chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. The reporter reported that the patient was vaccinated with Moderna COVID-19 vaccine and boosted as well. No treatment medication details reported.  Company comment- This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) which occurred at an unknown time with regards to Covid-19 vaccination. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) which occurred at an unknown time with regards to Covid-19 vaccination. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST. The vaccine had an expiration date March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Dizzy (passed out), low BP (89/52, repeat 96/56), pain radiating under right arm, chills, hip hurts from fall.
she got COVID-19; she got COVID-19; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got covid-19 on an unspecified date with outcome of unknown. It was reported that the patient got first dose of the vaccine last 15MAR2021. She mentioned that she got COVID-19, and was asking how long in between can she take the second dose. She asked what would happen if she took the vaccine at the recommended interval.   No follow-up attempts are needed. No further information is expected, batch/lot number cannot be obtained.
cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (174529). The reporter is the parent.  A 30-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
neck is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck is swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SWELLING (neck is swollen). On 28-Feb-2021, SWELLING (neck is swollen) had resolved. Not Provided          Treatment details were not provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Cough for 2 days  Fever yesterday  Normally on 3-4 L oxygen at home  Denies history of sleep apnea  Required BiPAP in ER  COVID positive  Vaccination in May 7/10/2021: patient discharged.
PATIENT IS 15 YEARS OLD BUT ON HER CONSENT FORM SHE PUT AS 16 YEARS OLD AND MOTHER TOLD DURING VACCINATION THAT PATIENT IS 16 YEAR OLD. PATIENT RECEIVED 2ND SHOT. LATER WE FOUND OUT PATIENT IS NOT 16 YEAR OLD YET. NO ADVERSE EVENT AS PER PATIENT'S MOTHER.
I had vaccination on 10/07/2022. On 10/31/2022 timeframe I started to experience an itch on my back down near my waist. It was a small area about 1 inch and 1/2. It started to progress in size. Since that period of time it is much larger and has expanded up near my shoulders. My primary physician gave me an ointment that did not work. I saw the doctor gave me another ointment 3 months after initial reaction. I have been using it twice a day and it relieves the itching for a couple of hours but then it does come back. I am making a follow up appointment within this week to go over other options.
This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 58-year-old patient who received SHINGRIX for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient felt like hit by a bus. The patient asked to the reporter how long do the side effects from Shinglex last. The patient was asked to provide the contact details, however the patient refused it and told that the patient will call to their physician. The patient refused to provide the prescribing doctor's contact details.
Information has been received from a physician concerning a 24 year old female with asthma and "problems with birth control", who on 18-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657736/0389U).  On 18-MAY-2007 the patient experienced stinging and pain around the injection site area.  The patient experienced shortness of breath 20 minutes after the vaccination, and it lasted for about 45 minutes.  The patient consulted with the physician and was given ADVIL for the injection site reaction.  On an unspecified date, the patient recovered from the injection site pain.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 24 year old female with asthma and "problems with birth control" and question of antibiotics, who on 18-MAY-2007 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 657736/0389U). On 18-MAY-2007 15-20 minutes post vaccination, the patient experienced stinging and pain around the injection site area of the left deltoid. The patient experienced shortness of breath 20 minutes after the vaccination, and it lasted for about 45 minutes. On 19-MAY-2007 the patient consulted with the physician and was given ADVIL for the injection site reaction. On 19-MAY-2007 the patient recovered from the injection site pain. There were no laboratory or diagnostic tests performed. The next dose of GARDASIL was cancelled. Additional information is not expected.
left arm is sore after the shot and it never goes away.  On 03/29/2021 i woke up my arms was very sore, i can barely lift my arm.  I am still feeling the soreness and it is swollen and it's warm.  I have been moving this arm all the time as instructed.
Within 24 hours, child's left arm became increasingly uncomfortable. On 9/18/02 at 9-10AM, left arm was warm to touch. Area of redness and edema approximately 3.5 inches in diameter. Child to go to MD this afternoon.
Sizeable amount of redness and swelling on left arm 24 hours after receipt of vaccines 9/26/03. Moderate amount of swelling and redness still noticeable 9/29/03.
Flu shot given 1:00 P.M. Started feeling tired & weak within 2 hrs. By 10:00 P.M. temp of 102.4 rapid heart & shortness of breath BP 141/79 took TYLENOL 2:00 A.M. 101.4 BP 137/88.
2nd dose administered too soon (15 days between doses) 1st dose administered 4/26/2021
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Medium
1.  Heavily swollen lymph node, underarm close to vaccination site, i .e. Left arm. Arm pit was very swollen, and pain was radiating to left breast  2.  100.2 fever 3.  Delayed periods - got the booster shot 6 days before periods started in October, that was the expected time and I have a very regular monthly cycle. But the periods in November got delayed by about two weeks- which never happened before. I assume it?s due to the vaccine. The cycle after this event resumed normally, meaning got back on track - usual 29 days cycle
received improperly stored VARlVAX; No adverse effect reported; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 24-SEP-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: S005078, expiration date: 19-FEB-2021 or lot number: R019237, expiration date: 04-JUL-2020) for prophylaxis (exact dose and route of administration were not provided). varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.  The vaccine experienced temperature excursion from -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius). The previous temperature excursion was not reported. The digital data logger was involved.
I got sicker with the second shot than the first; This case was reported by a consumer via interactive digital media described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient got sick with the 1st dose of Shingles vaccine. For tolerance to 2nd dose refer case US2021AMR158035. No contact details were provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158035:Same reporter US-GLAXOSMITHKLINE-US2021AMR158052:Same reporter
pt  was  given  2nd dose of the bivalent booster in error-- pt had no adverse effects
covid-19; covid-19; 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 61-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The Caller finished taking Paxlovid 4 weeks ago, he wants to know when he can get a booster vaccine. He was frustrated because everyone had a different recommendation on what to do, or how long to wait until someone can get their booster after Paxlovid- one pharmacy said 4 weeks, one said 3 months, its overwhelming as a consumer. Recognized AE after call, previous vaccines were inefficacious if patient received Paxlovid and then was interested in getting a booster- implies he and his mother had previous vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200754536 similar report from same reporter
had some side effects/had a hard time; got the Moderna vaccine and it made her tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had some side effects/had a hard time) and FATIGUE (got the Moderna vaccine and it made her tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had some side effects/had a hard time) and FATIGUE (got the Moderna vaccine and it made her tired). At the time of the report, IMMUNISATION REACTION (had some side effects/had a hard time) outcome was unknown and FATIGUE (got the Moderna vaccine and it made her tired) had resolved.            No concomitant information was reported. It was reported that, Patient got the Moderna vaccine and it made her tired and it took her a long time to recover. Patient had some side effects. Patient got it twice and the second time patient had a hard time. No treatment information was reported.  It was reported that the Patient had some Premarin vaginal cream on her finger and touched her eye and it started swelling and itching and was red. Patient was trying to figure out if it was due to the cream or if it was something else.   Reporter did not allow further contact
Nausea. Vomiting. Diarrhea 7+ days. Behavioral changes(mood).  Loss of appetite.
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 12 years old male patient who experienced patient was given two doses of t-dap he wanted to know if there were any side effects, while he received vaccines BOOSTRIX, MENVEO and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENVEO not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur lot number not reported. On 07-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5542AA. It was a case of actual medication error due to extra dose administered. One was ADACEL and the other was BOOSTRIX by Glaxo-Smith-Kline. The ADACEL was given in the left arm. 0.5 m. The patient was also given MENVEO by Glaxo-Smith-Kline. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
This spontaneous report as received from the patient's mother, refers to a diabetic 14 year old female patient. The patient had no pertinent drug reactions/allergies. The patient's mother reported a misuse adverse event in regards to GARDASIL injection. Reporter stated that the patient was administered the first shot of GARDASIL injection 9dose, route and lot number were not provided) for vaccination on 10-MAR-2013. The second shot of GARDASIL injection (dose, route and lot number were not provided) for vaccination, was administered on 08-MAY-2013. The third shot of GARDASIL injection (dose, route and lot number were not provided) for vaccination, was administered on 12-JUL-2013. Concomitant medications were not reported. Reporter stated that the third shot of the GARDASIL was given "two months too early". No adverse events were reported at this time. The patient saw the doctor. Patient performed a routine blood work (results not provided). No treatment was given for the adverse event. Additional information has been requested.
Right side of epiglottis swelled up and hinder swallowing pictures taken Benadryl Tylenol taken
Fever of 102.6 for approximately 12 hours; Body aches; Headache; Low energy; No appetite;
Feb 11:  Sore arm at injection site that lasted about 10 - 12 hours. Feb 11:  Was very tired in the afternoon and took a 2 hour nap; I do not usually take any naps. Feb. 12, afternoon:  Temperature 100ºF, mild sniffles similar to cold or pollen allergy, sinus headache; felt tired but not enough to nap. I took 2 aspirin.  The fever subsided within an hour.  I took 2 more aspirin every 6 hours on Feb. 12 and Feb. 13.   Feb. 13:  I still felt a little tired but not enough to take a nap. Outcome:  The aspirin resolved the fever and it did not recur.  The headache was very mild and I did not treat it after I stopped taking the aspirin on Feb. 13.  The sniffles and mild cold symptoms went away after a few days and did not require any treatment.
felt nausea,became diaphoretic, very pale, taken to cot to lay down,VSS, O2 saturations 97 to 99 %,  felt better but call friend to pick her up from clinic
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history were not reported. On 12-MAY-2017 the patient was vaccinated with an improperly storage dose injection of LIQUID PEDVAXHIB lot # M034187, expiration date  17-MAY-2019, (route and dose were not provided) for prophylaxis. The patient's concomitant therapies were not reported.  No adverse effects were reported. The reporter stated that on an unspecified date, the LIQUID PEDVAXHIB was storaged during a time frime of five hours at a temperature ranges of 32° Celsius (°C) and 35°C with previous temperature excursion. The call was not placed because of a digital data logger. Additional information has been requested.
Information has been received from a licensed practical nurse (LPN) concerning her 12 month old daughter with an allergy to "claferin" and a history of kidney reflux as a newborn, who in June 2004, at one year of age, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot number unspecified). Concomitant therapy included acetaminophen (TYLENOL). Within an hour of receiving the vaccination, the patient developed a high fever which was treated with acetaminophen (TYLENOL). The fever remained high and the patient experienced seizures 4 to 5 hours after vaccination. The patient was not hospitalized but treated at an after hours clinic associated with the hospital. It was noted that routine blood work was performed but no results were reported. The fever remitted after 1 week but the patient had speech and balance problems that lasted 1 month. The patient fully recovered in July 2004. The reporter considered the adverse experiences to be disabling. Additional information has been requested. It was mentioned that this case was reported to VAERS at the time of occurrence.
Pt inadvertently administrated - ROTARIX via intramuscular (IM) - 10/5/15. Pt returned to office 10/7/15 and given ROTARIX PO. No local RX seen at site from gettnig ROTARIX IM.
No adverse event; Expired dose of Moderna Covid-19 vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient).    Concomitant medication was not provided.   Treatment information was not provided.
General body ache; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (General body ache) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (General body ache) and FATIGUE (Fatigue). On 01-Apr-2021, MYALGIA (General body ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-102006 (E2B Linked Report).; Sender's Comments:  MOD-2021-102006:Second Dose
At 11 PM, painful aches in leg muscles and pain in knee and hip joints began.  Pain was a 4 or 5 on a scale of 1 to 10 -- definitely worse than flu-like aches and pains, but not disabling.  Around midnight, painful abdominal/stomach cramps and lower back pain began.  Pain was 6 on a scale of one to ten, and felt like a bad menstrual period.  I had already had my period the previous week, however.  I took ibuprofen and tried to go to sleep, but was in too much pain to fall asleep.  I called the 24-hour advice nurse around 1 AM, and she told me that because of the stomach cramps, I should go to the emergency room for monitoring in case I was going to have an allergic reaction.  I then went to the emergency room for about an hour and released at around 3 AM when I didn't develop any further symptoms.