chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna-patient reports after vaccine he was sick with nausea/vomiting for 30 hours. he reports migraines, dizziness, body aches. he reports he also experienced shortness of breath during this time
1h later, patient had chills/fever, lip swelling, difficulty walking, poor memory, headache.
Pt experienced cellulitis sometime after receiving a Tripedia vaccination. (No specifics provided)
Patient was given Daptacel instead of Adacel. No reaction. patient told to monitor. No other treatment required
first dose >42 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0153) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Patient received first dose of Moderna COVID19 Vaccine on 05May2021 and missed second appointment. Reporter confirmed that patient did not receive second dose yet and that it has been 43 days since first dose.   Reporter did not allow further contact
Sudden onset of lower abdomianl, back, groin pain such that she was unable to walk. Symptoms resolved over 30-40 minutes with 600 mg ibuprofen. No sequelae noted.
A day after I got the first Moderna shot, I noticed chest pain.  It felt like tightness and pressure.  The pain felt the worst  in between my breasts and radiated outward in a circle around my chest.  It hurt when I pressed down on my chest.  I tried massaging and stretching, it didn't help.   Went to ER on 3/27/21.
Swelling at injection site, knot under surface of skin, redness, arm/muscle pain, headaches, fatigue
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered. No further information was provided. No additional AE. No PQC.   ?    Names of vaccines involved (including lot/exp): M-M-R II LOT: T029550 EX; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered orally for prophylaxis (strength, dose, and anatomical location were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported: above 47 degrees of Fahrenheit (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA005640: US-009507513-2206USA006596: US-009507513-2206USA006597: US-009507513-2206USA006598: US-009507513-2206USA000873: US-009507513-2206USA006600:
MEMBER RECIEVED ANTHRAX VACCINE 02 DEC 07, W/IN 3 HOURS OF VACCINATION MEMBER HAD SEVERE HEADACHE AND NAUSEA, ACCOMPANIED BY SOEM VERTIGO AND BLURRED VISION.
2 weeks after last dose, has a 5 liter pleural effusion unexplained by cytology reports. Began treatment for metastatic disease, they now suspect CHF due to enlargement of the heart and recurring pleural effusion
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with dose 1 PNEUMOVAX 23. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that a patient told him she had an injection-site reaction after receiving PNEUMOVAX 23 sometime last year. The patient stated she developed redness and a rash at the injection site. She was treated with prednisone. The outcome of redness at the injection site and rash at the injection site was reported as recovered/resolved. The relatedness for redness at the injection site and rash at the injection site is unknown for PNEUMOVAX 23. The pharmacist was busy and not able to answer further questions. Additional information has been requested.
Fever; muscle aches; jaw pain; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, muscle pain and jaw pain. On an unknown date, the outcome of the fever, muscle pain and jaw pain were unknown.   It was unknown if the reporter considered the fever, muscle pain and jaw pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix a day before the date of reporting and had fever and muscle aches also had jaw pain. The patient asked whether these events had ever been reported.
A report was received from a health professional on 01/03/2002, concerning a 55 year old female pt who experienced persistent pain in her left arm and shoulder, 2 to 3 days after receiving Fluvirin on 11/15/2001. The pt has a medical history of hypertension, hyperlipidemia and myocardial infarction and was receiving ramipril, metoprolol succinate, atorvastatin, provella-14, multivitamins and acetylsalicylic acid concomitantly. It is unknown whether or not the pt had received an influenza vaccine previously. On 11/15/2001, the pt received a fluvirin injection into her left deltoid muscle. Two to three days later the pt experienced pain in her left arm and shoulder, which was treated with meloxicam. The pt however, is sill experiencing pain in her left arm and shoulder, although the symptoms are milder. The reporter has assessed the relationship of study medication to the event as probable. Following internal review on 03/18/2002, this event was upgraded to serious.
Client complained of redness at injection site (left upper arm). No itchiness or swelling at site. Cold pack was applied to site and client was watched by RN for remaining time in observation.
Some side effect; Pain at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE REACTION (Some side effect), INJECTION SITE PAIN (Pain at injection site) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
My body felt like it was burning from the inside out for weeks. I got rashes around my armpits, inner left thigh, lower and upper abdomen, behind my right knee, and a circle rash in the middle of my back. The burning lasted for a little over two weeks, and the severe itching and rashes continued for over two months. It is October 19,2021 today and the itching is better and the rashes are almost completely gone. On September 6th  the left side of my face went numb and following a pin and needling sensation on the left side of my face and head. That subsided in 3-4 days. H1 and H2 were given for 10 days, oral steroids, and one steroid injection was given, topical steroids were used, hydrocortisone cream, Benadryl, several OTC itching products were tried, oatmeal baths, essential oils with peppermint and which hazel provided temporary relief when my body was burning, but nothing helped with the itching. Time was the only solution.
pt devel status epilepticus 56hr p/vax;had fever to 102;had a nl LP;required lorazepam & phenobarb to control sz;
Pupil Right Eye,on Oct. 23 my right eye dilated , I received the booster on Oct 19.  The eye is still dilated and I was told its pupil.
Low grade fever and small red blisters concentrated on face, especially around nose and mouth and forehead. Several on the extremities.
I immediately felt like the vaccination went directly into my shoulder joint. The shot was administered too high up on my shoulder and I had immediate pain. The pain has gotten worse since the day of the vaccination and is painful 24/7. I am taking OTC pain reliever and was prescribed a steroid today that I will be starting tomorrow morning.
Red hives/blotches, violent sneezing, runny nose, coughing, wheezing, red race, wanting shoe off to scratch feet. Breathing treatment and dose of Benadryl, started immediately after shot. Lasted approximately 2 hours.
Patient administered a 2nd Moderna booster despite being under the age of 50 and not being immunocompromised. He received the booster to protect his wife, who is a severe asthmatic.
Patient felt dizzy few minutes after vaccine, he leaned on the wall and had assisted fall from the staff. Vitals signs were taken with noted hypotension. Family member stated the patient always anxious during doctor appointment of blood draw. Legs were elevated and fluid forced. Patient left the facility stable with family member.
Left outer thigh - large area of redness 8-10cm, area of induration 6-8cm. Area of shot administration.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of VAQTA (lot # and expiry date unspecified) which were improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to VAQTA. This is one of several reports from the same reporter (MARRS # WAES1503USA013938, MARRS # WAES1503USA014261, MARRS # WAES1503USA014262, MARRS # WAES1503USA014263, MARRS # WAES1503USA014264 and MARRS # WAES1503USA014265).
Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.
Fast heart rate; Raised blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 10:00 PM, the patient experienced PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever). At the time of the report, PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure increased: 213/97 mmHg (High) Raised blood pressure (BP 213/97 mmhg).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the Janssen given as an alternative on 9/15/21
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 7/2/21 and the second dose of Moderna COVID-19 Vaccine on 7/30/21. Patient also received a third booster dose on 11/10/21 which is 103 days after the second dose. The recommended waiting period between booster and second dose is 168 days (7 days/week x 4 weeks/month x 6 months). There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
BLOOD TEST ABNORMAL; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; PAIN; This spontaneous report received from a consumer via other manufacturer (Abbvie and Moderna) concerned a 54 year old male of unspecified race and ethnicity. Initial information processed along with the information received on 27-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and other pre-existing medical conditions included: There was no reported medical history. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received additional 2 dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported for second dose, and dose was not reported for third dose (booster dose) 1 total administered on 12-JAN-2022 for prophylactic vaccination which was off label use as an inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced pain. On an unspecified date, blood test abnormal. Laboratory data (dates unspecified) included: Blood test (NR: not provided) High (dose number in series 2).  Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported expiry: UNKNOWN) dose and frequency were not reported from 24-MAR-2021 for ankylosing spondylitis.  The patient received additional dose of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported, expiry: UNKNOWN) dose, start therapy date were not reported one in once was administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with elasomeran was not reported; and dose of adalimumab was not changed. The patient was recovering from pain, and the outcome of blood test abnormal, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of forehead swelling in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 1st September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th September 2018, 7 days after receiving SHINGRIX, the patient experienced forehead swelling, welts and rash. On an unknown date, the outcome of the forehead swelling, welts and rash were not recovered/not resolved. It was unknown if the reporter considered the forehead swelling, welts and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 64 or 65 years. The patient received SHINGRIX on left arm. The patient experienced swelling, rash, and welts on her forehead and face. On 10th August 2018, the patient was seen by her physician. The patient planned to continue follow-up with her physician on an unknown date. The patient wanted to remain anonymous.
Red spots oN Left ARM AND  Right thigh, Stanted size of quanteR get to Be size  of baseball withiN two days LateR. Itching horrible
Congestion, Fatigue, Fever  Positive Covid Test on July 26, 2022
Not even one week later I started getting cold sores (clusters) on my lips and in my nose.  This occurred for six strait weeks, and, now I still get them about once/month.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 29-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, rHA therapy type, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
S: Syncope/vasovagal after COVID vaccine while in observation lot. B: Staff responded to honking horn - pt reported he has just come to from passing out- had been on the phone with partner while event happened and she reported the same. Diaphoretic, lightheaded and out of it.  Pt laid flat and treated with ice and supportive care. Vitals stable. History of vagal response around shots previously. A: Syncope after vaccine R: Appropriate care provided.
A 25 y.o. male showed signs of respiratory distress and swelling around mouth about 15 minutes post vaccine. We immediately called 911 and an Epipen 0.3mg was administered. His breathing quickly began to improve. The paramedics arrived and transported him to the ER. His mother was with him throughout the process.
Light-headedness  a few hours after injection.  Following morning:  Very sore arm; very tired; slight sore throat; generally out-of sorts.  Started to improve in the evening.  Symptoms resolved by the next morning except for sore arm.   72 hours after injection, just a slightly sore arm and no other symptoms. Side effects were more than from a flu shot but were tolerable.
Received second shot at 0845 L on 20 May 2021.  At 1000 L a head ache began and as of 21 Jun 2021 it has not subsided.  Head aches on a 10 scale range between 2 and 6.  No OTC medication helps with the pain.
Member c/o broke out with welts on bilateral arms, neck and back. Itching.
Positive for COVID-19 after 1st dose; Cold like symptoms after 1st dose; Body aches after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose), NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergy to stone fruit) and Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose), NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose) outcome was unknown and NASOPHARYNGITIS (Cold like symptoms after 1st dose) and PAIN (Body aches after 1st dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Polymerase chain reaction: positive (Positive) COVID-19 Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Patient demographic details were updated, relevant medical history was updated, lab data was added, vaccine facility details were added, concomitant medication was added, event outcome for aches updated from unknown to recovered/resolved.
At 04:06 PM client came back into the room of vaccination and stated she felt "queasy" and her ears were ringing for the last 45 minutes.  There was no redness or swelling at the injection site.  Client's breathing was unlabored.  Her skin was pink and dry.  Client's vital signs:  Blood pressure-124/72, Pulse-68, Respirations-20.  After hearing her vital signs were in the normal range, the client went back to her desk.  I stopped at the client's desk to check an her and at that time she reported no change.  Recommended that if her symptoms worsened or did not get better that she consult her doctor.  Called client today (11/07/13) to follow up on her condition, but had to leave a message.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021 at 2:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 2:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).