chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received my first shot on 3/17/21,  missed  the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received my first shot on 3/17/21,  missed  the second shot) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (Received my first shot on 3/17/21,  missed  the second shot). On 17-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Received my first shot on 3/17/21,  missed  the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. Concomitant medication were not reported
PATIENT STATED THEY STARTING HAVING REDNESS AT SITE OF INJECTION STARTING ON 10/31/23.
On 1-3-06 discrete papules appeared on torso, itchy, increased rash on torso, flanks, groin, one spot inside cheek, spots on neck, ears, many with vesicles.  Photo documentation taken for chest.
1st vaccine given 4/19/21 in left arm at about 6:03pm  Waited at facility as advised for 15 mins before leaving. Seemed ok.  Got nauseous on the way home. Almost threw up in car twice and at home. Developed a stiff neck within two days. Pain and stiffness radiated to right arm. W/In 5 days I could not lift right arm above shoulder level. This lasted 1 week. Also felt sick and exhausted. Second vaccine was 5/10/21.  This was worse. Developed Meningitis type symptoms. Fever 102. Stiff neck, pain from cervical spinal column radiating up back of skull to top of head like a migraine.  Lasted for two weeks. Then got lockjaw for two weeks. Could barely open mouth.
RED SWOLLEN , TO INJECTION AREA , 4 DAYS POST VACCINE , NO FEVER
Moderna vaccine given to patient who was 17, under the recommended age of 18 or older for this particular vaccine.  There were no issues or side effects noted in the days following the vaccine.
Gave him another booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Gave him another booster 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 EXTRA DOSE ADMINISTERED (Gave him another booster dose). At the time of the report, EXTRA DOSE ADMINISTERED (Gave him another booster dose) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had no antibodies therefore another booster dose was given.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow Up document contain no new information.
Patient was in her nursing home room. Patient reported wanting a vaccination, but was having difficulty with her COPD acting up after her shower. She had asked that the pharmacist go into her room to administer. When going into room on 10/1/18 around 11:30 am I had her sign the consent form and asked if she had received the vaccination before. She reported she had received it for almost ~15 years now and that her healthcare provider wanted her to have it with her COPD. After administering the vaccination, I stayed and talked to her a little bit about her insurance and how she would be billed for the vaccination. She reported she was doing okay so I went ahead and left her room. ~30 minutes later the DON from the nursing home asked if we had an EPIPEN. She had called the nurse and LPN reported that she had a rash all over her body and was having labored breathing. Nurse reported trying to take a picture of the rash, but it was blurry. The nurse practioner was on site and gave order to administer the EPIPEN to patient. He was in the room with patient. Patient was also given BENADRYL, CLARITIN. Patient only needed one dose of Epi. Patient's rash went away and breathing became normal. She reported being okay. I checked back in on her before I left facility around 1:15 pm and she was doing okay. No rash remained.
Headache, fatigue, joint pain, muscle pain, angioedema (face, neck, arms), dry eyes. Severe pain in neck near implanted surgical metal. Period started 1 week early. Resolved I?m 48 hours with rest, heat packs, Tylenol and Benadryl.
Fever, Coughing, Runny/stuffy nose, lethargy, decreased appetite.
Experienced a lot of swelling; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (Experienced a lot of swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    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 SWELLING (Experienced a lot of swelling). At the time of the report, SWELLING (Experienced a lot of swelling) outcome was unknown.        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 treatment medications were reported.  The patient was injected with Restylane Kysse after receiving vaccine.
1 1/2 hours post I.M. influenza vaccine felt tingling in lips, S.O.B. some tightening in throat.
pt exp severe tenderness to lt arm which gradually inc & radiated to shoulder & neck along w/stiffness over a period of about 7hr p//immun;
Right upper arm pain since the flu shot (Nov 4, 2019) constant, sharp, when she sleeps it radiates down to the wrist and her whole  arm, no falls or injuries, no rashes.  9/10 pain. Occasionally radiating down her arm. Pt is also right handed. Right upper arm examination: tenderness localized along the lateral aspect between the deltoid muscle and the lateral/head of the triceps brachii. No erythema, edema, normal range of motion. compared to the left.
Pt received above vaccine @ 13:55, stated that he felt "pins and needles sensation top of right hand at 1530. 10/06/2021. Stated that "pins and needles " sensation top of right hand worsening  morning of 10/07/2021  . Pt stated  additionally that  right hand now lightly tight . Pt stated that "tingling" sensation is now extending from top of right hand to right wrist area.. Pt states he does  not have pain at this time
Fainted within minutes, hot. dizzy. Lasted approximately 15 minutes.  Headache appeared about 8 hours later and soreness.
She got her vaccine and has had chronic bronchitis every day with a lot of mucus production and sneezing.  Also has muscle pain, a lot of coughing to the point of gagging and throwing up.   She also has had headaches, bloating in her stomach all the time.  She has gone to the ER 3 times and they put her on antibiotics, a Medrol dose pack and the stuff she coughs up is pale yellow.  This has been since she received the 2nd vaccine and cannot get rid of it.  She had not had this condition prior to the vaccine.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical facility consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Medical facility is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
no adverse reaction from patient reported. patient was not 65 years old at the time of administration.
Information has been received from a physician concerning an 84 year old female with allergic to medications who on 20-JAN-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck), subcutaneously (lot # 663639/1707X). On 24-JAN-2009 the patient developed a vesicular, pruritic rash on her extremities after receiving the dose of ZOSTAVAX (Merck), the rash was described as "varicella like rash". The patient was not hospitalized but was in assisted living facility at time of vaccination and was moved temporarily to the skilled nursing portion of the facility. Patient was given one dose of acyclovir. The physician is not interested in PCR analysis. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested.
After getting shot I drove home. That night i felt fine and still feel fine. But while sleeping my dog tried to wake me up. I was having a bad nose bleed, while wearing my cpap. Also i had 2 more nose bleeds on the 14th.  After that  no more nose bleeds.I thought  you should know.
Gave me C19 sickness again for 2 weeks. No Long Haul Effects i.e.  Migraines, Brain Fog, Lost taste and smell capability, Vertigo, Nassau, Aches and Pains, Hair loss, Sores on my scalp, Vision loss, Memory Loss, Joint Pain, Chest Pain
Tightness in chest; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number EH9899), intramuscular on 15Dec2020 14:35 in left deltoid at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient states that she is on day 7 today, and yesterday, 21Dec2020, she woke up with tightness in her chest, like someone had wringed her rib cage. She states that she wakes up tightness in her chest again this morning 22Dec2020, patient states that as the day continues, it gets a little better. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was reported as not recovered. The event was reported as serious and seriousness criteria was other medically important condition.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Tightness in chest cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sore Throat, Red Itchy Eyes, Cough, Fever, Headache, Fatigue, Sinus Congestion, Sinus Infection, Dizziness, Incoherence, Inability to Concentrate or Focus - 10 days - Treatment with Augmentin 875mg for 10 days.
Diffuse pruritic erythematous macular papular rash with perioral swelling. Emergency Room evaluation and treatment with IV + PO steroids. Discharged same day.
Rash at site of injection.  Itching, swelling.  Tolerable.  No treatment needed.  Two days so far.
Chest pain, fast heart beat - painful lasted for 3 day.  Couldn't fall asleep
Today we had an improperly spaced dose given. A man came in for his second dose of Moderna, but he came in at 22 days instead of the 28 day interval. He was informed of the administration error. I called Moderna and as per their guidance they received from the CDC here is their recommendation: ?Repeat dose.* The repeat dose should be spaced after the improperly spaced dose by the minimum interval (i.e., 28 days after the improperly spaced dose for the Moderna COVID-19 Vaccine)".
Patient very shaky, feeling warm and having a headache.  Had BP of 155/88 with HR 102.  no trouble breathing but started to complain that her chest feeling heavy.  Paramedics  were called and patient transported to local hospital.
Starting 12/2 Patient reports an itchy rash appeared on her right arm that over the next few days spread to her front and back of thighs, upper back, arms, shoulders, sides and buttocks. She has taken benadryl and used cortisone cream to treat the symptoms.
This report was received from the investigator in a trial on 12 April 2010. A 20 year-old male subject received ACAM2000 (lot number not reported) on 23 January 2009. Five days after vaccination, the subject was diagnosed with heart failure, unspecified. On 30 January 2009, the subject had an MRI of the heart which was normal. On 17 February 2009, the subject had an echocardiogram which was abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Patient c/o lightheaded and nausea on 7/10/12 and c/o redness, swelling, warmth to injection side (L) arm. Took BENADRYL, ibuprofen, and ice which helped subside symptoms. I saw patient on 7/11/12 and symptoms improved. No rash or respiratory distress noted.
Breakthrough case admission after 3 vaccines Pfizer 3/4/21 lot# EN6206;  Pfizer 3/22/21 lot# EN6206;  Pfizer 7/20/22 lot# FP7135
Extreme large local reaction. Entire upper arm red, swollen, warm 24/48 hrs post vacine.
The patient presented to local Medical Center on 03/05/2022 with a known history of recent COVID diagnosis, hypertension, Addison's disease, factor V, CAD, CKD. He presented to ED with c/o AMS. Per EMS, the patient had bilateral lower extremity edema, O2 was 89% on RA, and temp of 102.2, and tachycardia. Portable CXR showed coarsened interstitial lung markings, and CT of the head without contrast showed chronic small vessel ischemic changes, but no acute abnormalities. CT of abdomen and pelvis with contrast that showed ground glass abnormalities.  The patient expired at the facility on 03/05/2022.
The patient woke this morning with red bumps on her cheeks, arms, back and stomach. Around 1pm the rash got much worse so the patient was brought into the office. The patient was treated with Atarax and Tylenol.
Information has been received from a consumer who is a certified medical assistant, through the Merck pregnancy registry concerning her 17 year old daughter with no pertinent medical history or drug reactions/allergies, who on 15-OCT-2006 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml).  There were no concomitant medications.  Subsequently the patient found out she was pregnant via a home pregnancy test.  The patient's mother stated that her daughter may have been pregnant at the the she received the vaccination, however it was uncertain of the exact date the patient conceived.  The patient's pregnancy was confirmed by subsequent visits to her OB/GYN in November 2006.  The patient had no symptoms.  Follow-up information received from the pregnancy registry revealed that this was the patient's first pregnancy and the estimated date of delivery was 11-JUL-2007.  On 27-JUN-2007, the patient gave birth to a normal male infant weighing 5 pound 6 ounces with a length of 19.5 inches.  There were no congenital anomalies and no other complications or abnormalities.  There were no complications during pregnancy, or labor and delivery, however it was reported that the patient experienced 2 or 3 urinary tract infections (no further details were provided).  No further information is expected.  Follow-up information received from the pregnancy registry revealed that this was the first pregnancy and the estimated date of delivery was 11-JUL-2007. On 27-JUN-2007, the patient gave birth vaginally to a normal male intact weghing 5 pounds 6 ounce with a length of 18.5 inches. The birth was reported as two weeks early (38 weeks). Apgar score was 8 at one minute and 10 at 5 minutes. There were no congenital anomalies and no other complications or abnormalities. The pregnancy was normal. There were no complications during pregnancy, or labor and delivery , however it was reported that the infant had a bruised caput one half inches nevue to the right forehead. It was also reported that the mother had experienced 2 or 3 urinary tract infections (no further details were provided). The baby was fed via bottle and was reported to have no developmental delays or other problems. No further information is expected. Pediatric medical records were received and reviewed; adverse experiences related to hepatitis B vaccine were indentified, and are described in WAES #080AUG00927.
A report has been received from a health professional concerning a 10 years old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient was administered FLUMIST, (intranasal) on 20-Oct-2013, and experienced hives that day on her lower body. Her upper body was itchy and she had no lesions. The patient's mother treated her with BENADRYL that night. On 21-Oct-2013, the patient was seen by the nurse. She treated the patient with BENADRYL. The event had resolved. The reporter considered the event to be non-serious.
Raised, red pruritic rash on stomach, left shoulder, left chest, & left side of back.
Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 05-MAY-2023, the patient received the 2nd dose of Bexsero. On 05-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 08-MAY-2023 At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. The reporter gave permission to consent follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Extreme muscle weakness in hands, arms, and legs. I couldn't put my socks on, hook my bra, or pull my socks over my heel. After 3 weeks of no improvement, I went to my healthcare provider. She said it was neurological.
tingling of lips, forehead flushed Narrative:  MEDICAL RESPONSE WAS CALLED AND EPIPEN ADMINISTERED1225 V/S 98.4 98-100-B/P 166/96 O2NSAT 99-100% BENADRYL PO GIVEN V/S 147/78-89P-
Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergies to medications, food and other. No patient had ever been diagnosed with positive for COVID-19. Patient did not receive prescription Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. No acute illness was reported at the time of vaccination and up to one month before. Patient had no chronic or long-lasting health conditions.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date when the vial was initially stored in the refrigerator was unknown as it was transferred from another store. The vial did not undergo any temperature excursions. The vaccine had an expiration date of 18-Mar-2022 so a stability study was requested with Moderna. The results of the stability study show full activity against COVID-19. No treatment medications were reported.   This case was linked to MOD-2022-541343 (Patient Link).
Immunization given in R deltoid.  Inflammation occured in R Bicept.  Visibly apparent edema, red rash lateral of bicept, with raised reddish area.  Warm to palpation, appeared to beginning stage of cellulitis.  Administered diphenhydramine 25mg po approx. 8:20 PM (when reported) and iced locally.  No pain reported, however ROM was impaired by the edema.
Patient is a4 month old male with no past medical or surgical  history presents  with bilious emesis on the morning of 7/7/20 .  The patient had been sick after  he got Rotavirus vaccine a week ago. Mom stated that he had decreased appetite  less activity and fever after 1st day of vaccination(Tmax 101.1F). Fever gone  after taking Tylenol. He hasn't had fever for 5 days and is getting better.  Since the night before admission the patient cried and was inconsolable. The  morning of presentation the patient had greenish color vomiting.  An Xray and ultrasound were performed and confirmed intussusception.
severe muscle aches; first dose on 31Dec2020/second dose on 18Jan2021; This is a spontaneous report from a non-contactable nurse (patient herself). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 18Jan2021 07:00 at single dose for COVID-19 immunisation. Medical history included Coeliac disease, allergies to yogurt and sulfa meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on 31Dec2020 at single dose for COVID-19 immunisation. The patient experienced severe muscle aches on 18Jan2021 20:00 with outcome of recovered on 20Jan2021 08:00.    No follow-up attempts are needed. No further information is expected.