chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm Soreness; Low grade fever of 100; swollen lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 041620A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100 (High) low grade fever of 100.         No concomitant medication were provided  Treatment medication was not provided.  Lab tests included - some tests were conducted on the lymph nodes, no results were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Some tests were conducted on the lymph nodes.
Just a couple days of cough,  runny nose. Positive home covid test- took three times.   Received and took paxlovid for prescribed number of days.
Headache. Congested. Runny Nose.  Achy.  Injection site very sore.  Slight fever.  Generally feeling poorly.
New patient presented for a Covid vaccine and was given the Pfizer Bivalent Booster, afterwards it was realized she hadn't had the primary series and should have received the Monovalent Pfizer vaccine. She has had NO adverse events.
On 2/17-The pharmacy received a phone call from patient. She spoke to me, the pharmacist, who administered the vaccine earlier that day. Patient said that the sight looked like a bruise and was tender. The patient was asked if there was any other adverse affects and, at the time, she said no. She stated that she watch to see if the redness would grow and call us if there was change. On 2/19 Patient came to the pharmacy in the morning and said she had a fever on 2/18 but she no longer had a fever. She had body aches as well. She stated that the sight was "slightly itchy" the previous day. I told her that she could take an analgesic (acetaminophen) for the fever and pain. She indicated that she didn't take anything since receiving the vaccine. I told her she could take Benadryl or any antihistamine for the itch. She told me that it didn't itch anymore. She thought the redness and bruise wasn't growing but it wasn't diminishing either. I told her that we could contact her physician, she said she would contact us if there is any further change. She stated that she no longer had a fever. I told her I would report the incident and I would research to see if she should receive the 2nd Shingrix dose since she had this adverse reaction that could be an allergic reaction.
The first dose was fine.  I just had a little soreness in my arm.  The second dose I felt like I had the flu.  I had a temp of 101.  My pulse was 100.  I was cold and did not have an appetite . I also felt very tired.  It only lasted about 15 hours or so. and then I just had  a little temp. And was fine after that.
rash/hives in all of face, parts of chest, back of neck and part of back  ER treated patient with Benedryl, prednisone and pepcic
Severe chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This 84-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via an unspecified route of administration on 16Feb2021 at 13:00 (at the age of 84-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. Concomitant medications included cetirizine hydrochloride (LITTLE), aspirin, tamsulosin, and simvastatin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN5318) on 26Jan2021 at 12:00 as a single dose in the left arm for COVID-19 immunization. The patient also previously received codeine, gabapentin, and penicillin from unknown dates for unknown indications and experienced allergy. On 17Feb2021 at 04:00 (also reported as 14 hours after the second dose of BNT162B2), the patient experienced severe chills lasting about 10 hours and extreme fatigue which lasted until about 48 hours after the second dose of BNT162B2. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of severe chills and extreme fatigue were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.    No follow-up attempts are needed. No further information is expected.
flu-like symptoms next day (Wed.). Thurs, felt fine Aug. 20. Took nap (6pm), woke up Thur, 9:30am (39 hr. later) in ICU after being unresponsive for entire time CPR done by husband after breathing stopped, breathing started, 911 EMTs called. Intubated in ambulance to ER where spinal tap was done, intabation again, transfer to Hosp (2+ hr. away) Admitted to ICU.  EEG, EKG, blood work etc. on ventilator until Thurs. am.  released Fri. 08/23/19  Returned for appt. with primary Dr. 08/29/19 follow up with cardiologist and neurologist(9/05).  Cardiac cath on 9/16 with heart monitor for following 2 weeks. sleep study 11/7 w/ EEG. There were no difinitive  results from any of the Testing. All 4 doctors  advised not getting second shot, as did pharmacist. The reason I am reporting this now is that a friend, 80+ yr. old female, just had same symptoms although she had vaccine several months ago.
This spontaneous report was received from a medical assistant and refers to a 17 year old patient on an unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, due to human error, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (strength, route of administration, lot# and expiration date were not reported) for prophylaxis, instead of MENVEO. No adverse effects were reported.
Patient woke up in the middle of the night with swelling in the face, tachycardia 125-130 bpm, BP 142/90, achy joints, sore throat, labored breathing, chills, nausea, fever 102.7
Case previously recorded as MA2009-4086. Initial case report received from a physician on 09 NOV 2009. A 1-year-old female patient was accidentally vaccinated with FLUVIRIN (batch no. 1009225PA) i.m. into the thigh on 09 NOV 2009. No adverse effect was reported. Reference no: NA09-007868.
Slight swollen/sore throat; Slight swollen/sore throat; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included slight high blood pressure and medicated for hypothyroidism, under control. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 06:45, morning after second dose, the patient experienced slight swollen/sore throat that started getting better after couple hours. The clinical outcome of the events slight swollen/sore throat was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 68 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 19-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patient's will be contacted for revaccination.
pt return to store approximately 40 minutes ( per pt) after receiving the vaccine and told us that she felt a knot in her throat and her lower lip was swollen and felt numb. Took pt into the vaccination room, took her blood pressure ( 125/82). There was no rash or hives. Pt was alert, oriented but complained that her throat still felt tight and there was a knot. Pt was asked to remove the mask so we could check for edema. Her lower lip appeared very swollen. We told her that it could be an allergic reaction and needed to administer the EpiPen and call 911- pt received 1 dose of epi pen 0.3mg into the left thigh through clothing at aroung 12:30 pm .We called 911 and continued to monitor patient while waiting for EMs to arrive. Her second BP was  122/75 after the EpiPen and she said the knot was still in her throat. EMS arrived very shortly after and took over. They told her that they would take her to a hospital to monitor her.
About 3 hours after I received the shot, I started having pain deep in my left armpit.  Pain in armpit became worse as the night progressed, making it very difficult to sleep on left side.  The next day I awoke with continued pain in my armpit and with swelling present in my armpit.  2 days post shot,  deep armpit pain remained and swelling became worse.  It is now 8 days post shot, swelling remains but at about 25% of what it was.  Pain in armpit is still present but could be defined as slight.  Ibuprofen had decent effect on armpit pain but did not decrease swelling.
7cm X 8 cm red, warm area on right arm near injection site, rash hard with yellow dots and itchy according to mom, 3 cm x 5 cm intact blister, night prior mom reports child was sweaty on chest.
Got the vaccine and developed COVID; Got the vaccine and developed COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable physician. This pharmacist reported similar events for two patients. This is the second of two reports for Infection Control Nurse's daughter. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), 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 got the vaccine and 10 days later, got COVID, so, she got swabbed on unknown date. The patient was wondering if she needed to start over or if she was okay to get the second dose. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported "got COVID",  based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021001217 same reporter/product, similar events, different patients.
I spent New Years Eve vomiting. I tested positive on January 2, 2023. I had stomach pain, headache, and brain fog. I did not seek care from a doctor. I was tired and out of it. I had stomach pains in places I never felt before. The pain was in the interior left side. I never took any thing. I recovered after 5 days. A month after this case, I started having shortness of breath about a month after having COVID-`9. This was very uncontrolled and random. This was well into February. On Sunday of last week, I started sneezing and so I tested and was negative for COVID-19. I was very tired and fatigued. I was congested and very thirsty. I had a cough and runny nose. The cough was productive and is still this way currently.  I began taking Paxlovid after doing a telehealth visit with the state. Since taking the medication, my symptoms have improved. I still have a productive cough and a low-key type of brain fog.  I kind of feel like I have recovered but I am afraid of contracting it again.
This case was reported by a pharmacist (the subject's brother) and described the occurrence of hardness at the injection site in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. The subject's medical history included breast surgery. The subject receives unspecified concurrent medications. On 2 November 2007 the subject received 1st dose of Fluarix at 1 ml in an unknown arm. At an unspecified time after vaccination with Fluarix, the subject experienced hardness at the injection site, injection site pain, injection site swelling and injection site discomfort. This was considered to be a local reaction. The pharmacist considered the events were disabling as the subject has had difficulty performing her job. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Fluarix.
Large amount of swelling, and pain which limited rotation. Faint rash still present 48 hours later.
Heart palpitations, episodes of rapid heart rate, dizzy and light headedness, clammy hands, raise in blood pressure. Symptoms happening daily.  Have been sent home repeatedly from work beaux of symptoms.
Headache; Upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 02Mar2021 20:30 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 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 an unspecified date in Mar2021, the patient experienced headache and had upset stomach. The reporter considered the event as non-serious. The patient treatment received was unknown. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Soreness; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 18-Feb-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-049706 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049706:Crosslinked with dose 2
This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of M-M-R II (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M010426 with expiration date on 01-MAR-2018, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours (dates between 30-JAN-2017 and 30-MAY-2017) or 12 hours (on 15-FEB-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 1044 hours. This lot # was also exposed to a storage temperature of 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 12 hours (on 15-FEB-2017). For the lot # L032181 with expiration date on 25-AUG-2017, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA002362: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
March 6-30 -- > headache every day, primarily tension type; variety of meds used to treat  March 16- April 4-- > Vertigo, Brain Fog; 50 mg of meclizine daily
5/29/2022 Nasal congestion, sinus and head fullness, with a slight cough. 5/30 Symptoms increased in intensity, with fatigue and mild body aches.  At home test Positive. Sought care on 5/30. Urgent care performed an antigen test for COVID 19. Doctor prescribed Molnupiravir and benzonatate. 6/2 Started to feel better. Cough lessened as did nasal congestion.
J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 AMYLOIDOSIS, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 ATRIAL FIBRILLATION, PERSISTENT J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 LEFT ATRIAL MURAL THROMBUS J96.00 ACUTE RESPIRATORY FAILURE 10/4/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
A 15 month old male received injections of Prevnar (third dose), MMR II, and ActHIB on 1/5/02. The infant had pre-existing upper airway congestion and nasal drainage. Concomitant therapy included Phenergan VC syrup. Approximately 12 hours post vaccination, the infant developed fever and a seizure. He needed valium to breathe. Magnetic resonance imaging, electroencephalogram and lumbar puncture results were negative. The infant was hospitalized for 3 days. The diagnosis was atypical febrile seizure. From additional correspondence received on 9/4/02, no further medically significant information provided. Case is closed.
it was reaction that I got my left arm got a burning in it; my whole left leg from my left side of my body, my buttocks, all down the leg are twisting it is like shot one down to it; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced it was reaction that I got my left arm got a burning in it on an unspecified date with outcome of unknown, my whole left leg from my left side of my body, my buttocks, all down the leg are twisting it is like shot one down to it on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
BODY ACHE; FEVER; BACK PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced back pain. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and back pain, and the outcome of body ache was not reported. This report was non-serious.
flu, nearly died from that; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a 40 years old and unknown gender patient who had flu, nearly died from that after receiving influenza vaccine.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had flu, nearly died from that (influenza) (unknown latency).  It is unknown if there were lab data/results available  It is unknown if the patient experienced any additional symptoms/events  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.