chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: El9272, Expiration Date: not reported) via an unspecified route of administration in left arm on 27Jan2021 09:00 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included dust allergy, mycotic allergy, allergy to animal, asthma, hysterectomy and hernia. Concomitant medications (within 2 weeks of vaccination) included zolpidem tartrate (AMBIEN); ropinirole; atorvastatin and solifenacin. The patient experienced diarrhea on 27Jan2021 at 12:00 AM. Treatment was not received for the adverse event. The event was recovered on an unspecified date.
Left thigh - red and swollen locally but quite large 3"x3" -raised w/in 24 hours of vaccination. Pt feeling well otherwise. Very low grade temp 99.3
My daughter had viral arthritis which began a week after receiving her shots. My perfect 4 year old daughter could no longer hold my hand due to pain. She could not pull her own pants up or down or turn the pages of her books. She suffered for 7 weeks during this time I took her to an ER which said that she was fine. A doctor that diagnosed her with JRA, a rheumatologist who went from JRA, inflammatory arthritis to finally a diagnosis of viral arthritis. She went to hand therapy and eye doctors to rule out JRA eye complications. She is perfect now except for the tiny red freckles around her eyes which developed when she was throwing up from the pain medication, Tylenol and Motrin. She has been diagnosed with viral arthritis but the Dr never PM pointed the Rubella vaccine. When I did some research the two causes of viral arthritis is having measles, mumps or rubella which her blood test. Would have confirmed or after rubella vaccination. I am convinced that the vaccination is to blame for what happened to her.
Patient received Covid-19 Vaccine, mRNA, Bnt162b2, Lnp-S (Pfizer) on March 8, 2021 batch # EN6205 and second shot on March 29, 2021 Batch# ER8727. Admitted to Hospital, April 6, 2021- DIAGNOSIS double pneumonia, kidney failure, lung disease, heart failure. Sepsis. Discharged April 12, 2021. Cardio appointment April 14, 2021 - progress good. Admitted to ER April 16, 2021, Extreme hypoxemia (71), difficulty breathing. Intubated in ICU on April 17, 2021, given last rites. Needs higher quality of care. Airlifted to ICU April 20, 2021- June 4, 2021 DIAGNOSIS: ACUTE HYPOXEMIC RESPIRATORY FAILURE, PERSISTENT ATRIAL FIBRILLATION WITH RVR, ACUTE KIDNEY INJURY,  HYPERNATREMIA, GRANULOMATOSIS WITH POLYANGITIS WITH MULTISYSTEM INVOLVEMENT, INTRA-ALVEOLAR HEMORRHAGE, VOLUME OVERLOAD, VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE), INFECTION due to ESBL-producing Klebsiella pneumonia, SEPSIS
He developed acute heart failure, renal failure, rhabdomyolysis, elevated LFTs, thrombocytopenia.  Seen initially in outpatient clinic for SOB that was attributed to COPD and skinning coyotes, then had repeated visits for worsening SOB and ultimately to outside ED for worsening edema and hypoxemia with subsequent transfer and admission to our facility requiring non-invasive vent support.  Started on continuous renal replacement therapy (CRRT).  Found to have global hypokinesis and severe L main coronary blockage and underwent complex PCI intervention, then developed post procedural hematoma with persistent acute thrombocytopenia since admit.  Fem stop placed and bleeding controlled, but he developed worsening shock in the setting of multiorgan failure and ultimately transitioned to comfort care.
No adverse event; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     The patient had no allergies.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (primary series) and PFIZER BIONTECH COVID-19 VACCINE (primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 19-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients).    No concomitant medication was reported. Dose number reported was first booster. No treatment medication was reported.
fall; She is currently homebound unable to walk; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She was just discharged from the hospital due to a fall.  She is currently homebound unable to walk. She states the hospitalization was not due to vaccine. Her first dose was administered at her house by an ambulance.  She is calling to see how to schedule her second dose. The outcome of the events was unknown.
Patient received her vaccine at 2:13P and was recommended to wait 30 minutes in the observation area. After waiting 30 minutes patient went to the bathroom and then returned at 2:45P and reported mild throat tightness. RN responded. Vitals taken at 2:49P and 2:58P were within normal limits. Patient reports having previous anaphylaxis reactions to mushroom and bee stings. Also, reports mild allergies to peanuts and eggs. Patient reports no history of cardiac issues. Patient has history of asthma and pre-diabetes. Patient reported itching around the injection site but did not have hives present on either arms, chest, or neck upon inspection. Patient reported that she had not had anything to eat today and drank one cup of juice earlier in the morning. Patient reports that the feeling felt similar to her previous mild reactions to peanuts. Recommended that patient wait to be monitored and be seen by a provider due to previous history. Patient was seen by Dr.  50 mg of Benadryl given PO at 3:09P. Patient expressed she would like to stay in observation "a little longer" for further monitoring. At 3:35P patient reported that the swelling had gotten better and was ready to leave. Patient had her personal epi-pen in her purse and verbalized when it was appropriate to use it. ER precautions also given and patient verbalized understanding. Patient left to take bus home at 3:36P.
flu like illness; Dry mouth; Feverish; Joint Soreness; Fatigue; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness) and FATIGUE (Fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like illness), DRY MOUTH (Dry mouth), PYREXIA (Feverish), ARTHRALGIA (Joint Soreness), FATIGUE (Fatigue) and MYALGIA (Aches) outcome was unknown.            No relevant concomitant medications were reported.
vaccine was left in freezer for too long and was no longer good, pt came in and was given vaccine again
Heart palpitations; tachycardia; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 09Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "PCOS" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering", described as "Heart palpitations"; CHEST PAIN (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering"; TACHYCARDIA (non-serious) with onset 09Oct2023 at 19:00, outcome "recovering". The events "heart palpitations", "tachycardia" and "chest pain" required emergency room visit. Therapeutic measures were taken as a result of palpitations, tachycardia, chest pain with "Torodol."  Additional information: No known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
there was a little blood at the injection site this time; patient received booster (dose 3); patient received booster (dose 3); headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported; Expiration Date: 31Jan2022) via an unspecified route of administration on 04Oct2021 as dose 3 (BOOSTER), single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  On 04Oct2021, the patient experienced a little blood at the injection site and received booster (dose 3). On an unspecified date in Oct2021, the patient experienced headache. The patient wanted to know how long the vaccine could be out. The patient was concerned that it was sitting around. The patient wanted to know how old the vaccine was. The patient stated that she received her booster dose today in the same arm she got her previous doses. The patient said that there was a little blood at the injection site this time, but there wasn't any blood when she got the 1st 2 doses. The patient said she had a little headache. The patient wanted to know if injection site would more likely bleed after the booster. The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
One golf ball sized mass, one smaller mass at injection sites on right thigh the night of vaccine administration, fever <101, very fussy for > 5 hours with inconsolable crying.
Pt said he didn't sleep well Monday 9/11, then on Tue around noon he noticed a large red welt around his right arm at his elbow (not around injection site). I viewed the welt looking for a pierce in his skin because it looked like a welt from a spider bite, but saw no break in his skin. He did report that he had been trimming trees on Monday. He said he had felt tired since getting the immunization too. I advised him to take an antihistamine and ice the welt. He said the welt (which was quite large 6in x 3in) was larger prior to coming to pharmacy. I told him if it got larger again, or if he had additional complications to go to Dr and also report to us.
Information has been received from a medical assistant concerning a 38 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free). Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset. The patient was seen by the physician. It is unknown if the patient recovered. It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event. Additional information has been requested.
This spontaneous report has been received from a pharmacist regarding a male patient of an unknown age. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that on an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis, that was reconstituted with DILUENT MRK (dose, frequency, route of administration, lot number and expiration date were not reported). According to the reporter, the patient developed a swollen red knot at the injection site. There was no further information provided by the reporter. The outcome of vaccination site swelling and vaccination site erythema was unknown. The causality assessment between vaccination site swelling and vaccination site erythema with ZOSTAVAX and DILUENT MRK was not provided. Additional information has been requested.
Patient called on 10/03 and stated that 8 days after his flu shot his arm started to swell.
Temp 105 axillary x 1 at home < 24 hours after vaccines administered.
This spontaneous case, initially received on 01-Oct-2018, reported by other health professional (pharmacist), concerning a 58-year-old, adult, female patient. The patient's medical history and concomitant medications were unknown. On 01-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250797 and expiry date: 31-May-2019). At the time of report, there were no adverse reactions. The reporter assessed the case non-serious.
The same day as injection started with severe swelling on (R)-det and neck, and severe headache. Pn across back, entire arm and across chest by Thursday night. Itch that started on Friday down entire (R) arm. By Sunday morning woke up with rash and swelling on face by Sunday afternoon had to go to ER with difficulty breathing and loss of voice. I had a fever from 1-12-12 until currently. Blurry vision.
LPN inadvertently administered a higher-than-authorized dose volume (1 mL administered instead of 0.5 mL) of Moderna. This was the recipient's second vaccine dose of the Moderna series. The recipient was informed of the administration error and counseled per CDC "Interim recommendations for COVID-19 vaccine administration errors and deviations." The recipient denies any local or systemic side effects following vaccination at this time. Will follow-up with recipient daily for the next 2 days. Recipient has name/number of who to contact if any questions/concerns.
I had the normal headache, fever and chills during the first 24 hours post-vaccine and that went away normally. However my headache lingered and morphed into facial pain. Eventually I went to my ENT to check for a sinus problem. I got a CT scan and it didn't show a significant issue. I have experienced facial and jaw pain every day since I had this (second) vaccine. Many days it radiates to my neck and upper shoulders. Often I feel like I have a mild concussion-I get weird sensations when looking at a phone or computer and/or being still seated or standing. More recently, I can actually see my face twitching on the sides of my mouth and cheek. I feel like my shoulders, neck and face are always tensed up involuntarily. Sometimes I feel it in my ears-not a ringing, but a popping/pressure feeling. I was on prednisone for a couple weeks before the CT scane and that didn't change anything, and when I take IBU profin it doesn't help, so it doesn't seem like normal inflammation. I used to practice yoga and now can't invert my body without pressure that causes more pain after the fact. Since it has been 8 months with no improvement, I am getting scared and want to get to the bottom of this.
12/29/20 , left arm soreness, sinus issue, throat issue,  which by 12/30/20 sinus/chest congestion with cough.  HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu.  1/8/21, felt more fatigued and cough felt more violent.  Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers.  1/20/21, first day of feeling overall improvement, still ongoing cough.
so cold that I was sleeping with coat on and covers piled; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Reflux esophagitis, ROPINIROLE HYDROCHLORIDE (REQUIP) for Restless legs.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, 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 FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever). On 08-Apr-2021, FEELING COLD (so cold that I was sleeping with coat on and covers piled), CHILLS (chills) and PYREXIA (fever) had resolved.            Treatment medications was not provided. Medical history included current condition of blood pressure.  The symptoms lasted for about one or one and half days. Patient scheduled to receive booster dose on 29 Dec 2021.
Pt recvd MMR vax on 18DEC87 & 25FEB91 pt devel temp 2 days later devel rash, cough, stuffy nose & dec in appetite; On 1MAR91 pt seen & found to have neg throat cult but dx as having rubeola;
Patient completed Pfizer primary series in June 2021.  Received booster vaccine with Moderna today.  At this time, patient is experiencing no adverse reactions.    Parent and patient both wanted the patient to receive a Moderna booster and were aware of the EUA covering for 18+ years of age, but still pressed through with the vaccine error only identified after administration.
I had to be in bed for 3 days, hardly able to move, due to exhaustion, malaise, weakness, headache  I hurt all over and had chills.  My hips hurt, my jaw joints, my hair follicles (head), my eye ball sockets ached.  My ears rang  (they do ring under normal circumstances but I have become accustomed to that, but this was much louder)  I had diarrhea for 2 days. and didn't have a normal defecation for about a week.  I lost my appetite for 4 days.  I should note that not understanding the possible repercussions of side effects, I played a particularly tough tennis match on the morning of the injection.  I never have these types of reactions after tennis though., no matter how tough the match is.  I will report separately if needed,about the 2nd injection in the series.  I had the same symptoms less the diarrhea and loss of appetite was only for 1 day. (second shot was 12/5/19)
Unable to raise upper left arm above her head, up above her shoulder; left arm has two huge bruises; she can raise her arm up now, but can't reach her right ear, it's still a little sensitive- the bruised part is.; having some stiffness; This is a spontaneous report from a contactable 84-year-old female consumer (patient). An 84-year-old female patient unknown dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/lot number: EP7534, Expiry date: unknown), via an unspecified route in the upper left shoulder on 19Mar2021 at 11:20 (age at vaccination: 84-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included unknown medication for her heart and blood. Patient declines to provide further details about her medications, stating she does not want to raise any eyebrows that are not necessary. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, patient was unable to raise upper left arm above her head, up above her shoulder, left arm has two huge bruises that are now black and maroon in color. The bruises are about 3 inches long in a horizontal way. It looks like one big blob. She will see her see her primary physician tomorrow; she has been told to do that. She clarified she can raise her arm up now, but cannot reach her right ear, it was still a little sensitive, the bruised part is. She mentions having some stiffness. Therapeutic measures taken as a result of the events included, she initially applied ice, and then a small amount of heat 2 days later. States that it has been 10 days since she had side effects. No relevant tests were done. The clinical Outcome of unable to raise upper left arm above her head, up above her shoulder was recovering; left arm has two huge bruises, it was still a little sensitive, the bruised part was not recovered.  No follow-up attempts are possible. No further information is expected.