chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 02/10/01, this patient developed a red raised rash on her legs, arms, and stomach. Areas different sizes with largest about dime size. Areas worse on 02/11/01 and went to ER. The patient was given Benadryl IM, she had a low grade fever after the injection.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline) On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the vent was unspecified. The sales representative was told of three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780793A and A0780845A for the two additional reports of swelling.
Patient complained of numbness in  left leg.  EMT called. Assessment done. Vital signs stable. No further treatment needed.
Pt recv vax on 4/3/99; on 4/4/99 pt exp oblong/ raised/ erythematous/ warm area on arm w/ itching; tx=antihistamines, antibiotics
I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I gave a moderna vaccine that was expired.  It was punctured the day prior so it was over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Patient tolerated the vaccine administration with no problems in the left deltoid. I had plans to monitor her for thirty minutes as she had anaphylaxis to a penicillin injection as a child. She was walked to the waiting room at which time she felt completely well. After five minutes she felt comfortable, but at the ten minute marker she stated that she felt dizzy. I instructed her to remain seated and rest. At the thirty minute mark she said she still felt dizzy which I then led her to a room for her to lay down with her feet up. While walking down the hall she felt dizzy, but made it to the room. After laying down for 30 minutes she felt better and was able to walk down the hall several times without difficulty.
PATIENT COMPLAINED OF BURNING RADIATING FROM INJECTION SITE TO FINGERTIPS IMMEDIATELY AFTER INJECTION.  I ADMINISTERED DIPHENHYDRAMINE 50 MG INTRAMUSCULAR INTO THE RIGHT DELTOID.  I OBSERVED PATIENT FOR 20 MINUTES AFTER DIPHENHYDRAMINE ADMINISTRATION.  SHE REPORTED RESOLUTION OF SYMPTOMS AFTER 20 MINUTES OF OBSERVATION.
Pfizer bivalent booster dose was given past the BUD of 2/14/23. The vaccine was given on 2/16/23- no adverse reaction reported.
It's been lousy; Rash that's formed at the application site; Welt like rash; Loose bowels; Fever; Felt flu-like; Fatigue/I feel fatigue/Fatigue was reported as worsened; Bones ached; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 75-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the left arm on 02Jul2019 15:15 at single dose to prevent pneumonia in a doctor's office. Medical history included low thyroid diagnosed 25 years ago and it was ongoing. History of previous immunization and family history relevant to the adverse events was reported as none. There were no concomitant medications. The patient had a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) pneumonia shot on Tuesday 02Jul2019. Twenty four hours later on 03Jul2019, she had a fever but had no adverse reaction in her arm. Patient reported that she never took her temperature, but she knew she had a fever. Then she felt flu-like: her bones ached and everything. She also felt fatigued on 03Jul2019. Reported that she was very healthy and works out 6 out of 7 days a week. Patient also had loose bowels on 04Jul2019. On 05Jul2019, she asked her husband to scratch her back, and her husband saw this rash on her hip on her left side, it was like a welt about 4.5-5 inches long and 1.5 inches wide. The welts stick out and are bright pink. Reported that she had never had anything like that, and she wished they told her or she never would have gotten it. She washed the rash with soap and water, and thought if this was MRSA it would be awful. She has to go back to a doctor to see about her rash that had formed at the application site. So she had side effect from pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine from the injection. Further reported that vaccine had been lousy on her and she felt fatigue and everything. The events did not require a visit to emergency room and no investigational assessment done. Patient recovered from fever on 03Jul2019, was recovering from flu-like, not recovered from fatigue, loose bowels, and welt like rash. Outcome of the other events was unknown.  Information on the batch number has been requested.
History of Shingrix, then had shingles, suspected vaccination failure; Shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for product used for unknown indication.   On an unknown date, the patient received Shingrix and Nucala at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Nucala was discontinued (Dechallenge was unknown). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Nucala.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The sales representative learned the event from the doctor.  The patient involved who was on Nucala for a while doing great and history of being vaccinated with Shingrix.  The patient had a Shingles outbreak but recovered.  The patient was taken off Nucala due to this event.  No other information was provided.  It was unknown if patient received 2 doses of Shingrix or 1.  The reporter was consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever and chills began at 11:15 PM on the date of the vaccination continued into the next day at 9:30 AM I took NyQuil and Alka-Seltzer and slept until 8 o?clock in the evening at which time my bones were aching so bad I took more NyQuilAnd slept into the next day finally woke up at 6 o?clock and felt good enough to go for a walk and take a shower and eat something and then by 9 o?clock I went back to bed and slept until 4 AM at which time I woke up and felt good
Information has been received from a registered pharmacist concerning a female patient with no pertinent medical history or drug reactions/allergies who on 24-AUG-2011 was vaccinated with 1ml RECOMBIVAX HB (lot# 671032/1106AA, exp: 05-APR-2014) by intramuscular. There was no concomitant medication. "Within 24-48 hours after the dose of RECOMBIVAX HB", the patient developed "itching all over the body". The patient sought medical attention by calling pharmacy. No lab diagnostics study was performed. The patient self-treated with BENADRYL and AMBIEN. The patient fully recovered on an unspecified date. Additional information has been requested.
"Starting around 3PM or so the localized muscle pain, stiffness around the vacc site became pretty intense. Got to the point that about 7 or so I put an ice bag on it to help, half hour later I started having body shaking chills and from that point on for several hours, I got sicker than I've been for some time. Didn't vomit but felt very nauseous and the chills turned to feelings of strong fever accompanied by even some disorientation. Took my temp a couple times, 1st was 97.7 and a couple hrs later went up only as far as 99.5, which of course isn't that bad, however the way I felt I expected it to be 102 or so... Tried to go to bed at 10PM, but had a lot of discomfort and only had spot dozing until probably 3AM, when I finally drifted off to some decent sleep. This morning I feel kind of lightheaded, with only mild pain at the vacc site"
pt in 48hr p/vax w/redness measuring 50 cm x 45cm, sl swelling, & sl warmth;pt denies any tenderness;no knots felt by palpation;mom states redness began 15AUG96 & has inc only sl since;cold compresses applied;
period lasting 2 weeks after vaccine. i have the mirena iud implant and haven?t gotten a period at all in 3 years until i got the vaccine. painful cramps.
difficulty breathing; I started feeling sick as a dog.; My lungs were hurting, I couldn't hardly breath. I had labored breathing.; I had a bad fever.; I was nauseous. I almost vomited in my car.; body aches; was weary for a week. I didn't have stamina or strength; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), MALAISE (I started feeling sick as a dog.), PULMONARY PAIN (My lungs were hurting, I couldn't hardly breath. I had labored breathing.), PYREXIA (I had a bad fever.) and NAUSEA (I was nauseous. I almost vomited in my car.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had it for a month) on 15-Aug-2020.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing), MALAISE (I started feeling sick as a dog.), PULMONARY PAIN (My lungs were hurting, I couldn't hardly breath. I had labored breathing.), PYREXIA (I had a bad fever.), NAUSEA (I was nauseous. I almost vomited in my car.), MYALGIA (body aches) and FATIGUE (was weary for a week. I didn't have stamina or strength). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) (oral) ongoing from 24-Apr-2021 for Fever, Myalgia and Fatigue, at a dose of 600 milligram twice a day. On 24-Apr-2021, NAUSEA (I was nauseous. I almost vomited in my car.) and MYALGIA (body aches) had resolved. On 25-Apr-2021, MALAISE (I started feeling sick as a dog.), PULMONARY PAIN (My lungs were hurting, I couldn't hardly breath. I had labored breathing.) and PYREXIA (I had a bad fever.) had resolved. On 30-Apr-2021, FATIGUE (was weary for a week. I didn't have stamina or strength) had resolved. At the time of the report, DYSPNOEA (difficulty breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient called local Public Health Office today 10/28/2022 to report bruise on arm since vaccination on 10/12/2022 & pain behind her knee on the right side. Encouraged Pt. to apply warm and cold compresses to bruise & encouraged pt. to contact her primary care provider to report the pain in back of knee on right leg.
This case was reported by a pharmacist via sales rep and described the occurrence of general body pain in a 51-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (on an unspecified date 1st dose received, for tolerance see case US2018GSK112756). On 13th June 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain was unknown and the outcome of the fever was recovered/resolved. The reporter considered the general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that after the second dose, the patient of 102 degree F. The reporter stated that the onset time and exact duration of these symptoms were unknown. The reporter did not have any additional details. This case has been linked with case US2018GSK112756, reported by the same reporter.
Nausea & chills, t99 started 18APR92, h/a; rt arm very tender, red, warm 8cm red area; DPH lotion & DPH given;
Woke up this morning with shortness of breath. Progressing during the day and am now having constant substernal chest pain and palpitations.
ARM STIFFNESS AROUND INJECTION SITE; SORE ARM AROUND INJECTION SITE; 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 not reported, batch number: Unknown) dose was not reported, administered on 10-AUG-2021 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 10-AUG-2021, the patient experienced arm stiffness around injection site. On 10-AUG-2021, the patient experienced sore arm around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm around injection site and arm stiffness around injection site was not reported. This report was non-serious.
Hospitalized 11/6/2021; COVID-19 positive 11/6/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: Primary Care Physician at Discharge: Admission Date: 11/6/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Respiratory failure, acute-on-chronic [J96.20] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 87 y.o. female with PMH significant for COPD, HLD, HTN, hypothyroidism, history of ischemic CVA, compression fracture, GERD, depression, and sick sinus syndrome status post pacemaker who presented to the ED on 11/6/21 after exposure to COVID with four day h/o of lightheadedness, cough and weakness. In the ED, she was hypoxic requiring 4L O2 rather than her baseline of 3L. She was started on Remdesivir and Decadron and admitted for hypoxia 2/2 COVID.   Patient had progressive hypoxia requiring high flow nasal cannula. She was transitioned to IV salumedrol 40mg q6 hours due to wheezing concerning for COPD exacerbation. She was also given albuterol q4 hours scheduled. O2 requirements continued to increase to % FIO2 on HFNC. Long discussion with patient and family regarding GOC. Ultimately elected to pursue comfort measures. Hospice was consulted an patient made GIP Hospice. Started on Morphine and Versed Gtt. Passed away at 2206 on 11/14/21.
Arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm became sore) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm became sore). At the time of the report, PAIN IN EXTREMITY (Arm became sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient arm became sore. No concomitant medications were provided. Treatment medications were unknown.
Hospital Course: Patient admitted to the ICU in cardiogenic shock.  Intra-aortic balloon pump.  Multiple vasopressors.  Intubated-mechanical ventilation.  Appropriate sedation.   EMD arrest 5/2 spontaneous recovery.  Family meeting wife and daughter agreed to  A1 designation.  0725 recurrent hypotension nonresponsive to vasopressors, calcium, serum bicarbonate.   Pronounced dead at 0754.   _________________
Bell's Palsy/Paralyzation/Weakness of left side of face started Sept 15th around 6pm.; Pain behind left ear; numbness in lips; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0182), via an unspecified route of administration, in right arm on 12Aug2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes type 2, congestive heart failure, asthma, COVID-19 and allergy to shellfish and codeine. Concomitant medication included lisinopril, metformin and glipizide. No other vaccine was given in 4 weeks. Since vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration, in left arm on 14Jul2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization. The patient experienced numbness in lips which started on or around 10Sep2021. Pain behind left ear on or around 14Sep2021. Paralyzation/ Weakness of left side of face started 15Sep2021 around 18:00. The patient went to ER fearing a stroke and was diagnosed with Bell's Palsy. Therapeutic measures taken as a result of the events included medications valacyclovir, prednisone and amoxiclav. The events resulted in emergency room/ department urgent care. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected
pt recvd vax NOV92 & on 25FEB93 lab eval showed abn liver function tests; No further details were provided;
Hospitalization due to COVID-19 Reported per Janssen COVID-19 Vaccine EUA
9/19/12 In with question about site of pneumonia shot - Rt arm is swollen & warm to touch & itching. Rt. arm is swollen & warm at site of shot. Rt. inner arm above elbow is swollen, warm to touch with fluid accumulation under the skin. Localized reaction to pneumonia shot. Referred to PMD for evaluation - client to call clinic with results from visit to PMD. 9/20/12 Client called clinic - reported she saw Dr. 9/19/12 pm & she told client to take BENADRYL - the doctor called vaccine company & discussed reaction to vaccine with them - Dr. saw client 9/20/12 & gave shot of DECADRON - client say area on arm is red with warmth & itching & has enlarged in size - Dr. will continue to follow-up on her status - clinic will call client 9/21/12 to recheck status. 9-21-12 Left message for client to call clinic. 9-22-12 No response from client.
A parent reported that her 17 month old daughter received her 1st dose of Prevnar, along with doses of DTAP and MMR II vaccines on 9/8/00. On 9/10/00, the child's mom reported that her daughter awoke screaming. She had developed a "bumpy rash" and experienced itchiness of her feet. A red rash developed on her back and hip. The child's mother indicated that since 9/10/00, her daughter has experienced restless sleep and continues to pound her feet. The mother stated that the rash resolved in 5 days; but reappeared all over her daughter's body. As of 9/28/00, the child's mother stated that her daughter's feet remain itchy. Additional information received from the child's physician on 10/27/00, stated that the child had been seen on 9/11/00 and again on 9/26/00. The child had been examined on both of these occasions by another physician who felt that the rash was eczema; "not a reaction to any vaccine." The physician stated that the child had been adopted from Russia on 8/27/00.
Narrative: PER DEATH CERTIFICATE- PATIENT PASSED AWAY AT HOME. CAUSE OF DEATH CKD AND DMII (INSULIN DEPENDENT). Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine.
experienced mild wheezing.; experienced shaking hands and legs.; legs went weak; felt very nauseas/ nausea was more intense; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0105) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19. The patient had history of known allergies to molds, pollen, dust mites, drugs allergy: codeine (MANUFACTURER UNKNOWN) and (DURICEF). Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) of 100mcg and loratadine (MANUFACTURER UNKNOWN) of 10mg tablet, all from unknown date for unknown indication and also previously second dose of varicella zoster vaccine rgE (CHO) (SHINGRIX) (Lot Number: 58160-0823-11 on 12Mar2021 for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 14:00, within five minutes of receiving the vaccine, the patient felt very nauseas, about 20 minutes after vaccine the legs went weak and nausea was more intense. Healthcare workers made the patient sit with feet propped up. About 30 minutes after vaccine the patient experienced shaking of hands and legs, about one hour after vaccine experienced mild wheezing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures included treatment with inhaler, consumption of snack and water. The clinical outcomes for nausea, shaking of hands and legs, mild wheezing and weakness of legs were recovering.   No follow-up attempts are needed. No further information is expected.
Afebrile sz post DTP; pt recvd 4th dose of vax & 5-10 mins later on way out of ctr pt fell to ground, eyes rolled back & pt had grimacing (clenching) w/mouth; pt taken to ER; bradycardia;
Information has been received from a 19 year old female patient with no pertinent medical history who a few months ago received the first dose of GARDASIL (lot# not reported) and approximately 4 or 5 months ago was vaccinated with the second dose GARDASIL (lot# not reported). There was no concomitant medication. On 18-MAR-2009 the patient visited the nurse practitioner and a pap smear was performed. Patient was told by the nurse practitioner that according to the pap smear results she was positive for HPV (unspecified type). At the time of the report, the patient had not yet recovered. Additional information has been requested.