chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was a little sore to the touch/arm was sore to touch/pain in his arm was excruciating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore to the touch/arm was sore to touch/pain in his arm was excruciating) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 025C21A) for COVID-19 vaccination.     Concomitant products included OXYCODONE for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore to the touch/arm was sore to touch/pain in his arm was excruciating). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore to the touch/arm was sore to touch/pain in his arm was excruciating) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was reported. The patient reported that the patient had back and neck issues and took oxycodone.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received does not contain any new information.
9-10-07- Date vaccine given - 9/11/07 patient called to report "her arm became swollen - about the size of a goose egg and approximately 4" diameter - hot to touch and extremely painful. Took Tylenol every 4 hours last night". Had appointment on 9/11 and is doing better. Patient reports no other treatment.
The patient became diaphoretic, nauseated and fainted. Her pulse and BP were undetectable by manual and mechanical means for 10 minutes, though she was alert the entire time. She was alert within seconds of fainting and was back to normal condition within 20 minutes of onset of symptoms.
At 4am I felt nauseous  and dizzy. I went to the bathroom to get a drink of water.  I felt like I had a fever snd had the chills and was sweating. I felt like I was having a vasovagal response and I banged my head on the granite vanity counter twice. I blacked out for a period of time. I developed headache/concussion symptoms on Monday feb 8th and wend to see a concussion specialist on tuesday feb 9th and was diagnosed with a concussion.
When I woke up the next morning, my left side of my face/eye was swollen and numb.  I currently have Bells Palsy since October 2020 and it felt like it was giving me a reaction to the Bells Palsy.  It lasted for three days.
No additional adverse event; GARDASIL 9 was accidentally administered to 5 year old patient due to name error; This spontaneous report has been received from a nurse, referring to a 5-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-OCT-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml once (strength, route, anatomical site of administration, lot number, and expiration date were not reported) as prophylaxis. It was accidentally administered to the 5-year-old patient due to name error. The reporter stated that vaccine was intended for 15-year-old patient with similar name (product administered to patient of inappropriate age). No additional information provided. No additional AE reported (no adverse event). No PQC reported.
"Numb from chest down from MENACTRA". 11/30/09 Medical records received from date 9/25/09. Neuro consult. DX: transverse myelitis, poss demyelinating disease, toxic metabolic etiologies. Presenting SX: back numbness, the next day torso numbness. Assessment: neuro assess WNL. f/u appt. revealed abnormal MRI cervical spine T2 lesion at C2-3. Will f/u pt. closely. OV 10/16 and 11/16 marked improvement decreased symptoms.
Dry mouth, unable to resolve by drinking water, gargling, swishing with olive oil. Continues over one month after initial dose.
This spontaneous report as received from a pharmacist refers to a newborn patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-SEP-2016, during administration of a dose of RECOMBIVAX HB 5/0.5 mcrg/ml, lot # M010671, expiration date 02-JUN-2018, the needle and syringe came apart (due to user error), resulting some vaccine going on the patient's leg and only a partial dose of RECOMBIVAX HB being administered. No adverse effect was reported. Additional information has been requested.
Medial swelling and joint discomfort in both knees- more pronounced in right knee.
Louder Tinnitus, brain fog. Started the next morning. Itchy rash at injection site one week later. Gone by time to see Dr.. Called to ask about appointment, it was agreed, no more need to go at that time. Tinnitus settled down a little before second dose. After second dose tinnitus has become much worse. It goes from loud to louder. I do know how to live with my tinnitus. This is Much worse than when I first started to have it. Brain fog comes and goes. Has not improved. Dizziness (vertigo?)  has to be added now too. Have needed to sit down several times now, this is not normal for me. Feet and hands will feel as if I wearing thick gloves. Comes and goes.
An adult dosage of the Pfizer Covid19 vaccine Age +12 was mistakenly administered to a pediatric patient.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 24-APR-2015, was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Second shot day passed 10days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second shot day passed 10days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRODUCT DOSE OMISSION ISSUE (Second shot day passed 10days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second shot day passed 10days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient said that Tuesday her chest felt heavy like she couldn't breathe so she took an antihistamine. She said that made her feel better but the next day she had a fine rash on her injection arm. The rash was still there today and is now on her back.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown demographics. No information regarding patients' concurrent conditions, medical history and concomitant therapies was reported. From 17-FEB-2017 to 12-APR-2017, those patients received improperly stored doses of VARIVAX (doses and route of administration were not provided) lot # M039317, expiration date: 20-SEP-2018. Properly stored sterile diluent (STERILE DILUENT) (lot# and expiration date were not provided) was used for reconstitution of the vaccine. The time frames for temperature excursion were as follows: -14 degrees Celsius (C) to - 10 degrees C, for 38 minutes. The temperature excursion was detected by "data logger". There were no previous temperature excursions. Additional information has been requested.
High onset fevers 103F Max. Fever reducers can't get body temp brlow 99F
Chicken pox disease - started 01/28/05 approx 50 pox noted
pt presents to hospital via EMS with chest pain and increasing SOB x 4-5 dys; history of COPD; O2 sats 64% on RA per EMS; O2 supplementation; given steroids, heparin, and ABX; non-ST ovation MI, stent placed; pt intubated and experienced several cardiac arrests; family made pt a DNR and he passed away in the hospital
2 1/2 cm redness at injection site. Right - circular local reaction with pimples within circle.
Patient had no other issues due to receiving the recalled vaccine; incorrect product storage; Recalled product administered; This spontaneous report was received from a nurse referring to a 3 month old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 23-OCT-2020, the patient was given a recalled and improperly stored (clarified internally) hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5 mcg/5 ml, single dose vials, lot # T007984, expiration date on 01-NOV-2022, for prophylaxis (route of administration and anatomical location were unknown). Patient had no other issues due to receiving the recalled and improperly stored vaccine.
AM 18NOV92 stiffness pain in joints; AM lt hand swollen-no ability to bend fingers; pins & needles lt digits numb; pain, swelling, numbness to lt middle fingers; c/o sl swelling to this area;
a few weeks after receiving the 2nd vaccine, I would break out in itchy red hives which last about 2 hrs and then slowly subside. They would come daily, and show up in different parts of my body- mainly extremeties, trunk, and palmar hand and sole of feet. I would put benadryl cream on them if it was itching particularily badly. After about 3 months I thought I may have developed a gluten sensitivity and decided to eat a gluten free diet. The hives continues and slowly have subsided after 6-8 months.  I have not been ill, or have I tested positive for Covid at any time since the hives started.
A few hours after the shot both my legs started hurting a lot. I thought it was just normal body aches but now 5 days later I can barely walk because my legs hurt so much from the hip to the knee.
I have developed an illness closely resembling pneumonia; This is a spontaneous report received from a contactable consumer (patient). A 32-year-male patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration, administered in Arm Left on 02Apr2021 15:00 (reported as 3:00 PM) (Batch/Lot Number: Unknown, reason=Misplaced/discarded) as SINGLE DOSE for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no known allergies, not tested positive post vaccination, no covid prior to vaccination and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient reported that: "i have developed an illness closely resembling pneumonia " on 04Apr2021. The outcome of the event was not recovered. There was no treatment for the reported events. The event resulted in Emergency room/department or urgent care.  Information on the lot/batch number has been requested.
patient became lightheaded within minutes of receiving vaccine and had to lay down.  he began to feel better a few minutes later
The morning after the vaccine mom noticed a red area approximately three inches by 1.5 inches and in the center were 4-5 blisters. Pt was seen by PCP and antibiotic was prescribed in case erythema became worse. Mom was instructed to administer Benadryl on morning of the 9th as site became itchy. When seen in office to 8/9/17 area was much smaller and blisters were drying up.
Left deltoid area: red, swollen, painful x 4 days. Advised pt. to go to PCP for assessment and treatment.
After 24 hours after injection woke with a severe ear ache, swollen glands and sore throat on the Right side only. Took ibuprofen for pain/inflammation for two days, called Primary care for appt. to see if I had an ear infection or red throat.  Was seen by Dr. four days after vaccine, was told that ears were clear and throat looked good.  Lymph nodes in neck seemed swollen.
Severe arm pain, swollen lymph glands in neck and under left arm and headache.   Severe fatigue, muscular wasting of bicep muscle at injection site.  Ongoing muscle weakness and pain in left arm.
feeling very sick,Soo sick and can't speak on the phone; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very sick,Soo sick and can't speak on the phone) 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced ILLNESS (feeling very sick,Soo sick and can't speak on the phone). At the time of the report, ILLNESS (feeling very sick,Soo sick and can't speak on the phone) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable
Hypersensitivity reaction. Redness, flushing, runny nose, watery eyes. Gave Diphenhydramine 25mg PO. Symptoms subsided after about 20 minutes. Patient stayed in the clinic for observation for approximately 1 hour.  Advised to call 911 and seek emergency medical care if any symptoms started again after leaving the clinic. Patient expressed understanding.
7/4/2021: 15 year old male with autism and ADHD that presents to PICU from another hospital status post cardiac arrest times two. Mom states that patient has been having coughing for the past 2 weeks. Went to PMD on 6/25 who noticed wheezing on his exam. Ordered a CXR for 6/29. The next day, told mother of the results which showed pneumonia, "fluid in lungs." Started on albuterol q4, cefdinir, and OTC cough medicine with no improvement of symptoms. Began having decreased appetite, urine output. Had a couple episodes of post tussive emesis with blood tinged secretions. Abdominal pain started the day before admission. Patient continued having increased coughing and shortness of breath. On day of admission, patient was walking up the stairs to take a shower. He then fell and hit his head on the wall. Denies LOC at that time. Stated that he could not breath. Patient brought to ER. Patient went into cardiac arrest at 1840 until 1910. CPR was done, given epinephrine, and intubated. Then went into cardiac rest again. Placed on Vent, TV 450, PEEP 6, Rate 15, Peak pressure high 30s. Given ceftriaxone, vancomycin, toradol, 40mg lasix, 4mg zofran and 2L NS bolus. CBC, CMP, blood gas, troponin, pro BNP, RVP/COVID ordered. Started on versed (6.5), epinephrine (20) and norepinephrine (10) drips. Was then flown by helicopter to our PICU.  Of note, patient had second dose of Pfizer vaccine on 6/19. Mom believes symptoms started just before his vaccine dose.
Dizzy, nauseous, fever, headache, arm pain, feeling unwell. Went back to bed to rest- so far.
Patient received Shingrix on 10/18/21 that expired on 10/1/21. I have not heard from the patient regarding any adverse reactions.
Patient was admitted to Hospital from 3/28 - 4/2 after suffering a stroke two days post second Pfizer dose. Patient continues to have left sided weakness, particularly in the LUE. - Acute right MCA stroke - Left hemiparesis - Left-sided neglect -Situational depression
Not sure if it related but what happened is that I fell constantly, hard about 4 times. My blood sugar went higher, I am more fatigued. They put me on Trulicity and I was on there about 6 weeks, and my blood sugar has came down back to normal. I have lost about 70 pounds since then due to this. I am off of all prescriptions medications but my appetite has not returned to normal since. My legs and feet still get a tingle numb feeling.
Got sick with first one; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and got sick. The reporter inquired that what if he or she not take second dose.
This spontaneous report was received from a registered nurse and refers to a 35 year old female patient. The patient's concurrent conditions and medical history were not reported. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. Again on 21-DEC-2016, she was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. Both lots underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 50 days (lot # M015735) and 85 days (lot # M018436). It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Pt recvd vax 3MAR93 w/in 24 hrs, react of swelling, erythema & hot touch developed from shoulder to elbow; treated APAP; seen in ER on 5MAR93;
Urticaria beginning on 4-2-06.  First dose Hepatitis B vaccine was given on 3-31.  Responded to diphenhydramine and prednisone with resolution by followup visit on 4-10.
Very sore arm showed up a few days following the shot.  Redness in circle and hard to the touch.    Painful. I understand there is something called "Covid arm."  It did not itch; just pain.  Not keeping me from getting 2nd shot.  Will use other arm.
Sore arm; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of the receptionist at the outpatient clinic. The age at vaccination was not reported. The patient had sore arms and muscle pain with the vaccine. He did not have the patient identifiers. Caller did not provide his doctor's address on the phone. This case has been linked with case US2019087036, US2019AMR088911, and US2019AMR088873 reported by the same reporter.
Patient developed fever starting on the day of vaccine administration that lasted for 6 days. Patient developed diffuse skin-colored maculopapular rash. Mom called 11/24/2007 at 3:30 pm and was seen on 11/26/2007. At that time pt had no fever, did still have the rash. More likely viral illness, reporting because occurred just after vaccination
APPROXIMATELY 25 MINUTES AFTER FIRST DOSE MODERNA PATIENT COMPLAINED OF "ITCHING TO LEFT SIDE OF NECK/SHOULDER THEN LIPS ITCHING, THROAT NUMBNESS AND WORSENING OF ITCHING TO LIPS AND "FEELING REALLY WEIRD".  SHE WAS TREATED ON SITE WITH 0.5MG EPI IM X 3 AND BENADRYL 50 MG IM X 1 THEN WAS TRANSPORTED BY EMS TO THE ER.  SHE WAS EVALUATED AND RELEASED WHEN CLINIC CALLED TO CHECK ON HER LATER IN THE AFTERNOON
During an records audit, it was discovered that the 17 year old patient received the Moderna vaccine. Patient did not report any side effects or adverse events to this healthcare facility.
A week or 2 post vaccine, I felt like I had a little hair in my eye. Then I saw a little bubble in my eye. Around 2 weeks before 02/22/2021 I went to see an Optometrist, He first prescribed non-steroid eye drops, and then steroid eye drops, after seeing me several times and it was not getting better, so he sent me over to another Ophthalmologist. That doctor, on 03/18/2021, diagnosed me with an eye cyst. He increased the amount of steroid as well as and he also gave me glaucoma medication. Prednisolone and Prolensa and he also put me on at first Primidone and after a while he switched me over to Latanoprost. By 06/08/2021 it had resolved, the doctor took me off the medications, except the latanoprost. A third dr. for my regular eye exam, she told me not to take the Latanoprost anymore.
The day of cold chills, headache. the next day headache foggy feeling, three days afterwards wanting to cry panic attack had the feeling of dieing
immediate swelling at injection site, 2-3 rash wheel continuously with associated rash to reporting date
No adverse effects were reported; A patient received an improperly stored ROTATEQ; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unspecified date in November 2019 (reported as 04-NOV-2019 or 05-NOV-2019), patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot number S004253 expiration date in 21-OCT-2020) (dose and strength were not reported).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a lowest temperature below 36 degrees Fahrenheit (°F)/ 2 degrees Celsius (°C) (1.3C) for the time frame of 2 hours and 18 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Approx 2 hours after receiving PNEUMOVAX, pt reports swelling (7 inches) & redness 4 x 4 in which is present today.
Systemic: Dizziness / Lightheadness-Mild, Systemic: ANXIETY-Mild
TIRED; This spontaneous report received from a consumer concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 01-APR-2021. This report was non-serious.