chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was excursion from their freezer on 01-Oct-2021. Storage condition at the time of the excursion: Frozen. Vial size: 7.5 mL. Maximum and minimum temperatures reached : Minimum:-4.2 degrees F; Maximum 5.7 degrees F. Excursion duration: 6 minutes.  No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information contain included patient and suspect details.
Within 15 minutes of receiving Moderna vaccine, lightheadedness lasted for about 20-30 minutes. Within 2 hours left knee joint pain lasted 3-4 hours. Next morning (October 12, 2021) noticeable blood red color from mouth while brushing teeth for 2-3 minutes.
24 hrs after getting shot, patient felt pain at site of injection. Few hrs later a red rash began. Next morning redness was bigger, area was swollen & more tender.
Patient came in on 10/2/17 after receiving vaccine w/a large red patch and swelling (fluid around elbow) on his right arm. No redness around injection site. Instructed him to make apt w/ MD to be seen.
immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; immense arm pain/very large welt/red mass on my arm. It is very warm to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular at left arm on 19Feb2021 at 09:00 am (lot number: EN6201) (age at vaccination 36-year-old) as dose 2, single for COVID-19 immunisation. The patient had allergy to sulfa from an unknown date and unknown if ongoing. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular at left arm on 21Jan2021 at 09:00 am (lot number: EL3248) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history was not reported. The patient concomitant medication included levothyroxine. 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 experienced immense arm pain/very large welt/red mass on the arm and It is very warm to the touch on 14Feb2021 at 04:00 am. The patient stated 2nd dose was on 11Feb2021, on 14Feb2021 she woke up with immense arm pain and when looked at it, she had a very large welt/red mass on my arm. It was very warm to the touch. She knew arm pain was a side effect and with Moderna, redness can appear but she did not see that redness was an effect with Pfizer. The redness continues to grow in size. The patient had not received any treatment for the events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
I have had chest discomfort at moderate to intense level for one week and somewhat dinmished the second week. I had intense nausea for three days an still lingering nausea after two weeks. I had loose stools 4-t5 times a day for two weeks. Lymph nodes somewhat enlarged  after one week still remaining.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of PNEUMOVAX 23 (lots # L008664 exp date 03-NOV-2016 and L003188 exp date 06-JUN-2016) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient experienced no symptoms.; administrated MMR II via intramuscular injection; This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R036582, expiration date 17-DEC-2020, for prophylaxis, via intramuscular route, which was considered incorrect route of administration (strength, frequency and anatomical location were not provided). The patient experienced no symptoms.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, FATIGUE, CHILLS, PAIN/SWELL INJ SITE Narrative:
This spontaneous report was received from a medical assistant and office manager referring to five patients of unspecified gender and age.  In February and March 2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M040270, expiration date 29-APR-2019 or lot number M018958, expiration date 03-MAR-2018 (dose and frequency were not reported). No adverse effects were reported. The doses were stored in temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 61 hours. Data logger was involved. There was no previous excursion reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA011636:
09/25 - awoke with flu-like symptoms, body aches, extreme fatigue, and redness, pain, and swelling in upper arm site   09/26  - flu-like symptoms continued, body aches, increasing fatigue - "dragged self out of bed", temp of 99.9, increased redness and swelling of arm site, 09/27 no aches, still fatigue, temp 99.7, on 09/28 arm still hot, red, hard, swollen, no temp, no body aches, but still quite fatigued
Joint pain; hurting under her arm; swelling in the lymph nodes; top part of the arm was swollen; problems in breathing; problems with breathing; heart was beating very fast; fast heart rate; chest pain; legs were just trembling; legs trembling; Dizzy; chest was a little tight; Arm was really hurting; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 (Lot Number: EN6206) (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included hysterectomy on an unspecified date and limitations on the left arm (several tests and MRI conducted; patient went to physical therapy). The patient had a test before and everything shows well. The patient did not have diabetes and was not overweight. Concomitant medications included estradiol (0.1 mg patch) for estrogen (as reported). The patient previously received a flu shot and vaccine for hepatitis B for unspecified indications. On unspecified dates in Mar2021, the patient experienced a little bit of joint pain. An hour after the vaccination, she experienced hurting under her arm and also had swelling in the lymph nodes. The top part of the arm was swollen for like two days. Within an hour and a half to get home, the patient started having problems in breathing and claimed that her heart was beating very fast and felt like chest pain. The patient laid on the couch, and when she stood up, her legs were just trembling and even a slight walk to the bathroom was scary for the patient because and claims that her legs almost felt like she did not have control and they were just trembling for no reason. The patient felt dizzy and was afraid to go to sleep. The patient experienced problems with breathing, fast heart rate, and legs trembling for about 3 days. The next morning, her heart was not racing but still had some problem with breathing. She added that her chest was a little tight. She also added that her arm was really hurting when she was working and could not even take her clothes off when she got home. The patient has seen her doctor for a lab test. The patient was upset and was afraid of getting the second dose. The patient recovered from "top part of the arm was swollen", legs trembling, and fast heart rate on unspecified dates in 2021 while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant list is provided.   Reporter did not allow further contact
pt recv vax 10APR96 & 5JAN97 pt devel chicken pox consisting of approx 60 lesions;the pt recovered from sx on 13JAN97;
Itchy maculopapular lesions, generalized, x5 days. Treated with Calamine lotion, Benadryl for itchiness.
I noticed I was extremely fatigued since I had both of the vaccines, then I noticed my eyes had turn yellow as if I had Jaundice. I went to an urgent care appointment and they did a full panel, my labs came back abnormal first and my potassium levels were low and they referred me to a liver specialist. They did not prescribed any medications.
This spontaneous report received from a patient concerned a 57-year-old Hispanic or Latino female of unspecified race. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient had no known drug allergies, no known previous medical conditions, and no previous medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total, administered on 14-SEP-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. The patient stated that she traveled to her sisters for Christmas on 25-DEC-2021 where COVID-19 was rampant, and she wanted to test herself to see if she had contracted covid-19. On 30-DEC-2021 she tested herself with rapid antigen test and was negative. On 01-JAN-2022, she tested herself again with a rapid antigen test at home and the test result was positive (suspected covid-19 infection, and suspected clinical vaccination failure). She stated that she developed symptoms including rash, blood shot eyes, muscle aches all over body, fever, cough, sore throat, runny nose, and felt like she was going to lose all her teeth. She stated that her doctor had called her in a prescription for Azithromycin 500mg 1 daily for ten days, ibuprofen, and dexamethasone 6mg. She was also given a prescription for tobramycin eye drops for her blood shot eyes. She stated that on 12-Jan-2022, she finally tested negative based upon an at home rapid antigen test and that her symptoms are much better compared to 5 to 6 days ago. The action taken with covid-19 vaccine was not applicable. The patient was recovering from suspected covid-19 infection, felt like going to lose all teeth, and blood shot eyes, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000211462.; Sender's Comments: V0. 20220121251-covid-19 vaccine suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Information and f/u has been received from a registered nurse concerning a 25 year old female with no known allergies or reported medical conditions who on 18-SEP-2007 was vaccinated IM into the right deltoid with a first dose of Gardasil (Lot # 656371/0181U). Concomitant therapy included MENACTRA intramuscular in the left deltoid. On 18-SEP-2007 shortly after receiving the first vaccination of Gardasil the patient felt lightheaded, and fainted. It was reported that she lost consciousness for five - ten seconds and revived on her own. The patient was laid down on the floor and given soda and cold compresses. A full recovery was made within 20 minutes. The nurse followed up with a phone call on 19-SEP-2007 to her family and she was reported to be fine. Unspecified medical attention was sought. No additional information is expected.
Non pustule raised rash to shoulders, chest, back and neck with minimal itching. Has used Aloe Vera lotion to ease rash. Denies changes to soaps, detergents, deodorants or other environmental factors. Also denies taking medications at the present time. Patient was given (2) doses of the pediatric Hepatitis B vaccine with lot #2474H from Glaxo Smith Kline in the Right Deltoid.
improperly stored rotateq was inadvertently administered to the one patient; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age, gender and ethnicity. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-NOV-2019, the patient was inadvertently vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658256; expiration date: 18-NOV-2020; dose, frequency and route of administration were not reported) for prophylaxis. The vaccine was stored in above 9 Celsius degrees (9.4 Celsius degrees) within 20 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA002735: US-009507513-1911USA002785: US-009507513-1911USA002713: US-009507513-1911USA003116:
Localized swelling to right arm at the site of the injection, beginning the day after injection.
This spontaneous prospective pregnancy report was received from a registered nurse, referring to a 17 year old female patient with a well controlled asthma. Concomitant therapies included unspecified prenatal vitamins and VENTOLIN as rescue inhaler. It was reported none concomitant drug reactions or allergies. In 2015, the patient received a dose of GARDASIL (strength, dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis Approximately on 07-AUG-2018, the patient became pregnant with Last Menstrual Period (LMP) of 24-JUL-2018 and Estimated Date of Delivery (EDD) of 30-APR-2019. On 22-AUG-2018 at her family physician, without knowing about the pregnancy, she was vaccinated with GARDASIL 9 intramuscularly (strength, dose and dose number were not reported), lot number N035957, expiration date on 10-OCT-2020, for prophylaxis. On 05-SEP-2018, it was determined after a pregnancy test that the patient was pregnant. It was reported that the patient was doing fine and any treatment was not given. At the reporting time the patient had 8 weeks and 1 day of gestation. Initial exposure to GARDASIL 9 was at 4 weeks. The pregnancy outcome was pending.  No adverse effects were reported.
Subsequent to two doses of varicella virus vaccine live, laboratory evaluation revealed that the pt failed to seroconvert.
This spontaneous report as received from a consumer refers to one of her two daughters, a female patient of unknown age. On 01-SEP-2012 the patient was vaccinated with the first dose of an unspecified HPV vaccine intramuscularly for prophylaxis. Since that date, neither of the patients had received subsequent doses in the series of the vaccine, which was other-than-indicated. No adverse effects were reported. This is one of two reports received from the same reporter. (other MARRS # 1306USA002420) Additional information has been requested.
twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived.
It started with a slight tickle in the back of my throat then I started getting a sinus pressure headache. I thought it was sinuses related, then I had a slight fever that was barely above 100. I started taking medications for that and just felt like I had a sinus infection. It wouldn't go away so I started talking ADVIL, MUCINEX and other sinus medication. It never moved from my head into my chest or anything. I went to my doctor and I asked for medication for my sinuses. They did a COVID-19 test and I actually came back positive. I can't remember if they gave me medication, but I went home and stayed in bed and kept testing until I was negative. The headache eventually went away and I wasn't super tired. I just kept testing positive until it finally stopped. That was pretty much it with the COVID-19 infection. It was pretty mild. Right after Christmas, I came down with pneumonia and it's still in my chest a little bit. I tested myself again to see if it was COVID-19 but it was negative. With my hands, nobody in my family has this type of problem. I had gotten surgery for my knuckle in 2021 before receiving the third dose of the COVID-19 vaccine. I had a blister on my knuckle and it had caused pressure on my nail, so I had to get surgery for that. It's happening on the other hand, but currently not impacting the nail bed. My fingers are stiffer than they used to be and I've been diagnosed with arthritis. Recovered from COVID-19 infection, still lingering symptoms from Pneumonia, not recovered from the hands.
I have been suffering from reoccurring hives that have had to be treated with oral and topical steroids. The MD stated that she had never seen hives look like that and forwarded pictures to dermatology, who stated that those were hives related to either medication/vaccine.
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt.   Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste.  As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side.  My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing.  The tingling turned into numbness in my mouth and tongue, all the way back to top of throat.  I called my primary care doctor at 12:10 pm and left a message.  I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction.  I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful.  We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly  for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10.  We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl.  4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing.  5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides.  6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the  left.  8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same.  8:48 pm jaw really aches. Intestinal discomfort. Going to bed.  10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts.  March 5, 2021  4:00 am. Body aches have lessened. Left arm sore at shot area.  5:45 am  eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen .  7:00 am went on a walk. Noticed some achyness throughout body. Very tired.  10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye.  Very tired. Lymph nodes still swollen and sore.
At public immunization clinic vaccines prepared for client (child 1). Name of client (first and last name) was called but another child client (child 2) and mother responded and came to the vaccination area. Child 1 never responded or heard name called. Both clients speak little of the language. Names were not that similar but mistaken nevertheless by client 2 (7 years old) and his mother. Did not verify again as client 2 entered room crying and clinging to mother.
Active onset of shingles - radiating pain across back toward stomach, blisters and sores. Still active.