chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20H) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.
pt recvd vax 1PM & pt's grandma called 2 hrs later & said pt had not stopped crying since the vax given;came back to clinic for evual which was neg x/for poss rxn to vax
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 12 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-APR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.32 degree Celsius. The time frame was 0.77 hours on 02-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
12/29 vaccination Evening, I had a slight temperature of 99.1.  12/30 100.0, went to work, had gone up to 102.3. Sent home. Extreme fatigue, slight HA, slept till  3.  12/31/20210Fever *telemed that Thursday with County Health to get cleared to work / paramedic.  *COVID + 10/2020; Fever for 14 days
Sore arm, redness at the injection site with pain. Flu-like symptoms. MD visit required lab works done. Systemic in reaction diagnosed. Antibiotics required.
Received flu shot on 10/22/16. Patient cannot lift arm for 3 weeks and arm is sore the whole time. Patient made appointment with doctor.
Left armpit pain; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), duloxetine hydrochloride (CYMBALTA), naproxen (MANUFACTURER UNKNOWN), rizatriptan benzoate (MAXALT) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 06Feb2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 25May2020, the patient underwent COVID-19 test via nasal swab and the result was negative. On 28Feb2021 at 02:00, the patient experienced left armpit pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been not tested for COVID-19. The clinical outcome of the event left armpit pain was resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
redness and cough for 2 days with fever followed by papules transformed into blisters, trunk, face and eruption in that order of appearance.
Reports Right shoulder pain Then pain in knees, ankles, hives Hip weakness Hard to get out of bed in AM
Facial Swelling/Urticaria developed the night of 11/20/21. Pt lives in city and did not go to Medical Center ER until 11/22/21. Was attempting to treat sx's with OTC Benadryl with not much relief.  Staff administered IV diphenhydramine, methylprednisolone, and famotidine. Advised to take OTC Claritin x5 days after discharge. Phone call f/u made.
Vomiting, fatigue but can't sleep, foggy brain, forgetting information feeling like I lost time and space for days, headaches, panic attacks, chest pains feels like my heart is swelling and rapid heart beat.
Dizziness, lightheadedness, nausea, vomiting, sensitive to light, headache, ear ache, unsteady gate. Treated with Valium, Prednisone, Mecklizie, bed rest.
Recvd DTP #5 15AUG91 grandma says arm started to swell right away & became reddened; Today 23AUG91 area still inflammed 5 1/2cm by 6cm; no pain associated with it; area had been feverish in beginning only inflammed area;
onset of rash upper chest neck & back w/in 24hr of vax accompanied by fever 101 (approx);rash & Fever persisted 5 days;
A report was received from a health care professional on 21Nov02 concerning a 11 vaccinees between the ages of 56 and 84 years who were inadvertently administered 1ml Fluvirin on an unreported date. On an unreported date a 11 vaccinees were inadvertently administered 1ml Fluvirin. No adverse events were reported. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicated that a 71 year old female vaccine was inadvertently administered 1.0ml Fluvirin on 21Nov02. Cross Ref with: PJP200200806, PJP200200906, PJP200200905, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.
Severe fatigue, loss of appetite, muscle and arm soreness, spreading redness on arm in a map shaped pattern, spread to neck and chest. Diagnosed in urgent care with cellulitis.
Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 9:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Apr-2022 stored in refrigerator on 06-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  There is no temperature excursion. The vaccine was stored in the refrigerator on 06-Apr-2022 at 10:30 AM.  No treatment information was provided.
Mom called stating Babysitter called her at 10:14am today reporting the following:  front arm near shoulder (HBV)vaccine has a light red circular mark, warm and sore to touch, no swelling nor rash noted.  The injection on the back side of the arm (MMRV), is redder in color, also warm and sore to touch, redness is 1/2 inch in diameter with it moving down the arm toward the elbow by 1 inch, no rash or swelling noted.  baby sitter applied a cold pack to area and will repeat process for 30m every hour as child tolerates.  no fever no headache, no nausea/vomiting, no irritability of patient.   Tylenol given per weight/age (mom said got over the counter and followed label directions.)  advised Urgent care should the areas of irritation/redness get larger, get more painful or a fever of over 102.5'F develops.  will follow up with mom tomorrow. she is aware this report is being done.
Initial report received from a healthcare professional on 31 January 2013. A 11-year-old male patient, had received subcutaneous dose of MENACTRA vaccine (lot number-U4428AA, site of administration: back part of the L upper extremity), received intramuscularly ADACEL vaccine (lot number: C4311AA, site of administration: left deltoid) and GARDASIL (Manufacturer-MSD, lot number: 0636AE, site of administration: right deltoid) on 28 January 2013. The patient had no illness at the time of vaccination and concomitant medications were not reported. On 30 January 2013, the patient developed large site reaction of redness, swelling and warmth at injection site which had spread to most of the upper left arm. Corrective treatment details included warm compresses, MOTRIN for inflammation and any pain and BENADRYL 25 mg PO q 6hrs. for itching at the site. It was reported as the patient's did not improve from the events physician plan to treat us cellulitis with IV antibiotics. Laboratory details were not reported. At the time of this report, the outcome of the events was unknown. Documents Held by Sender: None.
5/24/22 patient had mild macular-papular rash. This progressed and patient was seen again on 5/26/2023 where he had crusted lesions across his entire body, on face, and in mouth.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 159001A, expiry date March 2018). On 7th June 2017, the patient received the 1st dose of BEXSERO. On 7th June 2017, several hours after receiving BEXSERO, the patient experienced fever, general body pain, nausea, light headedness, headache and injection site numbness. On an unknown date, the outcome of the fever, general body pain, nausea, light headedness, headache and injection site numbness were unknown. It was unknown if the reporter considered the fever, general body pain, nausea, light headedness, headache and injection site numbness to be related to BEXSERO. Additional details were received as follows: In morning, the patient received a dose of BEXSERO. Soon after vaccination (less than a day after vaccination), the patient developed numbness at injection site. By 6 PM that evening, the patient developed a fever of 100 degrees F, nausea, lightheadedness, headache, and achiness all over. On the day of reporting the patient still had a low grade fever of 99.6 degree F. The reporting nurse practitioner stated that the patient had not yet taken any medications for reactions, at the time of reporting.
Swelling around the injection site; Redness 3 inches in diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness 3 inches in diameter around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by reporter. Treatment details were not provided.
arms were sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arms were sore at the injection site) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arms were sore at the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arms were sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mother noted rash on back of left arm - site when MMRV was given. Rash noted the morning of 7-24-14. Vesicular rash.
Pt stated she felt dizzy/lightheaded, then complained that her legs felt "heavy", that she could not go back to work, and that she felt she was "going to die".  Taken to ED via wheelchair and directly placed in room. Treated for anxiety with Ativan 1mg PO and discharged home at 2:53pm.
I received a request by patient to get an influenza vaccination at around 11:40 AM on 11/12/2013. He said that he had never had a reaction to any vaccine in the past and had had the influenza vaccine in the past with no problems. He said he was feeling well today and noted that he had allergies to Motrin, Ibuprofen, Demerol, Norvasc and Altace. I administered the vaccine at 11:45 AM. At noon I received a call from his wife telling me he was having anaphylactic-like symptoms, with difficulty breathing and possible throat swelling. I asked her where the patient was and she said he was at store in downtown and that he was on his way to her. She told me he has had anaphylactic reactions in the past. I told her that she should call 911 if he indeed was having those symptoms. She stated she would call me back with an update.
pt recvd vax & extremities turning cyanotic-skin cold to touch; pt's face pink-upper extremities pink;
I have never had allergies in my life.  But following my COVID19 vaccine, i developed what is either allergies to the environment or a chronic cold. Sometimes it clears up after a few hours in the morning, sometimes it clears up in the fresh air outside, other times it does not. But since my vaccine, about 5 months ago, i wake up every morning congested with cold-like symptons (running nose, sneezing, congestion).
Pt. had (one dose) GARDASIL 8-4-08. Came in office 8-31-10 with genital warts and perianal warts, Neg for sexual activity reported. Referred locally to OBGYN. She has transverse vaginal septum incompatible for sexual activity. She has also been referred to GYN for further care.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # K010221, expiration date 30-JUL-2017 (strength, dose, route of administration and indication were not reported). there was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
2 1/2 to 3 in  diameter on lower (R) arm of erythema. Where Varicella  vaccine was given.
Pt reports 2 days after vaccination she had a dizzy spell of approximately 2 minutes that came and went intermittently for the next few days. Last dizzy spell 6/17/21. Now resolved as of 7/1/21.
15 minutes after administration of vaccine (in left arm), patient began exhibiting rosy cheeks, and reported a burning sensation on the bottom of chin. Patient was then further examined and observed by staff for another 15 minutes. This did not get better or worse. No immediate action taken other than an additional 15 minutes observation. The mother instructed to administer Benadryl and/or if worsened take her child to the ER.
This spontaneous report as received from nurse practitioner via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and administration unknown). No concomitant medication was reported. Approximately in January 2014 (reported as sometime last week) the patient experienced seizures (medically significant). The patient was referred to Emergency room for treatment. Patient sought medical attention. The outcome of seizures was unknown. Causality was unknown. No product quality complaint was reported. Upon internal review the event seizure was considered as medically significant. Additional information has been requested.
joint and muscle pain all over; joint and muscle pain all over; She had weird dreams, very strange dreams, and couldn't sleep; She had weird dreams, very strange dreams, and couldn't sleep; still has a problem lifting her left arm that she received the injection in; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscular on 06Jan2021 at 11:30 at single dose in left arm for covid-19 immunization. Medical history included coronavirus in Nov2020. The patient's concomitant medications were not reported. The patient reported that She had her first dose of the Pfizer Covid Vaccine yesterday at 11:30 am. She had a really bad reaction. She was fine and then all of sudden her joints and muscles hurt a lot all over. She wanted to find out what she could take for the pain. Treatment: She took aspirin. Reported she had a lot of pain, every joint and muscle hurts in her body. The pain did not start right away, she was fine at first and then the pain started all of a sudden. She had weird dreams last night and could not sleep all night. She still had a problem lifting her left arm that she received the injection in. She wanted to know if it was ok to take aspirin or something better like Tylenol. She wanted to know what she could take. Reported she had coronavirus in Nov2020. The outcome of events joint and muscle pain all over was resolving, outcome of other events was unknown.
Pt was admitted to an inpatient psych unit and was negative on admission, but due to exposure was tested again and was COVID positive.
pt stated that he got flu like symptoms including tight muscles, headache, body aches, chills, he was nauseated.   He woke up feeling a little better but still has head ache, body aches and some nausea.
Mother states client complained of swelling of Rt knee on July 29 with continuing pain and swelling until seen by physician on August 3.  Client now taking Ibuprophen, wearing flexible brace, using ice and unble to work for one week.  Mother further states client has has swelling of this knee before, but never for this long (usually 1-2 days duration).  No elevated temperature.
got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075839, US-MODERNATX, INC.-MOD-2021-075230, US-MODERNATX, INC.-MOD-2021-075415 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075839:case created for first dose for unknown male patient US-MODERNATX, INC.-MOD-2021-075230:Cross linked case US-MODERNATX, INC.-MOD-2021-075415:Cross linked case
Patient received High Dose flu shot and Saturday had hives. Went to hospital and recieved steroids and eyes were able to be open 2 days later on the 8th.
BURNING IN BOTH ARMS, GOING ACROSS HER CHEST.  UNDER HER COLLAR BONE.  TERRIBLE SLEEP PATTERN, VOMITTED TWICE, AND VERY TIRED
Difficulty sleeping; A little dizzy; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), DIZZINESS (A little dizzy) and ARTHRALGIA (Joint pain) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 041821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INSOMNIA (Difficulty sleeping), DIZZINESS (A little dizzy) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) on 18-May-2021 for Joint pain, at a dose of 500 milligram as required. At the time of the report, INSOMNIA (Difficulty sleeping) and DIZZINESS (A little dizzy) outcome was unknown and ARTHRALGIA (Joint pain) had not resolved.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Left arm swelling, redness from shoulder to about 2 inches from above elbow. No treatment needed.
Arm Pain; Aches; Rash behind her neck; Chills; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products usage were not reported by the reporter. Treatment details not included.