chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had COVID positive result.; Had COVID positive result.; Cough; Fatigue; Sore throat; Headache; Loss of smell; Muscle body aches; Inability to stay awake; congestion; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 35-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 02Feb2021 (at the age of 35-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies maybe Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had no COVID prior vaccination. On 26Jul2021, the patient experienced cough, fatigue, sore throat, headache, loss of smell, muscle body aches, inability to stay awake, congestion or runny nose. The patient was COVID tested post vaccination on 29Jul2021, nasal swab taken, and the polymerase chain reaction (PCR) test done which showed COVID positive result. As a result of events the patient visited to doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse via Poison and Drug Centre refers to an unknown number of patients of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates in 2017, multiple unspecified patients were vaccinated with PEDVAXHIB for prophylaxis. Dosing details, route of administration, lot number and expiry date were unknown. On an unknown date, in the beginning of 2017, the vaccine was reported to have been out of range (incorrect product storage). It was reported that "the other employees who record the temperature never reset the button". On 03-JAN-2017, for example, the "min/max" temperature was "33/47" (units unspecified) and "she didn't reset the button". The temperature was observed to be 43 (units unspecified) when she arrived at the office and when she left, it was 47 (units unspecified). It was never observed to be out of that range. It was also reported that "on the 3rd, 4th, 5th, and 7th, everything was in the same range and was 43, 38, 35, 45, 43, or 45" (units unspecified). As of 06-MAY-2017, it was not known if the patients were still administered the PEDVAXHIB. This report is one of three reports that are linked via same reporter link. Additional information has been requested. Sender's Comments: US-009507513-1705USA007741: US-009507513-1705USA004287.
Within 10-15 minutes of receiving the shot, my face and ears became very flushed and hot; I felt as if I had a large dose of a Medrol Dose-pak/steroid. I did not have any difficulty breathing, nor did I feel my throat constricting or other symptoms of anaphylaxsis. Since my symptoms were relatively minor, I did not alert the volunteers at the vaccine site that I needed to see the paramedic on duty. The only concession I made to my symptoms was that I allowed my adult daughter, who came with me for a vaccine, to drive us home. My symptoms subsided within 30 minutes and have been gone ever since.
Starting the morning after the vaccine I noticed an itchy rash had developed on my arms, abdomen, and upper legs.  The rash reminded me of the look of a poison ivy rash (however, I had not been outside nor in contact with poison ivy).  After 2 days the rash on my arm turned almost red/purple in color and spread from the "bumpy" look of a poison ivy rash, to a low-sitting dark-colored rash.  The itchiness subsided somewhat by day 3, but the appearance of the rash remained.  After about a week the rash was gone.
Itching all over; Injection site redness; Injection site itching; Injection site induration; Pain in arm; A spontaneous report was received from a consumer concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was little sore/pain in extremity, last week there was a knot there/injection site induration, arm started itching/injection site pruritus, red circle where shot was administered/injection site erythema, whole body feels itching/itching all over.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, Aldactone a, carvedilol, metformin, atorvastatin, omeprazole, hydrochlorothiazide.  On 5 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscular in left arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient experienced arm was little sore/pain in extremity. On 7 Feb 2021, the patient experienced last week there was a knot there/injection site induration. On 14 Feb 2021, the patient experienced arm started itching/injection site pruritus. On 19 Feb 2021, the patient experienced red circle where shot was administered/injection site erythema, whole body feels itching/itching all over. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm was little sore/pain in extremity, last week there was a knot there/injection site induration were considered resolved on 13 Feb 2021. The outcome of events arm started itching/injection site pruritus, red circle where shot was administered/injection site erythema, whole body feels itching/itching all over was considered not resolved.
Diarrhea; teeth were hurting; nose was dripping; could not even lay down or sit up; severe headache, my head felt like it was going to blow up; Vomiting; nausea; A spontaneous report was received from a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vomiting, diarrhea, severe headache/headache, teeth were hurting/toothache, nose was dripping/rhinorrhea, could not even lay down or sit up/discomfort and  nausea.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event included nortriptilina, cranberry [vaccinium macrocarpon], ginger [zingiber officinale rhizome], ubidecarenone, vitamin d3 and diazepam, isopropamide iodide.  On 08-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   In Feb-2021, the patient stated that she had a bad reaction to the vaccine, and she experienced vomiting, diarrhea, severe headache and her head felt like it was going to blow up. The patient's teeth hurt like she had four root canals done without even actually getting anything. The patient also had dripping nose. The patient was not able to lay down or sit up and she felt awful. The patient had been to the emergency room where she was given an intravenous drip (IV) for nausea and medications for pain. Patient felt better after 24 hours but she stated that she still felt like beaten up but was much better. The patient took Motrin (ibuprofen) couple of times a day. The patient had little bit of headache at the time of the report.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vomiting, diarrhea, teeth were hurting, nose was dripping, could not even lay down or sit up and nausea was recovering/resolving and the outcome for severe headache my head felt like it was going to blow up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Within a few minutes of receiving the Pfizer Covid vaccine the patient passed out. He fell to the floor. Person standing near said it looked like he hit his head on the sign he was next to but when he came to said his head did not hurt just his back and his arm which appeared to have carpet burn/scratch. He said he did not remember passing out only feeling nauseous. After a few more minutes he passed out once more. Firefighter checked vitals and said they were all fine. Patient declined transfer to a medical facility but did have someone come to pick him up. It was recommended to him to be checked at a medical facility but it is unknown if he did.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY, start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient did previously receive a COVID-19 Vaccine. The patient was treated with Paxlovid from 04Mar2023 to 08Mar2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300107531 Same patient, different drug and event.;
Received vaccine 9A, 12P started having difficulty swallowing/tightness in chest. Was noted by floor MD with hives. Was given po BENADRYL with no relief. Went to facility without cont'd difficulty swallowing/breathing. Admitted to ICU, given VERSED, albuterol. Vaccine given 10/21/11 was D/C from hospital 10/22/11. Asthma vs vaccine reaction.
profuse sweating; diarrhea; bile; severe abdominal pain; headache; violent vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting). At the time of the report, HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medica Treatment patient in ED for 3-4 hrs. patient stated she received fluids, haldol, and other meds she didn't know. She felt better after her ED visit and had no further symptoms.   Reporter did not allow further contact
Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; Covid Toes. Red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe; This is a spontaneous report from a contactable consumer reported for himself.  A 73-year-old male patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261), at the age of 73-year-old via an unspecified route of administration in Right arm on 05Feb2021 15:00 at single dose for covid-19 immunisation.  Medical history included hypertension, asthma, pulmonary embolism, elevated cholesterol, Peanut allergy.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included warfarin, atenolol, simvastatin.  The patient experienced Covid Toes, red and purple discoloration spots on distal tip of big toe L foot and red spot dorsum of second toe on 15Feb2021. The events did not result in emergency room or physician office visit. No treatment was received. Seriousness was reported as no, no result in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was not recovered.
Patient received immunization in vaccine clinic on 04/18/2022. Called into Health office on 04/19/2022 c/o dry mouth, fatigue, and headache. Patient believes SX are d/t receiving 4th dose of Pfizer vaccine day before. Advised patient to rest and push fluids. If SX worsen or do not resolve report to UC.
throw up again; Sore in arm; Feeling lightheaded; slept most of the time; Throw up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded), SOMNOLENCE (slept most of the time), VOMITING (Throw up) and VOMITING (throw up again) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 032M20A) for COVID-19 vaccination.     No Medical History reported by reporter.  Concomitant products included CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULPHATE) from 26-Apr-2020 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN 81), LOSARTAN, ATORVASTATIN and TICAGRELOR (BRILINTA) from 15-Apr-2019 to 01-Apr-2020 for an unknown indication.   On 17-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded) and SOMNOLENCE (slept most of the time). 17-Feb-2021, the patient experienced VOMITING (Throw up). On 02-Mar-2021, the patient experienced VOMITING (throw up again). On 18-Feb-2021, PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded), SOMNOLENCE (slept most of the time) and VOMITING (Throw up) had resolved. At the time of the report, VOMITING (throw up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Additional information provided:VAERS form-Concomitant medications, Dose 2 details ,New events and details of events added
Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)
A contactable female consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Apr2021 at a single dose for covid-19 immunization. The patient relevant medical history and concomitant medications were not reported. On an unknown date, the patient got her period, but her flow was heavier than normal. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Client is an adult female who came in for a Pfizer booster and received a Pfizer pediatric (5-11 year old) dose. Client was made aware of the error 12/8/21 @1626 by the lead nurse. Client to come in for a revaccination on 12/13/21.
Tightness in the chest and throat, some dizziness. As soon as I returned home I took 3 Claritin pills.
Patient is a 68 y.o. male admitted with pna due to covid-19. Pt received 4 doses of remdesivir. Improved from nc to room air. Received steroids, nebs, abx, supplements. Seen by psych due to concern for SI, but cleared from this standpoint. Started on celexa. Ct PE and echo reviewed. Dc with close f/u
Pt vaccinated with HIB/MMR/TINE vomited 5 mins of vaccination, swelling of both eyelids, mottling of skin w/redness & swelling of hands & feet.Urticaric lesions on trunk w/congested nose.
Day after vaccination given, (R) arm tender to touch only. On the morning of 7-16-16 (R) arm around injection site swollen, warm to touch reddened at 2 inches around injection site and some bruising. Redness and warmth continued. Seen by internist (friend) on 7/16/16. KEFLEX x 10d prescribed slowly resolving. Hematoma also around site.
I got symptoms of joint pain, particularly in the hands, knees, elbows, and hip. I also had a severe headache and feeling of hot and cold. I got a COVID-19 test that showed negative. My symptoms continued and I went to my primary care physician which agreed to COVID. The majority of the symptoms lasted for approximately 4 days. I still have lingering issues with headaches and joint pain.
4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: During a school vaccination clinic, the patient was inadvertently administered a dose of expired Bexsero, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094010:same reporter US-GLAXOSMITHKLINE-US2021AMR094020:same reporter
Malnourished, SATS levels were high, diagnosed with PMR, severe pain in the back area, achiness, severe stiffness, prescribed Prednisone.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (patient had a reaction) and product dose omission issue (longer than month since first dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (patient had a reaction) and product dose omission issue (longer than month since first dose). At the time of the report, vaccination complication (patient had a reaction) outcome: unknown. Product dose omission issue (longer than month since first dose): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Patient stated she started running 102 degree fever the evening of the vaccination (2 days ago). Her injection site has progressively gotten bigger and redder since that day. She tried ice, OTC pain reliever (Tylenol/Ibuprofen), and oral and topical Benadryl, none of which helped the side effects. She is sweating today.
There is no adverse event. This is reported due to administration error. First dose Moderna COVID vaccine was given on 4/17/21, but the 2nd dose Moderna COVID vaccine was given 1 day too early on 5/10/21 (i.e. 23 days after 1st dose). Minimum frequency between 1st and 2nd Moderna dose is 24 days.
No adverse Reactions Reported. In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.)
Twelve hours after I received the Moderna Covid-19 vaccine, I experienced sever shaking, tremors and chills.
Intense headache, fatigue, chills, body aches beginning the morning after vaccination. These symptoms have persisted for 48 hours after vaccination. On Monday, April 12th at 2:45PM, I experience a full-body fainting and collapse onto the floor when attempting to stand upright.
Patient received TWINRIX #2 on 6-17-08, called to office on 6/23/08 - complained of redness and swelling at injection site - This developed on 6/18/08 - itching developed 1 day later on 6/19/08. Seeing his doctor today 6/23/08.
This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) ) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (One patient received the Moderna Primary Series vaccinations greater than 35 days apart), EXPIRED PRODUCT ADMINISTERED (Pediatric patient received Moderna Covid-19 vaccine that was past the 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Oct-2022 and was administered on 28-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         4 Patients received the vaccine. Individual vials that came from an unbroken carton. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 25-Oct-2022. The vial did not undergo any temperature excursions. No treatment medication was provided.