chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel like in a fog; severe headache/all over the top of my head and throbbing; chills; anxious; could not relax or sleep; Soreness at the injection site; Diarrhea for 3 hours; exhausting/fatigue; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24May2021 (Batch/Lot Number: ER8735) (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications included fluoxetine; mirabegron (MYRBETRIQ); propranolol and lithium; all taken for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 03May2021 (at the age of 50-years-old) in the right arm for COVID-19 immunisation. Patient had vaccine number 2 in the afternoon. On 24May2021 at 23:00, patient began to experience a severe headache. It was all over the top of her head and throbbing. Patient had the chills, anxious and could not relax or sleep.  Patient was unsteady on her feet. Patient had soreness at the injection site and diarrhea for 3 hours. It was exhausting. This morning (date unspecified), she still have not had any sleep.  She had a slight headache and fatigued. She felt like she was in a fog. No treatment was given to the patient. Since the vaccination, patient has not been tested for COVID-19. Outcome of headache was recovering, diarrhea was recovered on 25May2021, while remaining events was not recovered.  Information on the lot/batch number has been requested.
11/23/2021 at about 10 pm you developed a headache and a sore right arm.  Then 11/24/2021 midmorning at about 10 am she noticed hives developing on her arms, they were very itchy.  The hives spread over her whole body  by about 7 pm.  Her entire body was itchy.  She also developed body aches and chills at about 10 am.  She stated she took a extra strength tylenol and rested.  11/25/2021 she reports that the chills and body aches resolved, but the headache and hives continued.  The hives gradually faded day by day.  Today she still has faint hives on her chest and arms.  Her headache resolved on 11/27/2021.  She placed ice on the hives as needed to control the itching.  She did not seek medical attention.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant (The bone marrow transplantation was done at SEP 2018.) in September 2018. Concurrent medical conditions included Acute myeloid leukemia. Concomitant products included TACROLIMUS, ALLOPURINOL and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided          No treatment information was provided.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-106467 (Patient Link).
10/03/07 approximately 2:15pm vaccination with Pneumovax and Fluzone approximately 1030pm chills at bedtime. 10/4/07 (AM) Itching: skin inflammation; skin warm to touch. 10/5/07 (approximately 12N) - Symptoms remain. Patient will take Benadryl 25mg, PRN.
Extreme fatigue, foggy thinking, and malaise that was intense for 36 hours. Symptoms gradually decreased from hour 36 to hour 72. Still feeling more tired than usual, but it's mild and I obviously cannot pinpoint the cause.
Injection site pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. On 2nd August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, the injection site pain and fatigue experienced for 3 days and then resolved. For the tolerence of 2nd dose refer case US2019AMR188461. The reporter consented to follow up.
Information has been received from a physician concerning a 14 year old male who on 11-NOV-1996 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 25-JAN-2000, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 12-NOV-2009, the patient experienced mumps (the date diagnosed was reported as 03-JAN-2010). The patient was afebrile and did have parotitis. The outcome for mumps was not reported. Follow up was received from a physician. It was reported that the 14 year old patient experienced mumps on 12-NOV-2009. The diagnosis date was on 12-NOV-2009. On the same date, the patient had several tests performed: IgM was <1:10, IgG was 3.36 and serum amylase was 95. The patient had right parotitis and was afebrile. On 27-NOV-2009, the patient had several tests performed: IgM was 1:20:00 and serum amylase was 9.04. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Soreness in forearm of arm in which vaccination was administered pt said soreness is getting worse.
About 3 hours after receiving the vaccine I started to feel pressure to have a bowel movement.  It came on suddenly.  While on the toilet I felt a little nauseous.  For a minute or so, I thought I was going to throw up as well.  The nausea passed after a few minutes, but I felt very fatigued.  Got home and have been laying down.  It's now 5:20pm, 3 hours later, I'm feeling better, but still a little tired.  I have a slight "flu like" feeling that I feel "off".  I blessed with good health but I feel a little "off kilter".  I thinking I'll feel better tomorrow.
Information has been received from a physician concerning a female (age not reported) who was vaccinated with a dose of Gardasil vaccine (lot # not reported). There was no concomitant medication. Subsequently, "two to three days after vaccination", the patient developed super clavicle lymph nodes.  The patient's super clavicle lymph nodes persisted. Blood test and chest x-rays were performed (results unknown). There was no product quality complaint. Additional information has been requested.
pt recvd eval on 2JUN92 believes having rxn to Hep B vax; states w/in 2-3 hrs of receiving vax exp fever/chills (did not take temp); nightmares; states still feels exhausted, does not feel like self; c/o lightheadedness;
Dizziness- began about 15 min post shot & lasted about 15-20 min. Increased heart rate - began about 1 hr post shot & lasted 2-3 hrs- said she counted 120 beats/min & states she is normally @ 80-9-/min. Lt wrist and hand hurt for short time on Sunday AM (3 days post shot) Did not seek medical treatment - states as a child she had problems with vaccinations, i.e. fever of 102 degrees.
25WKS PREGNANT WITH DRY HEAVES. PARAMEDIC CALLED,   RESOLVED, REFUSED TRANSPORT TO HOSPITAL
Pt vax /w DTP developed T105.6, crying, irritable, less than 24 hrs /p DTP, IV fluids & Rocephin IV & Decadron, cultures all neg; CBC consisant /w viral synd also had maculopapular rash. pt improved & decreased fever, D/C /w no restrctions.
congested/snotty; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested/snotty) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced NASAL CONGESTION (congested/snotty). At the time of the report, NASAL CONGESTION (congested/snotty) outcome was unknown.            No concomitant and treatment medications provided.  Patient called to ask if being congested and snotty are side effects of the Moderna Covid-19 booster. Patient reported that she got her booster yesterday, 08Nov2021 around 10:30 am through their health department  This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Nasal Congestion. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Nasal Congestion. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
bruise in armpit; pain in armpit; This case was reported by a pharmacist via call center representative and described the occurrence of contusion of axillary region in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th May 2019, the patient received Shingrix. On 26th May 2019, 2 days after receiving Shingrix, the patient experienced contusion of axillary region and axillary pain. On an unknown date, the outcome of the contusion of axillary region and axillary pain were unknown.   It was unknown if the reporter considered the contusion of axillary region and axillary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix, two days later, she reported experiencing a bruise and pain in her armpit. The reporter consented to follow up. The reporter had limited data about the patient at the time of report.
I ALREADY SUFFERED FROM TINNITUS BUT AFTER THE SECOND DOSE OF MODERNA ONT HE ABOVE MENTIONED DATE, THE TINNITUS HAS WORSENED.  IT HAS BECOME MUCH LOUDER AND IS VERY DIFFICULT TO DEAL WITH, WHEREAS PRIOR TO THIS SECOND INJECTION IT WAS BEARABLE. NO TREATMENT. PROBLEM IS ONGOING AND HAS NOT RESOLVED ITSELF.
This spontaneous report was received from a 67 year old female consumer referring to herself. The patient had no pertinent medical history. The patient's drug reactions/allergies included sulfa drugs and penicillin. Concomitant therapies included rosuvastatin calcium (CRESTOR) and valsartan (DIOVAN). On 27-NOV-2017 at 11 a.m., the patient was vaccinated in the arm with one injection of PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 27-NOV-2017, about 2 hours after vaccination, the patient's face began to turn red (erythema) and the arm that received the injection turned blue (cyanosis), crawling red (erythema) and began to swell from her shoulder to her elbow. The patient reported that the injection site turned hard (injection site induration), became a warm lump (injection site warmth, injection site mass) and it was painful (injection site pain). She also experienced unspecified elevated blood pressure after noticing the symptoms. The patient visited an urgent care outpatient medical facility where a physician prescribed a topical cream for the arm swelling; additionally she used warm compresses all night. No laboratories or diagnostic test were carried out. The patient reported that she did not sleep well (poor quality sleep) the night of 27-NOV-2017 because of the painful swelling in her arm that received the PNEUMOVAX 23 injection. At the time of the report the swelling had decreased and the red color (erythema) had turned to pink (recovering); however, the outcome of blood pressure increased, injection site pain, injection site warmth, injection site mass, injection site induration, cyanosis and poor quality sleep was not reported. The reporter did not assess the relatedness of the adverse events with PNEUMOVAX 23.
Information has been received from a registered nurse concerning a patient of unknown age and gender. On 12-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, strength, route were not reported, lot # J011830, expiration date: 26-DEC-2014). No adverse events were reported. Additional information has been requested.
Received Influenza Vaccine 9/16/21. Two days later presented to our ER with dysphonia and dysphagia. MRI/MRA showed no sign of acute stroke. Consult with Dr. suggested possible variant of Guillan Barre Syndrome. Transferred to Facility. He was intubated initially to protect his airway. Subsequently extubated and died. Diagnosis of Myasthenia Gravis was also considered and test has subsequently come back positive for this antibody.
INFLAMMED LUNGS AFFECTING HEART; This spontaneous report received from a consumer via  social media via concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. As Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced inflammation of lungs that was affecting his heart, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210850188.; Sender's Comments: V0: 20210861653-COVID-19 VACCINE AD26.COV2.S- inflammation of lungs. This event(s) is considered unassessable. The event(s) has an unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt received DTAP injection approx 10AM 5/24/16. Parent stated child fainted 6 hr's later for 30 seconds.
Patient only received half of the dose of Menveo as it was not reconstituted properly. Made the patient aware of the dose, pt has not had any reactions.
Severe joint pain in elbows, wrists, fingers, shoulders, thoghs & calves, stiff fingers, chills, fever of 101.5.
swelling of thigh lt @ inj site, sl tender & warm; tx compresses, APAP resolved p/ 1 1/2 days;
headache; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Aug2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Aug2023, outcome "not recovered"; CHILLS (non-serious) with onset Aug2023, outcome "recovered" (Aug2023); PYREXIA (non-serious) with onset Aug2023, outcome "recovered" (Aug2023), described as "fever". Additional information: The caller mentioned that she took the vaccine last sunday and had a general side effects like chills and fever. She added that it went away and everything was fine but yesterday and today she have been having a really bad headache and wanted to know if that is normal with the vaccine because she's having a bad headache.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax;red & swollen at inject site;cried unconsolably for 3 hr; apap given at 3pm & 8pm;stopped crying p/ 2nd dose of apap;no MD visit at time of tx;
OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 24-MAR-2022 11:35 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2022, the patient experienced off-label use, and vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052091 and 20211051934.
I got my flu shot on Tue Oct 10-2017 around 4:30 pm. About 30 mins later my left arm started feeling numb and weak with so pain. Wed I had muscle aches and chills but no fever. Thurs started feeling weakness a little more in left arm. Friday I started feeling more dizziness.
Large rash at injection site (right arm) that was swollen, hard and painful. It was the size of a small envelope.
pt recvd flu shot 27OCT95 lt arm has been sore; noted occasional itching 2NOV lt upper arm & 3NOV lt arm red & itchy
PATIENT WAS GIVEN SHINGRIX #1 AFTER VERBALLY AGREEING TO THIS VACCINE LATER DURING OFFICE VISIT, HE INFORMED PROVIDER THAT HE WAS GIVEN MODERNA COVID VACCINE #1 YESTERDAY WAS NOT INFORMED BY DEPT OF HEALTH (ADMINISTRATOR OF MODERNA VACCINE) THAT HE SHOULD NOT RECEIVE OTHER VACCINES 14D AFTER OR BEFORE COVID VACCINES.  NO ADVERSE EFFECTS IN OFFICE AND PATIENT MONITORED >15 MIN; ADVISED TO BE SEEN IN ER IF SEVERE AE'S OUTSIDE TYPICAL PRESENTED.
patient with ankle/leg swelling within a few days of vaccination I have treated with diuretics and if not effective will treat with prednisone.   Noted today, no treatment response available at this time
Dizziness; Sore arm; Chills alternating with a feeling warm; Chills alternating with a feeling warm; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Chills alternating with a feeling warm), CHILLS (Chills alternating with a feeling warm) and FATIGUE (Tiredness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B210 and 027421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to codeine), Food allergy (allergy to green pepper), Food allergy (allergy to egg plant), Food allergy (allergy to parabens), Toothpaste allergy (allergy togel toothpaste), Seasonal allergy and Hypercholesterolemia. Concomitant products included ROSUVASTATIN and EZETIMIBE for Hypercholesterolemia, UBIDECARENONE (COQ10 [UBIDECARENONE]) and LUTEIN [XANTOFYL] for Supplementation therapy, CENTRUM SILVER WOMEN 50+ for Vitamin deficiency NOS.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Chills alternating with a feeling warm), CHILLS (Chills alternating with a feeling warm), FATIGUE (Tiredness) and PYREXIA (Fever). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), FEELING HOT (Chills alternating with a feeling warm), CHILLS (Chills alternating with a feeling warm), FATIGUE (Tiredness) and PYREXIA (Fever) had resolved.            No treatment product information was provided   This case was linked to MOD-2021-053363 (Patient Link).   Reporter did not allow further contact
Patient received a third dose of COVID vaccine at this facility.  He had received a first dose at another store on 4/16/21 and came to us on 5/12/21 for what we thought was his second dose.  We were able to bill his second dose to his insurance successfully, so we were unaware that he had gone to another facility outside of the system and received another dose in April.  The error was brought to our attention.  We attempted to reach the patient to inquire about adverse effects due to receiving an extra dose of vaccine, but the only phone number we have on file has been disconnected.  We do not know if he suffered any adverse effects.
Moderna COVID-19 Vaccine EUA 11:30pm- significant pain from injection site at shoulder down to wrist (wrist felt sprained) 12:30-5:00am- severe nausea and profuse sweating, likely a result of fever 11:30am- swelling of deltoid muscle on same side as injection site that persisted for at least 8 hours (currently still swollen at time of filing this report)
Drooling, coughing, and red rash. Treated with epinephrine, Benadryl, and Prelone. Diagnosis of anaphylaxis due to MMR per allergist.
Fatigue for one week after receiving vaccines; napping throughout day, nausea; reduced appetite extreme tiredness; nasal congestion since vaccine was given.
She began feeling badly the day after 2nd dose.  Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and  she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.
Pt had red bumps on torso, groin area and arms-discreet vesicular lesions with erythemic base
patient stated he had not been vaccinated until he received the dose of moderna on 10/08/21, already received 1st dose of pfizer
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant male (age unknown) patient whom gave ACTHIB with a saline diluent not the one that comes with it, while he received vaccine ACTHIB, PREVENAR and DTAP. On 23-Aug-2018, the patient received a 0.5 ml fourth primary dose of suspect ACTHIB VACCINE (lot number: UI944AA, expiry date: 02-Dec-2019) via intramuscular route in the left thigh. Patient also received PREVENAR and DTAP on the same day. It was a case of actual medication error due to wrong solution used in drug reconstitution. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.