chrisvoncsefalvay/vaers-outcomes huggingface dataset:
p/vax pt exp an inj site rxn which consisted of significant redness & edema;
Reaction began with swelling, pain, and redness in right upper arm on Friday night.  Fevers on Saturday and Sunday as well as headache and continued extreme pain/sensitivity in arm.  Following on-call nurse directions, Saturday night began using Ibuprofen and acetaminophen alternately to reduce fever and pain. Was still not feeling well Monday and Tuesday. Fever and headache returned on Wednesday. Arm finally began to feel better late Thursday into Friday, but began to itch. Arm still slightly itchy eight days following injection.
This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a family nurse practitioner (FNP) concerning numerous patients who on an unspecified dates were vaccinated with HPV (lot # not reported). Subsequently, the patients experienced stinging and sore arm after the vaccination. The outcome of the stinging and sore arm was not reported. No other information was available at the time of reporting. Additional information has been requested. Information has been received from a certified family nurse practitioner (CPNP) concerning a 25 year old female clinic employee who in August 2006 was vaccinated with the first dose of GARDASIL (lot # not reported). In October 2006, the patient was vaccinated with second dose of GARDASIL (lot # not reported). In February 2007, the patient was vaccinated with third dose of GARDASIL (lot # not reported). In October 2006, the patient experienced stinging and sore arm after the second vaccination. The patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CPNP via telephone. The sore lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been requested.
Sick from first 2 shots/I got so sick from the first 2 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "Sick from first 2 shots". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick from first 2 shots/I got so sick from the first 2 shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On October 17, 2022 I received a flu shot and 1st dose of a Shingrix Vaccine. They were each administered by injection into my left arm. The flu shot was administered first and the Shingrix was administered second by a different professional. I sat in a chair as the shots were administered. The person who administered flu shot kneeled on the floor next to me and administered the shot in an upward trajectory.  I felt this was odd at the time and also felt it was a much more painful shot than it needed to be. The person who administered the Shingrix shot administered it standing next to me and it seemed to have a normal trajectory and normal level of pain associated with an injection. By the  next morning upon waking, I was experiencing significant pain from my left shoulder up into my neck. Moving my left arm can be very painful and holding my arm in different positions is painful. This pain persists. The pain radiates from left shoulder, across shoulder blade and up into neck. Moving my head to the left and down will cause pain. The pain will sometimes radiate down my upper left arm. At times, the upper left arm twitches. The pain has occurred consistently since the administration of the vaccine and has made certain tasks difficult. By the end of the work day, I often find the pain to be very intense after sitting and typing at a computer for the day.
I was feeling very nauseous and sick during the evening of the vaccination. The next morning around the nausea was extreme. At around 2pm I started vomiting and had to take my clothes off.  My blood pressure dropped; I had a hypotensive event. I had to undress and yelled for ice and something to cool me off. I was vomiting a lot. I just laid in the bed until the ice cooled me off after serval hours. I finally felt around 8pm that night I felt that I could eat some crackers. That evening I was starting to feel better It was very gradual, I did not feel totally normal until 24 hours after that event.
This case was reported by a consumer and described the occurrence of vomiting in a male patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced vomiting, diarrhea, fever, chills and sweating. On an unknown date, the outcome of the vomiting, diarrhea, fever, chills and sweating were unknown. It was unknown if the reporter considered the vomiting, diarrhea, fever, chills and sweating to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, the next day after vaccination, he spent with vomiting, diarrhea, fever, chills and sweats. He stated he was completely out of commission. The patient enquired, whether he should have the 2nd round of vaccination with SHINGRIX and does he has to look forward to have more of the previous side effects.
mild dyspepsia; loose stools; Moderate deltoid soreness at injection site; chills; myalgias; hyperalgesia; headache; fatigue; grogginess; This is a spontaneous report from a contactable physician reported for himself. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 07Jan2021 08:45 at single dose in left arm for covid-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included triamcinolone 1% cream and diphenhydramine 2% cream.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on 17Dec2020 05:00 PM at single dose in left arm for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced moderate deltoid soreness at injection site within 2-3 hours; chills, myalgias, hyperalgesia, headache, fatigue, grogginess from 12-36 hours post injection (on 07Jan2021); mild dyspepsia and loose stools 24-36 hours post-injection (on 08Jan2021). The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021.
Chest pains and difficulty breathing. It became worse and he became extremely weak and sluggish. By Jan 1st wife took him to the ER. On the next day he under went surgery.
Redness, swelling, itching upper part of left arm surrounding site of Tdap, MENVEO injections. Firmness and warmth noticed by mother on 4/3/18 evening. Mother gave ZYRTEC 4/4/18. Dr prescribed BACTRIM oral antibiotics. Dr advised BENADRYL, cool compresses, ibuprofen. Patient still currently taking BACTRIM. 4 days post injections, still with redness and swelling.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L040053, expiration date 10-MAY-2017, (dose, route and frequency were not reported) for prophylaxis. Information regarding concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Approx. 1-2 hours, post vax, pt complained of shortness of breath with raspy cough. Appeared to have laryngospasm. Was seen by his MD and dx'd as a reaction to flu vax and given inhalers. Received lung RX with albuterol at MD's office.
I  developed Tinnitus soon after the first vaccine dose. Now I am experiencing severe headaches after the second dose. Headaches started two days after the second shot and have not stopped yet eight days after the shot.
severe enough to prevent me from sleeping or moving without vomiting; fever; chills; severe joint pain; sore throat; headache; dizziness; nausea; severe enough to prevent me from sleeping or moving without vomiting; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 10:15 (age at vaccination 32 years) as dose 2, single for covid-19 immunisation. Medical history included covid-19 prior to vaccination. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) occasional. The patient had no allergies. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:15 as dose 1, single for covid-19 immunisation. Facility type vaccine other was mass Vaccination Drive. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 21:30 the patient experienced severe enough to prevent me from sleeping or moving without vomiting, fever, chills, severe joint pain, sore throat, headache, dizziness, nausea. Patient received treatment for reported events took Excedrine. The outcome of event was recovering.  No follow up attempts are needed. No further information is expected
Muscles and joints swelling on both sides of the body.  Slow progression of pain until the pain was to much to work.  Muscles feel like the are torn and joints are swelling and painful like arthritis.
Information has been received from a physician concerning a 40 year old female who experienced pain on her shoulders, knees and sometime in her hips almost like arthritic pain after receiving the first dose of GARDASIL vaccine (Lot # was not available).  It was reported that the patient already completed the series last week (approximately 16-APR-2009) and after receiving the third dose of vaccine she experienced the same symptoms.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
Patient could not lift arm and experienced pain when trying to lift arm starting 6:00pm post injection received at 3:30pm on 11/3/21.  Patient is still experiencing pain, but can lift arm more than after initial onset. Patient can lift arm around 40 to 50 degrees close to 72 hours post injection. Patient is taking ibuprofen and will make appointment to see MD on 11/08/2021.  Patients wife states that daughter is nurse and stated that the injection was given too high.
Patient ID:  Age: 63 y.o.  Admit Date: 8/17/2022  2:43 PM  Discharge Date:  8/20/2022  Admitting Physician:   Discharge Physician: MD     Discharge Diagnosis:  Principal Problem:    Syncope  Active Problems:    DM (diabetes mellitus)    A-fib    COVID-19 virus infection    Headache    Essential hypertension           HPI:       Patient is a 63 y.o. male who is seen at ED after an unresponsive episode.  Patient currently reports that he lives at SNF and he went to the nursing desk and that was the last think that he would remember.  It was reported that he did have a syncopal event at the facility.  He reports that he has not noted any palpitations, chest pain, or SOA.  Admits to hx of seizure. Pt was difficult to arouse in the ED and a stroke alert was called.       Hospital Course: No notes on file     . Was admitted to neurology floor. He was on telemetry and there was no evidence of arrhythmia to explain this symptom. Orthostatic vitals not obtain as patient has difficulty sitting up or standing up from bed. He was given IV fluid hydration he was seen by neurology. Impression was possible pseudoseizure versus CVA versus acute metabolic encephalopathy. He has Covid 19 infection. He has no evidence of nocturnal infection. MRI of the head can be done as he have a cardio mems and spinal stimulator. He has been complaining of headache and he was given a cocktail for migraine headache and currently is improved. His back to his baseline. He was on airborne isolation because of the Covid 19 infection. He will be discharged to nursing home today.           Physical Exam on the Date of Discharge:  Physical exam:   General Appearance: alert, NAD   Neck: no JVD, no LN enlargement   Lungs: clear, no wheezing    Heart: RRR, S1 S2 heard   Abdomen / GI: soft, non-tender, no ascites   Extremities / musculoskeletal:  edema, no synovitis    Skin: no rash, dry skin   Neuro: follows commands, moves extremities            Consults:    IP CONSULT TO SOCIAL WORK     Significant Diagnostic Studies:     CT head: No acute abnormality.        Disposition:  SNF     Discharge Condition:  good
Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is ranging  from 130s-180s, becoming more elevated with activity. At rest it's varying from 90s to 130s. It is now 1/27/21 at 8:50am and symptoms have continued.
4AM on 6/24/14 feeling sick, vomiting and chills - Temp 101.5 - now at 9:37AM. (R) and (L) upper arms are not swollen, red, or tender to touch. 6-24-14 9:47AM I spoke with Dr and explained child's illness. She said to have mom give TYLENOL and ice chips and Gatorade. I then called and spoke with older brother and told him to tell mom to give ice chips slowly and give TYLENOL. Then to start sips of Gatorade if vomiting stops. I told brother I would call back in 2 hours to check on patient. 6-24-14 11:51AM Spoke with 15 yr older brother and he states patient's keeping down water and Gatorade. Brother states patient is feeling better and resting. I told brother someone would call tomorrow. 6-25-14 - TC at 8AM no answer. 6-25-14 10:15AM TC - no answer. 6-26-14 - 11:40AM TC to home. I spoke with brother and he states patient was Ok yesterday. He reports no more fever, nausea or vomiting.
reactions to the second shot; lymph node swelling; 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 VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, VACCINATION COMPLICATION (reactions to the second shot) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
VERY RED SWOLLEN AREA ABOUT 2 INCHES IN DIAMETER WHEN FIRST NOTICED AT 11 PM, 5-19-11. NEXT MORNING AREA IS LARGER, (4 IN.) MORE SWELLING, ITCHY, SENSITIVE AND SORE TO THE TOUCH. FEELS VERY HOT AND HAS PROGRESSIVELY WORSENED THROUGHOUT THE DAY.
Fever, chills, Fatigue, headache, shortness of breath/hard to breath, blacked out, fast heart rate, not able to stay awake skin was pale.
Headache, body ache, fever (101.6), swelling and pain at site.  Hardness at site and intense itching, also red and hot about 3" diameter around site injection.
Pt recvd 3 doses of Engerix-B vax on 6AUG90, 11SEP90 & 21FEB91 & 3FEB92 titer was tested & the response was neg; it was assumed that pt was not protected against Hep B; will get an addtl dose;
Had vaccine at 4 pm on 6/23/21 1 am woke to racing heart and palpitation lasted two hours and resolved 6 am woke  fever chills and achey 10 am racing heart, palpitations then resolved 1pm severe chest pain, severe tachycardia and low BP Went to ER  continued to be tachycardic and low BP, chest pain less, had episode of HR shooting up to 180 and then violently throwing up cardiac labs and EKG were normal left with tachycardia on standing and suggested we follow up with cardiologist asap- appt is 7/6/21 received one bag of IV fluids fever, erratic heart rate and lethargy resolved on 6/27/21
Pt received two vaccinations on 4/2/13 including pneumococcal  (R deltoid) and Tdap (L deltoid). Two days later pt presented with rash and minor swelling of (R) arm. Denied SOB, or other systemic sxs of hypersensitivity. Tx plan included diphenhydramine 50mg QHS and cetirizine. Pt denied ED visit or prednisone taper.
COVID-19 vaccine EUA. Patient contacted TCHD to cancel her second dose of  COVID-19 vaccine due to "bad reactions to initial vaccine". NP spoke with patient and obtained the following information: She has fibromyalgia but didn?t indicate that on her form or tell the nurse. She also had COVID in late November/early December. She reported a headache and arm soreness immediately following the vaccine, then fever, lethargy, body aches, and weakness that started 2 days later. The fever lasted almost a week and the other symptoms lasted about 2 weeks and she missed a week of work. Her doctor advised her to defer the second dose of the vaccine.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. The report refers to a 7 month old infant patient of unknown gender. On 11-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date: 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Varicella approx 50 pox. Child with ITP (stable). Started on Zovirax 600mg QIB x 5 days. will repeat platelets 09/23/2005.
7:10 PM Pale, weak, dropped to floor after vaccine. Cold compress, lay down with elevated feet. APG 6, BP 120/56. Vomited 7:50 felt better. Temp 97.2 degrees at 7:40 PM. 8:15 PM-left for ER via rescue. 8:15 PM Pt sent to hospital.
Mother reported within 7 minutes of receiving VARIVAX vaccine patient c/o hurting in chest and throat area and felt sick to his stomach. No shortness of breath. Lips slightly swollen, splotchiness on face, neck and chest. Eyes swollen. BENADRYL and TYLENOL were given. All symptoms subsided except eyes were still swollen until 2-5-09 mid morning. Mother reports that child vomited in office parking lot once after 4 year shots were administered 1-11-08. He received DTap; IPV; MMR and Hep A.
This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PROQUAD Lot # L034930, expiry date 03-MAR-2017; Lot # K022444, expiry date 13-MAY-2016; Lot #, reported as L040415, expiry date 13-APR-2017; Lot # L030584, expiry date 10-FEB-2017; Lot # L032759, expiry date 24-FEB-2017; Lot # L004005, expiry date 05-AUG-2016 (dose and route were not reported), were given to unspecified patients on unspecified dates. It was reported that the nurse did not know which of the above lots were actually administered. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Case number PHEH2014US025353, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 53 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
This spontaneous report as received from a physician via a company representative refers to a 12 years old female patient. Lab diagnostic studies showed that she was MTHFR homozygous. The patient was vaccinated intramuscularly with GARDASIL on 14-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In September 2012 (reported as two weeks post vaccine) the patient experienced a stroke (hospitalization and medically significant by MAH). Unspecified treatment was given. The outcome of stroke was not provided. The relatedness for stroke was not provided for GARDASIL. Additional information has been requested.
Initial unsolicited report received from a pharmacist on 29 September 2016. This case involves 66-years-old male patient who was vaccinated with dose of Fluzone HD (Batch number: UI666AB, expiration date: 13 April 2017, route of administration was not reported) in left deltoid on 19 September 2016 early in the day. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) includes none. Concomitant medications were reported as none. On 19 September 2016, in the evening few hours following vaccination patient began to feel soreness in his Left arm and stated that pain became increased, and persisted for the next 11 days. On 29 September 2016, 10 days following vaccination patient's pain has decreased but arm hurts with movement. Lab data was reported as none. Patient received three ibuprofen each day for pain as a corrective treatment. Outcome of events was reported as unknown. List of documents held by sender: none.