chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The person administering the injection had some difficulty getting the injection to go where it was supposed to go. I believe it was not injected into my muscle. Also, today (the day after) I do not have any soreness in my arm, and I've  always had soreness in my arm after every flu shot and Covid shot I've had in the past.
Initial and follow-up information has been received from a licensed practical nurse and physician concerning an 84 year old male with hypercholesterolaemia and penicillin allergy who on 02-NOV-2007 was vaccinated SC with a single dose of ZOSTAVAX. Concomitant drug therapy included simvastatin tablets. On 21-DEC-2007 the patient developed a red, raised rash on his right cheek of face as confirmed by nurse. On 28-DEC-2007 the physician examined the patient and diagnosed possible herpes zoster. No labs or diagnostic studies were performed. Details of the treatment plan were unknown. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
There was swelling, itching, redness, and hardness about the size of my palm around the injection site for five days, I experienced fatigue, headache and swollen lymph nodes for three days. I applied cortisone topical cream at the site for relief.
little red bumps like mosquito bites; throat is little itchy; itchy again on her bra line and on her back; welting on her inner arm a little bit on the bottom and the top; itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), URTICARIA (little red bumps like mosquito bites), PRURITUS (itchy again on her bra line and on her back), URTICARIA (welting on her inner arm a little bit on the bottom and the top) and THROAT IRRITATION (throat is little itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (itching). On 02-Mar-2021, the patient experienced PRURITUS (itchy again on her bra line and on her back) and URTICARIA (welting on her inner arm a little bit on the bottom and the top). On 03-Mar-2021, the patient experienced THROAT IRRITATION (throat is little itchy). On an unknown date, the patient experienced URTICARIA (little red bumps like mosquito bites). At the time of the report, PRURITUS (itching), URTICARIA (little red bumps like mosquito bites), PRURITUS (itchy again on her bra line and on her back), URTICARIA (welting on her inner arm a little bit on the bottom and the top) and THROAT IRRITATION (throat is little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Trampemine ointment.
About an hour after being vaccinated, I got very pale, and almost had a syncope episode at work.  I felt weak kneed for about 2 hours afterwards, and was still wobbly knees the next day.   I also had muscle/joint aches the same day, which went away within 24 hours.  In the past 6 days, I have had reoccurring headaches, fatigue, and  this morning, had a severe enough headache to bring on nausea.   I am med compliant with all my meds and I take care of my Type II diabetes,    I am also a volunteer firefighter - advanced EMT, so I know when there is a problem.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of GARDASIL were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Earlier that morning  took 25mg of Benadryl to address allergic reaction of contact dermatitis. After receiving Covid Moderna vaccine: 30 minutes after shot: tiredness, mild lightheadedness 60 minutes after shot: light rash noticed on forearms and palms with itchiness.  The light rash and itch lasted for approximately 3 hours from initial shot.   Took 25mg of Benadryl as the arm with the contact dermatitis continued to itch beyond the 3 hours. 17 hours after the shot, woke up with an enlarged tongue.   19 hours after,  took picture and sent to Dr. and was directed to take 50 mg of Benadryl and go to the emergency room. 22 hours after, received epinephrine shot and famotidine.  Oximeter reading and pulse rate were within normal range, blood pressure was high.
Nausea, lethargic, tiredness, abdominal cramps, severe pain at site of Covid injection
Severe headache still going on; Chills for at least 29 hours; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Severe headache still going on) and CHILLS (Chills for at least 29 hours) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis and Obesity.    On 20-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Nov-2023, the patient experienced HEADACHE (Severe headache still going on) and CHILLS (Chills for at least 29 hours). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) at a dose of 500 milligram and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at a dose of 500 milligram. In November 2023, CHILLS (Chills for at least 29 hours) had resolved. At the time of the report, HEADACHE (Severe headache still going on) had not resolved.            No concomitant medications were reported.  Reported that patient had chills for at least 29 hours. Severe headache still going on. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.   This case was linked to MOD-2023-750533 (Patient Link).
Had swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had swelling in legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21-A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement (last year (before vaccine).) in 2021.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Had swelling in legs). At the time of the report, PERIPHERAL SWELLING (Had swelling in legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       No concomitant products were reported. It was reported that patient postponed the second dose. Greater than 35 days since first dose.Had swelling in legs. Had taken some water pills. Hip replacement last year (before vaccine).
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. Since 01-APR-2015, the patients were vaccinated with doses of ROTATEQ orally (lot # K009901, expiration date: 08-MAY-2016; lot # K023534, expiration date: 22-MAY-2016; lot # K020181, expiration date: 24-JUN-2016; dose was not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have never had blood clots. I was in a boot cast and noticed my foot extemely swollen. I had been going to the doctor every week but after the shot , my foot swelled and had lots of purple and redish marking. I went to a specialist who did an ultersound and it was said I had gotten blood clots. They put me on Xarelto.
Pt was admitted to the hospital for reasons unrelated to COVID.  Admission screening yielded positive results.  Pt is asymptomatic for COVID.  Due to pt being high risk monoclonal antibodies and remdesivir were given.
Erythema and inflammation onset appr 24 hours after injection; at 48 hours post injection - (L) anterior thigh with 11x15.5 cm area of erythema, warmth, inflammation. Diagnosis: cellulitis. Treatment: Cephalexin 500mg PO BIDx14 days.
Started with heat sensation throughout body, dizziness, feeling faint.  Then extreme shivers, diahhrea for nearly an hour, then total exhaustion.  Arm pain actually not much worse then flu shots.  No fever.  Went to bed after ?spell? and today I seem alright.
Initial report received on 13 July 2011 from a health professional. A female patient, whose medical history, obstetrical history, and concomitant medications were not reported, received an intramuscular injection of ADACEL (lot number C3828AA) on an unspecified date. The patient was pregnant. She had no risk factors. The date of her last menstrual period was unknown. The estimated date of delivery is 07 September 2011. The patient had no adverse event following vaccination. Follow-up information was received on 24 February 2012 from a health care professional. Based upon the new information provided (hospitalization), this case has been upgraded to serious. The patient was 27-year-old and received the injection of ADACEL on 29 March 2011. The patient was hospitalized from 29 March 2011 to 30 March 2011 with right hand fifth metacarpal fracture and acute postoperative pain. On 30 March 2011 the patient had an open reduction of fracture with internal fixation, carpals and metacarpals surgery. On 31 March 2011, the patient had an MS triple screen. Neural tube defect, down syndrome and trisomy-18 were all negative screens. The patient had no illness at the time of vaccination. The patient had a history of iron deficiency anemia and an allergy of swelling of the hands and right foot with acetaminophen and ibuprofen. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Information has been received from a female consumer who on 10-OCT-2010 was vaccinated intramuscularly with a booster of VARIVAX (Merck) (Lot# unknown). The patient stated that on 11-OCT-2010, she had a red spot where she got the shot. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. No further information is available.
pt came to clinic for flu vaccine. pt completed vaccine consent form and his "62" was mistakenly read as "67". pt given High Dose FLuzone to which pt consented. NO harm reported. PT when contacted was actually thankful he got the higher dose and NP explained indications. NP had also contacted CDC vaccine hotline and spoke with an employee who reported no expected harm and should be counted as flu vaccine for this season.
Day of: soreness of left arm, increasingly  became worse. Next day: body ache everywhere. Worse with movement. Left arm very painful. Migraine. Sore throat, 100 degree fever
she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling.  The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month.   Pfizer :  Lot: 12831/8/21 Lot 9261 1/25/21
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a three years old patient (gender not reported) who was vaccinated with a 0.25 ml of FLUZONE QUADRIVALENT (lot UT62259KA and expiration date not reported) via unknown route in the left deltoid on 13-Sep-2018. No other vaccines were given. The patients medical history and concomitant medications were not reported. It was an actual medication error due vaccine underdose (as the patient vaccinated with a 0.25 ml instead of 0.5ml). No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Breakthrough varicella-like papules (6)/vesicles(6); temp = 103; developed cellulitis @ left hip area
Very sore arm, painful to lift and lay on; Strong fatigue/ tired; General feeling of unwellness; Possibly a little chilled; Headache; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENU198) via an unspecified route of administration in the left arm on 28Feb2021 at 10:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included mild traumatic brain injury, hypothyroidism, cold intolerance, and mononucleosis. The patient had known allergies to eggs when she was a baby so not sure if she still has the allergy and possibly penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ethinylestradiol/ drospirenone (NIKKI), lactobacillus acidophilus (FLORAJEN), and fibre/dietary (BENEFIBER); all for an unknown indication from an unknown dates and unknown if ongoing. On 28Feb2021 at 12:45, the patient experienced very sore arm, painful to lift and lay on, strong fatigue, so that the patient had to take nearly a 3 hours nap and was still tired afterwards. The patient experienced a general feeling of unwellness, possibly a little chilled (as she was having hypothyroidism so was having cold intolerance). The patient had no fever and photophobia. The patient tried getting a headache but it never amounted to anything. On 01Mar2021 (reported as the next day), her arm soreness has gotten a lot better but was still present. The patient was trying to get a headache again but has not amounted to anything yet. She was still a little tired but not as bad as yesterday (28Feb2021). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events very sore arm, painful to lift and lay on, strong fatigue/ tired, general feeling of unwellness, possibly a little chilled, and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
She got her vaccine, she felt fine until about 9:50 PM when she started to get chills, and then started to get really really chilled.  She went to bed, covered up with all her blankets and then had fever, her neck started getting sore, ears were hurting and put a washrag on her head  and headache no the back of her head. Took her temp and it was 102, and laid in bed as she was really cold and she was tired.  By the next day her fever broke and she was feeling better and still very tired.  On Sunday she was feeling better, and she is back to being normal today.  She took Tylenol for her fever, which it was gone by the next day.
no patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 10-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine was exposed to temperature of  9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005595: US-009507513-2006USA005637: US-009507513-2006USA005636: US-009507513-2006USA005639: US-009507513-2006USA005635:
Had second  injection 10 am on 1/16/21 . Woke up at 1:30 am during night on  1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol.   Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Tingling in hands which went away after a while. Called EMS per patients request, vitals were fine, symptoms improved after about forty minutes
This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9. On an unknown date, the patient experienced incorrect product storage. No adverse effects were reported. Temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 4 hours. Previous temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 1 hour. Data logger was involved.; Sender's Comments:  US-009507513-1708USA010558: US-009507513-1708USA010559:
felt awful like they had the flu for 48 hours post vaccination; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This is 1 of 3 reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced felt awful like had the flu for 48 hours post vaccination on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082187 same reporter,event/ different patient
Left arm redness, induration, pain within 24 hours of pre-K boosters. Lasted greater than three days: self resolved.
Patient felt nauseous and lightheaded several minutes after receiving vaccine while sitting in chair in observation area. Was given ice pack, water, juice and snack. Taken to health suite via WC and placed on cot, supine with LEs elevated to rest for several minutes. VSS. Symptoms resolved after several minutes and patient able to go home with father.
Night of admin. pt. began with warmth, redness, and sl. swelling. Next am had slight depression of center and deep purplish-red area about 2cm/diam. with raised border;by eve had papular rash around area which has now extended to trunk, arms, legs,feet, hands, face. gave 7.5mg of prelone bid x 3 days, and benadryl 6.25mg prn
STIFF AND SORE NECK FOR 2 DAYS AFTERWARDS.  PATIENT WAS ABLE TO TREAT IT WITH ALEVE AND IT FELT BETTER.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored VAQTA (lot # L018499, expiration dates 25-FEB-2017 and L028666, expiration date 04-NOV-2016, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Bright red rash on back and neck and down spine.  Also under breasts and in between breasts. Rash on the neck felt warm to touch.  Patient called about 4pm and stated she was also feeling 'queasy'.  Rph suggested she take Ibuprofen for the rash and inflammation and the heat of the rash.
Site: Redness at Injection Site-Mild, Additional Details: patient called on 10/18/22, and reported that her injection site(immunized on 10/17/222) is red and seems like an infection or something, so she said that she is going to her dermtologist to get checked. No further descriptions at this moment.
15 year old received Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received Moderna COVID-19 vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
cold; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (cold) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-395678 (Patient Link).
Severe nausea, dizziness, light headed, muscle aches, headache, eyes puffy in morning, joint pain.  Had to leave work because I couldn't function.
Medical assistant accidentally administered the wrong dose. Asked the caregiver how old the patient was, and she said 5 years old. After checking birthday patient is 3yrs 10months.  Patient received 10 mcg of  Pfizer instead of 3mcg. Observed patient for 30 minutes and did not have adverse reactions. Discussed with care giver to report any side effects. Also contacted local County public health clinical line.