chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warm; Injection site induration; General malaise; Sore throat; Achey; headache; Chills; Diarrhea; Injection site red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise) and OROPHARYNGEAL PAIN (Sore throat) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar affective disorder, Headache, Insomnia and Drug allergy (ibuprofen). Concomitant products included TRAZODONE, ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC), SERTRALINE, BUSPIRONE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red), CHILLS (Chills) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey) and HEADACHE (headache). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE INDURATION (Injection site induration), MALAISE (General malaise), OROPHARYNGEAL PAIN (Sore throat), PAIN (Achey), HEADACHE (headache), CHILLS (Chills) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Approximately 15-20 minutes after vaccine administered red streak at injection site developed and patient had complained of itching all over.  Patient took Benadryl PO and signs and symptoms resolved.  No shortness of breath.
This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 18-year-old female patient received the first dose of TRUMENBA intramuscular, in deltoid, on 28Dec2015, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccines received on the same date. The patient experienced soreness in the injected arm, hot area around the injection site and a two inch area around the injection site raised, all in Dec2015 (on 28Dec2015 or 29Dec2015). The reporter recommended ice and ibuprofen as needed. The events resolved on 30Dec2015. The reporter considered there was a reasonable possibility that the events were related to the vaccine. No follow-ups attempts are needed. No further information expected.
don't feel good; legs hurting very bad; Headache; wrists sores and hurts; whole body hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting). At the time of the report, FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Urine analysis: abnormal (abnormal) Pee-pee is not good.         Concomitant medications included blood pressure medications  Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-074896.
swollen, red, sore, felt hot Pt taking ibuprofen and applying ice when felt hot
Information has been received from a pharmacist concerning his 87 year old grandmother with diabetes and high blood pressure who in January 2011, was vaccinated with ZOSTAVAX (Merck) (dose, route and lot# not reported). Concomitant therapy included medications for diabetes and high blood pressure. In approximately January 2011, about 1 week after vaccination, the patient developed shingles. Since developing shingles the patient had moved to a nursing home and "now has trouble walking" and was hospitalized. Unknown IV therapy was given for the events. At the time of the report, the patient had not recovered. Shingles and trouble walking were considered to be disabling and an other important medical event by the pharmacist. Additional information has been requested.
Swollen eyes.  Respiratory wheezing.  Patient called his doctor who wanted him to go to the ER, but patient refused.  Instead took Benadryl; relief of symptoms obtained.  Slept 1 1/2 hrs. Took Tylenol Cold & Flu tab.  Allergy s/s gone in AM.
Flu-like symptoms; Aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on the left arm on 16Feb2021 (11:30) as dose 2, single, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on 26Jan2021 (11:30) (when the patient was 35 years old), intramuscular on the left arm for COVID-19 immunization. On 16Feb2021 (23:00), the patient had flu-like symptoms, aches and chills. The patient did not receive any treatment for the reported events. The outcome for the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Resolved by 11/5/10. Headache, fever and 3cm red circle at injection site.
Pt was given first dose in series at our pharmacy. He came in for the follow up booster and received it.  Pts wife  called stating he had received the 2nd shot of the series a couple of weeks ago at a different facility
Pt received a light dose of the Pfizer covid 19 vaccine. 0.8mls of NS was used to dilute vaccine not 1.8 mls.  A dose of 0.3 was removed from that vial then another 1 ml of dilute was added. That diluted vaccine dose was then given to this pt. Pt contacted and message left.
Pt had initial slight blurriness in Left eye on the initial day of vaccination. The day following vaccination patient reports sight was dim and blurry. By Saturday 4/30, pt reports no sight in left eye but sight returned later that evening. Sunday May 1, patient reports complete loss of vision in left eye. Patient daughter says he is going to doctor today.
Hospitalization and death within 30 days of vaccination.  Obituary stated that he died at Hospital.
Received Janssen vaccine on 3/10/21; Moderna vaccine on 11/11/21 COVID-19 positive by PCR on  12/10/21, 1/10/22 admitted to hospital on 1/10/22 d/t SOB, ongoing weakness, dyspnea, myalgia following COVID diagnosis in Dec 2021. Diagnosed w/ COVID pneumonia, patchy bronchopneumonia underlying history of cystic fibrosis w/ h/o lung transplant 2015, Type 1 DM, Stage III CKD
DID NOT TAKE THE LAST DOSE THAT WAS DUE YESTERDAY; This spontaneous case report (PVX2019-2122) was received from a nurse on 19-Aug-2019. It described an adult female consumer who "did not take the last dose that was due yesterday" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer was on therapy of Vivotif and forgot to take last dose, which was due yesterday (18-Aug-2019). It was reported that she would be back in town on 21-Aug-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take the last dose that was due yesterday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose that was due yesterday" was considered as not applicable.
Patient states that left arm swollen and that he had a fever after pneumococcal vaccine. Patient states that it felt like he had a tight rubber band around the right arm. States his arm was really hard like metal and painful. Patient states that he had to take tylenol for fever, which did not return after he took the tylenol. Swelling lasted 2-3 days and the pain lasted a few more days than the swelling. Patient states that his arm is back to normal now without any lasting effect. Image attached to e-mail.
he received the first dose of Pfizer COVID vaccine on 09Mar2021.On 17Mar2021, he tested positive for COVID and is wondering if he is still able to get his second dose on 30Mar2021 as scheduled.; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 09Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021, patient underwent lab tests and procedures which included sars-cov-2 test which patient got positive for covid and was wondering if he could still be able to get his second dose on 30mar2021 as scheduled. The outcome of the event was unknown. No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
DEATH; THROMBOCYTOPENIA; This spontaneous report received from a health care professional via social media (media) concerned multiple patients of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that "he was aware of media reports and various other avenues of reporting for 6 deaths (cause of death unspecified) and other severe adverse events like thrombocytopenia following vaccination with Janssen covid-19 vaccine." The reporter stated he could not recall where or when they first heard of these media reports and had no additional information to provide. It was not reported if an autopsy was performed for the patients who died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210952656 - Covid-19 vaccine ad26.CoV-2.s- Death, Thrombocytopenia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient given Pediatrix instead of DtaP that was orders. No adverse signs or symptoms. Mother of child notified.
On 04/02/2002 developed fever, runny nose, noted red dots on genitalia.
facial numbness that started on her cheek, nose, and neck; This is a spontaneous report from a contactable pharmacist. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (pending clarification) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that within 10 minutes of administration, the patient experienced facial numbness that started on her cheek, nose, and neck. Three weeks later, she still has the numbness. The patient has reported improvement, but it has not been totally resolved. The patient described it as receiving a shot of Novocaine from the dentist but does not describe the sensation of paralysis or bell's palsy. The reporter asked whether or not the patient should receive the second dose of the vaccine after experiencing this side effect. Her 3-week mark was on Friday, in which she has missed her second dose (pending clarification). The patient received an unspecified treatment for the event. The outcome of event was recovering.  Information on the lot/batch number has been requested.
pt presented to ED with hematuria; diagnosed positive for COVID 3 days prior to this admission; given monoclonal antibodies; urology managed hematuria; DNR/DNI; pt experienced acute hypoxia requiring NRB mask to maintain O2 sats in low 80s; condition worsened and pt died in the hosp
I felt fine other than a sore arm but then Friday morning I woke up coughing and i had a 100F fever and about an hour later it was 100.6F. I had chills, shivering, headache, took tylenol, fever was down to 100F. Went to the local UC   and had a COVID 19 test and was negative (rapid test). Today I woke up, no fever, a headache in the morning, but now it is gone, no fever at all today.
Patient reported to the pharmacy 10/26/2020 that they had a rash that started on 08/20/2020 at around 8:00 pm and spread Monday to their whole body.  The rash was described as red and itchy.  The patient was advised to seek medical attention and counseled to take oral Benadryl.  The patient said that they did not want to take oral Benadryl and was just going to use topical Benadryl until they could see their doctor later the week of the 26th.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pt received ADACEL injection 4/19/10.  Pt seen again 4/21/10 for large red, swollen, warm area on right arm at injection site.
On November 01 at 09:00PM- up all night with fever, chills, headache and back ache for 20 hrs. My arm was really sore for 1 week. November 7 in AM had nasal stuffy, and arm was fine now. The stuffy nose and continued and in a few days, I couldn't taste and smell my coffee and went for Rapid PCR to test for Covid-19 which was positive on November 10, 2021. No fever and just a bit congestion. November 13 and 14 while quarantine Angioedema - I had facial swelling in my face and cheek. Still can't taste or smell.
At site of DTAP/IPV injection, pt with 7cm of induration and erythema.
Pt recd series of 3 vaxs (20mcg,IM, rt deltoid) 26NOV90, 2JAN91, & 24MAY91; 29MAY91 Pt expd chilling, hot flashes, weakness, burning in chest, bad headache, & lightheadedness; no rx given; Pt reported to be "OK" now;
11pm throwing up and fever (101.8) all thru the night. The next day fever was gone by about 9am and vomiting done. He slept the entire day only waking twice for a small snack. He was difficult to wake and slept thru bathing and dressing. Continued sleeping until 9am the next morning 6/17/2012
2 hours after injection (vaccine given 9:30am 9/15/16) patients arm became red swollen and painful unable to lift.
for primary series and then got booster of Moderna COVID-19 Vaccine; tested positive for COVID-19 after Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19 after Moderna booster) and INTERCHANGE OF VACCINE PRODUCTS (for primary series and then got booster of Moderna COVID-19 Vaccine) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: ( for primary series) and   (for primary series). Past adverse reactions to the above products included No adverse event with.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced COVID-19 (tested positive for COVID-19 after Moderna booster). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS ( for primary series and then got booster of Moderna COVID-19 Vaccine). At the time of the report, COVID-19 (tested positive for COVID-19 after Moderna booster) and INTERCHANGE OF VACCINE PRODUCTS ( for primary series and then got booster of Moderna COVID-19 Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2022, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 after Moderna booster.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse has 2 patient is in their 30s that had one booster. Concomitant medication was not reported. Treatment medication was not reported.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious of Covid-19, after mRNA-1273 vaccine received as 3rd dose. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Prior to the Moderna dose the patient has received two doses of JANSSEN COVID-19 VACCINE NRVV AD26 (JNJ 78436735)  dates unspecified. The current pandemic situation of Covid-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with history of interchange of vaccine products, who experienced the unexpected non-serious of Covid-19, after mRNA-1273 vaccine received as 3rd dose. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Prior to the Moderna dose the patient has received two doses of JANSSEN COVID-19 VACCINE NRVV AD26 (JNJ 78436735)  dates unspecified. The current pandemic situation of Covid-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Chills, aches, fever started at 3 am the next day and lasted until the afternoon.  I started taking Ibuprofen as soon as I got home from the vaccine and continued taking every 4 hours until all symptoms were gone about 24 hours later.
Patient states he was at the drive-through Covid clinic obtaining a Johnson & Johnson vaccine, and during his 15-minute observation period, he abruptly felt lightheaded, was seeing stars and had tunnel vision, and then he lost consciousness.  He denies a cardiac prodrome including chest pain, pressure or palpitations.  He was identified by clinic staff and was transported by ambulance to the emergency department for further evaluation.  He denies tongue biting or urinary incontinence.  He does have a history of near syncope with previous injections.  EKG is ordered and patient is asymptomatic and discharged home. He had an episode of emesis the same of of his discharge and he recovered after taking a nap.
3 days p/vax pt devel sz which were difficult to control & were dx as febrile sz then devel chronic sz disorder;
Client states around 10pm on 7/9/08, she experienced redness and swelling on her right arm on the outer side (client described area as where her shingles vaccine was given). Client states within 2 days the area continued to swell larger and became hot to the touch and she felt "bumps" underneath her skin in the same area. Client states these symptoms lasted at least 10 days and when she was in her garden "bug bites" to the site made her arm worsen. Client saw her dermatologist 7/24/08 and received a "steroid" shot. Client began to feel relief and states as of 7/25/08 her symptoms had stopped.
No adverse effects, but booster was given to 14 year old accidentally on 12/21/2021. Booster was not approved for <18 by FDA until January 2022. Patient's mom was informed (who brought in the child originally).
7/19/2021: Patient came to ER due to weakness, diarrhea and abdominal discomfort. One week prior he developed decreased appetite as well as abdominal cramping with increasing pain. Patient tested positive for COVID on 7/19/21.  diagnosed with: sepsis due to COVID-19 infection, bilateral pneumonia 7.25.21: discharged home.   Note: COVID-19 vaccinations status: S/P 2 doses of Moderna Vaccine in April of 2021
This case was reported by a physician to a sales representative and described a subject of unspecified age and gender who did not respond to immunization to Twinrix for prophylaxis. On an unspecified date before 14 February 2006, the subject received 6th dose of Twinrix. At an unspecified time after vaccination with the 6th dose of Twinrix, on an unspecified date on or before 14 February 2006, titers to hepatitis A antibody and hepatitis B surface antibody were negative.
Pt recv vax & pt exp paresthesias radiating down rt arm accompanied by some weakness in the triceps;pt underwent a neuro exam;
Expired dose administration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HT429, expiry date 8th August 2021) for prophylaxis.   On 17th September 2021, the patient received Boostrix. On 17th September 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 17th September 2021, patient was given an Boostrix vaccine, which was expired on 8th August  2021. The reporter consented to follow up
My daughter stomach was hurting her really bad she would barely eat, she then started vomiting and having eye problems were her eyes are rolling around and she says feel really watery! Doctor says might be mini seizures but hasn't done any testing.
Pt. rec. vaccine on the afternoon of 5/29/07 the morning of 5/30/07 there was a small area of redness, by that afternoon, pt complaining of pain and area swollen to 2" x 2" diameter with redness