chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U010395 expiration date 01-APR-2023 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
3 hours after IPV developed rash. Flesh colored bumps better the next day, then more the next day, itchy. Mom requested report be filed.
Developed a rash on neck and arm, it would go away for a few days, then moved to his neck and body. It's continued rotate through his body.
This case was reported by a nurse and described  the occurrence of an itchy rash in a 25 yr old male pt who received hep B vaccine recombinant (Engerix B).  The pt was not taking any concurrent medications. She had no history of allergy to thimerosal. On 28Oct2003, the pt received the first dose of Engerix B (lot ENG5447A6) in her left arm. Prior to the vaccination, isopropyl alcohol was applied to the injection site. Following the vaccination, an adhesive bandage was applied to the injection site. At an unspecified time following the admin of Engerix B, on 28Oct03, the pt developed an itchy rash that spread from her left shoulder to her left elbow. The events resolved approx one week later, on an unspecified date in Nov 2003.
Eyes swollen no other symptoms. Patient given Benadryl 1 tsp at office start Crapred 15mol/5ml at 2 tsp daily x days. Patient doing well as of 8/22/07 per mother.
Pt DOB 1/4/1994. Pt had his first dose of Pfizer and was sitting in post observation. Per post observation staff to this writer: Pt began to jerk and slumped to his right side. Pt became diaphoretic, eyes were fixed but was able to answer all questions. Pt was laid onto cot feet elevated until Aid arrived. Guest reports he came from the gym and has not eaten today. Pt back to baseline and cleared to d/c home. Pt mother came to drive Pt home.
Chills and fever started within 4 hours of the shot, followed by a severe migraine headache lasting two days along with soreness and weakness in the arm that was vaccinated.  Day 2 had a fever of 102.5 on and off throughout the entire day and night, along with nausea, vomiting, and some diarrhea.  Dizzyness and fatigue lasted into the 3rd day.
Loss of complete hearing same day. Locked/blocked ears, ringing, swooshing, can hear, ech around any noise or when speaking.  Saw primary care providers.
Had no effect anywhere except a soreness to right knee. However, on March 11, 2021, I received the second vaccine of Pfizer, and 40 minutes after the shot, my right knee became stiff, extremely painful and that continued until the doctor ordered prednisone on April 02, 2021. I was unable to walk on that knee without the use of crutches or a cane. Sharp contrast from just before the vaccines.
Started having seizures "in the last 2 weeks". Saw PMD who recommended additional testing. Parents are waiting to see if seizures improve. They sound like absence seizures.
pain in arm, fever, chills, warmth at injection site for three days, redness at injection site
ITCHY, RED RASHES ALL OVER BODY INCLUDING LEGS, ARMS, STOMACH, CHEST AND BACK.; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-JUN-2021 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 06-JUL-2021, the subject experienced itchy, red rashes all over body including legs, arms, stomach, chest and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy, red rashes all over body including legs, arms, stomach, chest and back. This report was non-serious.
Chills, muscle fatigue, muscle pain, fever (102.7), sweats, loss of coordination
Received flu vaccine 9/25/17. Evening of 9/26/17 noted some redness around the site. By 9/27/17 redness had expanded to area 15cm long by 10cm wide on outer aspect of shoulder around the injection site. Firm, discretely bordered, NOT tender, not itchy. My impression is exuberant local inflammatory reaction. She had never had a similar reaction in past. We are using a different brand of flu vaccine this year. Patient has no history of atopic disease, however she does react strongly to poison ivy.
Shingles on left thigh. Given Zovirax orally 200mg QID x 5 days.
Patient reports that about one week after receiving their first dose of PFIZER, an abscess is evident on the right side of his body in the hip area which develops an ulcer with suppuration. The patient is treated by Doctor who prescribes anti-inflammatories, antibiotics and burned the ulcerated wound. The procedure required Local Anesthesia (lidocaine) currently the ulcer continues even with prescription drugs.
Mild rash and swelling at the site below the site of injection, may be cellulitis possibility. There is no swelling at the site of injection.
Didn't feel well around 4:45 p.m.  Laid down to rest, went to bed early.  The next morning I  was dizzy didn't do much.  Late afternoon I decided to go out and get my mail.  Reached down to pick up a solar light on the ground and just went face down in an icy snowdrift.  A neighbor came to  my rescue the police and fire came,  eventually I went by ambulance to the hospital to be examined.
This spontaneous report was received from a registered nurse refers to a 15-month-old patient of unknown gender. The patient was vaccinated with, 0.65 milliliter ZOSTAVAX (lot# not reported) on 25-SEP-2012. No concomitant medications were reported. Reporter mentioned that the patient received ZOSTAVAX instead of VARIVAX (Merck). The patient was not experiencing any known symptoms. No further information is available. Additional information has been requested.
Information has been received from a physician concerning a 65 year old female who was vaccinated with a second 0.5 ml dose of PNEUMOVAX 23. On the same day the patient also received a dose of flu vaccine in the same arm. "Recently", the patient developed a "severe injection site reaction" and was hospitalized for 2 days. The patient was treated with intravenous antibiotics. Subsequently, on an unspecified date, the patient recovered. Follow up information was received from a registered nurse (R.N.) who reported that the retired female with chronic obstructive pulmonary disease, allergy to penicillin, clarithromycin, metronidazole and isoniazid, asthma and hypertension and emphysema who at 12:45 pm of 17-OCT-2008 was vaccinated in her left deltoid with a second dose of PNEUMOVAX 23 (lot #657526/0555U) and a dose of FLUZONE (lot #U2805AA). There was no illness at the time vaccination. Concomitant therapy included tramadol HCl, ADVAIR, hydrochlorothiazide, aspirin, prednisone, EFFEXOR XR, theophylline, AMBIEN, ULTRAVATE, AZULFIDINE, lisinopril-HCTZ, albuterol and tiotropium bromide. In the P.M. of 17-OCT-2008 the patient experienced increasing pain and redness at injection site, fever, chills, shortness of breath, nausea, vomiting, headache and stiff neck and was hospitalized (4 days). Blood culture was negative. On 24-OCT-2008, the patient recovered. Additional information is not expected.
Symptoms reported on 2/8/21.  On 2/6/21 - patient reported experiencing fever and shivering. On 2/7/21 - patient reported experiencing atrial fibrillation (he has a past medical history of A Fib but has not had it for a long time). The patient treated the fever and shivering with Tylenol 2-3 doses and symptoms improved. No fever or shivering today. He treated the A Fib with his prescribed Cardizem and it resolved in approximately 6hrs.
Patient seen in the ED on 12/14/22 for evaluation of shortness of breath, tachypnea, cough with increased sputum production, and chills for the past two days. COVID PCR test preformed in the ED resulted positive. Patient was admitted to the hospital 12/14/22 - 12/22/22. Discharge diagnoses include acute hypoxic respiratory failure with right-sided pleural effusion, congestive heart failure, and COVID, among other diagnoses. Patient did require supplemental oxygen to keep saturations greater than 90%, however was able to be weaned off oxygen prior to discharge.
Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day.  The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.
Pt vaccinated with MMR c/o soreness under arm, tenderness in neck glands. Fine red rash over body especially on neck. Developed diarrhea, dizziness, edema in knees, thumb stiffness.
Vaccine given on 8/17/06. Mother reported Sat am that left arm was red, swollen from shoulder to elbow. Gave Tylenol and cold compresses.
the medical assistant only administers the dilutant into the patients arm instead of combining.  The two the brown cap antigen.
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number 5Y9N9, expiry date unknown) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (1st dose received on 08 June 2022, from batch number X9HS4 and refer case US2022AMR171034), Hiberix with an associated reaction of skin discolouration (1st dose received on 08 June 2022, from batch number EK5Y2 and refer case US2022AMR171034), Pediarix with an associated reaction of skin discolouration (2nd dose received on 11 Aug 2022  from batch number N7HL3 and refer case US2022AMR171039) and Hiberix with an associated reaction of skin discolouration (2nd dose received on 11 August 2022 from batch number BD27G and refer case US2022AMR171039).   On 13th October 2022, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 3rd dose of Hiberix. On an unknown date, the patient received PREVNAR. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171034, US2022AMR171039   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix. The reporter consented to follow up. Additional supportive information: This was 1 of 19 linked cases, reported by same reporter. It was unknown if the reporter considered the skin discoloration to be related to Prevenar.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
Client c/o tightness in throat 8 minutes after receiving Dose 1 of Moderna vaccine. Pulse 90,O2 sat.96,BP 150/110.Bendryl 50 mg po given,after10 minutes client c/o worse tightening of the throat,paleness and red raised rash noted on both arms and chest. Epi pen administrated O2 sat 98, pulse 80, BP 120/90. EMS called . Client transported to Hospital via ambulance.
Fever started Friday evening. Cold symptoms.  Went to ER on Sunday at 9 pm with a fever of 103.3. Diagnosis at ER was URI and otitis media.
Patient stated that she experienced significant swelling, redness and warmth in her right arm.  She also had pain and movement difficulty.
Fatigue, Headache, Temp of 100F, Constant shivering and chills for 10 hours, muscle aches.
Continued low grade fevers, chills, myalgia and headache 14 days following vaccination
This spontaneous report was received from a physician, via company representatives and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours highest recorded temperature). The vaccine status was reported and "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several reports received from the same reporter. Additional information has been requested.
Employee reports she "felt chest pain and her throat closed up. Took Benadryl and went to bed. She reports she took Benadryl again the next day and went to work, where she then noticed her arm was swollen and reports she had an asthma attack. She went to the ED for treatment, where she reported it as a "flu reaction".
weakness in both legs & arms, diff walking began 22ARP95; gradually has gotten worse last seen by chiropractor for 1 mo, then saw PMD 6wks later; referred to MD for arthritis eval NOV95;
Erythema and swelling of arm from shoulder to elbow with discomfort, slight pain.
mild chills; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (mild chills) and HEADACHE (slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced CHILLS (mild chills) and HEADACHE (slight headache). At the time of the report, CHILLS (mild chills) and HEADACHE (slight headache) had resolved.            Concomitant products were not provided. Treatment products were not provided.
Dizziness; Fever; Throwing up voilently; Knot at injection site; Felt there is bubbles in her ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear), DIZZINESS (Dizziness), VOMITING (Throwing up voilently) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included MECLIZINE HCL for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear) and VOMITING (Throwing up voilently). On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). At the time of the report, VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear), DIZZINESS (Dizziness), VOMITING (Throwing up voilently) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include, pharmacist recommended dexamethasone,but it did not help her. She gave consent to follow up with safety.She asked whether she should take the second dose of the vaccine   This case was linked to MOD-2021-142085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The caller is returning safety's call to request the correct email address. Case #MOD2021142085 On 09-Jun-2021: The caller is returning safety's call to request the correct email address. Case #MOD2021142085
Mom brought child back to Health Dept about 1 hour after vaccine administration - "hives" back of neck, back, few both thighs, scattered on trunk and few behind ears. Pt playful. RN phoned primary care physician's office. Recommended Benadryl. RN had Mom speak with MD office giving doses over the phone, didn't feel necessary client make appt. Mom stated outfit pt had on was new, had not been laundered.
Information has been received from a physician concerning one of her female nurses who was 60 years of age with high blood pressure, who on 15-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included losartan potassium (MSD), 50 mg daily; and atenolol, 25 mg daily. On 29-MAR-2007, while in the shower, the patient noticed she had developed 7 red spots along the thorax that are unilateral. The lesions are papular, none appeared to be vesicular, which the physician believes is shingles. It was reported that she had no other signs or symptoms, no pain and "does not feel sick". There was no recent varicella exposure. The patient was scheduled to be seen by the physician on 31-MAR-2007. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
has his second shot scheduled for today but he has a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold). At the time of the report, NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (tenderness at the injection site) outcome was unknown. Not Provided          Patient stated that she was taking medicines for Arthritis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
1 day p/vax pt exp itching @ inj site;itching resolved spontaneously p/15hr;this is 1 of 2 pt of this facility, out of 53, patients, to have an adverse exp p/vax;
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
On 04/18/2002, the child refused to bear weight and said that it feels like needles. Parent denied fever or any other symptoms.