chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA Patient received dose #1 of Moderna Vaccine on 1/20/2021, and dose #2 of Moderna Vaccine on 2/26/2021 from a Facility. The patient was admitted in 7/9/2021 with a diagnosis of Acute respiratory failure due to COVID-19. Patient expired on 7/28/2021 despite treatment with supplemental oxygen, steroids, and remdesivir, and tocilizumab.
Pt came in for PPD reading. Mom stated she had just noticed redness on (L) arm where shots were given. No fever, 3/10 pain, measurements of 90x90, slightly warm, pt's mom was advised to put cold pack in area to help with swelling, and take TYLENOL if any pain.
COVID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 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.  On an unspecified date, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217340. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as no covid symptoms experienced) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220240603.
Swelling, redness, tenderness and achy arm at site where vaccine was administered - symptoms started 3-4 days after receiving vaccine - area red - about 1.5 x 2 inches.
Sebaceous cyst on right shoulder that had been there for many years became irritated and infected.
blistering in the upper part of her torso; rash in the upper part of her torso; hands itched; feet itched; fever of 100.4 deg. F; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched) and PYREXIA (fever of 100.4 deg. F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE and Sumatriptopan for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched), PYREXIA (fever of 100.4 deg. F) and HEADACHE (headache). At the time of the report, BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched), PYREXIA (fever of 100.4 deg. F) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2 days post #1 Anthrax vaccine developed severe dermatitits, macularpapular rash on the chest,:back,arms, and thights.  Quarters x 1Day, RX:  Dehenydramine PO 50 mg cap Q 8 hrs PRN. Triamcinolone 1% QD.  Start date 05/25/07.
Violent vomiting 8-9 times a day; Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking; Could not get out of house; Extreme headache/was more severe for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking), HOUSEBOUND (Could not get out of house), HEADACHE (Extreme headache/was more severe for 2 weeks) and VOMITING (Violent vomiting 8-9 times a day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 029A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine allergy) since 01-May-2021, Drug allergy (All pain medications) since 01-May-2005 and Back pain since 10-Oct-2016. Concomitant products included MONTELUKAST from 05-Jan-2019 to 28-Oct-2021 and BIOTIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking), HOUSEBOUND (Could not get out of house) and HEADACHE (Extreme headache/was more severe for 2 weeks). On 08-Nov-2021, the patient experienced VOMITING (Violent vomiting 8-9 times a day). On 11-Nov-2021, VOMITING (Violent vomiting 8-9 times a day) had resolved. On 13-Nov-2021, HOUSEBOUND (Could not get out of house) and HEADACHE (Extreme headache/was more severe for 2 weeks) had resolved. At the time of the report, DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking) had not resolved.            Concomitant medications include multivitamins and edlderberry 100 mg. Patient received flu vaccine injection on left arm on 18Oct2021.  No treatment information was provided   This case was linked to MOD-2021-388568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contain no new information. On 22-Nov-2021: Significant Follow up received on 22-Nov-2021 contains medical history and concomitants updated and event onset and end date updated for vomiting.
Vaccine should have been discarded on 6/14/23 due to BUD but was administered on 6/15/23 anyway.
Approximately 5 minutes after Hgb +vacc + administration tremors. Pt was pale. After waking pt was dazed within cyanotic lips and brady to 60s. Was pale and dazed for 20 minutes. This was followed by 30-45 minutes of sound sleeping (barely arousable). Dx vasovagal vs. seizure.
Case number PHEH2016US025909, is a spontaneous report initially received from a consumer (patient's mother) on 03 Oct 2016. This report refers to a male patient. Past medical history was not reported. Current condition included mild egg allergy which was diagnosed after allergy testing. Concomitant medication was not reported. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date 2 years ago. After vaccination, he experienced hives and rash. The outcome of the events was reported as complete recovery on an unknown date. The reporter assessed the events as non serious. The causality of the events was not reported. Non significant information received from a consumer on 03 Oct 2016: Updated reporter information.
He said he is experiencing some muscle soreness.; Sore throat; Stuffy nose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 24Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for immunisation; varicella zoster vaccine rge (SHINGRIX), on 24Oct2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 24Oct2022, outcome "unknown", described as "He said he is experiencing some muscle soreness."; OROPHARYNGEAL PAIN (non-serious) with onset 24Oct2022, outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 24Oct2022, outcome "unknown", described as "Stuffy nose". Additional information: The patient reported having some muscle soreness after the vaccination. The patient stated that he had muscle soreness, sore throat, and stuffy nose.    Follow-up attempts are completed. No further information is expected.
SORE ARM; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER). At the time of the report, VACCINATION SITE PAIN (SORE ARM) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  Concomitant medications  were not given.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-Significant FU - Address Provided; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Pt. given Moderna booster at 5 months instead of 6 months from last vaccine.
On 10/04/11 patient came to pharmacy complaining of welts on body that patient claims was from the flu shot given on 9/24/11.
pain in left arm; pain in her left arm that radiates up to her shoulder; pain up shoulder; got vaccine subQ versus intramuscular; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 14th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, radiating pain, shoulder pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, radiating pain and shoulder pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain in arm, radiating pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: Caller was a nurse stating that she got the first dose of Shingrix vaccine subcutaneous versus intramuscular in left arm.  Since getting the vaccine subcutaneous, she has had pain in her left arm that radiated up to her shoulder. In November 2021, patient received second dose of 0.5 ml Shingrix via intramuscular route in right arm. The consent to follow up was not granted. Additional Supportive Information: As patient received Shingrix via subcutaneous route instead of intramuscular route, which led to intramuscular formulation administered by other route.
Woke up at 3am with aches all over my body in joints especially, and a headache. Experienced dry mouth. Hands appeared swollen. Felt chills and a possible low grade fever, later one had a cold swear and pain continues at 4pm on the day after the dose.
Per father's report - 30 minutes after getting vaccine child had hives, facial swelling and difficulty breathing. Child had to be taken to Emergency Room, parents took child to another facility to ER so we have no visit notes to refer to.
This spontaneous report as received from a registered nurse refers to a 2 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
COVID vaccine breakthrough case. Pfizer 12/16/21 FK5618, 1/6/22 FK5618 and Bivalent 2/24/23 GM1767
3  days later experienced nausea, headache, loss of energy.  On the  5th day I got tested for  covid19  just to sure and it was negative. On the 8th day area around the injection sight had a rash and was swollen. On the ninth day arm is still red, swollen and hard.
Swollen lymph nodes in left axillary the size of a tennis ball for about 4 days but not completely subsided after 2 months.  Painful kidneys for 4 days followed but low back pain for 3 days.
Information has been received from a physician concerning a 4 year old male patient who in 2006 was vaccinated with VARIVAX (Merck). The patient developed a mild case of chickenpox (amount of lesions was unknown) last week in May 2009. The patient had sought physician for medical attention. Additional information has been requested.
Me and my husband are have light patches forming on our skin. Like early stage of Vitiligo.
Extreme arm soreness, fever, aches, chills, pain in right shoulder blade, nausea, skin sensitive to touch, headache
devel tactile fever @ 11PM 5MAR97;2AM episode of unresponsiveness, stiffening of extremities, drooling, shallow resp;neg cyanosis;+postictal to ER presumed febrile sz;w/u including LP neg;seen 6MAR97 in office;OM
DR'S OFFICE CALLED US TO INFORM US THAT PATIENT HAD A REACTION AT THE SITE, CELLULITIS IS NOW OCCURRING.
Pt arm began to turn red and swell . patients arm was itching and the muscle felt tight and painful .
Expired vaccination was given to the patient (Vial was punctured about 24 hours before the vaccination). Patient hasn't reported any adverse effect. Moderna company was informed and discussed about the next step.
A spontaneous report has been received from a health professional concerning a patient of unknown gender. No information regarding relevant medical history concomitant disease or concomitant medication was provided. The patient was receiving FLUMIST Quadrivalent started on 14 OCT 2014. RN reports we had three patients who received FLUMIST Quadrivalent 2-3 days ago and they had came back to clinic with flu-like symptoms. The reporter stated patients had muscle aches and low grade fever. The outcome of the events of three patients who received FLUMIST Quadrivalent 2-3 days ago have come back with flu-like symptoms and muscle aches was unknown. The reporter considered the three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms and muscle aches as non-serious.
His lips are swollen; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FF8841) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "His lips are swollen"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "got sick".  Additional Information: Caller is asking if swollen lips is a reported side effect with the Pfizer-BioNTech COVID-19 Vaccine. Her 16 year old son got the vaccine yesterday and that's when he got sick. Covid vaccine, adult a Pfizer product. Caller states she is calling about the Pfizer Covid vaccine adult, FF8841. Caller states her son got the vaccine yesterday and he is 16 years old. Caller states his lips are swollen, and that a side effect.  Follow-up attempts are completed. No further information is expected.
vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022; patients received doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions. It was reported that 4 does were given from 1 vial. No treatment medication was reported.
weak; tingling from hip to toes; wanted to sleep and sleep; legs were hurting; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 17Feb2021 (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient felt weak, experienced tingling from hip to toes, wanted to sleep and sleep and her legs were hurting but no swelling. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
after shot was given 11:05am patient began to pass out in observation area called 911 arrived at 11;15am and released patient at 11:30am
Painful injection site - left arm; body aches; chill; Temperature of 100.9 degrees Fahrenheit; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an intramuscular route of administration in the left arm on 20Jul2021 at 08:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from unknown date. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 02:45, the patient experienced painful injection site- left arm, body aches, chill, temperature of 100.9 degrees Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  painful injection site- left arm, body aches, chill and temperature of 100.9 degrees Fahrenheit was recovering at the time of this report.
I was so much pain a few days and then a few days after that, I found it hard to breath and my heart was palpitations. I went to ER and was told my blood pressure was very high. My doctor referred me to a Cardiologist and I still have the shortness of breath and heart palpitations. I was prescribed various medications such as blood pressure pills.
While pushing FLUMIST in the 2nd nostril, child jerked head backwards and said "some got in my eye - it hurts." Called Medimmune - flushed child's eye with sterile water 5 min. later.
For 2 days I felt a little subdued, just a little tired. 2 days after the vaccine I started to feel really bad. I was outside doing yard work that Saturday for a couple of hours then it felt like I pulled a muscle. Later Saturday night, I noticed my left calf muscle was hurting. I also developed a cough but was gone in 2 days. I noticed my leg started to swell up but I thought it was due to the yard work. I did some research then I scheduled an appointment with my doctor. They did find blood clots in my leg and my oncologist attributed it to the vaccine.
Patient states having tingling sensation between cheekbone and ocular orbit bilaterally 30 minutes following first dose of Pfizer covid-19 vaccine, lasting 1-1.5 hours
Acute blood loss anemia. He was treated with transfusion and initially with octreotide and IV PPI for possible GI bleed. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 13 Oct 2006 with an oral dose of Rotateq. No problems were reported, it was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Numbness and tingling on injection side (left) of body around temple/ear/eye/cheek.  Minor headache on left side and extreme fatigue approximately 6 - 8 hours after injection.  Lasted approximately 24 hours after injection.
joint aches several hours, severe headache beginning at base of neck and gradually moving up into temporal area duration +/- 30 hours; loss of appetite 24 hours; fatigue +/- 30 hours; rash/hives on chest & abdomen +/- 30 hours
Itching on arms, face, back, eyes.   Mild raised rash on upper back.  Face flushed.
rash on arm approximatley 5 days after shot, hot to touch, uncomfortable, can be itchy - sensitive to touch  seems to be spreading
2nd dose after 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days) had resolved.