chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump on lower lip, left hand corner...cover 1/3 of that side.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER261) via unspecified route of administration in the left arm on 27Mar2021at 11:30 (at the age 63 -years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included ziprasidone 80 mg (MANUFACTURER UNKNOWN) from unknown date for unknown indication, buspirone 15 mg (MANUFACTURER UNKNOWN) from unknown date for unknown indication and bupropion 200 mg (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not known allergies to medications, food, or other products. On 29Mar2021 the patient experienced lump on lower lip, left hand corner. the events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for events. The clinical outcome of lump on lower lip, left hand corner resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Received 2nd dose of vaccine on 6/19/2021, left ear started feel muffling when hearing sound the next morning . Symptom got worse on  the third day. Went to see pediatrician on that same day. Checked hearing, which was fine. Doctor couldn't find out why. Was told to wash nose for a couple of days and went back to the office if symptom did not get better in one week. Washed nose once with Sinus Rinse. Symptom got better on day five and completely recovered on day six.  Also, on day five (6/23/2021), found a dime sized ulcers on the left side scalp of his head about one and half inches above his left ear. The ulcers seemed healing today, so he will not go to see doctor for that. He did not do anything different and never had that issue before.  These were not listed as potential side effects and scared me.  Think he will be fine. Wish some one could alert me ahead of time.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles, but it was not very bad. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Hypotension - SBP 76, lasting about 2 hours, resolved with rest, fluids Generalized malaise - about 4 hours Lightheadedness - about 2 hours
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (60 patients received doses that were past the storage conditions) and EXPIRED PRODUCT ADMINISTERED (patients were receiving doses that were stored for too long) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (60 patients received doses that were past the storage conditions) and EXPIRED PRODUCT ADMINISTERED (patients were receiving doses that were stored for too long). At the time of the report, PRODUCT STORAGE ERROR (60 patients received doses that were past the storage conditions) and EXPIRED PRODUCT ADMINISTERED (patients were receiving doses that were stored for too long) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported
Pt. had swelling, pain, slight infection but ER MD thinks it's more of an allergic rxn.
dizziness that lasted about 10-15 minutes when I could not stand.  And a headache.   No lingering effects the next morning.
High grade fever greater than 103 degrees F. Weakness/fatigue. Trembling.
The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over; Pain was really bad for 3 days, I couldn't get out of bed; My feet hurt all summer; Was nauseated; She had headaches; Had a fever of 104 F; She used a Decadron taper once & it helped with the pain in the joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated) and HEADACHE (She had headaches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Trigeminal neuralgia (for 7 years.), Fibromyalgia (For Years) and Chronic migraine (for 20 years).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, 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 experienced PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints). The patient was treated with DEXAMETHASONE ACETATE (DECADRON A) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (The 2nd dose hit me like a truck, I couldn't do anything, was in pain all over, couldn't do anything without pain/ was painful all over), MOBILITY DECREASED (Pain was really bad for 3 days, I couldn't get out of bed), PAIN IN EXTREMITY (My feet hurt all summer), NAUSEA (Was nauseated), HEADACHE (She had headaches), PYREXIA (Had a fever of 104 F) and ARTHRALGIA (She used a Decadron taper once & it helped with the pain in the joints) outcome was unknown.            A couple of weeks ago it felt like she had shards of glass in her eye.  No Concomitants product was reported.   This case was linked to MOD-2021-367302 (Patient Link).
Tingling in left hand at on set of injection in Left  arm, Redness on abdomen, generalized itching from scalp to ankle. crawling  sensation under the skin, 3 hrs - after injection,  itching from Feb 5 until Feb 8th(Present time) Treatment- Benadryl 25mg and anti-itch cream.  .Off and on  Nausea from Feb 5 until Feb 8 ( present time).Treatment -  crackers or food.  Severe ear ache Right ear on Feb 7th. Pressure and pulsation. No hx of ear aches. Treatment, Nasal spray, Allergy Medication (Loratadine) Benadryl. Heating pad applied to Right ear
About 12 hours after my 2nd dose of Pfizer vaccine I had extreme chills, fever of 102 degrees, vomiting, and severe headache. Most lasted about 36 hours and all gradually went away. Severe headache was the last symptom to go away but receded about 6 hours after other symptoms .  About a week after 2nd dose my injection site became  very sore for 3 days. Had not been very sore prior.
Contracted COVID 5/30/22 after receiving a booster on4/13/22
Weakness; Dizziness; Body aches; Fever; Sharp pains in her left knee and ankle; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 90-100 (High) Racing heart rate was 90s-100 while patient was just sitting.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had super sharp pains in her left knee and ankle, it felt like it was coming from the flesh near the patella.  No Concomitant medications were reported.  No Treatments were reported.
Info has been received from a health professional concerning a pt who was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live. Subsequently, the pt experienced chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
08/22/12 - reported nausea/vomit/diarrhea and rash evening post vaccination, rash cleared up but returned 1-2 days later, continued to have N/V/D, c/o sore throat. Denial respiratory issue immediately following vaccination but use of inhaler for asthma times 1 during week. Encouraged patient to seek medical assessment with her doctor she verbalized that she would.
Itching and redness all over. 50mg oral Benadryl given@ 10:13 AM.
Rash started on left arm 3 days after Moderna booster (site of COVID-19 vaccine). Very itchy. Spread to back, legs, chest and scalp over the last 9 months. Treated with Clobetasol and prednisone. The rash is still very heavy on my back after almost 10 months.
2 days of itchy rash that resembled measles. 10 days after MMR given.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 32-year-old male. Neither medical history nor concomitant medications were reported. On 23-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Major Hives all over body. Gave Benadryl they went away but came back even worse at night.
VOMITING; DIARRHEA; NAUSEA; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 11-APR-2021, and tiredness on APR-2021, and had not recovered from nausea, vomiting, and diarrhea. This report was non-serious.
Patient was fussy on 11/04/2009, he was hard to calm down in the morning at approx 4 am I awoke to sounds of him choking, I picked him up and then he was fine,  I took him to daycare that morning and received the phone call at 4:30 pm that he was being rushed to the ER.  12/22/09 Death Certificate Received, DOD 11/05/08, Cause of Death: Sudden Infant Death Syndrome (SIDS) at daycare.  12/22/09 Autopsy received. Cause of Death: Sudden Infant Death Syndrome (SIDS). Additional information abstracted: Had been fussy and more congested lately. Chronic inflammation in the large airways likely due to viral infection.
Inject site area is red, raised, and warm to touch. Pt has taken Ibuprofen, BENEDRYL tabs and BENADRYL gel for treatment. Injection site area is 2.3 inches in diameter and is no longer painful.
Experienced life-threatening blood clots in both lungs (bilateral pulmonary embolism); chills; flu-like symptoms; difficulty breathing; chest pain; nerve pain in neck; severe rib pain; spitting up blood constantly; severe aches and pains all over my body; This is a spontaneous report from a contactable consumer.  A 19-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:45 (Batch/Lot Number: ER8737) (at age of 19-year-old) as single dose for COVID-19 immunisation.  Medical history included Polycystic Ovarian Syndrome, and eczema. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20) and hydroxyzine, both taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient previously took propylene glycol, scopolamine and experienced drug allergy. The patient previously took the first dose of BNT162B2, administered in Arm Left on 16Mar2021 12:00 PM (at age of 19-year-old) (Lot number: EN6207) for COVID-19 immunisation. It was reported on 09Apr2021 12:00,  the patient experienced chills and flu-like symptoms that developed into difficulty breathing/chest pain. Nerve pain in neck, severe rib pain, and spitting up blood constantly. The patient started spitting up blood about two days after the vaccine. The patient experienced severe pain and difficulty breathing on12Apr2021. The patient received help from urgent care on 14Apr2021. On 14Apr2021, the patient was directed to receive a CT scan which revealed severe blood clotting in lungs. Rushed to ER where the patient was then admitted to the hospital overnight for observation and to receive blood thinners and pain medication. In the week since leaving the hospital the patient has experienced severe aches and pains all over her body and have continued to spit up blood. The events were reported resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).The patient was hospitalized for the events for 2 days. Events treatment included: O2, Blood Thinners, Oxycodone, and Morphine. No COVID prior vaccination.  COVID tested post vaccination on 14Apr2021, Nasal Swab, COVID-19 RNA - SARS Cov-2 test result was Negative . The outcome of events were recovering.
patient called the pharmacy and shared that she had received her pneumonia vaccine on 12/20/21 and her arm was now swollen from shoulder to elbow.
This medically confirmed report (initial receipt 29-Aug-2012) involves a 20 year old male who was enrolled in a retroactive surveillance study from a large database. Concomitant medications included prednisone, ranitidine, hydroxyzine HCl and epinephrine. The patient's past drug history includes IXIARO (batch number: JEV08L17), ACAM2000 (batch number: VV04-003A), MMR II (Batch number: 0763Y) and BIOTHRAX (Batch number: FAV235). On 24-Nov-2010, the patient received suspect vaccine, AFLURIA (CSL vaccine, Batch M51207). Co-suspect vaccines received on the same day include IXIARO (Batch JEV09L36A) and BIOTHRAX (Batch FAV242). On 24-Nov-2010, the same day as vaccinations, the patient had an anaphylactic shock however was diagnosed with 'other anaphylactic shock' as per ICD9-CM (International Classification of Diseases) code 995.0) on 03-Dec-2010 during an outpatient visit, without further specification. He received unspecified drug treatment. Patient outcome is unknown. Reporter comment: As per the decision of the drug safety monitoring board on 05-Jul-2012, the case was assessed as possibly related (may not be excluded, though not very likely). The causality assessment of possible is in relation to IXIARO only and not in relation to the concomitant vaccines. The reporter believes that the case does not constitute an adverse reaction for influenza vaccine. Note the reporter (pharmaceutical company) captured the additional event of 'Inappropriate schedule of vaccine administered' as preferred term due to a schedule deviation in relation to IXIARO - a second vaccination two months after the first. Follow-up (06-Sep-2012) and correction: Reporter comment on origin of report and product causality, correction to diagnosis date.
Daughter-in-law reported that 10 days post influenza vaccination (11/04/2005) patient became paralyzed.  Was admitted to hospital and was treated for Guillian Barre Syndrome.     12/06/05: Updated report - patient remains hospitalized and has regained some feeling/movement.  Has feeding tube in place and is being treated for bleeding ulcers.   NOTE:  #13 will not allow me to enter greater than 9 previous influenza doses.  Patient has actually received 20+ doses.  Discharge summary includes cough, cold, dysphagia, parethesis, weakness, tachycardia, pneumonia, pneumoperitneum.  Medical records state reflexes decreased.
Pt states she feels lightheaded. Vitals obtained. No other symptoms identified or reported. Pt states her blood pressure was a little low before leaving home, reading was 128/79, HR 68. Pt currently 140/82, HR 67, O2 Sat 96%, RR 18. Pt educated on symptoms of adverse reaction. Pt offered further treatment; however she refused and states she now feels fine. Son is with pt & will be driving her home.
Swollen area about about 3 inches in diameter immediately after injection.  Physician and staff provided excellent care.  Antihistimine and ice pack.
Mild flu-like symptoms: aches, mild fever, nausea, vomited once, the worst symptom was lower back pain, it was pretty bad. I had covid last year but didn't have any issues with lower back pain then.
Two days after receiving Fluzone HD, the patient experienced flu like symptoms (aches, pain, fever 102'F), severe joint pain, hives, a black scab about 1/2 inch across the should- pt believes from injection and not adhesive from bandage, redness, swelling and constant urination (about every 20 minutes). The patient started to feel better after 2 days; however, reported it was a week later when he finally felt well enough to go out to the grocery store.  The patient has not seen a doctor yet and self treated with a topical antibiotic ointment.
Rhabdomyolysis; not able to work; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), IMPAIRED WORK ABILITY (not able to work) and FATIGUE (Tiredness). On 02-Apr-2021, RHABDOMYOLYSIS (Rhabdomyolysis) outcome was unknown, IMPAIRED WORK ABILITY (not able to work) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood test: abnormal (abnormal) The result came and showed that he is diagnosed with Rhabdomyolysis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  The reporter mentioned that he as well as his doctor is not saying that it is because of the Moderna Vaccine. Since he never experienced this before and happened 2 days after the vaccination, his doctor suggested to report to Moderna. He mentioned that he's been dealing with this symptom for two weeks.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
No additional AE reported; Patient received a smaller than recommended dose; This spontaneous report was received from a registered nurse referring to a 65-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 27-SEP-2022, the patient was vaccinated with a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (exact dose, route of administration, vaccine scheme, and anatomical site of vaccination were not reported; lot number U035117 has been verified to be valid, expiration date reported and established as 18-AUG-2023) (incorrect dose administered).  No additional adverse events were reported (no adverse event).