chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 16 year old female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL. On 31-JUL-2008 she received a second dose of GARDASIL (lot #660553/0070X). On 11-DEC-2008 she received third dose of GARDASIL (lot #660553/0070X). Concomitant therapy included hormonal contraceptives (unspecified). On 18-JUN-2009, the patient went to the emergency room with a pulmonary embolism and was admitted to the hospital. The patient had been placed on COUMADIN. On an unspecified date the patient recovered from the pulmonary embolism (PE). Follow up information has been received via telephone call from a licensed practical nurse who reported that on an unspecified date, the patient was placed on oral contraceptive (name not available) for heavy menses. On 02-JUN-2008 the patient received HAVRIX (unspecified) (lot # AHAVB264CA) and MENACTRA (lot # U2623AA) in addition to first dose of GARDASIL. On 31-JUL-2008 no other vaccines were given. On 11-DEC-2008 she received HAVRIX (unspecified) (lot # AHAVB291CA) and FLUZONE (lot # U2083AA) in addition to third dose of GARDASIL. On 18-JUN-2009 the patient presented to the emergency room with chest and back pain. Chest computed axial tomography showed multiple PEs in both lower lobes and the patient was hospitalized. The patient was started on heparin drip, oral contraceptive was discontinued ( patient told never to resume it again); switched from heparin to LOVENOX injections. On 22-JUN-2009 the patient was discharged, the patient was placed on oral COUMADIN. At the time of discharge the patient was able to resume all previous activities. Chart did not show if the event was considered life threatening. No further information is available.  9/29/09 ER records received DOS 6/18/09. Assessment: R/O Pulmonary Embolism. Patient presents with sharp pains (L) rib area midside up to (L) shoulder. Worsens with deep breath, movement. Birth control pills. Transfer to higher level facility recommended. 12/10/09 DC summary and Hospital records received for DOS 06/19/09-06-22/09. Pt presented with constant chest pain at rest . Consult  with pediatric hematology: treated with Heparin protocol then transitioned to Lovenox in order to intitiate Coumadin after discharge. All birth control pills stopped. Discharged home stable. DC DX: pulmonary emboli
I gave patient the flu vaccine. I thought he was okay afterward. He stood up and walked back into the pharmacy. I did not realize that he was dizzy, lightheaded or had any adverse reactions. We had been talking and laughing. I saw him walk to the computer terminal and it looked like he rested his head on the terminal, and I thought he was joking, but before I could say anything, he fell straight on the floor. He partially landed on a box and partially on the mat. He laid face down in the floor, and his wife, who happened to be visiting the pharmacy, rushed to his side, while I called 911. She turned him over and he was bleeding in several places, due to the fall. He was unconscious for about 30 seconds and then he started talking. He said he was okay but he seemed confused and a little disoriented. I was on the phone with 911 so I didn't hear the entire conversation. He laid there as we took the instructions of the 911 operator and gave him clean paper towels to wipe his head, and ice pack and waited on the EMT people to arrive. The EMT people arrived shortly after, and they helped him out of the pharmacy. I did notice that his coloring was pale as he left.
More than 35 days from first dose; tongue swelling; LIP SWELLING; heart racing; eyes felt funny; nervous; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swelling), LIP SWELLING (LIP SWELLING), PALPITATIONS (heart racing), EYE MOVEMENT DISORDER (eyes felt funny) and NERVOUSNESS (nervous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NERVOUSNESS (nervous). On 09-Mar-2021, the patient experienced SWOLLEN TONGUE (tongue swelling), LIP SWELLING (LIP SWELLING), PALPITATIONS (heart racing) and EYE MOVEMENT DISORDER (eyes felt funny). On 22-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose). At the time of the report, SWOLLEN TONGUE (tongue swelling), LIP SWELLING (LIP SWELLING), PALPITATIONS (heart racing), EYE MOVEMENT DISORDER (eyes felt funny), NERVOUSNESS (nervous) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-Jun-2021: Event was added.  No treatment information was reported.
big knot came up on arm-it got hot & was red all the way down to elbow & it hurt real bad;it still is sore & hurts & big welts came up on arm;
2PM vax given 22FEB93 pt slept for 2 hrs p/shot & then cried for 4 hrs; t104 & has been crying since off & on till 830AM;
Patient developed a rash shortly after receiving the PNEUMOVAX 23 vaccine. Her right arm is red, swollen and radiating heat. I spoke to her Dr. and he is going to see the patient at 1 pm today.
04/30/2022, I experienced very mild symptoms. I had chest congestion, cough, scratchy throat, stuffy nose and an on and off mild fever that wasn't persistent.  I had been around someone with COVID-19 is why I recognized the symptoms. On 5/1/2022, I tested positive at home for COVID-19. I had a PCR test on 5/2/2022 and tested positive for COVID-19. I did a rapid COVID-19 test this morning and tested negative. My symptoms are better. I still have a cough and started feeling intense fatigue yesterday.
Initial case received from a physician on 29 July 2014. Numerous patients (ages and genders not reported) were diagnosed with pertussis within one year of receiving the fourth dose of either ADACEL, DAPTACEL, or PENTACEL. According to the reporter, the patients were mildly ill at the time of testing, and all tested positive on PCR. Past medical history, dates of administration, lot numbers, treatment, and outcome were not reported. The events had also been reported to the State health department. No additional information was provided. Documents held by sender: None.
Itching, hives in patient given 80mg Benadryl oral at 1206.
Patient reported noticing red itchy blister-like bumps that started three days after vaccination, mainly on torso, and some on right thigh. Patient described it as red patches that appeared like rashes or large chicken pox but not like shingles. She stated the bumps lasted for about a week before disappearing.
Upon walking to recovery area patient went pale and fainted. Witnessed fall, fell and hit head on the floor. Vital signs taken: BP:110/60 HR:70 SpO2: 98% in RA. Pt initially did not recall receiving vaccine but when asked orientation questions, she answered all appropriately (A&Ox4). Within five minutes EMS on scene to assess pt. Pt could not recall last meal, BG checked and was 91. Upon sitting up pt was nauseated and dizzy. Pt transferred to ED for follow up care.
Swelling and numbness in right side of face. Physician recommended icing and swelling went down after a day. Still have tingling sensation at times
Moderna vaccine was administered to a 17 year old. Administration error. Contacted  state DOH and also consulted CDC document dealing with this type of error and will follow up with 2nd dose of Moderna after 28 days as directed.
Patient experienced swelling of both hands and wrists within hours after getting vaccine.  Noticed slightly more swelling on immunized arm. Swelling still maintaining same level 4 days after injection.  Patient is on dialysis. Patient advised to contact his physician for any additional advise or treatment.
Right thigh had 5cm redness; central bluish discoloration 1cm;  had pain and tenderness with swelling. Had a fever X 2 days but none today. Right hip and knee FROM; pt walking well. Will follow-up over the next week.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I personally am aware of an individual who was a very dynamic individual prior to taking the anthrax vaccine; however, upon her return from being deployed, she was unable to continue in her civil service position due partially to memory loss. Additionally, she is unable to drive amongst other medical problems. (OMIC)
Had significant local reaction - sterile abscess/cellulitis occurring ~10 hours after administration. Seen next am with an 11x8.5 cm left lateral/deltoid area mass that was stiff, warm, painful with decreased mobility because of pain. recommended ice pack, Benadryl, ibuprofen. Resolved by day 4.
neck redness and swelling; neck redness and swelling; Pain; nausea; diarrhea; sore throat; sob; This is a spontaneous report from a non-contactable Nurse. This 45-year-old female Nurse (patient) reported for herself. A 45-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6200, Expiration date: unknown), via unspecified route, administered on 04Mar2021 03:15 AM (at the age of 45-year-old) as Unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not have COVID-19. No Covid tested post vaccination No. On 05Mar2021 (20 hours 45 minutes after the vaccination), the patient experienced pain, nausea, diarrhoea, sore throat, shortness of breath, neck redness and swelling. Atarax, ibuprofen albuterol treatment received . The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Patient had a syncopal episode approximately 10 minutes after injection. She briefly passed out. She was gently lowered to the floor. She had no injury.
My period came 2 weeks early. My last period prior to this was on April 30th and I started to get spotting on May 13th, 9 days after my first covid shot. After 2 days, the spotting turned into an actual period. I am not on BC, nor have I taken any emergency contraceptives or done anything different than normal. While this may be unrelated to the vaccine,  i also have had a slight cold since about the 14th as well.
This spontaneous report as received from a nurse refers to a 15 month old female patient. On 02-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX injection (lot # and expiration date not provided) (dose not reported). It was reported  that the patient received improperly stored (Oka/Merck) VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath (still current) Chest pain and tightness (still current) Increased heart rate (2 weeks) Feeling of heart palpitations (still current at times) Headache (still current) Joint pain (still current) Fatigue (still current) Nausea (1 week)  Diagnosis  of Costochondritis Treatment: Ibuprofen 600mg 3x/day for 2 weeks
I was having trouble breathing and I went to the doctor, and he discovered that I had Polyps in my nose. He prescribed Flonase first to see if that would shrink them and it did not. I had to have surgery to have the Polyps removed from my nostrils. I can breathe much better now.
he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.; 4 Weeks later a rash appeared on her body.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.) and RASH (4 Weeks later a rash appeared on her body.) in a 98-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Dose Lot:012M20A & Exp. Date: unknown) on 18-Feb-2021, Moderna COVID-19 Vaccine (Second dose Lot: 014M20A & Exp. Date: unknown) on 18-Mar-2021 and Moderna COVID-19 Vaccine (First Monovalent Booster dose  Lot: 035121A & Exp. Date unknown) on 22-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 02-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.). In December 2022, the patient experienced RASH (4 Weeks later a rash appeared on her body.). At the time of the report, PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.) had not resolved and RASH (4 Weeks later a rash appeared on her body.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient reported that doctor suggested to use a lotion. She stated even Benadryl did not help her.
Information has been received from a registered nurse concerning a 14 year old white female who on 08/11/1999 was vaccinated with a dose of varicella virus vaccine live.  In November 2003, the patient developed shingles on her face.  On 11/30/2003, the patient was diagnosed at a hospital urgent care facility.  Subsequently, the patient recovered with no problems.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date in September 2012 (reported as past week) the patient was vaccinated with PNEUMOVAX 23 injection (lot # not reported, expiration date unspecified), unspecified dose. No concomitant medications were reported. The pharmacist reported that an unspecified patient received an expired dose of PNEUMOVAX 23 on an unspecified date in the past week (approximately on an unknown date in September 2012). No adverse effect reported. No further information is available. Additional information has been requested.
Information has been received from a health professional concerning a 23 year old white female, with no known drug allergies, who on 11-FEB-2008 was vaccinated with a first dose of GARDASIL in the left deltoid. Secondary suspect therapy included vaccination in the left deltoid with a first dose of MENACTRA. On 06-MAR-2008 the patient developed a knot at in left deltoid and a pain that radiates from knot to elbow up to neck and ear. It was reported that the patient had a cold at the time of vaccination. Additional information has been requested.
July 7, 2022 developed fever and chills, headache, malaise, sore throat.  Treated with tylenol, Paxlovid, albuterol and Alvesco inhalers.
60-75 hours after Menactra,  elevated fever and weakness. Progressed to high fever 103 and neck pain. Fever resolved after 24 hours. Other child in family got fevers after immunizations.
Pt says migraines got more intense and longer duration. Lasted  5 days and actually woke up from the pain. Felt uncomfortable tightness in chest with warmth and leg started to ache and feel very heavy. went to ER on 1/3/2022 where did Cat scan, chest x-ray, ekc and bloodwork. Everything came out ok and pt was released with symptoms abating. Did not take any Tylenol or motrin. Says had some chest discomfort for 1st 2 doses but only last 2 days and stopped.
Left arm aching, elbow pain lasting 2-3 weeks. Question development of simultaneous lateral epicondylitis.
Initial report received on 16 November 2006, from a health car professional.  A female patient received on 14 November 2006, Fluzone (U2187AA), into the left deltoid (route and dose not reported).  On 15 November 2006, a day post vaccination, the patient experienced injection site redness, induration and itching at the left deltoid, 5 cm diameter, well circumscribed.  No other signs (corrected) and symptoms were reported.  No corrective treatment was reported.  At the time of the report (16 November 2006), the patient had not recovered.  The patient's medical history, other medications, illnesses at the time of vaccination and concomitant vaccinations were unknown.  Follow-up information received on 20 December 2006.  The patient received Fluzone at approximately 3PM.  The next morning, she had discomfort in the left deltoid and on 16 November 2006, she noted a 5 x 5 cm oval shaped area of erythema and swelling at the injection site - described as itchy.  No significant discomfort.  She has had previous flu shots before with no adverse problems. The patient did not have any other vaccinations within 4 weeks of receiving Fluzone, did not have any illness at the time of vaccination and did not have any medical history.  It was reported the patient recovered.
fever; sorearm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sorearm), FATIGUE (fatigue) and PYREXIA (fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 41B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included QUINAPRIL from 02-Jan-2001 to an unknown date for Blood pressure high, ASCORBIC ACID (VITAMIN C WITH ROSE HIPS [ASCORBIC ACID]) from 01-Jan-2018 to an unknown date for an unknown indication, Clonapril 20 mg.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (sorearm) and FATIGUE (fatigue). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with AMOXICILLIN TRIHYDRATE (AMOXYCILLIN ALMUS) at a dose of 500 mg; CLINDAMYCIN at a dose of 300 mg; SULFAMETHOXAZOLE at a dose of 850 mg; TRIMETHOPRIM at a dose of 160 mg and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, MYALGIA (sorearm), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking Centrum Silver Vitamin Concomitant medication from date 01-JAN-2016.   This case was linked to MOD-2021-177205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Added Reporter Information. Added Concomitant medications. Added Facility information.
SWALLOM ARM, COLD CHILL AND FEELS LIKE SHE HAS THE FLU. FELLS VERY WEAK
Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025a21a and 00f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.      No concomitant medication were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  This case was linked to MOD-2021-331467 (Patient Link).
After the vaccine I got the covid arm. I had a fever of 102 degrees for 3 days. That's when the muscle and joint pain was really painful. It got better before the booster but the pain was terrible. After the booster I had a fever that was no more than 100 degrees. I got fatigue, muscle aches,  joint pain, and a metallic taste in my mouth. I've been to my PCP, a rheumatologist, and a dermatologist. I have been prescribed an anti-inflammatory Meloxicam 7.5mg tablets 1xday, Tramadol 50mg, and a muscle relaxer Flexeril 10mg 3xday. My white blood count has been fluctuating up and down.
This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, PULMONARY EMBOLISM (My husband is in the hospital with blood clits in the lungs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
After administering both vaccine patient got up and felt light headed and looked pale and  was bending over the counter. We got her to sit down and she drank water. Then she started to complain about sudden pain in her lower back. she sat for 15 minutes, after which she felt and looked much better and was able to walk. she was walked out to her car to make sure she was fine.
Moderna COVID-19 Vaccine EUA  itchy, red rash radiating around injection site and half way down upper arm. itch started on 3/8 and rash appeared on 3/10. no pain in arm initially until 3/8.
Patient was feeling nervous before the vaccination but developed a headache and increase in anxiety after receiving her first dose of the Moderna COVID-19 vaccine.  Patients vital signs were monitored, orthostatic vitals signs measured with no change. After resting for an additional 10 minutes she stated that she still had a headache but she felt less anxious. She required no treatment and left with her husband to go home.
Information has been received from a physician concerning a 24 year old female who on 08-SEP-2008 was vaccinated with a first dose of GARDASIL (lot # 0152X).  Concomitant therapy included ZOVIA.  On 15-SEP-2008 the patient experienced a rash on her face.  The patient did not seek medical attention but was told to take BENADRYL for the rash.  There was no lab test.  No further information was provided.  Additional information has been requested.