chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a registered nurse concerning a 24 year old male with rheumatoid arthritis with knee pain and swelling and an allergy to ALEVE and a history of hives who on 24-AUG-2007 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot #655500/1005F). Concomitant therapy included ibuprofen. On 27-AUG-2007 three days after vaccination the patient noted an acute onset of a non-urticarial, erythematous pruritic rash on the trunk, sparing the extremities and face. Cotemporal with the onset of his rash, he noted severe low back pain. The patient self treated with 2 doses of BENADRYL at home. On 28-AUG-2007 the patient contacted the office an was scheduled for an appointment later that day. On approximately 30-AUG-2007 the patient recovered from the rash and the severe low back pain was virtually resolved and the painful knee and wrist swelling had marked improvement. On 07-SEP-2007 laboratory and diagnostic tests revealed; blood pressure was 130-90, left knee synovial fluid was inflammatory and lacked crystals, routine cultures were negative, fungal cultures ultimately grew penicillin and epicoccum species (contaminates), purified protein derivative (PPD) tuberculin skin testing was negative, chest x-rays were unremarkable, health assessment questionnaire (HAQ) disability index was 0.1. Visual analog scale (VAS) were; global 5.5, pain 6.5, GI 3.0, fatigue 4.5. Current health status was 3. The physician felt that the flat, red, itchy and wide spreading rash may be secondary to therapy with PNEUMOVAX 23. No further information is available.
Soreness in left arm for two days.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer (patient-non pregnant) received the first dose of the bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,  Lot Number EN6201, Expiration Date: unknown), via an unspecified route of administration in Arm Left On 09Feb2021at 13:30  single dose for Covid-19 immunization. The patient medical history was not reported. concomitant medication included Levothyroxine, Pravastatin, Valacyclovir. The patient had not received other vaccine in four weeks. The patient was not diagnosed prior and post to the COVID-19 vaccination. On 09Feb2021 at 02:30 PM, the patient experienced soreness in left arm for two days.  The outcome of event was recovered.
Recipient developed a few hives on right lower arm.  Denied difficulty breathing or swelling in airway.  Given Benadryl and had him stay to be observed longer.  No new hives and no SOB.
Patient was wanting to get 2nd dose of Moderna at pharmacy and  employee noticed that patient was not quite 18 yrs old yet. We were notified of occurance and patient has scheduled 2nd dose at our location for May 6th through our scheduling tool.  We have reached out to patient today and left a message to make sure she is completing series. Patient has not notified us of any adverse reactions and hope that is the case since she scheduled 2nd dose  of this vaccine at our location.
Scratchy throat; Left hand begun to swell; Left hand tender; A spontaneous report was received from a consumer, concerning a 70 years female who was administered Moderna's COVID -19 vaccine has experienced scratchy throat, left hand swollen, tender and tight. The patient's medical history was unknown. Concomitant medications  description includes blood pressure medication and  rheumatoid arthritis medication, but specific medications were not provided. On 21 Jan 2021, prior to the onset of events, the  patient received  their first of two planned dose of mRNA-1273( Batch no.- 032L20A) in the right arm for prophylaxis of COVID-19 infection. The patient has experienced scratchy throat, left hand swollen, tender and  tight. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event outcome was not resolved.
Moderna Bivalent Booster that was administered past the expiration/beyond-use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date).    NDC was reported as 80777-0282-05.  No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot/batch #1024993 with an expiry date 17-OCT-2017 and dosing details not known. No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1024993 is an invalid lot number for GARDASIL 9. This is one of the four reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse referring to a 13 year old patient of an unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 28-MAR-2017, the patient was vaccinated with PROQUAD with lot # M042500 and an expiration date of 17-APR-2018 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Some of the vaccine leaked out while administering the vaccine to a patient; Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping). At the time of the report, DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was administered with the 2nd booster of the Moderna COVID-19 vaccine. From the patient point of view most of the medication was dripped out.  No concomitant medication was reported.    No treatment information was reported.
Gardasil 0.5 ml lot # 0930U, Exp 11/10 given IM inadvertently instead of Tdap.
subcutaneously instead of intramuscularly; subcutaneously instead of intramuscularly; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 15th October 2021, the patient received the 2nd dose of Shingrix (subcutaneous) and Influenza vaccine Quadrivalent unspecified season (subcutaneous). On 15th October 2021, unknown after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route and intramuscular formulation administered by other route were unknown.  Additional details were provided as follows: The patients might received her 2nd dose of Shingrix and a flu vaccine subcutaneously instead of intramuscularly. The vaccine was administered at a different unnamed facility. The pharmacist did not know which vaccine was given into which arm, only that she got one of the vaccines in her right arm, and the other one in her left arm. The pharmacist believes it was given subcutaneously because it was given into the back of the arm, which led to intramuscular formulation administered by other route and intramuscular formulation administered. The reporter did not consent to follow up.
Patient was seen in office 2/4/05 with a history of fever few days prior. Now with rash; rash congruent with post MMR rash but also with petechiae. Platelets were about 11,000. Admitted with ITP. Seen by heme-oncologist who felt this could have been either viral cause or post MMR.
Patient Received Covid19 Moderna on 3/12/21 for her second shot, she should have received Pfizer to match her first shot
Whole body aches; fatigue; headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not received any other medications  within 2 weeks of vaccination  The patient had penicillin allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   On 30Mar2021 at 17:30, the patient experienced pain at injection site which was started about 4 hours after dose and lasting at least 40 hours improving at the time of this report.. On 31Mar2021, the patient experienced body aches, fatigue and headache starting approximately 20 hours of vaccination and lasting approximately 24 hours. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events pain at injection site, whole body aches, fatigue and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Extensive swelling above shoulder to proximal 1/3-1/2 of forearm, with redness and warmth; decreased range of motion at elbow. Right axillary lymphadenopathy. Tx Benadryl, Keflex, CBC done.
Frequent rashes on whole body. They appear and go away relatively quickly, but some around my groin and armpits have been persistent. They are itchy but not painful.
Rt arm (on back of arm) redness 4x5 cm and warm. Fever 101.7. H/A, cough. Tx: Augmentin, Xopenex.
DIED AFTER COMPLICATION FROM THE JOHNSON AND JOHNSON COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient died after complication from the Johnson & Johnson COVID-19 vaccine. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0;20210516437-covid-19 vaccine ad26.cov2.-Died after complication from the Johnson & Johnson COVID-19 vaccine. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: DIED
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent which was properly stored. On an unknown dates started on or after 29-MAR-2017, the patients were vaccinated with improperly stored doses of PROQUAD, lot number M035689 with expiration date 06-FEB-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperatures between -9 Celsius (C) and 8 Celsius (C) during 39 hours, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002753.
Pain and burning in left arm.  Swelling and redness about the size of the baseball.  Can barely left her arm
pt devel sz;pt in hosp;MD felt was febrile sz;mom reports pt transferred to another hosp d/t CT scan was abn showed arterio-venous malformation;MD felt blood clot hemorrhaged which caused swelling brain;v, disoriented
Number 3 MMR was given this day (6/14/13). Patients 1st MMR recorded in EMR #2 was hot. Nurse did not check state registry prior to administration.
blisters on her upper lips; sore upper lip; achiness all over; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER (blisters on her upper lips), CHEILITIS (sore upper lip), PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever). On 05-Apr-2021, the patient experienced LIP BLISTER (blisters on her upper lips) and CHEILITIS (sore upper lip). On 04-Apr-2021, PAIN (achiness all over), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, LIP BLISTER (blisters on her upper lips) and CHEILITIS (sore upper lip) outcome was unknown.            Concomitant drug information not provided. Treatment was not provided. Consent to follow-up safety provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: NNI
11/13 While working, had emesis and pain shot up from chest and down left arm. Left fingers numb. 11/18 had same pain and went to ER. X-rays done and dye injected to detect clogged arteries; none noted. Given antibiotics for pneumonia left lung. Hospitalized 11/19-11/22. Patient states she called report in today 12/5/03. The adverse events described by the clinet may have been incidental to vaccine reception.
Rash, fever, pharyngitis - seen on 10/8/13 - discussed that presumably could be strep vs viral illness/rash.
100 Chickenpox Lesions, 8 days after vaccine. Exposed to Varicella 3.5 weeks prior to vaccine.
Information has been received from a health professional concerning a 15 year old female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported).  The patient's mother called and stated her daughter's menstrual period was delayed following vaccination.  Subsequently, the patient recovered from her menstrual period being delayed.  Additional information has been requested.
Itchy papular rash several hours after receiving PREVNAR-13 vaccination. Scattered mildly erythematous papules on the arms and upper chest.
Vaccinator was getting ready to administer vaccine needle inserted. mom let go of pt and pt pulled away.  no vaccines injected. Vaccinator switched arms. Full dose administered in other arm.
Information has been received from a pharmacist concerning a 71 year old male with high blood pressure and no drug reactions or allergies who on 09-OCT-2006 was vaccinated intramuscularly in the deltoid with a 0.5 ml dose of Pneumovax 23 (lot#651406/0620F). Concomitant therapy included COREG. That night at 2100 the patient experienced severe pain in the arm that kept him up all night. Unspecified medical attention was sought. The patient's physician told him to take ALEVE. No labs studies were performed. At the time of report the patient was "still sore but better". It was noted that the patient had not been vaccinated with Pneumovax 23 in over five years. No product quality complaint was involved. Additional information has been requested.
Got a large hard red raised rash on arm about an inch below the injection site, which started 36 hours after the injection. On the first day (4/19) it was about 2" X 2", then grew to cover a 4" X 6" area on the upper arm over the next two days. I called my insurance advice line and Nurse said to continue to take antihistamine and ice the arm. I had a routine annual Dr. appointment on 4/21 and she said to continue both. The hardness started going away on 4/22 and the redness faded to nothing by 4/24.
He was incontinent and slightly incoherent within the 2 days after receiving the vaccines.
Down for 3 days after 2nd dose; Could not  eat anything after 2nd dose; Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose). On 26-Mar-2021, DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose) had resolved.            No concomitant and treatment information were reported by the reporter
Pt received pfizer pediatric vaccine, undiluted, 0.3ml, when he should have received pfizer adult 0.3ml u
Pt was very tired after getting vaccine. Husband reported no fever. Pt slept most of day on 1/8/2020 1/9/2020 & 1/10/2020. On the evening of 1/10/2020 pt had 3 grand mal seizures. Pt also had a bad headache & nausea on 1/10/2020.
This is a spontaneous report from a contactable other healthcare professional. A 69 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 30Dec2020 09:45 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took levoquin. She is known allergic to levoquin. The patient experienced arm, neck, shoulder pain causing pain in extremity on 30Dec2020 09:45 with outcome of not recovered, she was given the covid vaccine in her upper bursa, nausea, muscle spasms, on 30Dec2020 09:45 with outcome of not recovered, can't sleep causing insomnia on 30Dec2020 09:45 with outcome of not recovered , headaches and bursitis on 30Dec2020 09:45 with outcome of not recovered. The patient underwent lab tests and procedures which included magnetic resonance imaging which showed communicated bursitis, sars-cov-2 test: negative on 31Dec2020, x-ray n/a on 31Dec2020..Therapeutic measures were taken as a result of this. No follow-up attempts are needed. No further information is expected.
Per mom, quarter size red spot on right leg.  Mom stated spot was warm and hard to touch.  Mom states no fever, child not favoring the leg. Per mom, child acting okay.
Really bad headache. She was fine when she was sleeping but when she was awake it was bad. Still has a small headache but not as bad as the first day.
Fever, Chills, 102 Temperature, Redness, Swelling, Severe Pain & Swelling at Injection Site approximate(ly 4"x 6" on left arm  Rash on arm, and neck, headache, nausea, loss of appetite, dizziness, body aches similar to Flu.  (Dr. Ordered Covid-19 test which came back Negative)
Started with hand numbness, then feet numbness then leg weakness and then arm numbness, hard time walking, standing up, frequent falls, hard time gripping things.
The pt broke out with an all over body rash that lasted through the following day. Two days later the pt vomited, complained of achy legs and a headache, but acting fairly normal.
2/04/21, 1:00 PM, chilled "to the bone", temp of 101 degrees, very tired, nauseous - at 3PM took Advil and got a little relief - fever broke early morning of 2/05/21, remained nauseous for two days and exhausted for two weeks with brain fog  Sore throat off and on, swollen glands off and on, occasional ear pain - this could be related to drainage, cause unknown  2/15/21 (about) sores began showing up - first two on the back of my left hand, then one on my left upper arm, today one on my right upper arm