chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body ache; Urinary tract infection; Chills; Tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache) in a 38-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache). At the time of the report, PAIN (body ache), URINARY TRACT INFECTION (Urinary tract infection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-May-2021,TCR Added
Patient received PNEUMOVAX-23 vaccine (Lot #L017265) SC in the left arm on 10/6. Patient also received influenza high-dose vaccine on 10/6, however, this was injected IM in the right arm. Injection site on left arm is tender, red and warm to the touch.
KNEE PAIN; NUMBNESS; TINGLING; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced knee pain, numbness, and tingling. Treatment medications (dates unspecified) included: diclofenac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling, and the outcome of knee pain and numbness was not reported. This report was non-serious.
This patient received a vaccine that was stored at an incorrect temperature. Upon recognition of the incorrect temperature, the pharmacy contacted the manufacturer to receive further guidance.  It was determined that the vaccine was in fact viable within the parameters it was stored and administered.  Patient reported no adverse events.
Ventral hernia with obstruction - mass was identified and gynecology was consulted intraoperatively.  Mass was excised.  On the night of surgery patient insisted on leaving AGAINST MEDICAL ADVICE. Presented at ED several days later with post-op concerns - treated and released. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
I had normal seasonal allergy congestion on Sat and Sun... took Claritin D for them (as usual) after I had the shot on Sat. Sat night couldn't sleep, then Sunday morning awoke with really bad congestion and a rash all over my chest, back, face & arms... and slept all day/night (~22 hours).
with no energy; was just tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was just tired) and ASTHENIA (with no energy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A; and 071A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Depression.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (was just tired) and ASTHENIA (with no energy). At the time of the report, FATIGUE (was just tired) and ASTHENIA (with no energy) outcome was unknown.            Concomitant medications included unspecified antidepressant and blood pressure medication.  No treatment information was reported.   This case was linked to MOD-2021-047855 (Patient Link).
Information has been received from a literature article title as stated above concerning a 14 year old female patient developed uveitis, following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476 days); time to onset was unknown in 1 case; the time to onset in this case was of 56 days from vaccination. There was one reported rechallenge of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of apailledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
No adverse event. Patient received an expired dose of MMR. Given 11/1/17 when exp date +10/22/17.
Fever began Thursday but was gone in a couple of days. On Saturday vomiting and diarrhea began; the vomiting lasted for a couple of days. Pt still has diarrhea (explosive one) so gets covered from head to toe. His diarrhea is getting better.
pt recv vax 19APR96 & 5JUN96 pt devel red bumps which were verified during a MD visit to be chickenpox;pt subsequently recovered;
p/vax pt started running fever up to as high as 104;pt sibling had been feverish 2 days prior to getting inj but self wasn't ill;MD said it was a virus;
This spontaneous report as received from a pharmacist refers to a 45 year old female patient. On 20-JAN-2014 the patient's husband was vaccinated with a dose of ZOSTAVAX, (lot # reported as J011337, Exp date 13-DEC-2014), subcutaneously (dose unspecified). The healthy patient was diagnosed with the shingles only a few days after (estimated as January 2014) her husband received the ZOSTAVAX. The patient began to experience a rash and discomfort, went to her primary care physician who diagnosed her with shingles. Patient was currently being treated with valacyclovir, gabapentin and acetaminophen, VICODIN for pain. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 17JUL98 & 18JUL98 pt devel hives, wheezing & congestion of the rt lung;seen in ER;parents were instructed to give DPH @ home;
Initial misuse report received from a healthcare professional on 24 JAN 2014. The case was received on 21 March 2014. This is an invalid case as individual patient identifiers are not reported. The patient inadvertently received a dose of YF VAX intramuscularly on an unspecified date. No adverse event was reported. List of documents held by sender: none.
mom reports egg-sized lump appeared on rt thigh on 8MAR97 (11 days p/vax);seen by MD who according to the mom dx hematoma & prescribed warm packs & APAP PCN during week of 22MAR-26MAR, mom reports lump caused inc distress, redness;dx absces
Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 09-AUG-2013, was vaccinated with a dose of GARDASIL (lot # H020002, exp: 08-AUG-2015) 0.5 ml, intramuscularly, which was improperly stored. The nurse reported that GARDASIL was exposed to a temperature of 62F for 360 hours from 06-AUG-2013 to 20-AUG-2013. The nurse did not have patient or physician details available at the time of call. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02762DA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided. Patient reported that he received second dose of mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Event outcome updated to recovered/resolved.
This spontaneous report was received from a pharmacist via a company representative, regarding a to a female patient of unknown age (over the age of 65). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, which had a lot # N022303 with an expiry date on 01-MAR-2018, (dose, frequency, anatomical location of administration were not provided) for prophylaxis. On an unspecified date after vaccination the patient experienced an injection site reaction" that consisted of "redness, swelling, and warmth to touch. She received BENADRYL as a treatment and fully recovered in about a day. The causal relationship between vaccination with PNEUMOVAX 23 and the events was not mentioned. This is one of two reports received from the same source. Sender's Comments: US-009507513-1711USA000350.
Started complaining of arm pain by 4 pm. Swelling by 6pm. On the 23rd when he came home from school his arm was red, hot, hard, swollen, painful. This morning it remains with the same symptoms and appears more swollen.
Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site.  By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested.  The sharp pain interfered with sleep and regular life activities.  On Tuesday morning I applied an ice pack, which relieved the pain.  After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter
The shot was administered about 2:00pm.  I was feeling fine, around 4:00pm I started coughing, throat began to tighten & become sore.  Began to have a weakening in the chest.  I took a tylenol & laid down.  After about 15-30 min I woke up & my lower lip, & around my chin were swollen.  My left arm (where the shot was given was really sore).  I began to feel weak all over.  My eyes became runny & very red, the numbness in my lower lip began to spread to my upper lip & I could feel tingling moving up my face.  I went to the Urgent Care & when the doctor felt around the top of my neck just below my bottom lip was tender.  My nose was runny, & I was coughing up some.  I threw up 3 times & was very nauseous.  I don't know if that was due to the shot the doctor gave me--I didn't become nauseous until after the shot.
Case received from another manufacturer (Merck) through Sanofi's affiliate on 24-Jan-2014. A patient (no details provided), with no reported personal and family medical history and no reported concomitant therapies, had received a dose of MENACTRA (batch number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced Guillain-Barre Syndrome. No further information was provided.
Tingling in arm, arm sore to touch, dry mouth, nauseous, headache
Patient was administered the vaccine. After administration we stood talking to his mother who had questions. After about 2 minutes they turned to walk away and he lost consciousness and hit his head on a counter. I unfortunately did not witness him falling. He regained consciousness almost immediately and I told him he needed to stay laying down for a few minutes first. After a few minutes he said he felt fine and we moved him to a chair. Within a few minutes, he became ill again so we had him lay down again in the consultation room. He then laid there for about 15 minutes before we moved him to a chair. He stated that before he lost consciousness his heart was racing. His mother states he's never had any problems with vaccinations in the past. After sitting for the second time he said he felt fine except where he hit his head which was a little sore. We contacted the father later that night and he said that he too had a similar episode with a needle stick a few years prior. The patient felt better later night per his father.
I felt sick, fever and headache; I felt sick, fever and headache; I felt sick, fever and headache; I got the booster on the left hand side; on that side, I have a giant like almost softball lump under my armpit like little below my armpit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2022 (Lot number: LOA615930) at the age of 49 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Aortic stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Immunization. The following information was reported: ILLNESS (non-serious), PYREXIA (non-serious), HEADACHE (non-serious) all with onset 10Mar2022, outcome "recovered" (12Mar2022) and all described as "I felt sick, fever and headache"; SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "I got the booster on the left hand side; on that side, I have a giant like almost softball lump under my armpit like little below my armpit.". Therapeutic measures were taken as a result of illness, pyrexia, headache, swelling.  Additional information: Patient received  booster on 09 Mar22 (clarified as 09Mar2022) around 6pm and then the next day he felt sick, fever and headache and then today it went away but he noticed under armpit on the site of, he got the booster on the left hand side, on that side have a giant like almost softball lump under armpit like little below armpit." Therapeutic measures was taken extra strength Acetaminophen. It was like a pain reliever 500mg. He was taking like 2 every 4 hours, 3 times. He took it just 3 time, like one in the day time, one in the night and slept 12 hours and then took 1 more time."
Patient developed an infection 7 days post-injection. Patient experienced arm redness/swelling/pain and fever of 100f.  Patient also had chest pain.
Fever; injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not applicable. A pharmacist reported that over the years, some patients experienced injection site soreness and a fever in the few days immediately after the immunization with Shingrix. The reporter did not consent to follow-up.
Pt recvd 11MAR93 & 19MAR93 devel blotchy, spotty erythematous rash; 20MAR93 exp stiffness & pain in neck; 21MAR93 awoke w/pain through all of joints, excluding hips; devel joint swelling; tingling from elbows to fingertips; diff walking;
Only adjuvant administered; patient received only Arexvy adjuvant today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: patient received only Arexvy adjuvant today). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 30-OCT-2023 The pharmacist called stating patient received only Arexvy adjuvant today (on the day of reporting), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
PT RECEIVED FIRST DOSE OF MODERNA VACCINE.  AFTER  10 MINUTES POST-OBSERVATION AREA, SHE STARTED TO COMPLAIN OF DIZZINESS. WE PROVIDED ICEPACKS AND HAVE HER LIE ON HER BACK FOR ANOTHER 15 MINUTES.  PT STATED THAT SHE HAD NOT GOTTEN ANY THING TO EAT SINCE THE MORNING AND IT MAYBE B/C OF HER LOW BS.  HER BP WAS STABLE 125/85.   THEN PT WAS ABLE TO WALK TO THE CAR WITH HER BOY FRIEND 'S ASSISTANCE.  SHE WILL CALL US IF THERE IS ANY WORSENING S/SX.
80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup.  WBC  16.91 4/27/2021
Hard swollen arm with extreme pain, tenderness, itching and irritation. Followed by extremes shortness of breath with rest, heart palpitations and mild intermittent chest pain.
Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 19-Nov-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. 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 VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)). At the time of the report, VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.
02Nov reaction ER day visit 14Nov reaction cephalaxen anafalaxin hospitalization for 3 days; other vaccine same date product=Senior dose flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:00 as dose 1 (bivalent), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation.  The patient's relevant medical history included: "All Penicillin" (unspecified if ongoing); "apples" (unspecified if ongoing); "stone fruits" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; LEVOTHYROXIN; SERTRALINE; ATENOLOL. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 01Nov2022, outcome "unknown", described as "other vaccine same date product=Senior dose flu vaccine"; ANAPHYLACTIC REACTION (hospitalization, life threatening) with onset 14Nov2022 at 12:00, outcome "recovering", described as "02Nov reaction ER day visit 14Nov reaction cephalaxen anafalaxin hospitalization for 3 days". The patient was hospitalized for anaphylactic reaction (hospitalization duration: 3 day(s)). The event "02nov reaction er day visit 14nov reaction cephalaxen anafalaxin hospitalization for 3 days" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction. Additional information: Vaccine administered at pharmacy or drug store. No other vaccine in four weeks. No other medical history. Treatment received for the event anaphylaxis: Benadryl, Pepcid, prednisone, epi -3. No covid prior vaccination. Covid had not tested post vaccination. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.