chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of received only 0.1 ml in one nostril was received from a consumer concerning a four-year-old male. Neither relevant medical  history nor concomitant medications were reported for this patient. The patient got 0.1 ml of FLUMIST in one nostril on 29-Sep-2011. On 03-Oct-2011, the patient received 0.1 ml of FLUMIST in each nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Left arm swelling from shoulder to elbow; redness and warmth also noticed. Area is hard and itchy at injection site.
Site reaction began approximately 6-7 hours after receiving vaccine including swelling, redness of 2" diameter around injection site and pruritus.  Swelling diminished after 2 days.  Redness and pruritus still present 72 hours post injection. Treatment with OTC topical hydrocortisone cream and fexofenadine 60 mg q 12 hrs. effective for pruritus.
After eating most meats and / or vegetables,  a rash appears on my body that last about one day.
Narrative: She notes having developed nausea about 12 hours after the initial vaccination, which lasted for about a day. During that time, she took acetaminophen. She denied other adverse effects including vomiting, abdominal cramping and diarrhea. No therapies were applied or tried. She was able to tolerate oral intake during episode.
burning sensation reaction locally in arm; tender to touch arm; swollen / arm; severe reaction of red / arm; This case was reported by a physician via call center representative and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) (batch number 4Z43X, expiry date 22nd February 2022) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced burning sensation. In December 2020, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the burning sensation, pain in arm, swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the burning sensation, pain in arm, swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of at vaccination was not reported but captured as adult as per vaccine indication. The patient was vaccinated with Shingrix. The patient experienced burning sensation reaction locally in arm and provided with ice therapy then patient felt okay to go home. The patient called physician back with severe reaction of red, swollen and tender to touch arm. The physician was uncomfortable with providing patient details of adverse event. The reporter did not consent to follow up.
ON OCT 22, 2009, AFTER ADMINISTRATION OF SEASONAL FLU VACCINE, IT WAS DISCOVERED THAT PT HAD RECEIVED A SEASONAL FLU VACCINE ON SEPT 29, 2009. UPON INVESTIGATION, IT WAS DETERMINED THAT THE EARLIER VACCINE HAD BEEN DOCUMENTED ON THE INCORRECT PT CHART. PT DID NOT EVIDENCE ANY ADVERSE EFFECTS OR SYMPTOMATOLOGY FROM THE DUPLICATION OF VACCINE DOSES.
Cheeks & forehead flushed. Inj. site with mild erythema. Mom instructed to apply cool compresses & give Benadryl 6 hrs x 3days if itching. May give OTC Motrin/Tylenol x 48 hrs. RTC to ER if gets distressed
headache and rash on chest, took benadryl and it cleared up did not see doctor
Patient woke in the middle of the night after receiving the shot earlier the previous morning with considerable arm pain. She noticed when she tried to move her arm, she couldn't. She presented to the pharmacy 5 days later (9/1) and she could not more her arm up past her elbow. She says it's getting better day by day, but wanted to report the adverse event. I counselled her to call us back, or call her doctor, if it does not get better and she was satisfied with that. She thinks she will have full recovery at some point.
Patient presents to the emergency department with feeling anxious and frightened. She was admitted with altered mental status. She was discharge 12 days later to a skilled nursing facility.
I began having an eczema flare after 15 years of dormancy. I have eczema in places I've never had it before including my neck, back, behind my knees, and my vagina.
1600 Pt bad at clinic c/o having reaction - red rash noted on arms, legs, face - stomach and back approx 2 min hard hot redness area noted at injection site- left health unit to see doctor @ clinic.
Tingling, numbness in left foot after about 20 minutes. Moved up to left shin about 5 minutes after. Did not stop until about 4 hours later. After the four hours, the sensation was inconsistent for the rest of that day. I no longer felt it the next morning.
Pt was sitting in chair for their 15 minutes and fainted/fell from her chair 14 minutes into her observation time. Patient said she felt very hot and light-headed. When I looked at the patient she was sweating. She fell head first onto the floor and I kept her laying on her side for about 15 minutes. Patient said she did not want an ambulance called and said she was fine just laying down for a few minutes. Her roommate was called to watch over her after she received her dose and walked her home. Patient said that she did not faint on her first 2 doses or pfizer but has fainted before on flu shots.
Pityriasis Rosea - herald patch appeared about 4 days after vaccination. More small patches appeared on the chest and back 5 days later.
Patient stated that Shingrix caused a swollen, red spot on her arm that was slightly painful.
2 days after vaccination, had fatique, A few days later, body tremors and shortness of breath. A few weeks later, after sinus surgery, had 12 pound weight loss, rash, palpitations, tremors .  Had abnormal bloodwork, was ordered by dermatologist for rash, then referred me to my internist, who tested thyroid and diagnosed with hyperthyroidism.  He referred me to endocrinologist who ran more tests and diagnosed me with Graves Disease.  Am on Propranolol and Tapazole and am being monitored by endo
On the third day after vaccination on the same side as I got the shot, I had physical pain in my shoulder. I could see that the lymph nodes around my clavicle were visibly noticeable. It hurt to put my arms down because the lymph nodes were also swollen under my arms. For two days there was pain with the lymphadenopathy. It took a total of seven days before the lump was no longer visible. I also had a rash around the area of the shot on the second dose of the vaccine. The same thing happened after the first dose but it was not as bad.
7/16/21 Pfizer Lot #EW0176 2PM Health Center/Clinic  Friday Side Effects: Headache, arm sore (6/10), swollen and warm to touch at injection site  Saturday side Effects:  Headache, arm sore (9/10) (hard to move) and swollen at injection site, chills, sore throat  Sunday Side Effects: Headache, arm sore (4/10)  Monday Side Effects: Mild soreness at injection site only  Other: Bruise at injection site for 16 days  Medications taken: Tylenol 500mg every 5-6 hours as needed   8/6/21 Pfizer Lot #EW0168 2PM Health Center/Clinic  Friday Side Effects: Headache, arm sore (5/10) and swollen at injection site, extreme nausea  Saturday Side Effects:  Headache, arm sore (7/10) and swollen and warm to touch at injection site, chills, sore throat, swollen neck glands, sinus pressure, fever (up to 101.2), muscle aches (calves specifically), joint pain (wrist, fingers, toes specifically), extreme nausea, elevated heart rate (up to 145 standing still), chest pressure  Sunday Side Effects: Headache, arm sore (2/10), swollen neck glands, sinus pressure, fever (up to 100.4), diarrhea, abdominal pain, chest pressure  Monday Side Effects: Itchy, red rash on vaccine arm, bloody nose, diarrhea, abdominal pain, chest pressure  Tuesday Side Effects:  Itchy, red rash on vaccine arm, abdominal pain  Wednesday Side Effects: Red rash on vaccine arm, abdominal pain  Thursday Side Effects: Rash on vaccine arm  Friday Side Effects: Rash on vaccine arm   Medications Taken: Tylenol 500mg every 4-6 hours as needed Benadryl 12.5mg
At 10:45 am, RN, administered the 10-mcg Engerix-B (Hep B vaccine) to 53-year-old female client. Client tolerated dose well. After administration, Nurse realized that the Engerix-B 10-mcg pediatric dose had been administered rather than the 20-mcg Hep B adult dose. Nurse explained the situation to the patient and asked her to stay so that Nurse could call the State Immunization Nurse line for expert advice. Patient agreed with the plan. Nurse called State Immunization Nurse. Nurse advised RN to readminister the pediatric 10-mcg dose on the same day. Nurse reported the advice to client, who agreed with the plan. Nurse then administered a second 10-mcg dose to the client at 11:15 am. Client tolerated both doses well and was observed for 15 minutes after each dose.  Client received a total of 20 mcg of the Hep B vaccine on 8/14/2023.
Moderna COVID-19 Vaccine EUA  Swelling and stiffness in right armpit and right latissimus dorsi, with tingling/numbing sensation  through to the fingers in the right hand (primarily third and fourth finger). Symptoms began 48 hours after the injection of the second dose.  There has also been nerve problems in the left arm starting on 1/27, about 22 days after the first dose of the Moderna vaccine taken on 1/5, in the left arm. Loss of motor function and clawing of the fourth and fifth finger resulted in the left hand. As of 2/1 motor function returned, however forth and fifth fingers are still not able to enforce resistance against external pressure. The lot number of the first dose is #025J20-2A
Fever Roseola -Information has been received from a licensed visiting nurse concerning a 12 month old hispanic male with no known allergies, no known birth defects, no known medical conditions, and otitis media diagnosed on 17 Nov 2000 at the time of vaccination who on 15 Nov 2000 in the morning was vaccinated SC in the right arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 631639.0109k.  The patient was also vaccinated with a first dose of varicella virus vaccine live MSD lot # 636356/0531k given sc in the left arm and the fourth dose of hib conjugate vaccine lot 560903a given im in the right thigh.  On 18 Nov 2000 the patient developed a fever greater than 102 degrees.  On 20 Nov 2000 when the fever susided the patient developed a red macular papular rash on his abdomen and lower back which spread to his entire body, except for his palms face and sides, consistent with roseola.  Subseqently, the patient recovered from his experiences.  No further details were reported.
fatigue, rash to upper torso, back, face, abdomen, warm to touch and itch
Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided. Patient asked whether to take Excedrin?.
Sore arm; Body weakness; Hot flashes; Fatigue; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Body weakness), HOT FLUSH (Hot flashes), FATIGUE (Fatigue) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Body weakness), HOT FLUSH (Hot flashes), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Body weakness), HOT FLUSH (Hot flashes) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided    This case was linked to MOD-2021-026552 (Patient Link).
The pt received Varivax on 10/13/95. Dx'd with Chickenpox on 1/10/02 by MD. The disease is still present on 1/11/02. This is not typical of a dx of Chickenpox in a pt who had received the vaccine.
fever 101-jumpy, when falling asleep would startle, arm became rigid (this is how mom explained it); seen in ER according to hosp record, mom stated pt had sz @ home arm was rigid for 1 second & then pt cried; pt noted to be hyperirritable;
Received an expired booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow up document contains no new information.
Rash at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: Negative. On an unknown date, Blood immunoglobulin G: Positive. On an unknown date, Blood immunoglobulin M: Positive. On an unknown date, Polymerase chain reaction: Negative.     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.   Concomitant product use was not provided.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Not specified This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021. The most recent information was received on 25-Jan-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: Negative. On an unknown date, Blood immunoglobulin G: Positive. On an unknown date, Blood immunoglobulin M: Positive. On an unknown date, Polymerase chain reaction: Negative.     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.   Concomitant product use was not provided.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Not specified
She didn't have a whole lot of energy; Pain to the arm, the night after she got the shot; She was fatigue, really fatigue; Nausea for a couple of days/some nausea; went to take a nap for 28 minutes but woke up 5 hours later, never does that; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that), ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea). In April 2021, the patient experienced HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that). At the time of the report, HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that), ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-342868, MOD-2021-343171, MOD-2021-343138 (Patient Link).; Sender's Comments: This case concerns an 46-year-old female patient with unknown medical history, who experienced the unexpected non-serious events of hypersomnia, asthenia, pain in extremity, fatigue and nausea. The event occurred between 1 to 3 days after receiving the first dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as only first dose details were provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt says she has an achy left arm then started getting chills, body aches, and 98.5 fever.  She took Tylenol that helped with her symptoms.  She woke up today w/ a headache that has now subsided. Pt no longer has any of these symptoms.
Noticed pain right away. Noticed redness 04/22/05 around 1:00PM= had not looked at arm at all before this time.
full blown case of varicella p/recv the vax;recv vax 12mo;
(L) mid thigh-red, warm. Treatment-ibuprofen, BENADRYL, cold compress.
Dizziness, weakness, pain, fatigue, headache, muscle pain, joint pain, chills
Caller states she just had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller states she just had a sore arm) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (She takes Asthma inhalers) and GERD. Concomitant products included CLONAZEPAM (KLONOPIN), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller states she just had a sore arm). At the time of the report, PAIN IN EXTREMITY (Caller states she just had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was taking a tranquilizer very seldom along with other concomitant drugs.   This case was linked to MOD-2021-281133 (Patient Link).   Reporter did not allow further contact
Developed diffuse erythematous puritic rash from head to toe with 45 min -> 1 hr of 4 injections given. Given Benadryl IM and Depo Medrol IM, rash resolved within 15 min. BP 90/52 resp WNL
Patient was admitted with an episode related to his schizoaffective disorder and was tested prior to admission.  He was covid positive, no treatment was required for COVID.
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
nausea, tired & sleepy, large wheal on arm which was hot to touch; tingling infingers, aching all over; arm swollen; wheal approx 2" diameter;
Very sore and swollen lymph node in right armpit, general body aches, exhaustion without ability to fall asleep (restlessness during day and at night)
irritability, aches and pain, nausea X 36 hours; one week later broke out in shingles across left forehead. The patient has a history of shingles in that same dermatome
Injection site was red, hot, swollen and itchy. The area was hard and raised, slightly larger than egg sized. After 10 days, area is no longer red. It is occasionally sore and itchy. Treated with antihistamine and Advil.
I got the shot about 10:15 am everything was good. About 5pm I started with a headache and my arm was hurting a little. Then I felt really bad everything hurt. Around 10pm I had 100.7 fever and my head was still pounding.  I took Advil for my head but it did nothing at all. I could not sleep at all. Then around 3:30 Am I finely fell asleep. I woke up at 10 am I hurt a little but no temp it was 98.1
seen in ED with SOB; diagnosed with COVID pneumonia; treated with antibiotic and steroids; worsening SOB; O2 supplementation in ICU with BiPAP 100% alternated with Vapotherm and NRB adjuncts; was able to be moved to medical floor; later experienced code blue, (likely GI bleed), CPR performed; intubated with mechanical ventilation; transferred to SICU; family chose to not perform additional CPR or other aggressive support if needed; pt's condition worsened; in house hospice was chosen and pt died in the hosp