chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing ears; Body aches; Shooting pains; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 20Apr2021 at 10:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mangoes and cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received prednisone (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 20Apr2021 at 22:00, the patient experienced body aches, ringing ears, chills and shooting pains. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, ringing ears, chills and shooting pains were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient had a warmed, itchy, and reddened area to the right deltoid. Patient denies fever and chills. Patient reports nausea this morning. Patient was sent to Emergency Department for follow up.
oropharynx lower lip with several clear liquid vesicles consistent with cold sores, no exudates, no tender or swollen anterior cervical lymph nodes, mucous membranes moist, NCAT, EOMI Resp: no respiratory distress, no audible wheezing, no accessory muscle use, speaking in complete sentences
The patient reports that he had electric shocklike pain immediately after the injection that radiated from his right arm to the hand. He additionally had similar shocklike pain on the right leg and even the left leg. On his way home from the office he develops severe headache while driving.  Additionally he had nausea and lightheadedness with body aches. Overnight, nearly 12 hours after the injection he developed tactile fever and body chills along with diffuse body aches.
Approx. 2 1/2 - 3 hours after injection, faint like s/sx; felt throat "closing".  EMS called - VSS, BB 245, patient wanted transport to ER.  Was told she was dehydrated & given 2 l fluids.  Back to work on 9/16.
menstrual period began a week earlier than scheduled and lasted longer and it was a heavier flow.
Initial report received on 08/17/2005 from a healthcare professional.  A 24 year old female patient received a first dose of Menomune, administered intramuscularly in error in the left deltoid on 08/11/2005.  That same day the subject developed large diffuse hives and itching that became progressively worse over the next 72 hours.  She was subsequently taken to the emergency room by her Mother and treated with Benadryl and a five day steroid taper pack.  At the time of this report the patient had recovered from these events.  Followup information received on 11/10/2005.  The reporter records hives in the illness at time of vaccination box of the VAERS form.  Further information is not expected.  At the time of this report, the patient had recovered.
5-10min p/vax pt c/o hyperventilation, & anxiety;pt had inc resp rate & inc BP;pt taken to ER;tx w/epi & sent home;
This spontaneous case was reported from a nurse concerning a 18 years old, patient of unknown gender. The patient's concurrent, historical conditions, concomitant medications and drug reactions or allergies were not provided. The patient was vaccinated with the first dose of GARDASIL 9 series for prophylaxis (dose, route, anatomical side of injection, lot#, date of expiration were not reported) on unspecified dates, outside the recommended dosing schedule according to the prescribing information. No adverse effects were reported.
This spontaneous report was received from a pharmacist concerning to unspecified patients at their facility, that then and in the past may had received a dose of M-M-R II (lot number not reported) (dose and route not reported), and had low rubella titers. Those patients were immunized with M-M-R II prior to being discharged from the hospital on an unspecified date. Concomitant therapy was not reported. The outcome of low rubella titers was unknown. Additional information has been unspecified.
Vaccine #1 given on  5/7/2021. Janssen Lot: 204A21A. Left Deltoid. Intramuscular.
arm is red at the injection site, It is red straight going down my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is red at the injection site, It is red straight going down my arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm is red at the injection site, It is red straight going down my arm). At the time of the report, VACCINATION SITE ERYTHEMA (arm is red at the injection site, It is red straight going down my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-022253 (Parent-Child Link). This case was linked to MOD-2021-022253 (Patient Link).   See case MOD-2021-022253 for details regarding the child case.
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. It was reported that "yesterday", on 26-AUG-2009, the patient developed an injection site reaction after receiving PNEUMOVAX 23. It was reported that the patient had local redness and swelling at the injection site. The patient sought unspecified medical attention. The outcome of the patient was not reported. Additional information has been requested.
Shot given to me in left arm at the pharmacy where the rx had been sent by my doctor.  I had head ache right away and a little dizzy then 2 days after shot broke out in hives on neck/face and a rash on arm right below injection and on the right side of my abdomen
Painful swollen lump at injection shot day after injection, pain resolving within 2 days. Itchy red circle appearing a week after injection and is ongoing.
Severe itching and whelping at the injection site AFTER 8 days from injection date given and still lasting after 3 full days
Bacterial infection - redness, warm to touch, swelling-spreading (upper arm). Emergency treatment - antibiotics and steroids.
Tachycardia (110 bpm supine at rest), chest pain, fever (100.3ºF), headache, chills and insomnia. All symptoms with onset around 2:00 am on 11/6/2021.
SEVERE PAIN IN THE SHOULDER AND DIFFICULTY MOVING ARM WHERE SHOT WAS GIVEN.
Painful cramps, heavier period on first day with clots. Not my usual period, heavier.
Herpes Zoster Information has been received from a physician concerning a 10 year old white male patient who in the PM on 12-NOV-1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #627748/1059H). On 29-DEC-2005 the patient presented to urgent care with eye pain. "The Urgent Care staff really didn't do anything for the patient at that time." On 31-DEC-2005, the patient presented again to the urgent care and was diagnosed with herpes zoster which was all over his right eye and forehead, scalp and the top of his head. It was noted that he developed vesicles with scabbing, itching and dermatomal distribution. The diagnosis was confirmed by an ophthalmologist. It was noted that the patient recovered. There was no product quality complaint involved. Follow-up information has been received indicating that a specimen of a scabbed vesicle was sent for VZV identification testing. Results of the test indicated that the specimen was inadequate, therefore, no values were reported. No additional information is expected.
This spontaneous report as received from a consumer refers to a 82 year old female patient. On an unknown date in 2007 or 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported, route was under the skin in her arm). Concomitant medications were not reported. The patient had shingles a few years after getting the vaccine. She went to the emergency room on an unknown date in FEB-2013, with burning, itching red blisters under her breast going in a strip to her back. The patient stated that today she woke up with red spots on her right ankle and groin that are itching and hurt. Treatment rendered for the events included valacyclovir and prednisone. The outcome of the reported events were unknown. The patient sought medical attention. Additional information is not expected.
1.5 days after vaccination I develop severe, debilitating spasming of the left leg and lower back. Associated inability to ambulate on my left lower extremity for 4 weeks. I also had numbness along the lateral foot and calf. I am just now recovering from this adverse reaction with physical therapy. I had never had spasming or pain like this in my life.
Patient received vaccine which had temperature excursion of negative 3 degrees Celsius for 22 minutes, No AE; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 28-Jul-2020.  This case involves a 2-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (Batch number UJ261AAA, expiry date:14-May-2021) via an intramuscular route in left thigh for prophylactic vaccination, which had temperature excursion of negative 3 degrees Celsius for 22 minutes (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of pneumococcal vaccine conj 13v (crm197) (Prevnar 13); a dose of rotavirus vaccine live reassort oral 5v (Rotateq); and hepatitis B vaccine (Hepatitis B Vaccine) for prophylactic vaccination.  This was a case of actual medication error due to product storage error temperature too low.  Reported stated that they had a temperature excursion yesterday with Pentacel and had questions about revaccination. It was reported that Pentacel was administered to a patient after the excursion. Caller wanted to know if the patient needed to be revaccinated. It was reported that the data logger had a momentary glitch and was out of range for 22 minutes and the temperature was negative 3 degrees Celsius.  At the time of report no adverse event was reported.  Outcome: not applicable.  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 and Module VI of the 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
To my knowledge, the patient hasn't had any adverse effects from the vaccine, but today (10/12/2022) it was brought to our attention that this lot number expired on 9/30/2022, so he received an expired vaccine.
Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the right side of the chest, along with systemic symptoms including fever and malaise. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt had fever of 100, malaise with the injection site, arm and chest inflammation for about 1 week.  Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 1 inches by one inch in size no pain.  Clinic staff mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
I had a headache. I was very fatigued. I had a fever and diarrhea. I had chills, sweats and I actually missed two days of work after that. I went to the ER July 5th at 4AM. I was vomiting and started having pain in my left jaw. I started having a cough and felt like my chest was filling up with fluid. My husband took me to the ER. They did run bloodwork, and everything came back negative, and it showed something for my EKG. The next day they gave me a stress test which was medication induced. It was found during this test that I had an anomality which they transported me to hospital. I was admitted to hospital on the telemetry where they had me hooked up to a heart monitor and scheduled me for an angiogram. They went through my wrist instead of the artery of my leg. On Thursday, I was released from the hospital. They changed my meds due to the test results at that time.
Two day after vaccine I had a pain on my left side, left chest under or near left breast.  It was a constant pain or discomfort.   It lasted from Friday-Monday .  I was concerned that maybe was a blot clot ( I have two clotting disorders)  I did know about this site until today.  It was not explained to me at the Vaccine clinic.
Recipient of her first dose developed isolated perioral numbness without any pruritus or other sense of swelling,, without shortness of breath, chest tightness, nausea, rash, or headache. Her blood pressure was taken several times with systolic pressures in 210 plus range and diastolics near 100.  She is under a physicians care,, takes no medications, and has never been hypertensive, including a meaurement at her recent physical. She declines further evaluation today but will contact her primary care physician for followup advice.  She has not had similar reactions to injections and was asymptomatic after 5-10 minutes.
Temp 103.4; Irritable x 1 wk; Fever x 72hrs
Within two days she noticed under her right arm swollen (has improved somewhat). She had the injection in her right deltoid. She started to feel very tired, lightheaded, dizzy (has spinning when she lies down), no appetite. Has not improved as of 5/26/05. The right side of her face is sometimes numb - mostly around right eye and below. Also noticed this in her ear as well. She has blurred vision in both eyes. She has had days where it lasts all day, and other days where it improves in the evening. She had nightsweats in the beginning.
Injection burning, then next morning temp 99 degree F and right arm red swollen and hot to touch has continued.
Seconds after an unknown dose of Moderna was injected, red rashes appeared on my  arm, itching, hives, generalized flushing, loss of muscle tone that I fell from chair to floor. I lost consciousness for few seconds. I remembered being carried and transferred to bed and then I started to have uncontrollable movements of my head and all extremities. The doctor called 911 and I was transferred to the hospital via ambulance. I was observed in the ER until night time of the same day and then I was discharged.
Pt. presented to pharmacy requesting a flu shot for the current year. She stated that she had had pain in her left arm since receiving an immunization on 11/21/2017. She stated that from "what she had read" she believed it was due to the pneumonia shot she received on the same day. We retrieved the paperwork from 11/21/2017 and it showed the immunization given in the left arm was FLUAD. Patient stated that since she received the injection her arm has been sore, even when she lifts her arms to move her hair. She has not seen a doctor about the pain. Patient was advised that she should contact her physician regarding the pain in the left arm and that all further flu shots should be given in her physician's office.
cough; felt bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and COUGH (cough) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZLA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (felt bad). On an unknown date, the patient experienced COUGH (cough). At the time of the report, FEELING ABNORMAL (felt bad) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Tylenol was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090146 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090146:Case for wife
2 day history of weight loss, tremors and unsteady gait. Past medical history: Recent illness with pneumonia. 2 weeks ago child was diagnosed with pneumonia, right lower lobe pneumonia on x-ray. Treated with Omnicef for 10 days.  Symptoms initially improved for 5 days.  On day 6 of antibiotics cough increased and complaint of stomachache.  Child was started on Zithromax and to continue course of Omnicef.  Child improved clinically and was seen in the office 4 days ago for well-child exam. He was given influenza vaccine 12/19/15. Last medications 5 days ago. Diagnosis Cerebellar Ataxia.
Severe, debilitating Tinnitus. Described as a loud swooshing noise in-ears that has not subsided at the time of this report. The Tinnitus started immediately after the first vaccination and became stronger and more debilitating immediately after the second Moderna shot. The patient has seen multiple doctors and they cannot give an explanation or cure.
Developed shingles, had had only the first dose; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for ulcerative colitis.   Concurrent medical conditions included ulcerative colitis (UC).   On an unknown date, the patient received the 1st dose of Shingrix and Xeljanz 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. Xeljanz was discontinued. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The age at vaccination was not reported. The patient developed shingles about one month after starting Xeljanz for her ulcerative colitis.  She had only the first dose of Shingrix. She had been discontinued (DCed) from Xeljanz and was recovering.  The reporter did not wish to be contacted for follow-up.
Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history and no allergies who on 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 659184/0843X). Concomitant therapy included VARIVAX (Merck) (MSD) and BOOSTRIX. The patient received her first dose of GARDASIL on 23-JUL-2009 and "passed out" while getting into the truck to go home and scraped her hands and knees. The medical assistant mentioned "when her mother got to the truck the girl (the patient or her sister) who was sitting in the truck did not remember getting into the truck". She did not indicate which girl it was. The patient was escorted back into the office and laid back down with the legs up and was given water "since it was really hot yesterday." The patient was discharged from the office to home with her mother and younger sister. No lab diagnostics study was performed. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive on 11Aug2021. Full vaccination (2 doses) completed in Mar2021. It was symptomatic, not hospitalized. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 11Aug2021. Positive rapid antigen Covid test following full vaccination. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
headache; pain In The back of my thigh; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Administered Tdap instead of Td to a 74 year old patient.  There were no adverse events.
Awoke at 6:00 PM 12/15/09, 112 hrs post vaccination with itchy rash on palms.  Rash progressed to legs and a general itchy feeling all over body by 3:00 PM.  Indicated yard work had been done the day before shot, including picking up yard / shrub waste.  Went to MD.  FU call back:  Symptoms not considered part of vaccination reaction.  Given antihistamine by MD.
Feels "woozy" and light headed, shaky per patient.  VS stable.  Unable to obtain Pulse Ox due to patient's nail polish.  Observed until 1718pm and wants to go home after something to drink.  VS continue stable.  No symptoms of anaphylaxis.
Arthalgia of joints.  Stiffness of extremities.  Tx:  Steroid, anti-inflammatory.