chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness; severe swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site). At the time of the report, TENDERNESS (tenderness) and VACCINATION SITE SWELLING (severe swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.    Reporter did not allow further contact
This is the 2nd of two SHINGRIX shots. Both this and the first were incredibly painful for nearly a week. I was unable to use my arm and had to wear it in a sling. It completely disrupted my life for most of that week until I could start to drive again. On a scale of 1-10, the pain was not bad while not moving the arm, but with use it was an 8 each time. It felt like I had a broken arm. Anytime I used the muscle the injection was in, or muscles that radiated from it (like rolling over in bed), it was horribly painful. I have HAD shingles in the past and was blinded in one eye from it, but I will never get this shot series again when it is due again in 9 years, I will take my chances. The pharmacists said it would not be very painful, they'd had no reports of that, and after that first one dreaded the fact I would need another. In general this shot is described as a "sore arm", or "mild soreness". While I had no malaise at all, the pain was awful, awful, awful.
pt states felt fine p/vax until 12NOV93 sudden onset h/a, eyes hurt, couldn't move neck, on 13NOV93 went to hosp, adm; dx viral meningitis; discharged 23NOV93; not yet back to work by report 29NOV93;
Tightness in the chest, dry cough, runny nose, aches, chills, eyes red and oozing, severe headache, sore throat started within two hours of having the shot.  Patient otherwise healthy with no problems prior to the shot.  Feel slightly better the next morning, but unable to go to work and still not well.  No treatment at this time.
(This is my second dose of SHINGRIX; I had a very similar adverse reaction to the first dose on 4/17/18. Initial reaction was not reported.) There was no reaction for 10 hours until I went to bed. Approximately 10-12 hours after the injection, I woke up with flu-like symptoms, which increased in severity over the next 12 hours and then dissipated. The symptoms included: chills and shivering, mild fever, very severe muscle aches throughout my body, headaches, mild nausea. Soreness in the arm at the site of the injection was present (although not in the first 10 hours), but was the least concerning reaction of the above. I did not go to work, stayed in bed most of the day, sleeping, sipping water, ate toast, took 2 ibuprofen. By late afternoon -- 24 hours after the injection -- I was feeling few severe symptoms, but was very fatigued. By evening the most of the symptoms subsided.
A patient of 10 years old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number JP55J5, expiry date 13th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The other health professional reported that, the patient received dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if this dose was valid or if needs to re done it. The reporter consented to follow up. This case was linked with case US2021160429, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160429:Same reporter.
packed a punch for me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The 2nd shot of shingles packed a punch for the patient. The patient stated that beat getting shingles though. The patient was asked if the covid antivaxers shun and shingles too.
Patient presented to the ED on 8/16 complaining of shortness of breath, fatigue, fever. Tested positive for COVID 6 days prior. Admitted for COVID pneumonia.
Heart attack (blood clot in major artery) approximately 6 weeks post 2nd Moderna dose.  Surgery done in cath lab to address blockage. Released from hospital several days later.
Vomiting, fever of 104.9, migraine, chills, body aches
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included osteoporosis. Concomitant products included PROLIA. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient planned to follow up with her physician on an unknown date. The reporter did not consented to follow up. Limited information was provided. The patient wanted to remain anonymous, and did not want to answer any further questions.
98 year old female presented to ER on 12/6/21 with complaints of worsening cough and lower extremity edema, tested positive for COVID-19 requiring 4 L of nasal cannula, vital signs blood pressure 145/71 heart rate 73 saturating at 94% on 4 L nasal canula. Lactic acid, CMP, CBC unremarkable.  BMP 947, troponin negative, CXR- Worsening bibasilar opacification, right greater than left. Worsening bilateral pleural effusions, right greater than left. CT chest-  Moderate right pleural effusion.  There is a small to moderate left pleural effusion. Subtle patchy ground-glass opacities in the bilateral upper lobes.  These findings are nonspecific.  Primary differential consideration includes alveolar pulmonary edema or changes from a COVID infection given patient's recent diagnosis   patient is admitted for acute respiratory failure with hypoxia likely due to COVID-19 pneumonia and CHF exacerbation, Given Lasix in the emergency. started Decadron, rocephin and azithromycin and Remdesivir.  speech therapy evaluated patient. thoracocentesis was performed by IR and removed 1.2 L from Rt pleural space.   Patient heart rate was running around 140-160 even with Cardizem and metoprolol order, cardiology is consulted but HR become controlled after thoracocentesis.   Patient was doing okay on the morning of 12/9/21 except some cough. But afternoon around 2:00 p.m., rapid response was called because patient was lethargic,vital sign showed bradycardia, hypotension 82/40 along with hypoxia required Non- rebreather mask.  chest x-ray- Increased volume left greater than right pleural effusions. Increased opacification diffusely may represent layering effusions with worsening atelectatic change.  Superimposed pneumonia not excluded. Patient began more alert and discussed with her about future goal of care and she would like to get comfort care management instead of aggressive IV antibiotics and antiviral medications.  Talked to patient's POA and update about patient current condition  And they agree with the plan. Patient is discharged with comfort care measure.
negative serological antibody test results after having the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (negative serological antibody test results after having the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (negative serological antibody test results after having the vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (negative serological antibody test results after having the vaccine) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-066059, MOD-2021-066059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received and contain no new information
Patient has had a lump at the injection site since the injection. It has not gotten smaller in the past 18 months. It is very itchy and has caused disturbance of sleep. It is so itchy that the first summer after patient could not wear shorts. The skin is now showing signs of the constant irritation from the scratching and grabbing at the lump.  Often it has a small scab.
Received Pneumovax Vaccine 11/22/2013 in the afternoon at Personnel Health. In the evening developed hives to left upper arm. Chills and pain to the left arm. Reported to Personnel Health on 11/25/2013. Took diphenhydramine 25 mg.
My mom had a adverse reaction and died; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My mom had a adverse reaction and died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Open-ended question: Please describe below all you remember about the Pfizer-BioNTech/Comirnaty advertisement you saw. Please include what you saw, what was said about Pfizer-BioNTech/Comirnaty, and what ideas about Pfizer-BioNTech/Comirnaty were brought out in the advertisement. That it is preferred by over one hundred people. I don't agree with this vaccination. My mom had a adverse reaction and died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My mom had a adverse reaction and died
DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter reported that, "My mother died from vaccine injuries." Cause of death was unknown and it was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:  20211127835-Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) 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(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccinated with vaccines that were in the fridge for 33 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
It first started with an eye droop and within 24 hours the whole right side of my face was drooping. I went to the doctors office and was diagnosed with Bell's Palsy. They gave me prednisone and valacyclovir. I took that for one-two weeks and I went for a follow up appt, 04/09/2021, and I still had a bit of an eye droop, but that has resolved now. I am a little worried that the prednisone will take away some of the effect of the vaccine.
15 MINUTES AFTER VACCINATION PNT FELT CLAMY/SWEATY AND NAUSEOUS. PNT FELT LIKE HE WAS GOING TO FAINT TO HE LAID DOWN ON FLOOR. PATIENT DID NOT FAINT . BLOOD PRESSURE WAS MONITORED AND RANGED FROM 80/60 TO 90/60. 911 WAS CALLED TO CONTINUE MONITORING HIM
Severe dry mouth resulting in the following: I have difficulty swallowing food. My tongue is on fire. I have difficulty speaking. I have a sore throat resulting from a dry throat.
sore arm after both doses of his Pfizer COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm after both doses of his Pfizer COVID". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT CALLED ON 10/12/23 TO REPORT A REACTION TO THE FLUZONE HD VACCINE THAT SHE RECIEVED ON 10/10/23. REACTION STARTED ON 10/11/23 - INJECTION SITE RASH AND AREA IS WARM TO TOUCH.
Saw heart was 89 bpm on  june 4. On june 11 heart was seen on u/s to have stopped.  Still waiting on miscarriage to happen naturally and it has not.
day 1- Red, warm, itchy rash with puss-filled blisters. On second day the blister subsided and flattened but rash spread
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M022407 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA005844: US-009507513-1708USA005843.
1 DAY AFTER VAX PT COMPLAINED HE FELT SORE WITH MYALGIAS. WHEN SEEN BY DR, PT HAD SOME SORENESS OF THE R. DELTOID AREA WITH SLIGHT INDURATION.
SORE ARM, HOT TO TOUCH AREA SURROUNDING INJECTION SITE, DIZZINESS, FATIGUE, BODY ACHES, HEADACHE, NAUSEA, JAW PAIN, METALLIC TASTE
The pt experienced left deltoid excoriation's, red wheals, swollen palpable mass, and nightmares.
Large plaque of erythematous rash at the injection site (right deltoid) associated with swelling in the digits of both hands, minimum pain, pruritus.
Lymph nodes swelling and have like 6 tumors; concerned getting Booster dose because don't want agitating lymphatic system and Irritation/she got lymph nodes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non HCP (Patient) reported that A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation; Solution for Injection), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lymphoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date (Batch/Lot Number: EL3302) for COVID-19 immunisation. It was reported that the "Patient called after her second dose of the Pfizer Vaccine (Covid-19 Vaccine) she got lymph nodes like lymph nodes are swelling and she was little bit concerned about getting her booster dose (Covid-19 Vaccine) because she already had lymphoma. She didn't want agitating her lymphatic system, so she just wanted to report this as well and just wanted the information about her lymphatic system and patient wanted to know if it same or expected irritation, lymph nodes have like 6 tumors, patient was trying to reduce lymph nodes swelling because she didnt want anything happened with her Lymphatic system.". The outcome of events reported as unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 (Lot number: FF2589) at the age of 25 years as dose 2, single and intramuscular, administered in arm left, administration date 02Sep2021 (Lot number: FF2588) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE;- FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 05Sep2021, outcome "not recovered", described as "After first vaccine received on 02Sep menstrual cycle was supposed to start on 05Sep. Started on 17Sep. After second dose received on 24Sep menstrual cycle was supposed to start on 27Oct". Therapeutic measures were not taken as a result of menstruation delayed. Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. After first vaccine received on 02Sep menstrual cycle was supposed to start on 05Sep. Started on 17Sep. After second dose received on 24Sep menstrual cycle was supposed to start on 27Oct. No Covid prior vaccination. No Covid tested post vaccination. Allergies: Unknown. No follow-up attempts are possible. No further information is expected.
Lower extremity erythema bilateral directly after shots.  Mottled skin on upper extremity and lower extremity after shots.
PATIENT IMMEDIATELY TURNED "LOBSTER RED" THEN VERY PALE WHITE FROM HER NECK  UP.  SHE STATED SHE FELT LIGHT-HEADED AND HAD TO LAY DOWN ON THE FLOOR.  SHE ALSO HAD A VERY FAST HEARTBEAT.  LASTED ABOUT 5-10 MINUTES TOTAL.
severe Migraine, minor Fatigue, minor Muscle aches symptoms onset around 08:00 pm, 05/06/2021, most severe overnight, and continues into the afternoon the following day. Symptoms slowly lessened in the evening the following day and recovered around 08:00 pm, 05/07/2021.
Left thigh with 11cm X 8cm area of erythema, edema and warmth. Temperature of 100F (R).
Dramatic arm swelling. At two weeks swelling gone but still has 25x25 mm herpetiform healing wound.
Can't stay awake and she is falling asleep; keeps forgetting things; She literally can't work, can't stay awake and she is falling asleep.; Passed out; Memory loss; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in right arm on 09Jun2021at 15:00 (age at vaccination was 31 years) as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization and no reaction on previous exposure to first vaccine. It was reported that patient was calling about the covid vaccine. She talked to someone earlier and is trying to figure out the next steps. She was having side effects. On 10Jun2021 at 10:00am, patient was literally could not work, could not stay awake and she was falling asleep then on an unspecified date in Jun2021 the patient experienced memory loss and was passed out in her car and visited the ER and she choose to go home, later she could not stay awake and on 10Jun2021 at 10:00am, she kept forgetting things and scheduled to visit a neurologist. Patient stated that she has never had this before, until last Thursday. Patient had blood test she clarified that it was inconclusive. Patient was taking covid vaccine because of her job she works with kids. Patient stated reason for no lot number of covid vaccine was other. Patient initially stated she has her vaccination card but not with her and then stated she does not know where she put them. The outcome of the events passed out, memory loss was unknown and outcome of the other events was not recovered.  Information about batch/lot number has been requested.
Fever highest at 102.9, chills, nausea, headache, body aches, extreme fatigue, loss of appetite. All have lasted through 5/7 with headache and fatigue persisting until 5/8