chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 72-year-old female patient. The patient's concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. The patient had lymph nodes removed in her left arm. On 29-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the right arm (lot # R002084, expiry date: 26-OCT-2019, dose not reported) for prophylaxis (reported as to complete the pneumococcal series). On the same day, the patient was also vaccinated with the high dose of FLUZONE (manufacturer unknown) on the right arm (dose, route, lot # and expiry date were not reported) for prophylaxis. Subsequently, the patient developed redness and swelling in her right arm. The pharmacist stated that, the patient saw her physician and she was diagnosed with the cellulitis in her right arm (cellulitis). Product quality issues was not involved. The outcome of cellulitis was reported as recovering. The reporter's causality assessment was not provided. Upon internal review, cellulitis was determined to be medically significant.
About 20 minutes after getting the shot I had trouble breathing, my heart started to raise, my blood pressure started to raise and I started having fever. I went to the doctor the next day because I was having chest pain and I went to the urgent care and they sent me to the hospital. They did blood tests, 2 EKGs, they gave me potassium and something for my heart, and something else but I do not remember what it was. They kept me for most of the evening but I was not hospitalized. I still have the chest pain and the rapid heart beat so I am still seeing my cardiologist. With the first dose I had a headache like my head was going to explode, then I had fever and chills for 4 days and then a headache for 2 weeks after that but urgent care told me not to come in. I only took Tylenol and Aleve.
29 weeks pregnant; ?COVID Arm? 3 inch diameter red, inflamed (warm to touch), hard reaction surrounding injection site. Started within 12 hours of receiving shot, increased some in size overnight between day 2-3; not very itchy but painful to touch and uncomfortable.
Patient received an expired dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated the vaccine vial was punctured at 10:00am on 13 Jun 2021 and should have been discarded at 10:00pm that evening. However, the patient was vaccinated at 1:00pm with the expired vaccine.  Concomitant medications were not reported.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
4/11/21 generalized fatigue  4/14/21 shortness of breath and chest pain 4/15/21 right lower extremity Deep vein thrombosis and bilateral Pulmonary emboli 4/16/21 mechanical thrombectomy of pulmonary emboli  4/15/21 - 4/18/21 treatment with heparin infusion which was transitioned to eliquis
Immediately after immunization of vaccine, patient reported feeling dizzy and immediately fell forward facing towards the ground. MOC assisted RN with lowering patient to the ground. Patient was placed with back to the ground and feet elevated. LVN called for assistance to grab vitals machine. Patient did not lose LOC but reported not remembering incident after immunization was given. Dr. notified and came to assess patient in room.
Tingling of tongue on R side, numbness of R side of face  lasted about 2 hrs
RASH ON HER LEGS THEN APPEARED ON ARM, CHEST, FEET / RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included: multiple sclerosis, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, Laboratory data included: Skin biopsy (NR: not provided) Unknown. On 07-AUG-2021, the patient experienced rash on her legs then appeared on arm, chest, feet / rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on her legs then appeared on arm, chest, feet / rash all over body. This report was non-serious.
Fever, chills, body aches, headache and overall exhaustion.  I went to bed feeling fine and woke up at midnight (about 12 hours after my vaccine shot) with chills and fever.   I took some ibuprouen and the fever reduced but not all the way.  The next morning I was exhausted and slept most of the day with a fever under 101.  The fever lasted for about 18 hours and finally subsided.  The body aches and exhaustion lasted 48 hours.  I took Tylenol and Advil throughout the adverse reactions.    I had a moderate case of Covid one year ago in March 2020 and I felt exactly the same after the shot.
Localized pain. Red. Hot. Headache. Loss of appetite. Next day: Headache. Neck pain. Evening: Armpit pain. Following day: neck pain. Armpit pain. Loss of appetite. ER visit. Swollen lymph nodes on neck and armpit. Red swollen area where shot was given.
Pulmonary infarction; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY INFARCTION (Pulmonary infarction) in a male 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 PULMONARY INFARCTION (Pulmonary infarction) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY INFARCTION (Pulmonary infarction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: (abnormal) revealed he had more than 100 blood clots in his lungs..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized with a pulmonary infarction and had lost permanently about a quarter of his lung. Discharged and was in stable condition.  Company comment  Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
PATIENT COMPLAINED OF FEELING FLUSHED AND DIZZY.  BENADRYL GIVEN IM RIGHT DELTOID.
The day after vaccine, induration at injection site measured 3". Mom treated with BENADRYL and ibuprofen. Reaction had resolved by 10/31/16.
Information has been received from a pharmacist concerning a 53 year old patient who on 17-JUL-2009 was vaccinated with a dose of PNEUMOVAX (lot# 662664/0981X). On 17-JUL-2009 the patient developed cellulitis of the left upper extremity, status post vaccination. The patient was hospitalized from 17-JUL-2009 to 20-JUL-2009. The patient was treated with IV antibiotics for 10 days. On 21-JUL-2009 the patient had a follow-up visit. The patient had a fever and swelling (not specified). At the time of reporting the patient was recovering. Follow-up information has been received from a physician concerning the patient who on 14-JUL-2009 (not 17-JUL-2009 was previously reported) was vaccinated with a dose of PNEUMOVAX. On 15-JUL-2009 the patient had localized pain at the injection site. On 16-JUL-2009 the patient's pain had worsened and the patient developed a fever. On 16-JUL-2009 the patient went to the emergency room and was admitted to the hospital for cellulitis on 16-JUL-2009 (not 17-JUL-2009 as previously reported). The patient was treated with ANCEF, NAPHACEL. On 20-JUL-2009 the patient was discharged from the hospital. The patient was prescribed KEFLEX and clindamycin on discharge from the hospital. On 21-JUL-2009 and 31-JUL-2009 the patient was seen by the physician for a post hospital visit. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several cases from the same reporter. No further information is available.
Fever of 103.2 degrees F.  Resolved after 24 hrs.  Fever then returned on 07/27/2010 (102.9 degress F) and resolved after 24 hrs.  Rash developed on 07/29/2010 at 12:00 PM.  This occured after receiving MMR vaccine.
Vaginal area went numb initially.  Over the course of a few weeks also lost feeling in buttocks and feet.
Injection site red and swollen.  Erythema and edema left deltoid area.  Keflex 250/5 one teaspoon, 2 times per day for 10 days.
pt recv vax & pt caught the flu p/shot;this case was reported by the consumer;
ERECTILE DYSFUNCTION/NOT BEEN ABLE TO HOLD, OR EVEN GET AN ERECTION; TAKING A TOLL ON MENTALLY; This spontaneous report received from a consumer concerned a 42 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced erectile dysfunction/not been able to hold or even get an erection, and taking a toll on mentally. Reporter stated that "I am writing to inform you that I believe your covid vaccine does cause erectile dysfunction. The patient and reporter never had an issue with his sexual performance. He was vaccinated and ever since had not been able to hold or even get an erection. Reporter also stated that patient had an appointment with a urologist on 10-JAN-2022. Reporter felt at the very least patient should be compensated for the financial loss he will incure. Not to mention the embarrassment and humiliation that come along with erectile dysfunction. It was really taking a toll on him mentally. They may seek counsel and go public if no action was taken". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from erectile dysfunction/not been able to hold, or even get an erection, and the outcome of taking a toll on mentally was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220103319-covid-19 vaccine ad26.cov2.s- Erectile dysfunction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore arm, fever, chills, headache, body aches, fatigue, shortness of breath when doing any activity, bladder pain & frequent urination.
Pt vaccinated with FLUOGEN developed sore throat, headache, earache, sinus drainage thru 22OCT90. Cough, congestion chest appt w/ Dr.  Given antibiotic & expectorant by MD dx URI. "Symptoms not due to influenza injection."
Red hives under chin, on neck, and on chest beginning 30 minutes after dose and lasting  approximately 1 hour.
The vaccine was administered on the date of expiration. Clinic staff was initially told the vaccine could be used but found out later in the day that it should not have been used.
Continued pain in left shoulder following flu shot.  Pain at night. Unable to lift arm with pressure.  Pain improved after 2 months, but still present.
Client alerted staff that she was feeling unwell, C/O  feeling flushed and C/O tingling of L arm at hand/wrist.  Upon assessment pulse ox was 98, P 88 BP 140/98. Skin was warm and dry. Neuro checks were negative. Denied SOB or chest pain. Client requested to rest a bit and contact family alone. After 2 minutes of rest client continued to complain of tingling in both arms and fingertips. C/O L jaw pain at this time as well. Client was conscious and awake. EMS was called and client was transported to local ER for evaluation.
Information has been received from a health professional concerning a patient who, "a number of years ago," was vaccinated with a dose of RECOMBIVAX HB. Subsequently the patient experienced a reaction. Additional information is not expected.
HIVES, SWELLING, REDNESS, ITCHING,  FROM INJECTION SITE TO ABOVE ELBOW FOR 5 DAYS . HISTORY OF ANAPHYLACTIC REACTION TO EGGS
tested positive for covid before, but still has the symptoms; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diarrhea, Shortness of breath, Cough, Loss of taste, Loss of smell, Sore throat and Congestion nasal.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms). At the time of the report, POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  It was reported that the patient received first dose of Moderna vaccine an hour ago in left arm.
Injection site pain day(s) after shot, increase left ear hissing and mild ear pressure weeks after shot. Increase ringing in left ear month(s) after shot with continue mild ear/head pressure. Blood pressure normal. Scheduled doctor visit for April 12th (earliest time I can get in)
After getting the booster I had a bad headache, fatigue, and pain in my arm. This was enough that I couldn't do my regular activates. The next day my heart went through aneurysm. This is when I called my cardiologist and was notified to go to the emergency room if nothing went back to normal with my heart rhythm.
Sore arm; Pregnant patient received the Moderna vaccine; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergic reaction NOS, VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Aug-2020 and the estimated date of delivery was 14-May-2021. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 10-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the Moderna vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, Nausea Vomiting, EXHAUSTION, INJECTION SITE PAIN
Swollen/tender lymph nodes under right arm; Swollen/tender lymph nodes under right arm; Hard for movement; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 18Jan2021 08:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. There were no other medications received within 2 weeks of vaccination. The patient experienced swollen/tender lymph nodes under right arm and hard for movement on 19Jan2021 08:00. Patient was recovering from the events and no treatment was received. The events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No symptoms were experienced from the adverse event. Patient was accidentally administered the pneumo polysaccharide vaccine instead of pneumococcal -13 vaccine.
5 Min after first does of Pfizer vaccine, patient c/o nausea and dizziness. Patient vomited. Vitals stable. Right before patient was to be discharged home patient said her throat felt tight and disclosed it happened right after vaccine. No wheezing, VSS, no rash, vaccine site WNL. Patient remained in observation. Benadryl 25mg PO given  at 1635. Monitored for 30 more min after dose. Patient reported improvement of symptoms, no further c/o tightness. Patient informed to take another Benadryl at home if symptoms occur again at home and to call doctor or go to ER. Patient aware to receive 2nd dose at doctors office. Patient discharged home with sister in no distress. Vitals remained stable throughout occurrence.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 027L20A), in left arm, on 04Feb2021 as dose 2, single (Lot number: 010mzoa), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 06sf21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Giant cell arteritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: 11 days after starting Paxlovid I had a bounce back experience; positive, notes: Five days later I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment start date was 01Aug2022, treatment stop date was 06Aug2022, for treatment of COVID-19. 11 days after started treatment with Paxlovid the patient had bounce back experienced and started testing positive again. Five days later the patient tested positive and not feeling great. The patient does not think the dose is sufficient to knock out the virus.
Started yesterday afternoon with fever and notice a few slightly raised spots on trunk. Today has raised spots on face, chest, arm, a few on back. >than 50 spots.
She has received her third rabies vaccine and has developed pain and stiffness in her shoulder and neck on the side of administration now down her back into sacro iliac area, thought she had a fever early on but not now. She is slowly improving and will continue to treat symptoms, rx for naprosyn 500 mg bid and percocet prn, will rtc if sx persist.
Pfizer Covid 19 vaccine vial opened 08/15/2022 @ 8:28am and expired 08/15/2022 @ 8:28 pm  On 08/16/2022 The Clinical Staff administered 0.3 cc of the expired Pfizer Covid vaccine @ 10:08am  Patient informed and is currently doing well However vaccine dose invalid and will need to be repeated
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. In August 2012, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported) and in August 2013, the patient received the second dose of GARDASIL (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports.   A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.