chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Hives. Unknown if r/t vaccine as several hours later. Benadryl PRN and sent to allergist for further evaluation before next set of vaccines. No other intervention required.
Patient completed COVID-19 vaccination on 3/18/21. Pt was admitted to the reporting hospital on 9/20/21 with complaint of fever, sore throat, body ache, and respiratory symptoms for over a week. Admission diagnosis was Acute hypoxic respiratory failure due to COVID-19. Patient did travel to (Withheld) 2 weeks prior to diagnosis. PCR testing was positive on 9/14/21. Patient was discharged after 5 days on 9/25/21.
arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 16May2021 (Lot number: EW0176) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "arm hurt". Additional information: The patient received the first Covid vaccine 16May2021, had no side effects with the first Covid shot other than the arm hurt. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Patient is 17 year old and was given Moderna.  Patient has not experienced any side effects.
On 6/6/2023, I realized I had been sneezing more than usual that day. I took a home antigen test and got a positive result. I then emailed my doctor for guidance. My doctor told me to self-isolate, get plenty of rest, and take in plenty of liquids. She also told me to contact her if any additional symptoms appeared. Aside from the increased sneezing on the first day, the only other symptoms I experienced were occasional coughing and fatigue. My symptoms were not severe enough to necessitate treatment with medication.
Information has been received from a physician, concerning an 18 year old female patient with allergic reaction to KEFLEX that involved a facial rash, who was vaccinated with the first dose of Gardasil (date and lot # not specified).  Concomitant therapy included MICROGEST.  Subsequently the patient developed a "ring of erythema" around the injection site, from which she recovered (duration not specified).  On an unspecified date, the patient was administered the second dose of Gardasil, and again she developed a "ring of erythema' around the injection site.  The patient contacted the physician (details not provided).  After an unknown duration, she recovered.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 3/14/2008.  Initial and follow up information has been received from a physician, concerning an 18 year old female patient , a student with seasonal allergies and reported allergy reaction to KEFLEX (caused facial rash date not specified), who was vaccinated with the first dose of GARDASIL (date and lot # not specified).  Concomitant therapy included MICROGEST.  Subsequently teh patient developed a 2-3 cm "ring of erythema" around the injection site, from which she recovered (duration not specified).  Following the erythema she developed a "persistent hypopigmentation around site."  On 04-FEB-2008, while experiencing axillary lymphadenopathy and being treated with KEFLEX, the patient was vaccinated , IM in the left arm, with the second dose of GARDASIL (date and lot # not provided).  She again developed a "ring of erythema" around the injection site.  Followed by persistent hypopigmentation around the site.  The patient contacted the physician (details not provided).  After an unknown duration, she recovered from a ring of erythema around her injection site:  the outcome of persistent hypopigmentation around site, and axiliary lymphodenopathy was not specified.  Additional information is not expected.
1 st dose  lot EL 9262 1/25/21 2nd dose Lot EN 6201    ornENG201  --this was hand written for sure if it is a 6 or a g  2/11/2021 March 4th ER diagnosed with A Fib-----cardiovert--on eliquis  twice a day and metoprolol 50 mg twice a day kept in hospital overnight-now home
Local site pain, swelling, erythema, and warmth;  Started yesterday, seems to be improving today
Personnell performing the injection, booster dose, injected 0.5ml (100mcg) of the Moderna COVID-19 VAccine instead of admninistering appropriate 0.25 ml dose (50mcg), no reports from receipient of any side effects from this at this time
pt recvd vax; devel inject site pain coincident w/ adm of TD vax;pain resolved w/in 4 days later;
Swelling and tightness of the neck and under the tongue that began acutely 25 hours after injection was given on the same side as injection site.
On March 1 2021, day of vacinne arm was achy. Then Tuesday afternoon eyes started itching. By 7:30pm my left eyes was bloodshot. Really, really red. I put some over the counter eye drops in both eyes on Tuesday night and Wed every 4 hours. Redness subsided 24 hours later, but eyes were still itchy. They Thursday night my left gland started swelling. On Friday it was very swollen. I could cup my hand around the swelling from check to neck. It hurt to swallow. I took my temperature every few hours and it was  never elevated. It was always normal . I took an ibuprofen, 800 mg and just relaxed around 5:00 pm. Still swollen on Saturday, but going down, Took another 800. mg of ibuprofen Saturday night around 8:00 pm and swelling continues to go down, but still swollen as of Tuesday, March 9, my birthday.         I did receive my Tetanus shot, preventative on February 15, 2021.
Information has been received from a physician concerning a 24 year old female who on 04-MAY-2007 was vaccinated with her first dose of Gardasil. On an unspecified date, the patient was vaccinated with her second dose of Gardasil. On 27-NOV-2007, the patient was vaccinated with her third dose of Gardasil (Lot # 659435/1265U). On 28-NOV-2007 the patient experienced flu-like symptoms, a headache, fatigue and arm pain. Patient outcome was not reported. Additional information has been requested.
Eye infection, neutropenia.  Eye swelling began 7/3, admitted 7/4, CBC showed low (<100) neutrophil.  Antibiotics administered, discharged 7/7
My son's DTP vaccinations--at Hospital on 12/1/92, 2/1/93, 3/18/93 and 1/20/94--were of a new acellular vaccine as part of a study. He had another Tetanus shot on 8-22-97 at the Clinic.  This past October he developed an intensely painful brachial neuritis of his right shoulder, arm and hand, and has still not recovered full use of his hand.  I am well aware that the time between the vaccine and the neuritis is years, but I was encouraged to report this.   Currently, he is unable to use his right hand. I consider this a disability, hopefully only temporary.
I am reporting on behalf of my sister. Her initial symptoms of swollen glands and fatigue occurred on 01/27/2022. The following days, she had a persistent high fever, some pain in her stomach (gallbladder/liver), went to urgent care, tested NEG for COVID (rapid) and was told to wait for PCR results as the said it had to be COVID.  About 5 days later, when her PCR came back negative, she was finally rushed to the ER - the fever seemed to be the biggest symptom. She had emergency surgery - removed her gallbladder (cholecystectomy);  went home less than 24 hours later. Woke up the next morning with a fever, very jaundiced, pain in her stomach & blood in her urine. She was admitted immediately upon arriving at the ER b/c she was as yellow as a banana. They tested her for everything imaginable, HIDA scan showed no blocked ducts, neither did the MRCP, but due to the fever, jaundice, and pain, they performed an ERCP, where they went in through her throat and found a tiny leak in a branch of a biliary duct, so they put in a stent. That didn?t help. Her bilirubin continued to climb, her red blood cell count & Hematocrit continued to tank, and her white blood cell count kept getting higher & higher. They tried to transfer her to a hospital with  liver specialists, but none had any beds.  Then her hemoglobin got so low, they had to do a blood transfusion x 2, and one more blood transfusion the next night. Currently, she?s got an extremely bloated stomach (Patient's tiny, but she?s got a ?gas baby?, I believe it?s called dis tension.) Her blood levels improved a little due to the transfusions, but the painful gas remains, she?s got swollen legs and feet, still jaundiced (though not as bad as before the transfusions). She?s so weak, but hasn?t had solid food in weeks. At one point, she had fluid around her lungs and in the space where her gallbladder used to be. Those issues resolved and returned. She had 2 days without a fever, but it came back during week 3. They?re treating her with steroids and an anti-viral b/c the only diagnosis they have is Epstein Barr (found in her liver biopsy). They say it?s the liver causing her illness, but don?t yet know if it?s an angry Epstein Barr virus ?awakening? or something else. (It seems very much like an auto-immune disease.)
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/4/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
1" needle used Left shoulder - 5 cm red area. - warm to touch. - swollen, firm, tender.  01/21/2005 Keflex 2 tsp po 250 mg/5cc 2x/day x10 days.
First it started with a thigh itching, and a headache, and then my arm swell, and I had a big knot under my right arm.
Information has been received from a medical assistant concerning a 67 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (LOT# 660718/0551X). On 09-OCT-2008 the patient experienced cellulitis at the injection site, and treated with cephalexin for 10 days. It was reported the patient sought medical attention: called physician's office. This was one of 4 reports from the same resource (Other 3 patient: WAES# 0810USA04401, WAES# 0810USA04371, WAES# 0810USA04374). Additional information has been requested.
Within 5-7 minutes immediately after first injection of COVID vaccine, experienced a feeling of adrenaline 'rush', increased heart rate, elevated blood pressure (139/111, when typical blood pressure is 95/60), and dizziness/lightheadedness. These immediate symptoms resolved within about 30 minutes following no treatment.  Two hours post injection, experienced extreme upper arm pain causing limited mobility, extreme fatigue, slight headache, muscle aches, and general malaise. These symptoms lasted about 36 hours.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous for prevent shingles (lot #, expiry date and strength not reported)) "when it first came out" developed singles "six years later". The reporter stated that the patient was diagnosed with the shingles by an Allergist on an unspecified date and prescribed VALTREX. The patient went to see the physician on an unspecified date after seeing the allergist and prescribed an unspecified pain medication for pain. The outcome of the events was unknown. Additional information has been requested.
Pt had been vaxed w/3 doses of Engerix-B when checked 1 yr later no titers were detected; recvd a booster dose of Engerix-B & subsequent titer testing revealed no titers;
Patient here for 2nd dose covid moderna vaccine. Reports that during her first dose, she had lightheadedness, increased BP, heart racing, acid reflux, symptoms resolved in 10 minutes. She was cleared by her PCP to receive the 2nd dose. On 1/23/20 at 1044, patient received her second dose moderna vaccine. At 1050, she reports feeling "heart racing", excessive acid reflux. VS at 1050, 165/95, HR 135, O2 100%. She denies n/v. +excessive burping. At 1055, VS BP 139/99, HR 95. O2 100%. Continues to have burping sensation. At 1114, VS BP 127/88, HR 86, O2 100. Provided fluids and snacks. Reports symptoms improved. But continues to have excessive burping. At 1129, BP 126/89, HR 107, O2 100%. Patient reports symptoms improved. Denies chest discomfort. But reports that she continues to have burping, relays that it is likely due to her history of gerd. She have not taken her medications yet (she takes omeprazole daily). At 1150, BP 151/94, HR 109. Patient reports feeling anxious , continues to have excessive burping, no heart palpitation. Transferring patient to ED. Patient initially declined and would like to go home instead. Discussed with patient and risks and benefits. She then agreed to go to ED for further evaluation. Patient was safety escorted to ED.
Itchy arm near site of vaccination; Rash near site of vaccination; three red areas about the size of a nickel each around the site of vaccine shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Allergy to keflex), Allergy to antibiotic (Allergy to Erythromycin), Fruit allergy (Allergy to Strawberries), Blood pressure high and Sleep apnea since 08-Jan-2017. Concomitant products included IRBESARTAN from 01-Jan-2000 to an unknown date for Blood pressure, PROGESTERONE;ESTROGENS from 01-Jan-2003 to an unknown date for Hormonal imbalance, VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot). On 04-Mar-2021, VACCINATION SITE PRURITUS (Itchy arm near site of vaccination), VACCINATION SITE RASH (Rash near site of vaccination) and VACCINATION SITE ERYTHEMA (three red areas about the size of a nickel each around the site of vaccine shot) had resolved.            This case was linked to MOD-2021-212844 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: Significant follow up received on 04-APR-2021, Patient demographics updated, medical history updated, concomitant medications updated, therapy details of suspect product, event term updated (rash to Rash near site of vaccination), additional events reported (Itchy arm near site of vaccination, three red areas about the size of a nickel each around the site of vaccine shot).
30OCT 24hr pain entire arm & hand;arm & under arm sore;med given didn't work-nothing really helped;13NOV shoulder x-ray & EMG p/5 wk some pain & some numbness down arm & hand;
Chills,joint pain,muscle aches,nauseated, headache, sore arm
pain in his stomach and nerves; pain in his stomach and nerves; can't eat or sleep due to the pain; This is a spontaneous report from a Pfizer-Sponsored program. A contactable consumer reported for a 21-year-old male patient (reporter's nephew). A 21-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. It was unknown whether the Reporter a Healthcare Profession (HCP). The patient medical history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient Concomitant medications were not reported. On an unspecified date, the patient after received the second dose of Pfizer covid vaccine a month and a half ago and immediately began experienced having pain in his stomach and nerves. The reporter that the patient has been in and out of the Emergency department and the doctors can't tell them anything but they said it is because of the vaccine. They were told by their doctors that they were not sure what was causing the pain. It was reported that on an unknown date, the patient can't eat or sleep due to the pain. He has been on pain medication since receiving vaccine. Caller wants to know if these side effects have been reported and what's the duration of the side effects. Therapeutic measures were taken as a result of pain in his stomach and nerves. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
I had reaction right away five minutes afterwards drowsy and metallic taste in mouth and :30 observation and extremely fatigue and a neck pain and 4-5 pain level issue 04/12/2021 04/13/2021. Doctor phone and recommended ER and next day tired and off and fatigue and felt off and went to urgent care 04/16/2021 and fever and blood pressure electro cardio gram and for stroke and heart and stroke and clots and no symptoms for clots results was good and not able to sleep and Friday was extremely exhausted and neck pain and fever and medication.  Fatigue and fatigue come and Motrine or Tyler. Still have neck pain and fatigue that comes and go not recovered.
This spontaneous report as received from a Nurse Practitioner via a company representative refers to a 1 year old patient. On 10-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) lot# H019521 (Lot # in validation) expiry date 24-OCT-2014. The Nurse Practitioner reported that the patient experienced a rash after the administration of VARVIAX (Merck) on 10-SEP-2013 and the patients parents called to the Nurse Practitioner on 17-SEP-2013 to report a rash on the patient's trunk (onset date; 17-SEP-2013). The patient's parents report that there was only a rash but no vesicles. The nurse practitioner had scheduled the patient to go to the office at the time of reporting (19-SEP-2013) to be evaluated. The patient sought medical attention. The outcome of the event was reported as not recovered. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fell and hit his head, paramedicas came and found him to be responsive and let him go after 20 minutes of observation. Seemed to be focused afterward, could stand without any problems
Both components of vaccine were not administered. Patient needed MCV and the office stocks MENVEO and only the Liquid portion of the vaccine was given. Liquid portion was not mixed with powder.
Case number PHEH2016US032279, is an initial spontaneous report received from a pharmacist on 07 Dec 2016. This report refers to a patient of unknown age and gender. Medical history included nursing home patient. Concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. The patient was administered last year vaccine by mistake. The pharmacist reported that, the 2015/2016 FLUVIRIN vaccine was still in the medicine refrigerator. No adverse event was reported following this maladministration (expired product administered).
Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling MNSC. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; No additional AE reported; This spontaneous report was received from an other health care professional referring to 12-month-old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-FEB-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) intramuscularly in right thigh, lot #W006412, expiration date 23-FEB-2024, (exact dose and dose number were not provided) for prophylaxis.  On 20-JAN-2023, the suspect vaccine experienced a temperature excursion from -14 to -10 degrees Celsius for 1 hour (product storage error). There were no reported previous temperature excursions. No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). It was indicated that medication error could occur during storage in clinical practice. Adverse event had been reported previously to manufacturer. The patient was vaccinated at private doctor's office/hospital. Temperature excursion occurred as a result of a reading from a Digital Data Logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007931: