chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE), PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and PRODUCT STORAGE ERROR (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    No concomitant medications were reported. No treatment medications were reported.
Covid-arm; delayed reaction red spot; delayed reaction itching; delayed reaction swelling; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-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 VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling). At the time of the report, VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Teatment included Benadryl and Hydrocortisone cream.. It was reported that it was a case of Covid-arm which came on day 10 and after taking Benadryl, it cleared up in 3-4 days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow up was received on 29 mar 2021 included, outcome of events changed to resolved, additional event of Covid-arm added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Fever, body aches, joint pain, foul urine, rash on bilateral arms, pain in arm and shoulder
Phone call from mother, stated client's father told her after receiving shots today, pt got into car, began to shake, arms extended out, and eyes open and staring. Episode lasted 30 seconds. Father reported patient doesn't remember what happened and was alert after episode. Client hadn't eaten prior to immunizations and he "had been worked up for past couple days about getting immunizations" per mother. I advised mother to follow up with her PCP if she is concerned.
stuffy nose; weak; Sleep poor; hot/cold sensation; hot/cold sensation; sweating; headache; fatigue and tired; Sneezing a lot; Watery eyes; Arm was hurting; This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (Sneezing a lot), LACRIMATION INCREASED (Watery eyes), PAIN IN EXTREMITY (Arm was hurting), NASAL CONGESTION (stuffy nose) and ASTHENIA (weak) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030NDEA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On an unknown date, the patient experienced SNEEZING (Sneezing a lot), LACRIMATION INCREASED (Watery eyes), NASAL CONGESTION (stuffy nose), ASTHENIA (weak), POOR QUALITY SLEEP (Sleep poor), FEELING HOT (hot/cold sensation), FEELING COLD (hot/cold sensation), HYPERHIDROSIS (sweating), HEADACHE (headache) and FATIGUE (fatigue and tired). At the time of the report, SNEEZING (Sneezing a lot), LACRIMATION INCREASED (Watery eyes), PAIN IN EXTREMITY (Arm was hurting), NASAL CONGESTION (stuffy nose), ASTHENIA (weak), POOR QUALITY SLEEP (Sleep poor), FEELING HOT (hot/cold sensation), FEELING COLD (hot/cold sensation), HYPERHIDROSIS (sweating), HEADACHE (headache) and FATIGUE (fatigue and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
First dose: felt gross; First dose: felt groggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: EW0150) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing), notes: From ages 3 years to 5 years. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Apr2021, outcome "unknown", described as "First dose: felt gross"; SOMNOLENCE (non-serious) with onset 03Apr2021, outcome "unknown", described as "First dose: felt groggy".  Additional information: The patient had the first Covid 19 vaccine he just felt pretty gross, and groggy the rest of the day after receiving the vaccine. The patient took First dose, early in the day. No vaccine administered on same date with the Pfizer vaccine. AE(s) did not require to visit Emergency Room/Physician Office. The patient had not received any other vaccination within 4 weeks prior Vaccination. The patient had no AE(s) following prior vaccination. No other products, no relevant tests.  No follow-up attempts are possible. No further information is expected.
It felt the flu x2; After my first dose about 3 to Four hours after I got a severe migraine; diarrhea; fever; body ache; body was just craving anykind of juice I got very thirsty; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included meningioma, stent in head, hypertension, rheumatoid, osteoporosis and disc degradation. The patient had unspecified allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 16:45 the patient experienced, after three to four hours of first dose, severe migraine, diarrhea, fever, body aches and could not got out of bed. It felt the flu x2 and the body was just craving any kind of juice as felt very thirsty. Had seen some of these side effects on the website but did not see some of the ones that what the patient had experienced. And it was known that quite a few people that have had the same. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event severe migraine, diarrhea, fever, body aches, felt flu, could not get out of bed and thirsty were recovering at the time of this report.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
pt cried strongly for approx 3 1/2 hrs; pt had sl fever;
This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die) and INJECTION SITE PRURITUS (Itchy area at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains). At the time of the report, ANXIETY (Severe anxiety), INFLUENZA LIKE ILLNESS (Felt like flu), INSOMNIA (No sleep), FEELING ABNORMAL (Felt like he was about to die), INJECTION SITE PRURITUS (Itchy area at injection site), INJECTION SITE SWELLING (Raised area at injection site), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headaches) and MYALGIA (Muscle pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Dull abdominal pain, all-over achiness, fatigue on day after 2nd vaccination. Around 2 a.m. (36 hours after vaccination), severe stabbing pains radiating from colon up through ribs on left side. Only shallow breathing possible; any more than that brought unbearable pain. Took 10 mg. of Bentyl  and another 10 mg about an hour later. Pain subsided in less than an hour after 2nd dose. Discomfort & occasional sudden pain in abdomen, along with achiness, through the next day. Continued to take Benadryl.  Dr. reachable by phone only said this probably not a repeat of the diverticulitis I have had several times over the past 15 years but simply spastic colon. By 3rd day, only mild abdominal distress & mild fatigue. I do not know whether this experience is related to the vaccine at all. I had no difficulties after the 1st Covid vaccine.
Minor Symptoms: Occasional burning tinge in right eye a few days after both doses. Metallic taste in mouth after first dose. Main symptoms: I had a bit of heat in the balls of my feet and discomfort in a few of my toes a couple of days before my 2nd dose. Nothing major. After the 2nd vaccine,  the soles of my feet felt intense burning. Really strong. This went on for a week or more, then the nerve sensations started moving up my lower legs. I also sometimes feel it in my forearms and hands, although not half as much as the feet and legs. It's a pins and needles, burning sensation and is extremely strong at times. When my feet rest on the floor, they feel like they are burning. Cool water and air feel strange on my skin of my extremities. It's very uncomfortable and has caused major stress for me. Sometimes feel it briefly on my face, shoulders, and other parts of body.
I started having pain in the same r-elbow on the same arm of injection, then two days later in the right wrist causing it hard to sleep at night. Then a couple days later my left index knuckle swelled. My pinky knuckle swelled and know I am having some numbness in my right hand. I have a doctors appt. scheduled for Dec. 5
Gradual onset back pain developed 4 days after receiving the vaccine. Symptoms progressed to include fever the next day. Went the ER and got diagnosed with Myositis (MRI T/L Spine), admitted for Sepsis. Subsequently 6 of 8 blood cultures were positive for MSSA. Currently recovering at home with Intravenous Antibiotics.
that he tested positive for COVID-19 earlier this month and was placed in quarantine. However, when he was brought to the ED and subsequently admitted on 2/11/22 after his fall, his COVID-19 PCR returned negative.   7/29/2021-Janssen 11/02/2021-Pfizer
PT. GIVEN EXPIRED DOSE OF MMR FOR 2ND DOSE. PT. NOTIFIED THAT THIS VACCINATION IS INVALID AND THAT SHE WILL NEED TO COME IN FOR REVACCINATION AFTER 4 WKS.
RED, HOT, PAINFUL, WELT AT INJECTION SITE 2" X 6".
2nd dose not received yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd March 2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient was self-reported this case. The patient reported that he did not received second dose of Shingrix vaccine but planned to receive the vaccine. The patient did not reported anything else. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Mother called me today to report they took child to hosp on 10/25/02 at 11pm due to fever and seizure.
arm pain at injection site & small comma rash at bottom of injection site two weeks later now have red rash area size of baseball   no pain
Redness and swelling below inject site, no fever noted, c/o pain, area warm to touch.
Severe burning sensation from my nose to bottom of my lungs that comes & goes ever since the first shot on 3-3 and then 3-31-2021.  Severe exhaustion that comes & goes as well. Have had numerous tests for issues with my heart- nothing found to be wrong.  Have taken nine weeks of steroids on & off, took an anti-biotic.  Both helped for awhile but then just comes back.  I stayed in bed most of the time for over a week & resting did not help.
I started with diarrhea a few days after I received my second dose of the vaccine.  It has got worse over the course of a week. I took immodium and peto bismol with some relief. I also have pains in my intestines. The pains only started in the last couple of days. I have a Dr. Appt today 2/17/21
ONE DAY AFTER VAX, EXP FATIGUE, BODY ACHES, JOINT PAIN, AND SICKNESS TO HER STOMACH. EVENTS LASTED ONE WEEK.
This is a literature report from The New England Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer
Flu/cold-like symptoms; Flu/cold-like symptoms; Coughing up green stuff; Coughing up green stuff; Labored breathing; Rash; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date not reported), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as a single dose for COVID-19 immunization. The patient experienced flu/cold-like symptoms, coughing up green stuff, labored breathing, and a rash on an unknown date. She went to the ED/ Emergency Room and they discharged her. She asked if these are symptoms other people experienced and the timeline of how long they may last. Seriousness of the events were reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength, does, frequency, route and anatomical location were not reported), lot # L012475 with expiration date: 10-JUL-2016, which was improperly stored. No adverse effects were reported. Other suspect and concomitant therapies were not reported. Additional information has been requested.
Approx 7 hours after vaccine awoke 9:30 PM with uncontrollable shaking, chills, fever, shortness of breath, weakness, and wheezing. Given 2 extra strength Tylenol. Around 2:30 AM, 5 hours later symptoms receded. After awakening around 7AM, still have weakness, and general ill feeling.
Patient was 12 years old at time of administration in November. She received 0.2mL of the Pfizer Covid-19 ages 5-11 vaccine. Upon return for her second dose on 1/17/22, I noticed the administration error that had been made. I informed the patient and her dad about what had happened for her first dose, and that based on the CDC's Covid-19 Vaccine Administration Errors Revaccination Guidance she did not need a repeat dose and that her second dose today of the Pfizer Covid-19 age 12+ vaccine would complete her series. I also informed them that I would submitting the information to VAERS and to please contact us if they had any further questions or concerns. On 1/17/22 she received a dose of the Pfizer Covid-19 age 12+ vaccine.
Headache, sedation, Fever, SEVERE PAIN, LYMPHADEMA,CHILLS,SWEELING AT INJ SITE Narrative: Went UC AND WAS REFERRED TO PC
Father called speaking with RN regarding client woke up on 7/30/02 morning with puffy eye lids denying redness or drainage from eyes; stated no fever, she feels fine other than swollen eyes. RN advised client see doctor today. Follow-up by RN called father. Client not seen by pediatrician but advised by phone to give her Benadryl. Father restated "she is fine."
72 hours post vax, the pt had warmth, redness, swelling, itching and nausea/vomiting.
Patient came into the pharmacy on 9/29/19 stating both forearms are a red rash. developed on 9/24/19 and got flu shot at store on 9/17/19.  Patient has not changed any soaps, or denied sunburn.
Fever of 100.4 degrees Fahrenheit for 20 hours, orthostatic hypotension -- not able to stand upright for more than 2-3 minutes at a time, sever pain in left arm, axilla, and left breast.
I had a stuffy nose, sore throat, headache and fatigue. I did not have a fever. On day 3 I had a severe sore throat. On day four all symptoms were almost completely gone. I tested positive on September 16, 2022 for COVID-19 on a home test. In October I began feeling symptoms for a different virus and on the night of October 27 I had sore throat, fatigue, sore throat and diarrhea, and a pounding cough. These symptoms lasted about two weeks. I tested negative for COVID-19 for this virus.
Nausea, throat tightness, dizziness, weakness, evaluated by EMS-refused transport to nearest ER
Pt recvd Hep B vax on 27FEB85, 29MAR85 & 28AUG85 & 14NOV91 lab eval revealed pos hep B core antibody; pt was asymptomatic;