SHINGRIX vaccine was initially administered subcutaneously under the tricep in the fatty part of the left arm, which led to inappropriate route of vaccination and then administered a second time an hour later intramuscularly about an inch from the first injections, which led to accidental overdose. The injection site was hot and there was a welt. The health care professional called medical information and described the previously reported weld as a red, raised, hot spot. Less than a week after receiving SHINGRIX, the patient experienced erection failure.
Intermittent temp up to 102 for 48 hours, then low grade temp for an additional 48 hours. Chills and shivering for about 2 hours during the first night. Headache, muscle and joint pain, dizziness, ringing ears and fatigue. Injection site pain, swelling, redness with warmth lasting 48 hours. Sore arm for 6 days
Initial misuse report received from a healthcare professional on 06 Mar 2014. A patient whose demographic details, medical history and concomitant medication were not reported received a dose of YF VAX vaccine on an unspecified date. (Route, dose, site and batch number not reported). It was reported that on an unspecified date patient received vaccine reconstituted with sterile water and administered. No adverse event was reported. Documents held by sender: none.
A medical assistant reported that the day after receiving vaccines the patient developed a fever and vomited twice. He also developed an injection site reaction characterized by swelling and tenderness at the site of Acel-Imune administration. On 8/4/00, the patient was seen by the physician and diagnosed with "local reaction to vaccine." He recovered. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of IPOL.