chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 22-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Very bad itching on arms, legs, back, check, stomach.; Bumps that would in same cases stay or others that would come and go. Only one filled with fluid.; Some left scarring.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, expiration date: not reported) via an unspecified route of administration, administered in left arm on Mar2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunization. Medical history included depression and anxiety start and stop date was unknown. Patient had no known allergies. Concomitant medication(s) included hydroxyzine (HYDROXYZINE), montelukast (MONTELUKAST), fexofenadine hydrochloride (ALLEGRA) and sertraline (SERTRALINE and Montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks. I saw the family physician twice and and then they sent me to the allergist. The allergist said it was not hives. It has gone with the exception of my chest still itching from time to time. Prior vaccination, Patient had not covid since tested no covid. On 24Mar2021, patient experienced very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some Therapeutic measures were taken as a result of very bad itching on arms, legs, back, check, stomach, bumps that would in same cases stay or others that would come and go. only one filled with fluid, some left scarring. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Oral and topical treatments. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Extremely sore arm at injection site, Friday PM. Mild headache, stuffy nose Saturday AM, very sore arm. Cough. Sunday AM and PM. Extreme headache, sinuses very sore and "full", ringing ears, hearing loss, dizzy, nausea. Sunday AM go to ER. Heavy cough. Extreme unrelenting nausea, headache, sinus pain. Sunday PM go to hospital. Cough, phlegm.
Quarter sized warm, red area with hard knot at HIB site.  Treated with Keflex.
I didn?t notice anything after the injection. The next day my wife asked about the bumps on my arms. I did nothing different and nothing new from any other normal day. Red rashes or bumps that look like pimples or blisters
sore arm; felt a little weak; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "felt a little weak"; FATIGUE (non-serious), outcome "unknown", described as "tired". Additional information: Caller reporting adverse reaction with the COVID19 Vaccine. While providing information for herself caller states her husband got the vaccine and he got the flu shot two weeks ago and had no reaction. He got a sore arm. Everyone in the family had a sore arm. Caller states that her husband didn't have a problem with the vaccines, he was just tired. They both were dead dog tired for 24 hours. They had sore arm, but the more they moved the arm around the better it felt. Her husband when he got flu shot he felt a little weak. He was doing work outside and had to come in and sit down. That passed. He got the flu shot at (name). Caller doesn't have her husband's vaccine card to provide NDC, lot, and expiry for the COVID vaccines. He has his card and is in (place)on a fishing trip. Caller clarified that her husband had Pfizer COVID vaccine and he got it a week before she did. It was a night mare to get appointments. COVID vaccines was a Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (03Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
vomiting; pain in her joints; fever; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), ARTHRALGIA (pain in her joints) and PYREXIA (fever) 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, the patient experienced VOMITING (vomiting), ARTHRALGIA (pain in her joints) and PYREXIA (fever). At the time of the report, VOMITING (vomiting), ARTHRALGIA (pain in her joints) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.  Concomitant medications were not provided.
Has been having stomach pain since she received the 3rd her rabies vaccine 7/24/14, severe pain, bilateral upper quadrants. The second to the last shot was given Monday 7/28/14 and last shot will be next Monday 8/4/14. Woke up at midnight with trouble breathing and pain in her upper quadrants, character: feels like knots, associated with mild nausea, some dizziness, hurts more when she eats, treatment: milk of magnesia.  c/o nausea.  Denies : vomiting. fever. blood in stool. heartburn. diarrhea loose stools. bowel pattern loose bowels, last episode this AM.
Approximately 1 week after injection, some redness and heat started around injection site.  This has gone on for 2 weeks with less heat and splotchy red around site and down arm about 4-5- inches.  Pain about 3 times a day --just for a second at the injection site,  Today on the day before next injection....redness has almost disappeared.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2023) Negative; (17Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received nirmatrelvir, ritonavir (PAXLOVID) as COVID 19 treatment from 09Aug2023 to 13Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Onset of facial drooping to right side of face the morning of 10/20/09 noted by patient.  Positive Numbness and inability to furrow brow documented. Rapid strep test done during physician visit.  Patient had a positive RST. Treated with LA Bicillin 1.2 million units IM given in clinic on 10/20/09. Patient also treated with Acyclovir 400mg po 5x day x 10 days, Prednsione oral taper and artificial tears. 10/29/09:  Medical Outpatient Record received for date of service 10/26/09. Dx:  Bell's Palsy. Assessment:  Presents with L sided facial pain and facial drooping since the am. Unable to completely close L eye.  Discharged to home with Acyclovir and Prednisone and artificial tears.
vomiting, lethargy, diarrhea which became bloody diarrhea- intussusception requiring surgery. Baby was operated at Hospital and did well.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. Since 22-SEP-2016, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # M029599 with expiration date 10-DEC-2017, therapy type rHA; Lot # M031944 with expiration date 27-DEC-2017, therapy type rHA;  Lot # M029595 with expiration date 10-DEC-2017, therapy type rHA; dose and route were not reported. The temperature excursion on an unspecified date was 6.4 Celsius (C) for 3 hours and 10 minutes. Previous temperature excursion was on 22-SEP-2016 of 4 C for 14 hours and 45 minutes. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Medical Assistant refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB, lot# K021444, expiry date 17-SEP-2016, 0.5 specific dose (frequency unspecified), in the arm (deltoid). No adverse effects were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Large oval red raised itchy blotch on the left arm.  Muscles in upper right arm tender.
Pt's symptoms were lightheadedness, pale, sweaty palms, nausea and weakness. Cool cloth to face and back of neck while seated. Took deep breathes. Pt has no apparent fear of needles. Had Wilm's tumor removed at 2 yr's old followed by 2 yrs of chemo. After 5-10 minutes Mother felt child was fine to leave. Color had returned to cheeks and no nausea. Stood up w/o dizziness. Mother intentd to keep pt from school today. At 06:00 pm Mother reports child is feeling fine with no furthur incident s occurring.
Vaccinator volunteer administered 10 mcg instead of 30 mcg.  FNP called to report. Authorities requests additional dosing.
Got sick from vaccine so blood sugar levels increase to upper 100s.  Was difficult to control blood sugars for about 3 days.  When illness subsided blood sugars returned to normal.
pt exp pain & swelling @ inject site w/in 12 hrs p/vax; following day, arm became very swollen & red; pt c/o severe pain; Epogen inject given @ a different site same day & also 1 wk prior to vax;
Warm, erythematous, tender rash with swelling of right arm from the shoulder to elbow where he had MENVEO and HPV vaccine. Small local reaction 5cm diameter with swelling, erythema and tenderness left deltoid where TDaP given. Instructed to do ZYRTEC 10mg daily, BENADRYL Q6H PRN, cold packs, and MOTRIN/TYLENOL per physician.
No known side effects occurred. The patient was given a dose of 0.5ml for their booster shot and should have received a 0.25ml dose.
I had a headache, nasal congestion, nasal discharge, and mild cough. I tested positive for COVID-19 at the doctor's office on 12/23/2022. They prescribed me PAXLOVID and benzonatate. A week later after completed PAXLOVID my symptoms came back and tested positive again for COVID-19. I had the exact same symptoms.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vaccinated with GARDASIL 9 lot # M020103, expiration date 15-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA006995: US-009507513-1611USA011948: US-009507513-1611USA011949.
Narrative:  73yo male pt had received covid vaccinations on 2/4/21 & 3/5/21. Pt with hx of leukemia in palliative care post chemotherapy. Pt died at HOSPITAL on 7/2/2021. Likely death is unrelated to covid vaccinations.
A nurse reported that a 17 year old female may have inadvertently received a subcutaneous injection of Flu Shield (2001-2002 Formula) on 13 Nov 2001. The injection was administered approximately 3 inches above her right elbow and that same day, the patient developed an injection site reaction characterized by redness and swelling. As of the date of this report, no further information was available.
red itchy rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash) in a patient of an unknown age and gender 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, 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 experienced RASH PRURITIC (red itchy rash). At the time of the report, RASH PRURITIC (red itchy rash) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.
2 days after vaccination, patient developed acute fulminant hepatitis, acute tubular necrosis and diffuse bilateral pulmonary infiltrates consistent with hypersensitivity pneumonitis. These findings resolved rapidly and were near normal by 3/24/21
Died; A spontaneous report, was received from a consumer on a social media, concerning a 38-years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and died.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received dose of mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 17-Feb-2021, social media interaction was posted concerning a death of a patient on an unknown date after receiving Moderna vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on an unknown date. The cause of death was not provided. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time.  No further information will be available.; Sender's Comments:  MODERNA, INC.-MOD-2021-018380:Same reporter; Reported Cause(s) of Death: Unknown cause of death
I have previously had all of the medications by Pfizer; I was diagnosed with COVID 19; I had the two shot was the two boosters; I had the shot already; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), outcome "unknown", described as "I have previously had all of the medications by Pfizer"; COVID-19 (medically significant), outcome "unknown", described as "I was diagnosed with COVID 19; I had the two shot was the two boosters; I had the shot already". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was diagnosed with COVID 19.  Clinical Course: Reported as, Patient went to the doctor Sunday and patient was diagnosed with COVID 19 and patient have previously had all of the medications by Pfizer. patient had the two shot was the two boosters (Clarified as Pfizer Covid19 vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythema 7.5 x 5 cm with induration at injection site.
This was the Booster shot (3rd shot). I had the Exact same symptoms when I had the 2nd COVID-19 Pfizer dose/shot in my left arm. The 1st and 2nd vaccine shots were done in March 2021. With the 2nd shot, my left arm was achey/painful. With this 3rd shot that I'm reporting here- the Booster shot that I got 12/26/2021, my arm hurt even worse and felt like it was going to fall off. I had difficulty lifting my arm. That extreme pain lasted for a week. And then my arm started with slight soreness on  the morning of 1/30/22  and then it felt the exact same (as the booster shot pain) later by mid-morning and throughout the day and through the week...like my arm was going to fall off. Again, it was difficult in lifting my arm. At this time, the major pain is primarily gone but there is the slight soreness I feel at times. I did take tylenol once.
Pt called 12/3 to report diarrhea (3 to 4 loose stools over the course of the day) that she believes was caused by her recent HAVRIX vaccination received 12/1. She has not sought treatment and plans to wait another day or two to see if it resolves on its own.
The vaccine was given on AM of 4/27 at the left thigh and mom noticed redness/ swelling at the left thigh on the AM of 4/28 (no associated itching). The swelling/ erythema worsened on 4/29 and, given suspicion for cellulitis, pt was started on Keflex on 4/29. Pt seen on 4/30 for follow up and infection is responding well to Keflex, ie swelling/ erythema are markedly decreased. Pt has been afebrile  and otherwise well appearing during this time.   Note: on 4/27, pt also received Hep A vaccine at the right thigh (which is normally appearing)
Information has been received from a 75 year old female consumer with a history of shingles who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed shingles.  No further information was provided.  Additional information has been requested.
My first symptom that occurred was a raised bump that painful to touch and sore formed near my collar bone. It has now hardened but is still in the place it appeared. I went to the urgent care for this.  About a week after I had tingling sensations in my elbow and along the arm that was injected causing numbness and pain the following day. My arm began to be inflamed to the point of not being able to bend it and utilize it for every day activities because of the amount of pain it was causing. The pain in my arm was not caused by overuse or force of any kind to have caused the injury it just appeared and increased in pain. I have not gone to see anyone for this symptom yet.
Pt recvd 3 doses of Hep B vax & was determined to be a non-responder; recvd booster dose of Engerix-B vax;
This spontaneous report was received from a health care worker referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On unknown date, the patient was vaccinated with an unknown vaccine, which was improperly stored at 1.9 degree Celsius for 3 hours and 12minutes, for prophylaxis. These improperly stored vaccines included VARIVAX lot# R017946 with expiration date 24-JUN-2020, lot# N031939 with expiration date 13-NOV-2019 (dose detail, route were not reported) and PROQUAD lot# R0202675 with expiration date 15-JAN-2020, lot# R024015 with expiration date 19-FEB-2020, lot# R023500 with expiration date 13-FEB-2020 (dose detail, route were not reported). There was no previous temperature excursion. The call was because of a data logger involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA006359.
Moderna covid-19 vaccine EUA Red, warm, hard/swollen approximately 2? diameter circle at injection site or possibly lower on arm first noticed this morning, on day 8 post-injection. It?s a bit sore, too. Read about ?Moderna arm? online today. I?m not concerned with the reaction, but I wanted to report it nonetheless. I plan to get dose 2 as scheduled, in the opposite arm. Thanks.
About 1 hr after the vaccine, he started to have left eye  blind spot, circular.  Also had mild vision change on the right but not as severe as left. Unable to see details of image. 2 hrs after receiving vaccine started to have headache on right temple.
Itchy bright red rash the size of my fists across stomach 8 days after 2nd vaccine Treated with cortisone cream fro 5 days Called dermatologist, couldn't see for a week On day 6, started to spread; went to urgent care; started 10 mg of predisone for 5  days; itiching subsided Saw Dermatologist; prescribed steroid cream for 2 weeks; it is slowly fading