chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red hot hard lump on the right of the injection site/hot/still warm to the touch; Red hot hard lump on the right of the injection site; Red hot hard lump on the right of the injection site/hardness; Red hot hard lump on the right of the injection site/redness/still red; Soreness in the arm of the injection/her arm was more sore than before; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness), VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, FOLIC ACID and VITAMINS NOS for an unknown indication.    On 02-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before). On 03-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch), VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red). At the time of the report, VACCINATION SITE WARMTH (Red hot hard lump on the right of the injection site/hot/still warm to the touch) and VACCINATION SITE ERYTHEMA (Red hot hard lump on the right of the injection site/redness/still red) had not resolved and VACCINATION SITE MASS (Red hot hard lump on the right of the injection site), VACCINATION SITE INDURATION (Red hot hard lump on the right of the injection site/hardness) and VACCINATION SITE PAIN (Soreness in the arm of the injection/her arm was more sore than before) was resolving.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up was received and contains significant information; suspect product details, concomitant details, additional events were added.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided.  On 30-AUG-2017, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # N003536 with expiration date on 02-NOV-2019 (dose and route of administration were not reported).  Since 21-JUN-2017, the administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent multiple temperature excursions between 32 degrees Fahrenheit and 49 degrees Fahrenheit, which lasted for 16 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved.  This is one of several reports received from the same reporter.
Serum sickness; onset with rash 1/25/2012 but she was also prescribed Amoxicillin, starting 1/18. She had previously taken Amox without incident; also placed on TMP/SMX on 1/25/2012; serum sickness dx 1/30/2012.
15 year old was given a dose of JJ COVID vaccine. No adverse event occurred, but wrong medication was administered.
syringe broke just below the luer lock hub; HCP reported that broken glass lacerated her thumb.; HCP reported that broken glass lacerated her thumb.; This spontaneous report was received from a registered nurse and refers to a non pregnant female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 14-JUL-2023, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 milliliter, lot number W039033, expiration date reported as 10-OCT-2024 but upon internal validation was established as 01-OCT-2024 (dose, route and anatomical location were not reported) for prophylaxis.  On the same date, while attaching needle to syringe, syringe broke just below the luer lock hub (Syringe issue). The reporter stated that the broken glass lacerated her thumb (Skin laceration, injury associated with device). The patient sought medical attention, the laceration was irrigated and bandaged by the health care professional.  At the time of the report, the patient was recovering from the skin laceration.  The relatedness between the event of skin laceration and therapy with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) was not reported.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patinet inidcated feeling a little light headed/dizzy, helped patient lay down and proved OJ, no allergic reaction was observed or reported by patient, per patient has history of feeling dizzy post vaccination, after OJ patient was oberseved for 30min and was without any symptoms or complicatoins, patient said he felt back to normal after OJ.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unspecified dates approximately in 2015, patients may have received doses of ROTATEQ lot # K010224, expiration date: 13-MAY-2016; lot # K011947, expiration date: 07-JUN-2016, lot # K009752, expiration date: 15-APR-2016 and lot # K020193, expiration date: 02-JUN-2015 (dose and route of administration were not reported) which were improperly stored at 12.9 Celsius degree for 90 hours on unspecified dates during the time frame of April 2015 to May 2015. There was no known adverse effects. This is one of several reports received from the same reporter. Lot numbers K009752 and K020183 have been verified to be valid lot numbers for ROTATEQ. Additional information has been requested.
Side effect after he got the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect after he got the dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect after he got the dose). At the time of the report, VACCINATION COMPLICATION (Side effect after he got the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
Temp of 100.6 deg. F. Febrile reaction lasting 3-4 days following headaches, chills, nausea, vomiting and myalgia.
Within one hour of first vaccination tinnitus started. No prior problems with ear ringing. Second Moderna vaccination administered exactly four weeks later (3/04/21) again within an hour, notably  ramped up the tinnitus.  Developed, congestion, headaches  (and fever) after both shots, but those passed. Still have the tinnitus, seems worse and more constant than ever.
Weakness, blurry vision, achy bones, tiredness, hard to breathe, weakness in muscles, brain fog,
It started after the first one and got worse after the second one. I had two separate issues happen. I got a bacterial infection from a bad injection from the needle (1st one) which is causing me a lot of arm pain). I also according the infection disease specialist after I was hospitalized told me I had an allergic reaction to something in the vaccine. Firstly after the first vaccine, I started getting shooting pains up the side of my face my my ears (nerve pain), It would come and go. Then a week after my first injection my shoulder swelled up like a rock hard balloon,  It was very painful and I couldn't raise my arm and the inside of my bicep was also painful and had a very large and swollen lump. My shoulder and arm also went red (was not itchy). With large white spots and a big dark red circle (which a year later is still there and very visible). I have a smaller red circle on my right arm (from the second vaccine). Then over the next few weeks I just didn't feel well, weird bubbling under my ribs, dizzy a lot, weird pains and sensations in my head, my heart was beating very fast and punching through my chest then I was resting, like it was trying to keep me alive. I also had a weird burning sensation in my scalp. The nerve shooting in my ears was also getting worse. This would happen sporadically and was very scary. The day of my second vaccine I called VAERS (no one answered), the CDC, my doctor, and the pharmacist and asked everyone if I should get the vaccine as my body doesn't feel right. They all said yes it's safe. I got the second vaccine against my better judgement (in my other arm). Almost immediately within 24 hours, my neck was inflamed and felt like it was on fire. My ears got full and I couldn't hear properly. A week after the vaccine my left arm started hurting really badly (not the arm I got the 2nd vaccine in, the first arm), my whole arm from shoulder to almost my elbow went red, the large bump came back worse and my heart was beating strangely. Online Dr. told me to go to urgent care. I went to urgent care and they admitted me to the hospital for 3 days and pumped me full of antibiotics. They threw around the word sepsis/suspected sepsis but I didn't have the symptoms, but my blood work was coming back with an infection and they were confused. I had a doctor and an infectious disease specialist. They said I had both cellulitis from the bacterial infection and had an allergic reaction to something in the vaccine, and was told I could NOT get the booster. The vaccine caused sporadic hearing loss, tinnitus, heart issues, dizziness, a lot of inflammation, weird brain whooshing feeling, and pain amongst many other symptoms. I had crazy inflammation in my neck/face for almost 8 months. A year later, I have permanent ear issues, my hearing drops out sometimes, I have tinnitus, permanent large red spots on both arms and a ton of PTSD.
On 10/1/01 at 16:00, pt had a fever of 105F. He was admitted to the hospital. Pt was treated with IV antibiotics for 2 days. Dx'd with viral syndrome.
METALLIC TASTE; COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: iron deficiency, and lower back pain, and concurrent conditions included: codeine allergy. The patient was not pregnant at the time of the report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 on left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. Concomitant medications included omeprazole (from 01-APR-2016) and zolpidem tartrate (Ambien, from JAN-2006) for unknown indication. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine, Spikevax) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 on left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. On an unspecified date in 2022, the patient experienced metallic taste (which lasted 5 days), and covid-19 (fatigue, headache, diarrhea and night sweats) (Dose number in series 2). The patient received non-company suspect drug Nirmatrelvir/ritonavir (Paxlovid) (form of admin, route of admin were not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, administered from 22-AUG-2022 to 27-AUG-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with paxlovid treatment withdrawn on 27-AUG-2022. The patient recovered from metallic taste, and covid-19, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
test positive for COVID19 5/1/2021 and had symptoms, chills, sweats, body aches, cough, headache, brain fog, congestion
given into the shoulder joint of the right arm; can hardly use his right arm.; arm / hurts bad (at the injection site area); This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included parkinson's disease and dementia.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   The reporter considered the injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the dose of Shingrix in right arm and less than 2 weeks after the vaccination the patient's right arm still hurt bad (at the injection site area) and he could hardly use his right arm. The reporter asked if the injection was given intramuscularly in the deltoid muscle,located below the shoulder and he stated that he thinks it was given into the shoulder joint of the right arm,which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:41 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 78.80.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 27-Oct-2021, At excursion time 09:00 AM, temperature was 29, at 10AM temperature was 32, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccines were moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were moved to clinic 29-Sep-2021 and 05-Oct-2021 respectively. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ oral, lot # J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stores as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
3/6 at 8 AM collapsed to the floor with generalized weakness, headache (5/10), severe nausea with dry heaves, copious sweating & minor nosebleed. No loss of consciousness. Was able to get to sofa about 8:30 AM and vomited scant amount of whitish fluid. Temp at 5:30 PM 98.1. Slept all day and all night. On 3/7 felt fine and resumed all normal activities. On 3/8 felt extremely fatigued from awakening at 7:30 AM until 11:00 AM. Fatigue resolved midday on.
Information has been received from a lawyer regarding a case in litigation for a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On 05-NOV-2014 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-OCT-2015 the patient was treated by a physician for the onset of a severe vesicular rash that had been present for four months accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed Gabapentin and valacyclovir (VALTREX) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/19, Pfizer, dose #1 02/18, Pfizer, dose #2 08/12 COVID swab, result: detected 08/12 pt cc: cough, exposure: unknown 08/13- 08/17 pt symptoms continue
Patient had syncope with some brief muscle jerks. Had recurrence of syncope or near syncope over a 20 minute period after the vaccination.
Extreme Pain in arm and shoulder. Cannot lay on shoulder. Primary care doc on Oct 2. Doc said bursitis from injection. Got worse, went to Walk in ER on Mon Oct 6, recd an anti-inflammatory. Doctor said I have frozen shoulder. Inflammatories helped for 48 hours. Very limited range of motion, cannot move arm above the elbow, cannot sleep on that arm.
light rash arms, bilat anterior & posterior torso, legs bilat;began 28JUN98 in PM dec appetite began 27JUN98 (mom attributed to heat);
I started getting the arm lymph nodes being swollen right above my breasts and I was really scared. I am still tired from the vaccination. I saw the Dr. and they told me to place cold/hot compresses in my breasts. The swelling and pain is gone. The terrible nausea and diarrhea that I experienced had gone away after the day of the vaccination.
Facial paralysis,  (Bells Palsy) Onset: 8/15 gradual paralysis to full paralysis by 8/17.
At 7 PM left arm became very sore ( could not move it front or back without pain.)  At 10 PM got the chills.  The next morning had a low grade fever most of the day and stayed in bed all day.  The next day was better and was up all day and my arm was still sore but not as bad and was able to move it in all directions.
Patient reported having 6/10 chest pressure, head pressure, diaphoretic, and heart palpitations Patient had history of heart attack 2 years ago Patient seen by medical team, vitals stable but heart rhythm showed controlled atrial fibrillation per paramedic Patient refused medical transport but son will be driving patient to hospital Patient signed AMA form
rash on his site of admin; he saw redness and flare at his site of admin; he saw redness and flare at his site of admin; This is a spontaneous report from a contactable HCP (parent) reporting on behalf of son(patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/Batch number and Expiration date not reported), via an unspecified route of administration on 16May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. He was not reported for history of any allergies. The patient experienced rash on his site of admin and he saw redness and flare at his site of admin on an unspecified date of May2021. The outcome of the events was reported as unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.