chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US022363, is an initial spontaneous report from a nurse received on 29 Oct 2015. This report refers to a 19 years old female patient. Medical history and concomitant medications were not reported. The patient received 0.5 ml of FLUVIRIN (batch number: 1515101) via subcutaneous route on 21 Oct 2015. On the same day after vaccination the patient experienced injection site reaction. Outcome of the event was unknown. The case was assessed as non-serious. Causality of the events was not reported.
reported to emergency room with swollen lips. was given prednisone and Benadryl
I had moderate to severe body aches, headache, chills.  The only unusual symptom was how high my fever was.  The highest I saw was 103.4 F.
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced two periods a month instead of one, longer, heavier, more frequent period, and painful period. The action taken with covid-19 vaccine was not applicable. The outcome of the two periods a month instead of one, longer, heavier, more frequent period and painful period was not reported. This report was non-serious.
Has onset of symptoms after receiving the COVID vaccine:  abdominal tightness, shooting pains in face, numbness to back of head over the next 3 days.  He is unsure if it is vaccine related.  He is following up with Clinic to determine if this is a reaction to the vaccine or if he has something else going on.
nausea, low back pain started on 2/6/2021.  nausea is intermittent.
pt recvd vax; devel redness & swelling at inject site, & a knot below the inject site;
Generalized redness in 24 hours. Friday 1/5/01 upper arm red and very painful. Today began to subside.
pt recv flu vax 7OCT96 & 10OCT96 pt had severe neck, head & back pain w/inc WBC & fever;adm to hosp w/dx viral meningitis;
Interchange of vaccine product; Patient given expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was expired on 01June2021 and the doses were given on 05June2021. No concomitant medication information provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Pfizer report was obtained as the follow up, co-suspect added, event added
Information has been received from a physician concerning a 14 year old female patient with no known allergies who on 17-MAY-2007 was vaccinated IM with 0.5 ml of Gardasil. That same day, 5 minutes after the injection, she felt nauseous which lasted throughout the night and on 18-MAY-2007 she vomited. The patient sought unspecified medical attention. No further information is available. Additional information has been requested.
injection arm became hot, swollen, and erythematous in an  uneven circle 2-3 inches below injection site
At first it was a complaint of arm & hand numb as well as sore & achy with fatigue.  By 08/07/12, it became sore throat, dry mouth & throat, fever up to 102.1 degrees, muscle pains in legs, arms, back, neck & jaw.  Joint pains in shoulders, hips, knees, back, neck & jaw. Very fatigued & thirsty. Left arm swollen from shoulder to elbow, sore & tingly, hot to the touch & firm. The injection points of the two vaccines he was given in the left arm are protruding outward.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, after 2 months of vaccination the patient got covid (suspected covid-19 infection and suspected clinical vaccination failure). As per reporter it was reported that "I got your vaccine, and two months later, I got Covid. Do you have one that works, Asking for a friend, as I don't trust anything you folks say anymore" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000213899. The suspected product quality complaint has been confirmed to be voided (does not meet PQC criteria) based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 25-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This updated information does not change the causality of the previously reported events. 20220150529- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot number L028276, expiration date 28-JUL-2017 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported.  Administered dose of vaccine was exposed to a temperature excursion of "11°F >5°F but <14°F" for 1 hour. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000973:
Initial unsolicited report received from a consumer on 26-NOV-2016. This case involves a six-year-old male patient who was vaccinated with a dose of FLU VACCINE (batch number, expiry date, dose, dose in series, route of administration were not reported) in left arm (just below the shoulder in the back), on 23-November of an unspecified year (reported as on Friday, Nov 23rd). Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient has significant swelling and pain from the injection site to the top of his elbow. Lab data was not reported and corrective treatment was reported as motrin and ice packs on the site. The outcome of the event was not reported. List of documents held by sender: none.
Pt.'s Daughter In-Law states that after receiving the 1st dose of Phizer 03/06/2021, started experiencing symptoms 30min with a slight headache lasting 2hrs. 03/07/2021 started experiencing symptoms vomiting until 10:00pm, loose stool lasting 1hr, 03/08/2021 loss of appetite with nausea. 03/242021 Primary visit routine Physical=Normal with Recommendations for 2nd dose of Phizer (03/27/2021). Pt. D.O.D 04/03/2021
1 pill of acetaminophen  was taken around 5 PM for arm and lower back soreness. Shivering, chills, radiating pain behind eyes started around 11 PM. Patient was kept warm and rested. May have developed fever throughout the night. Was given acetaminophen around 3 AM for headache. Adverse symptoms had ceased. Patient is now fatigued.
pt recv vax & pt ep severe herpes simplex meningoencephalitis & RSV infect;it was reported that lab tests revealed no specific IgG to HSV or to VZV, nl Ig;T cell studies & nitrogen stimulation of lymphocytes;felt to be life threatening;
Crying AM 19DEC91 thru day & night. Saw MD 21JAN91, fever 101 still crying thru night; diarrhea on 21JAN91- cried thru night 21/Jan. Today crying, diarrhea advised increased fluids (pedilite) & tylenol. Call MD back sx worsen or cont.
antibody test results were negative; drug dose administration interval too short; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 15th October 2018, the patient received the 1st dose of Engerix B adult. On 16th July 2019, the patient received the 2nd dose of Engerix B adult. On 18th October 2019, the patient received the 3rd dose of Engerix B adult. On 16th July 2019, 274 days after receiving Engerix B adult, unknown after receiving Engerix B adult and not applicable after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On 18th October 2019, the patient experienced drug dose administration interval too short. On 18th June 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too short were unknown.  Additional details were provided as follows: The patient received the same Engerix-B as he did and at the same time, but did not had an antibody test and her test was also negative.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The patient received 3rd dose early, which led to shortening of vaccination schedule. The Reporter did not had a valid LOT but would call back with that information.   The case number was given to provide that information to the GSK Response Team. The reporter consented to follow up.  This case linked with US2020109771, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020109771:Same reporter
Patient reports a half-dollar sized swelling on right arm where she believed the PREVNAR-13 vaccine injection site was located. This swelling developed 2-3 days after the immunization occurred. She said it was swollen and sore for a day or so, then subsided and peeled. She reported no other issues.
Have a fatty tumor and think that they shot it in there instead of in muscle; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of Covid-19 infection.  On 26 Feb 2021, after she received the vaccine, the patient reported instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, instead of putting the shot into their muscle, they have a fatty tumor and think they shot it in there was considered as resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Erythematous rash on trunk and arms, groin, buttocks, upper legs. No pruritic. At injection site. 6x4cm raised, warm, erythematous patch, Onset 3 days after vaccination. Given steroids PRN as antihistamines ineffective.
8PM shrill high pitched cry for 1/2hr pt to ER examine no sx;
Developed pruritic rash 4 days after second COVID vaccine injection that continued to progress for the next week despite the use of Benadryl
pt recv vax 20MAY96 & on 6JUN96 pt devel hep A & jaundice;pt had labwork done on 6JUn97, 10JUN97, 18JUN97 & 25JUN97, 8JUL9997 & 23JUL97;relevant consisted of hep A IGM, total bilirubin,LDH,alk phos, SGOT,SGPT,GGT, direct bilirubin,indirect
Patient diagnosed with COVID-19 after receiving COVID vaccine series. Patient unable to provide further information about vaccines.
Pt was given her vaccine and after blood dripped down her arm. It is possible that she did not get the full dose of her vaccine
PCV13 given 2/17/17 at 10:43 AM. Patient reported fever of 99 degree F, dizziness, extreme fatigue, vomiting, inability to move arm, bedbound, muscle pain in injection arm, and not being able to sleep for 2 days. Patient reported symptoms lasted for a few days but is feeling better today, 2/23/17. Patient still has some fatigue, but otherwise is okay. Patient declined appointment to be seen for symptoms.
I started with heart palpitations on 3/21. They were non-stop all day on 3/21 and 3/22. I went to urgent care of 3/22 and had an EKG and bloodwork. All were normal. Palpitations slowly subsided over the course of the next week or so and are non existent at this point.
I read today of "covid arm," as described in an article about a symptom that may arise for those who got the Moderna vaccine. I simply wish to share my reaction for the sake of the statistics. The evening after I took the first shot of the vaccine I had a hard red bump on my arm near the injection site. My arm ached that night, and was notably better already in the morning, without aches the following day. The blister was gone the next day. I'm relatively healthy, trail run and get strenuous exercise usually  twice a week.
next day leg aches, h/a, vomiting, fever, 1 1/2 wk later cough, congestion then h/a & fever returned;went to ER 30DEC95;rx w/Zithromax;sneezing, leg aches, cough, sore arm @ inj site, swollen & black now still bump there;
CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.
Patient's lower lip swelled. Described throat pressure. Remained conscious. EPIPEN given x1 dose - EMT arrived - pt transported to hospital for eval.
After visit was completed, I was called out of the next patient's room because child had complained of nausea vomited in the restroom. This occurred 5-10 minutes after immunization.  Mom states she held her and child fainted in her arms. On my arrival child was lying on an exam room table with a MA by her side. She appeared pale but was breathing well. Mildly bradycardic but regular with first auscultation which correlated with 68-70 per pulse ox. O2 sat 98%. Child began to blink her eyes and respond to our voice. Clinic did call EMS. Child maintained regular breathing. Inital BP high 70s/50 and steadily returned to her baseline of 80s-50s. Within 2-3 minutes child roused more, would answer simple questions, smiled. No signs of swelling, rash or wheezing. When EMS arrived, she was already responsive, all vitals at baseline. Child was able to sit up, drink some juice and eventually  stand. EMS offered transport but child was well appearing and mom felt comfortable taking her home. Explained vasovagal reactions to mom who herself had one as a child. Later in the day, nurse called back to check on family. Mom had noticed some faint "splotchy" spots on her chest. Child was otherwise back to baseline. Eating, drinking. Parents carefully observed child over the remainder of the day.
Patient had waited for about 10-15minutes after receiving the Covid vaccine (Pfizer), when they realized they were not doing well.  They felt nausea, dizziness, and lightheadedness.  They ended up vomiting once, and just felt terrible, but the vomiting supposedly helped.  Her breathing was okay, but we called the ambulance just as a safety measure.
Rash to injection site; Pain to injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain to injection site) and VACCINATION SITE RASH (Rash to injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Pain to injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash to injection site). At the time of the report, VACCINATION SITE PAIN (Pain to injection site) and VACCINATION SITE RASH (Rash to injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-091323, MOD21-091332 (E2B Linked Report).; Sender's Comments:  MOD21-091323:Crosslink MOD21-091332:Crosslink
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, injection site pain, faigue Narrative: Employee reports injection site pain/discomfort, chills, fever (102 F), headache, joint pain, body aches, nausea, and vomiting. Reports symptoms have improved as were worse overnight. Reports headache still remains (as of date of report on 01/22/2021). Reports was using Tylenol OTC (no dose/frequency provided).
Very sore arm for 1 day following the vaccine. Arm continued to be somewhat sore for another 2 days.
Patient received shot around 2pm and developed symptoms overnight.  Fever, sweats, body aches, cough and phantom pain on his amputated leg.
narrowing of the esophagus with the inability to swallow any liquids including water; vomit/mucus and acidic in nature; exacerbation of  pre-existing condition lichen planopilaris; exacerbation of  pre-existing condition lichen planopilaris; exacerbation of  pre-existing eosinophilic esophagitis; This spontaneous case was reported by an other health care professional and describes the occurrence of LICHEN PLANOPILARIS (exacerbation of  pre-existing condition lichen planopilaris), CONDITION AGGRAVATED (exacerbation of  pre-existing condition lichen planopilaris), EOSINOPHILIC OESOPHAGITIS (exacerbation of  pre-existing eosinophilic esophagitis), DYSPHAGIA (narrowing of the esophagus with the inability to swallow any liquids including water) and VOMITING (vomit/mucus and acidic in nature) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced LICHEN PLANOPILARIS (exacerbation of  pre-existing condition lichen planopilaris), CONDITION AGGRAVATED (exacerbation of  pre-existing condition lichen planopilaris) and EOSINOPHILIC OESOPHAGITIS (exacerbation of  pre-existing eosinophilic esophagitis). On an unknown date, the patient experienced DYSPHAGIA (narrowing of the esophagus with the inability to swallow any liquids including water) and VOMITING (vomit/mucus and acidic in nature). At the time of the report, LICHEN PLANOPILARIS (exacerbation of  pre-existing condition lichen planopilaris), CONDITION AGGRAVATED (exacerbation of  pre-existing condition lichen planopilaris), DYSPHAGIA (narrowing of the esophagus with the inability to swallow any liquids including water) and VOMITING (vomit/mucus and acidic in nature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter no treatment information reported by the reporter