chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost baby after receiving the covid-19 vaccine.; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority with Support from a non-contactable consumer. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter reported three same cases. This is one of the three cases. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on unspecified date at single dose, dose number unknown for COVID-19 immunization. Patient was pregnant at time of vaccination and event onset. Medical history and concomitant medications were not reported. Caller inquiring on if the vaccine was FDA approved. Started reading ISI and caller interrupted and asked about women that are pregnant. Caller stated that the patient had lost her baby after receiving the covid-19 vaccine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101200159 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200080 Same reporter/drug/event, different patients.
Received yellow fever vaccine 7/5/07, 40 min later developed red, swollen area from index finger to wrist on hand also, red area on side of face. Area on hand started burning. Developed 2-3 reddened area calf of leg the next day. No fever, itching or redness, hand red area become blistered and very painful. No fever also developed red swollen itching patches on scalp. No difficulty breathing. Pt went to ER. hospital on 7/6/07 was given Prednisone and Benadryl for allergic reaction and sent home. By Monday 7/7/07 - all reddened areas were resolving, itching gone, no fever, blisters did not break - resolved spontaneously
Up until the time I went to bed, on July 6, 2014, around 9:00 p.m., I felt perfectly well - all day long and for the past several weeks. I enjoy excellent health. However, on July 6, around 11:30 p.m., I woke up feeling ill, with flu-like symptoms (chills, ague, feverish). Felt sick to my stomach but didn't vomit. Tossed and turned all night long until morning. Felt ill all the rest of the day; took sick leave from work. Couldn't eat any food all day and night (was able to swallow a protein drink). Felt better the next morning (July 7) and went to work, but I still felt queasy. By noon, I felt better but still not hungry. As of this morning, 7/10, I still feel some adverse reaction (a bit queasy; no interest in food), but have managed to get back to a normal work schedule. This illness came out of the blue and was totally unexpected. The only thing I can conclude is that my sickness resulted from the Shingles vaccine I had on the afternoon of July 6. I'm not upset and don't mean to blame anyone for my illness - just an adverse reaction from which I recovered - but thoght I should report it. I was not aware I could get so ill from such a vaccine.
Per patient:  Received shot at 3pm and at 2am she felt sick and disoriented.  She passed out.  It took approximately 1 week to feel good again.  She declined receiving her second vaccination (2 months later).
Arm soreness at injection site within first six hours of injection, unresolved after three months. Rash below injection site (red, itchy, warm) within 48 hours of injection, resolved within one week. Muscular arm pain and decreased mobility onset approximately one week after injection, unresolved after three months with increasing pain and decreasing mobility. Medical attention sought approximately three months after injection; diagnosed with adverse reaction to vaccine by two medical professionals. Currently under treatment to increase mobility and decrease pain (six sessions completed at Rehab), treatment is improving condition, however, it is still unresolved.
p/vax pt stated arm was itchy & felt like it was spreading;arm appeared erythematous;pt monitored for 30min when started having trouble breathing;911 was called & epi given;pt pulse remained WNL;
Right sided Bell's Palsy- ER visit 03/24/22- improved in 3 weeks with steroid, reports resolution  June 14, 2022
While walking out of office, Pt fainted hit head, elbow on the wall near doorway, Eyes rolled back. Nurse sat her up. She got her balance and walked into a room, laid on table, drank juice - BP after incident was 132/56, then 10min later was 100/60. Dr. assessed Pt, 2 mins here with Pt. After approximately 20 min, Pt walked out office with mom.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/27/2022,  6/7/2022,  6/8/2022,  6/17/2022 -- RECURRENCE OF SAME SYMPTOMS
low kidney function, cant uintaite, vomiting , chills, burry vision, dry eyes, high temp, cant breath, tightness of chest, headache, loss of apatite, body aches, flu like symptoms
RECEIVED 1ST VACCINE 1/13 ABOUT 45 MINUTES LATER FELT LITTLE BRAIN FOG BUT WENT AWAY. ARM WAS LITTLE IRRITATED.  ON FRIDAY 1/22 WOKE UP TO INJECTION SITE ITCHY, BEET RED,HOT WITH HARD WELT LIKE AREA ABOUT 1 1/2 INCH ROUND WHICH SPREAD THROUGH DAY NEXT DAY LATE AFTERNOON STILL IRRITATED BUT FLATTENED OUT. TODAY 1/29  AREA IS STILL LARGE BUT FLAT COLOR PINK AND SORE.SECOND VACCINE SCHEDULED FOR 2/10/21. LITTLE NERVOUS AND CONCERNED  WITH ANXIETY OF UNKNOWN IF SAFE TO RECEIVE OR OUTCOME. READ ONLINE REGARDING SIDE EFFECTS NOT SURE AT TIME WHAT TO EXPECT . ON 1/22/21 I DID CALL CDC NUMBER PROVIDED AND JUST LEFT MY NAME AND PHONE NUMBER ON VOICE MAIL DUE TO HIGH VOLUME.  HAD NO RESPONSE.
Pts left deltoid appears red in the absorption path of the vaccine.  The site is tender to touch and febrile.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms. No co-suspect and concomitant therapies were reported. This is one of several reports from the same souce. Additional information has been requested.
Throat pulses for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat pulses for two weeks) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat pulses for two weeks). At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat pulses for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt recieved the ful vaccine in the left deltoid on Wednesday at 12:40 p.m.  On Saturday the patients spouse called and stated his wife was unable to get out of the bed, she has vertigo and vomiting.  He denies any local reaction to the vaccine.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 61 years old male patient who experienced left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store, he does need help lifting up his arm to place on steering wheel, left upper arm weakness and sore left deltoid region where ADACEL was given, while he received vaccine ADACEL. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 09-Aug-2018, the patient received a 0.5ml dose of suspect ADACEL lot U5979AA, expiry date 13 Jun 2020 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store (pain in extremity) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious he does need help lifting up his arm to place on steering wheel (injected limb mobility decreased) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious left upper arm weakness (muscular weakness) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious sore left deltoid region where ADACEL was given (vaccination site pain) with unknown latency following the administration of ADACEL. He does need help lifting up his arm to place on steering wheel and has weakness and pain. It does not hurt with internal rotation. He has no loss of strength or feeling in his hand. There is no marking at the injection site and no fever. He was doing pretty good the other day he was in and he still requires the other arm to lift the affected arm onto the steering wheel. Lab data was not provided. Final diagnosis was sore left deltoid region where ADACEL was given, left upper arm weakness, he does need help lifting up his arm to place on steering wheel and left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered/Not Resolved on an unknown date for sore left deltoid region where ADACEL was given, as Not Recovered/Not Resolved on an unknown date for he does need help lifting up his arm to place on steering wheel, as Not Recovered/Not Resolved on an unknown date for left upper arm weakness and as Not Recovered / Not Resolved on an unknown date for left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store. List of documents held by sender- none.
Hive like welts around immunization site appeared 10-15min after injection. Also hives started spreading down arm. Doctor informed & 1.5 tsp Benadryl given per doctor.
Patients received the vaccine pass 30 days in the fridge; Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa) and Drug allergy (statin drugs like Lipitor). On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 4 patients received their 2nd booster of the vaccine. Physician stated 3 Patients received the vaccine on 24Jun2022 and 1 patient received the vaccine on 01Jul2022.No patients reported having side effects. Patients are not immunocompromised. All patients were taking medication. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2022-615208 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-615208:patient 1- elderly female 2
My lips became extremely red and swollen a couple of hours after the shot.  I think there was some other minor face swelling around the nose, but the lips were the main issue.  I took Benadryl for a few days and the lips were back to normal in about a week.
approx 45min p/vax pt tongue began itching & lasted for 30min as stated by pt mom;
The patient stated on 10/09/2018 that her left arm has been sore to the point that she cannot lift her arm as she normally does. She stated that she feels swollen "knot" under her arm. The patient is following up with her primary physician 10/11/2018 at a scheduled appointment.
Patient experienced SOB, shooting lower back pain, and shaking within minutes of the injection.  Patient Symptoms lasted 15 minutes but consistently improved.  Blood pressure was checked 3 times (every 5 minutes): 113/73mmHg, 113/78mmHg and 111/75mmHg. Symptoms resolved completely within 30 minutes and patient left with his daughter.
approx 1hr p/vax pt devel tachypnea, stridor w/poor perfusion;resolved w/ nebulized tx of albuterol;then became febrile & limp-resolved w/in 1hr w/Ibuprofen;
9:30 pm 03-01-21 chills, diapohresis, fever does not register, abdominal pain with vomiting, elevated BP and blood sugar, vomiting continued but with low blood sugars and elevated BP til 03-03-21 eve, transported by EMS ambulance to ER, blood sugar 70 on arrival, had Fentayl and Ketamine with RL IV on transport, O2 DC'd on arrival? in distress when I arrived, O2 replaced. Labs avaialble at hospital,  Phenergan, Zofran, Valium, and D10W given. released with blood sugar 167, I gave insulin after DC. Still vomiting for 2 more days, then resolved. He began eating and retaining food. had loss of weight.
Fever 100 degrees, extreme body aches in every in of body, metal taste in mouth, soreness at injection site makes it painful to use arm, chills, no energy, significant stabbing pain in right knee and pain on left side of my chest. Eye balls feel very hot in the sockets and lungs feel inflamed but no cough.
0.25 mL of expired doses were given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 011M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (0.25 mL of expired doses were given) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up received on 04-NOV-2021 contains No new information.
Information has been received from a physician concerning a 17 year old female with low blood pressure who on 11-MAR-2008, 12-MAY-2008 and 13-SEP-2008 was vaccinated with a first, second and third dose of GARDASIL.  Respectively, no concomitant medication was reported.  The physician mentioned that after the first dose on 11-MAR-2008 the patient passed out in the office.  No injuries were sustained and the patient was discharged home.   The physician reported that three hours after receiving the second dose on 12-MAY-2008 the patient passed out while driving and hit another vehicle.  No injuries were sustained.  The physician reported that there were no adverse effects after the third dose.  The outcome of the patient was not reported.  The patient sought medical attention:  in the office.  There was no product quality complaint.  Additional information has been requested.
Patient was admitted with acute pulmonary embolism moderate load without cor pulmonale. We used heparin and did a biopsy of the liver this lesion here was high suspicion of cancer however came back as nodular cirrhosis. he is to be on Eliquis for 7 days at 10 mg twice daily and then 5 mg twice daily indefinitely he does understand he has a high risk of bleeding bleeding complications otherwise he did well his family was involved many hours were spent in counseling and discussion to the course of this admission.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
approximately 10 minutes into the prescribed observation period, the patient complained of "not feeling well",  he continued with complaints of dizziness, sweating  and nausea.  Patient felt the need to throw up but did not.  Cold compress was applied to the back of his neck, he was coached to take deep even breaths and to try to relax as he was becoming agitated.  An ice pack was applied to his neck and then removed and reapplied as patient complained of hot and cold.  After about 30 minutes patient began to feel better and his color returned to normal.  Patient left after approximately 45 minutes to 1 hour of observation.  At the time of departure he was animated and talking and not experiencing any more symptoms
This spontaneous report was received from nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554 and expiration date 25-DEC-2017) that went to 46.6 F for 8 hours. A data logger was used and there were no prior excursions. The vaccines are back in range. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient was nervous about the vaccination. She was seated for observation then fell to the ground during observation. She did not lose consciousness and was asked to stay until she fully recovered.
Wrong Vaccine Given. #3 Hep-B instead of the order for Hep-A/B combo (Twinrix). Pt was called requested to return for #3 Hep-A to complete the series. Pt was happy to return.
ER visit on 05/09/2021 due to left lower leg pain and swelling. Diagnosis was Superficial thrombophlebitis. Follow-up with primary care on 05/12/2021, then endovascular doctor on 05/19/2021 confirmed diagnosis, no deeper clots found at that time via ultrasound. Received prescription for blood thinner (Xarelto). ER visit on 05/22/2021 due to leg pain higher up the leg. Doctor had recommended ER if pain seemed to move up the leg. Diagnosis via ultrasound of a popliteal vein thrombosis behind the left knee. Follow-up with endovascular doctor, received prescription for blood thinner (Eliquis) instead of Xarelto due to nausea.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received BOOSTRIX (batch number 9Y57K, expiry date 25th August 2017). On 4th August 2016, the patient received BOOSTRIX 0.5 ml. On 4th August 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were provided as follows: The patient experienced soreness at injection site. The reported batch number (9457K) of BOOSTRIX did not exist and was updated to 9Y57K as per sales database. No other detailed information was provided.
Redness & itching began at injection site beginning afternoon/evening after injections were given. The next day, 9/25/18, pt reports itching stopped but redness had darkened & spread around arm & down to 1/3 length of upper arm. Area of redness noted to be the size of an outstretched hand, hot to touch & painful, causing difficulty raising arm to shoulder level or higher.
Four patients received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 73H93, expiry date 10th January 2022) for prophylaxis.   On 28th April 2022, the patient received Engerix B. On 28th April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: The medical assistant reported that the patient received an expired dose of Engerix-B vaccine. The consent to follow-up was given. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used. This case was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR072336:Same reporter. US-GLAXOSMITHKLINE-US2022AMR072337:Same reporter. US-GLAXOSMITHKLINE-US2022071926:Same reporter.
This case was reported by a healthcare professional and described the occurrence of near fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL. The subject's medical history included MRSA infection of the skin. On 2 February 2008 at 09:30 the subject received 2nd dose of HAVRIX (.5 ml, left arm) and the 1st dose of GARDASIL. On 2 February 2008, 12 hours after vaccination with GARDASIL and HAVRIX, the subject experienced near fainting, low blood pressure and rapid heartbeat. The subject was seen in the emergency room. At the time of reporting the outcome of the events were unspecified. On 28 February 2008 follow-up was received via the healthcare professional. She reported that on 02 February 2008, the subject experienced near fainting, low blood pressure and rapid heartbeat. The events resolved on 08 February 2008. On 11 February 2008, diagnostic test for influenza, CBC, ESR and CPK were normal. A CT scan of the head, chest x-ray and EKG were also normal. She considered that the events were not serious and she considered that the events were possibly related to the use of HAVRIX. She also stated that she was unsure which product were suspect.