chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Think it was not administered properly; Arm pain in the injection site; Joint pain in the injection site; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm and joint pain at the injection site and doesn't think vaccine was administered properly.   The patient's medical history was not provided. No relevant concomitant medications were reported  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that he received the Moderna Covid-19 vaccine on 09 Jan 2021. Per the patient, the vaccine was administered 2 inches higher than the usual intramuscular injection site. He reported that 16 hours later he was having arm pain and joint pain at the injection site. He did not believe that it was administered properly and that it is not injected into the muscle, but in the versa space. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The out come of the event, vaccine not administered properly is considered resolved on 09 Jan 2021. The outcome of the events arm and joint pain at the injection is considered unknown.; Reporter's Comments: This case concerns a male patient, who experienced a non-serious expected event of injection site pain, injection site joint pain and a non-serious unexpected event of product administered at inappropriate site. There were no reported AEs associated with product administered at inappropriate site. The events of injection site pain, injection site joint pain occurred same day after first dose of mRNA-1273, lot # unknown. No treatment was administered for the events. The event of product administered at inappropriate site was assessed as not-applicable. Based on the current available information and temporal association between the use of the product and onset of the events- injection site pain and injection site joint pain, a causal relationship cannot be excluded.
Extreme fatigue, burning eyes, swollen, painful lymph nodes a few days later on same side as vaccine, muscle aches, muscle weakness, headache, asthma.
Patient received H1N1 vaccine about 8:00am on 10/28/09. By 2:00pm started to have some facial swelling. Increased through afternoon. To ER 6:00pm. received Epinephrine and antihistamine. Doing well today (10/29).
Chills and headache beginning 3 hours after the vaccine. Treated with Tylenol and bedrest. Chills ended in 6 hours Headaches lasted on an off for a week.
2 1/2 x 3 cm area of erythema/swelling to R upper arm in deltoid area. Tender to touch.
Patient came down with shingles after receiving a DTAP vaccine. Felt that perhaps because patient had whooping cough as a child and was over 65 that they should not have received it. Patient does not know for sure if it cause shingles, but their immune system is usually strong.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient filled out screening questions saying she did not have prior covid vaccine but she has already had 2 pfizer doses  She was given the Janssen vaccine
minor little symptoms - fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (minor little symptoms - fever) 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 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 PYREXIA (minor little symptoms - fever). At the time of the report, PYREXIA (minor little symptoms - fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment medication was not provided by the reporter.
12/13/2002 Pt presented with MO after receiving flu shot 11/13/2002. C/O soreness in arm, espec. when he lifts it.  Note attached---12/13/2002 Client presented at health dept. Nurses were not present. client stated to secretary that his arm is still sore with flu shot on 11/13/2002, especially when lifting arm or to shave. States he applied warm compresses x 1 for 1 minutes. Advised to see PMD if continues. 12/13. I phoned pt's home. He was not available. Spoke with his wife. Re- interated that he should see his private physician; also that I would file a VAERS form. To call me back when he comes home.  12/30/2002 To date, no response from client. VAERS form filed.
Pt and mother reports loss of appetite the resulted in weight loss. Normal laboratory tests. Confirmed 18 lb weight loss .
Vaccine #2 04/20/2021 Lot # EW0164 Pt currently has Covid 19 vaccine
Hep A 1440 given instead of 720. No reaction as of contact with mother 10/09/06.
tired; sore arm; This is a spontaneous report from a contactable consumer. An 86-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on 13Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were reported. The patient did not take any other products. On unspecified date of Feb2021, the patient experienced tired and sore arm. Patient states he just has a question, states he works in health care, in administration. States he was vaccinated with the Pfizer vaccine and his mother received her first dose of the Pfizer Covid vaccine on Saturday, 13Feb2021. Patient states they gave her an appointment date for the follow up, her second dose is scheduled 18 days after the first dose as opposed to the recommended 21 days. Patient stated he had his second dose at 20 days after the first and the provider told him it was fine. Wants to make sure that it was okay if she gets her second dose at only 18 days after the first, cannot find any information about this. States she has had no serious issues after the first dose, states she was tired after first dose but unsure if that is related to the vaccine, did have somewhat of a sore arm. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information was expected.
rash in the stomach; headache; chills; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), CHILLS (chills) and RASH (rash in the stomach) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023 at 2:00 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, the patient experienced HEADACHE (headache) and CHILLS (chills). On 11-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced RASH (rash in the stomach). At the time of the report, HEADACHE (headache), CHILLS (chills) and RASH (rash in the stomach) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Post vax the patient was fussy, a fever of 102F, and redness and swelling on the right proximal thigh.
Lower back pain and kidney pain that started in the evening after receiving 1st Moderna COVID19 dose on 1/22/21, and has continued (1/25). Patient was advised to call public health COVID-19 hotline to call and visit a local clinic for followup.
The evening of Wednesday I began feeling chest pressure/discomfort and slight difficulty breathing. The same on Thursday, but a little worse. Friday morning at 4:30am I awoke from intense pain and pressure in my chest, difficulty breathing, and back/shoulder/neck pain. I went to the ER at 7:30 in the morning. Had tests taken, was given colchicine to help with the pain, and it did help lower the pain level a little bit. By Noon the pain was tolerable enough that I could go home. I was told to take ibuprofen to manage the pain. I took a nap but awoke at 2:30pm, this time with even more intense pain, my back/neck/shoulder muscles convulsing/twitching from pain and from being in a state of involuntary clenching as well as chest pain/pressure and difficulty breathing. I went back to the ER and after several more tests, an ECG gave the doctors cause to worry about the health of my heart (they were concerned I may be having a heart attack or heart failure). They kept me overnight and after taking more blood tests and ECG tests were able to diagnose me with Pericarditis on Saturday morning. I was prescribed colchicine, which I am to take twice a day for three months and ibuprofen to manage the pain.
Narrative:  Timing error, 2nd covid-19 pfizer dose given too soon (12 days) after first dose.
lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm) 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 reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm). At the time of the report, ARTHRALGIA (lot of pain in the shoulder joints.,It feels like it is in her bones,t is radiating down her arm) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Pt. states that after receiving the 1st dose of Jansen J&J 10/24/2021, started experiencing symptoms 10/26/2021 of continuous ringing in the both ears. ENT specialist appt. 12/15/2021, diagnosed with Tinnitus (previous use of Steroid Ear drops & Antibiotics) Follow-Up appt. 01/21/2022 for treatment.
Patient's period started on 04/08. It was a normal period. She received Johnson and Johnson vaccine on 04/10. States that night her menstrual flow increased tremendously and became very heavy.  Patient denies any abdominal pain.  Denies cramping.  States is changing "super" tampons about every hour or two.  States "I've never bled this much before in my life"  .She is currently on day 6 of menstruation and her periods are usually very light by now.  States "I wouldn't be worried about this if I was in pain, but it just doesn't seem normal not to have any pain".  Patient reports she has been getting lightheaded the past two days.  Not frequently, but she is lightheaded with position changes.  Patient educated that this is a sign of orthostatic blood pressure drop and could be related to blood loss.  Patient informed that it would be prudent to see a healthcare provider to find the cause of her bleeding.  Prefers to hold off for a few days to monitor bleeding before being seen by a provider and has an appointment with PCP next week just in case she needs it.
Information has been received from a registered nurse concerning a 15 year old female patient who on the afternoon of 13-APR-2011 was vaccinated with a dose of 0.5mL of GARDASIL (route and lot number not reported). On the morning of 14-APR-2011 while at school, the patient experienced changes in behavior and mentation. Nurse reported that the mother stated that teachers noticed the patient "acting goofy, giddy and laughing" and the patient's mother noticed mentation changes. Nurse reported that patient's mother took her daughter to the emergency room and the patient normalized there. An electrocardiogram, unspecified blood work and urinalysis were performed (results not reported) before the patient was discharged. At the time of the report, the patient recovered on 14-APR-2011. Additional information has been requested.
gotten very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: gotten very sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Shingles vaccine.  The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-Mar-2023 This case was reported by a consumer via interactive digital media. The reporter stated that he/she knew people who had gotten very sick from the shingles shot.  The reporter stated that he/she did not know and he/she did not get it. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR038234, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR038234:Same reporter
fever, headache, flushing on 4/27/21 starting at 7pm and continuing to 4/28/21 headache, joint ache, and signs of allergic reaction in right arm, around injection site. Redness, pain, slight itching, swelling, and heat. Symptoms of allergic reaction at site began 4/29/21. Had slight itching and redness with first vaccine, now second vaccine is more pronounced.
listlessness p/the shot t103-104 3-4 days p/shot;
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Patient was diagnosed or tested positive for COVID-19 and type of test was unknown.  Concurrent medical conditions included Drug allergy (Imitrex), Drug allergy (Niacin), Type 2 diabetes mellitus, Congestive heart failure, Hypothyroidism, Colon cancer, Bipolar disorder, Malignant neoplasm NOS (History of malignant neoplasm), Anemia, Dementia, Hyperlipidemia, Hypokalemia and Depression. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) for Dementia, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, ROSUVASTATIN CALCIUM (CRESTOR) for Hyperlipidemia, POTASSIUM CHLORIDE for Hypokalemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ACETYLSALICYLIC ACID (ASPIRIN 81), PANCREATIN (CREON), FENOFIBRATE, QUETIAPINE FUMARATE (SEROQUEL) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days after 1st dose). Patient was taking concomitant ASA 81 concomitant for heart health. Treatment information was not provided. This case was linked to MOD-2022-628590, MOD-2022-628596 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Follow up received contains significant information: Updated patient demographics, medical history and concomitant drug with indication. Narrative amended accordingly.
evening following vax devel vomiting, shaking, & massive stool; more sleepy, pale color, & eyes rolled back, t99.6;
3/23 & 3/24 - Sore arm 3/23 & 3/24 - Severe diarrhea which did make me weak 3/23 - 3/26 -My Sjogrens Syndrome had a flare but I previously never had such dry hands and dry legs. - I did have fatigue  4/1 & 4/2 - I had COVID arm -> I can share a picture of my left arm 4/9 thru 4/11 - Bulging temple on my left side just above my left eye appeared --  I took aspirin from 4/9 thru 4/12 to reduce chance of a blood clot -- This never happened like this in my life before and I had no headache and I was not dehydrated -- I can share a picture of the temple by my eye. I did feel fatigue.  4/7 thru 4/17 - The left side of my upper lip twitched for about a minute; it usually occurred in the morning when I woke up.  3/23 thru 4/17 -  My Sjogrens Syndrome dry eye inflammation and dryness increased in my left eye but has since gone back to pre-vaccine limited dryness
pt states that there was a swollen area on her arm, a bump, local injection site reaction. she pushed on it and it "burst," exudate was blood. she now how some white spots around the area and has been applying bacitracin.
Severe pain in arm and shoulder muscles and inability to raise arm in front or beside body more than 5 degrees without severe pain.  First noticed 2-3 hours after injection; pain increased over next 8 hours.  Took ibuprofen over next four days (2 every six hours for first 24 hours, 1 every six hours for next 3 days).  Pain began decreasing and mobility increased after72 hours. There is still slight pain but tolerable five days after injection.
Patient has developed a rash and warm to the touch since receiving the shingrix vaccination on 9/11/2020.
Headache; prevented me from sleeping restfully; 100.5 F fever; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were reported as not applicable. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient had not been tested for COVID-19. On 25Mar2021 at 23:45, the patient had headache in the evening that prevented from sleeping restfully. The patient woke up with fever of 100.5F. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sleep restless and fever was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
For 2 days after receiving both PREVNAR 13 and FLUZONE HD pt reported having chills (but no fever) and headache and was very tired. Symptoms resolved 2 days later.
In the evening patient could not sleep and had terrible night sweats, shivering, muscle aches and felt like had fever; it  lasted the entire evening. Next day felt like had terrible flu-bug, felt incapacitated and could not go to work.   Vaccine site looked fine and did not see any redness. Symptoms improved by 8/14 but still did not feel good.  On evening of 8/15, red rash appeared at vaccination site, it was hot and painful to touch and as wide, as a hand.   Patient contacted doctor on 8/15 but went in to another facility on 8/16.  Doctor (Dr. at the Urgency Room) thought it looked like cellullitis and prescribed antibiotic, Keflex.  Patient still does not feel well probably at 75% recovery. Arm rash has improved with the antibiotic, he can still see red spot with heat/warm, extreme redness in area has improved; 70-75% recovered.   Patient has not received any other steroid shot since vaccine administered; shot administered at Pain Clinic.  After first vaccine dose, only experienced mild symptoms that were not significant; resolved within 2-3 days and did not require doctor visit.  Patient received the first dose on 5/15 at the same facility
Case number PHEH2017US002456, is an initial spontaneous report received from a pharmacist on 20 Jan 2017. This report refers to a 58 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 19 Jan 2017 when he was 58 years old. It was reported that, FLUAD was administered to 58 years old on 19 Jan 2017. No adverse event reported following this medication error (drug administered to patient of inappropriate age).
Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022; 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) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 18-May-2022 and the vaccine was administered on 22-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  The reporter believed that lot numbers for previous doses of the patient was Moderna, but was unsure.  No treatment information was provided by the reporter.
Syncope, cool clammy skin, pale, drop in BP. Monitor vitals, elevate feet, transported to ER.