chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week after I got the vaccine, I started feeling muscle pain in my left arm (the same arm where  got the vaccine), even though the initial muscle pain had gone away 2-3 days after I got the vaccine.  The pain seemed to be mostly around the muscle where the vaccine was injected, but sometimes spread to other nearby muscles as well. 24 hours after that, a red spot (that was hot to the touch) appeared at the bottom of the muscle, an inch or two below the actual vaccination site. The pain was mostly gone by then, but the red spot is still there. I don't know how serious this is or if/when it will go away.
Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in the armpit of the arm of the injection and in her collar bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were for high cholesterol medication.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant FU - Only contact information updated
PATIENT WAS VERY NERVOUS ABOUT NEEDLES AND TOOK SHOT OK BUT FAINTED SHORTLY AFTER..RESCUE SQUAD CAME AND CHECKED HIOM OUT AND RELEASED HIM AS BEING OK.
per patient reports facial swelling after meningitis b was given on 07/20/2017
pt recvd vax 13JUN95 & 15JUN95 tested hep B antigen positive;tested core E antibody neg;Hep B E antigen neg & anti-HBe neg;pt was not treated;3 repeat test of Hep B surface antigen was neg;
Tonic clonic seizure lasting 15 min about 45 min after immun. Labs, CT nl
2nd shot - approx 12hrs after shot given - white bumps L arm between elbow - wrist, intense itching stopped within hour. 3rd shot 12 later red rash, felt hot, intense itching lasted maximum 1 hour. Little red bumps.
About 4 days later, patient started complaining of ringing in the ears. Patient had some ringing right after vaccine, but it subsided shortly. Ringing reoccurred prominently several days after administration and hasn't improved since.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration was reported as 6-Aug-2021.
Vaccine at 4:30. Stomach hurting around 5:15. Around 5:30 began diarrhea. Vomiting for next 8 hours. Also diarrhea for 24 hours. We called the doctor on call. Before vaccine, she had complained in AM of lightheadedness, which we thought was due to lack of sleep from a sleepover. Also, we learned after her vaccine that my brother tested positive for COVID and she had slept over at his house and been with him Monday and Tuesday. So lots of possible causes, including a stomach virus that?s been going around our area. She also had a low grade fever 100.3 the morning after the shot and we started a Tylenol regimen every four hours once the vomiting ceased. By the 24 hour mark post vaccine, she was able to eat and drink without diarrhea.
13 y/o patient was to received pfizer booster dose but was given pedi pfizer dose by mistake.
Left arm injection site, itcy and tingling on down both arms, flushed throughout body, 140/80 BP, HR 71 and RR 18.  Headache later that night, with chills and fever for 2 days.   Took Tylenol.
Redness, swelling, warmth at injection site approx size of egg. Unconsolable high pitch crying lasting over 4 hours.
This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number FK43S, expiry date 30th June 2019) for prophylaxis. Concurrent medical conditions included penicillin allergy and latex allergy. On 30th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 30th November 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pruritus, injection site erythema, allergic reaction and injection site lump. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus and injection site erythema were not recovered/not resolved and the outcome of the allergic reaction and injection site lump were unknown. It was unknown if the reporter considered the pruritus, injection site erythema, allergic reaction and injection site lump to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The patient received FLULAVAL QUADRIVALENT 2018-2019 season shot and tried to find out the components to the vaccine as she had allergic reaction. The patient stated that, when the other nurse was giving the vaccine, it started to itch a little, and a few hours later the itching was more and enough to take a BENADRYL. The itching repeated again on Saturday, Sunday and at the time of reporting. The site had a knot, size of quarter and was red. At the time of reporting, the symptoms were ongoing. No further details were reported regarding the event. The reporter gave consent to follow up.
Pt C/O severe arm/shoulder pain to (L) shoulder and arm on 10/15/2016. Patient now attempted to wait pain out but continues to have pain and now swelling to (L) shoulder.
C/O NAUSEA AFTER VACCINATION. sKIN WARM AND DRY AND ALERT AND ORIENTATED. GIVEN APPLE JUICE AND ICE PACK. fATHER, WITH CLIENT AT TIME OF INCIDENT. SYNCOPE RESOLVED.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient age was reported as 62 years and 5 months. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.Patient got Moderna with vaccine Ndc code.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.    No treatment medication were provided.
9 days after being vaccinated, patient had a 102* fever. The next day his fever was 101* and he broke out in 1-2 dozen red, raised spots on his trunk. The third day, March 3, he had no fever and hundreds of red, raised pimply type spots all over his body. They appeared in waves through out the day. Day 4 is today and he woke up with dozens of new spots on his face, neck and scalp. He has spots over his entire body, including genitals, feet, limbs, and hands. He isn't in any discomfort or itching.
Information has been received from a nurse midwife for the Pregnancy Registry for GARDASIL concerning a 26 year old female with an allergy to morphine, who on 12-MAY-2008 was vaccinated intradermally with GARDASIL (lot# not reported) while pregnant.  There was no concomitant medication.  It was reported that the patient received GARDASIL when the patient was 7 weeks 3 days pregnant (LMP = 21-Mar-2008) and the estimated date of delivery was 27-Dec-2008.  The patient was to get a tuberculosis skin test and in error received GARDASIL intradermally.  No product confusion was discovered, but the nurse midwife was not sure how the error was made.  On 12-May-2008 after vaccination, the patient developed a local reaction at the injection site, described as itchy, raised and red 2 cm in diameter.  Unspecified medical attention was sought during an office visit.  At the time of this report, the patient's local reaction at the injection site, persisted.  No other information available.  Additional information has been requested.
One day post-vaccination of her 2nd Moderna vaccine she developed a large, hot to the touch, red circular  raised rash approximately 4 inches in diameter surrounding the vaccination site.
Menstrual cycle was longer than usual (39 days vs 26-28 days), the duration of menstruation was doubled and was heavy, experienced headaches and cramps for 4 days, experienced tightness in muscles especially in abdomen and legs for 3 days, both feet were noticably swollen for 2 days.  Normally no cramps and never have headaches.
passed unexpectedly; This is a spontaneous report from a contactable nurse communicated to a Pfizer colleague. This nurse reported similar death events for 8 patients. This report is for 8th of 8 patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient passed unexpectedly on an unspecified date. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case. The event death with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021034595 same  drug, reporter and event but different patient; Reported Cause(s) of Death: passed unexpectedly
9/7/06 Patient called to report adverse reaction to Td received on 09/05/06.  Noticed yesterday upon arising at 0530 site was itching and swelled and red.  Stated had a knot already but worse.  Applied over the counter BENADRYL cream to site and helped and took BENADRYL by mouth at bedtime the night before.
Pt experienced swelling, redness and streaks going under arm pit from injection site. Injection site was like a boil. Pts entire right shoulder was hot, swollen, and reddened. Body temperature was 101F for approximately two days. Pt also had feelings of fatigue and a cough. Follow up on 01/30/2001: "None of this information was given to me.  Was told at open that visiting service should have given me this information."
Four days after vaccine, had a stroke and was hospitalized.  All tests given were inconclusive as why this happened.
Shaky, burning eyes, nose running, stomach upset, normal temperature but felt hot. Achy joints (had same reaction with the High Dose last year).
pt recv vax; in eve, exp grand mal sz,lasted 20 sec; had total of 2 sz in 1 hr; fever>105;
COVID arm, redness spreading from injection site, hard lump where the redness and swelling is. Itchy also.
Patient was inadvertently given 0.3ml of undiluted pediatric bivalent pfizer booster rather than adult booster. No adverse events reported. Patient was advised to monitor side effects and report any issues.
Felt weak/ Felt weak in the legs; Felt sick; Felt cold; Sick to my stomach; Left arm hurt up to the shoulder and down to my elbow; Could hardly sleep; Very bad headache/ Head hurt; Felt like I had a fever; Tiredness; Ached everywhere; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach) and PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030A21A and 025P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN (Ached everywhere). On an unknown date, the patient experienced ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), INSOMNIA (Could hardly sleep), HEADACHE (Very bad headache/ Head hurt), PYREXIA (Felt like I had a fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak/ Felt weak in the legs) had not resolved, ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), PAIN (Ached everywhere), HEADACHE (Very bad headache/ Head hurt) and PYREXIA (Felt like I had a fever) was resolving and INSOMNIA (Could hardly sleep) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication included blood pressure medication.  05-Nov-2021 at night, patient ached everywhere. Patient had a very bad headache, felt weak and sick. Patient also mentioned feeling cold, sick to stomach, like had a fever and head hurt. Patient's left arm hurt up to the shoulder and down the arm to the elbow. Patient could hardly get any sleep. Now, patient feels better but weak in the legs. Patient also feels tiredness which attributes it to not being able to sleep well.   This case was linked to MOD-2021-377971, MOD-2021-377972 (Patient Link).
Swelling and rash of left arm. Pt states four other team members with same lot number developed similar issues in the same time frame
Information has been received from a 72 year old female consumer with no reported medical history or allergies who on 15 Dec 2006 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included alendronate sodium and an unspecified thyroid replacement. Twenty four hours after vaccination, the patient developed hugh swelling in the lower half of her upper arm, which was firm, red and hot. As of 19 Dec 2006 she had a redness at the injection site which was 2 inches in diameter and had some swelling. Medical attention was not sought and the patient was recovering. There was no product quality complaint involved. No further information is available.
The patient developed a sore arm near the injection site after receiving the vaccine.; A patient received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 09-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular route (strength, frequency, and anatomical location were unknown) with lot # R018741 and expiration date 06-APR-2020 for vaccination. Additionally, after receiving the vaccine, the patient developed a sore arm near the injection site (pain in extremity). No treatment was given to the patient due to the event because she did not seek for medical attention.  At the time of the report, the outcome of pain in extremity was unknown. The reporter did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R018741; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
swollen tongue; swollen tongue and lips; worsened; rash; This is a spontaneous report from a contactable consumer (patient) via pharmacist. This adult female patient (age late 50) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 15 mins after the 1st dose Pfizer Covid vaccine, the patient had runny ones swollen tongue and lips. Benedryl was administered, symptoms improved then worsened. Transport was called to hospital epi administered. RX steroids at the time of reporting was day 9 post vacc administration, the patient was still on steroids and continued rash. The patient described blood dripping from arm post stick. The patient wonder if administration was not IM.  Event took place after use of product. Outcome of the events was unknown.   Information about batch/lot number has been requested.
within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; blood pressure: 178/90; within 8-10 minutes of shot, i began to sweat under my arms, my chest and back and head began to itch; This is a spontaneous report from a contactable other health professional (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 73-years-old, administered in Arm Left on 25Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included one kidney, left was removed due to cancer, no residual cancer, allergic to juniper. The patient was not pregnant. Concomitant medication included ezetimibe (ZETIA), escitalopram oxalate (LEXAPRO), pravastatin (PRAVASTATIN), and probiotics; all taken for an unspecified indication, start and stop date were not reported. Patient reported that, "Within 8-10 minutes of shot, I began to sweat under my arms, my chest and back and head began to itch. EMT took my blood pressure: 178/90, oxygen level was good. They called the EMT Ambulance, and transported me to the medical center > they treated me with IV Benadryl and steroids and I went home within two hours, with no further issues." The events started on 25Jan2021 12:00 PM. The adverse events resulted in Emergency room/department or urgent care, Hospitalization (0 days). The patient received IV Benadryl, steroids and prescription for Medrol for events. The patient underwent lab tests and procedures which included blood pressure measurement: 178/90 on 25Jan2021, oxygen saturation: good on 25Jan2021. The patient recovered on 25Jan2021 14:00. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility type vaccine was Health Clinic/Facility. At the advice of her allergist she declined to get the 2nd dose of the Pfizer vaccine. Her questions is should she take a the J&J vaccine and wanted to know if Pfizer could give guidance on the matter.  Information about lot/batch number has been requested.; Sender's Comments: Based temporal association, the reported events in relation to suspected drug BNT 162b2 cannot be totally excluded.  Case will be reassessed pending new information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
The day after the vaccine administration (1/18/14) pt suffered very low blood pressure and sugar levels. Pt is diabetic and had to took off his insulin bomb. Pt was suffering from fatigue 1/22/14 and could not breathe. Pt was hospitalized and Dx with pneumonia and a big infection in blood.