chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a PharmD concerning a 25-26 year old male whose vaccination history was unknown was vaccinated (route and site not reported) on 23-OCT-2007 with Pneumovax 23. On the same day the patient was concomitantly vaccinated with DTAP (manufacturer unknown) and influenza virus vaccine (unspecified - manufacturer unknown). On 24-OCT-2007, the patient developed influenza-like symptoms: headache, chills, fever and body aches which resulted in the patient missing two days of work. The patient sought unspecified medical attention and no further information is available. At the time of this report the patient had not recovered. The pharmacist felt that the patient's headache, chills, fever and body aches were disabling. This is one of several reports from the same source. Additional information has been requested.
Pt diagnosed with EBV and suspicious lesion removed which was benign - no relation to vaccine.
12-18 hrs after 1mm-cried x 20 mins, legs "beet red" knees down x40.  Then petichiae on legs below knees, non elsewhere.
day 2: itchiness, redness at injection site throughout the first week, injection site got more irritated, redness increased, swollen, almost looks like a bruise, mild itchiness day 7: injection site redness and swelling decreasing.
SWOLLEN LEGS; RASH; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021, the subject experienced swollen legs. On 16-APR-2021, the subject experienced rash. On 16-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, headache and swollen legs was not reported. This report was non-serious.
localized reaction, Left upper arm redness, warmth, tenderness, swelling. Symptoms started on day of vaccination, 8/21/23, with progression
I experienced what I would describe as a minor localized reaction. The symptoms I noted on Friday after the vaccine was an itchy sensation and under left arm lymph node tenderness on the side of injection. The area was red firm to touch and approx. 3 inches circular around the injection site.  The symptoms are slowly resolving with the redness/itchiness and firmness at the site. Lymph Node tenderness is resolved.
Patient claimed anaphylaxis. Stated that it didn't occur until 1 1/2-2 hours after vaccination but she went to the hospital and was treated accordingly.
I woke up in the middle of the night between midnight and 04:00 with a fast heart rate, shortness of breath and out of it but fell back to sleep and at 06:30 A.M woke up with chest tightness and pain by 01:00PM I was still feeling chest pain and tried to reach out to my primary care physician and was not able to reach him and call the insurance nurse hotline and was advised to go to the ED and after 7 hours of being at the ED the physician told me at 09:30PM that my CT showed inflammation and it could be the start of pneumonia and if I wanted a antibiotics and I declined. I had several tests done and they were all normal except for CT. The next morning I woke up and was fine.
After the injection, my arm was sore, heavy chest down the left arm with tingling,  titanium left breast marker was throbbing, cough with excess mucus.  No fever
Sore arm; Headache; Unresponsive/he was standing in aisle just staring; Catatonic; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic), DEHYDRATION (Dehydrated), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035B21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autistic disorder. Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced HEADACHE (Headache). On 09-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In 2021, the patient experienced STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic) and DEHYDRATION (Dehydrated). At the time of the report, STARING (Unresponsive/he was standing in aisle just staring), CATATONIA (Catatonic), DEHYDRATION (Dehydrated) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medications were provided. No treatment information was provided.  Company Comment: 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. However, the patient's past medical history may remain a confounder. Further information has been requested.; 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. However, the patient's past medical history may remain a confounder. Further information has been requested.
Patient developed myopericarditis two days following second dose administration. Patient had two days of chest pressure in the substernal chest
Severe Headache (7/10) and neck stiffness/aches, excessive tiredness at 12 hours post-injection.
Left lateral thigh with deep pink / purple indurated area with surrounding redness.  Inferior redness with warmth to touch.  Area does not appear tender to palpation.
pt had flushing and redness of cheeks and neck. 25mg of benadryl issued to patient.
Initial case received from a healthcare professional on 07 July 2011. A 2-year-old male patient, with a history of asthma and possible allergies, received an injection of YF VAX (lot number UF805AA) on 12 May 2011. Per the reporter, the patient had been feeling "under the weather" prior to vaccination; he did not have any specific symptoms, but felt like "something was coming on". On 13 May 2011, the patient had an asthma attack and was seen in the emergency department. He was treated with one 20mg dose of prednisone. Outcome was unknown. Per the reporter, the patient had not experienced any previous adverse reactions following vaccination. Outcome was not reported. Documents held by sender: None.
Stroke, neuropathy,  abnormal breathing, dizziness, post-prandial & postural problems, brain fog , fuzzy sight,tinnitus, headache,etc.
right arm was very sore; feeling horrible; Body aches; headache; joint pain; nausea; tired; chills; fever (100.4); muscles ached; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6199), via an unspecified route of administration in the right arm on 13Mar2021 at 10:00 AM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications include cholesterol off (not codable) (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN). The patient experienced sore right arm, slept on her left side on 13Mar2021 at 16.00, woke up feeling horrible, body aches, headache, joint pain, nausea, tired, chills, fever (100.4), muscles ache. Patient had taken 2 Tylenol (MANUFACTURER UNKNOWN) as treatment for reported events. The clinical outcome of the events body aches, chills, feeling horrible, fever (100.4), headache, joint pain, muscles ached, nausea, right arm was very sore, tired were resolved.   No follow-up attempts are needed. No further information is expected.
warm, feels warm; arm is little swollen; redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain). At the time of the report, INJECTION SITE WARMTH (warm, feels warm), INJECTION SITE SWELLING (arm is little swollen), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (pain) had not resolved.; 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.
Janssen on 5/6. Positive on 8/9 admitted on 8/15-current
A few minutes after receiving the shot I noticed extreme tiredness and light headedness. I got up to notify staff and my vision went and I began to feel nauseated. They helped me to a seat and I began sweating profusely and the nausea intensified. After several minutes the nausea and vision changes subsided and I continued to feel extremely tired and light headed.  The staff put a heart rate monitor on me and I saw that my heart rate was sitting around 38-42. I felt like I just wanted to close my eyes but the staff kept asking me questions. After several more minutes a cop arrived. Later on an ambulance arrived and when they put the blood pressure cuff on I noticed tingling in my hand from it. I continued to feel light headed and extremely tired through arriving at the hospital via ambulance around 10:30am. These symptoms gradually subsided throughout the afternoon leaving me with light headedness  only when walking or moving around. While at the hospital they did an EKG which showed inverted T waves (from what I remember of the PA's description) and so admitted me for observation and performed an echo which came back normal. I was discharged around 10pm on the same night.
BACK ACHE; INCREASED HEART RATE; FEVER; FATIGUE/VERY TIRED; This spontaneous report received from a patient via a company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced back ache. On 08-OCT-2021, the patient experienced increased heart rate. On 08-OCT-2021, the patient experienced fever. On 08-OCT-2021, the patient experienced fatigue/very tired. Laboratory data included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back ache, increased heart rate, fever, and fatigue/very tired on 09-OCT-2021. This report was non-serious.
Fever (over 102 degrees) for ~36 hours Chills Body aches Red hot at injection site for ~96 hours
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information was not reported.  It was reported that the Moderna vaccine was put out of the freezer on 01-Dec-2021 and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 05-Jan-2022. And it was also stated that the vial has not undergone any temperature excursions
Soreness and limited range of motion in (L) arm. Swelling at injection site. Difficulty in supporting weight on (L) arm in yoga; Unable to remove clothes over head. Treat with acupuncture and PT.
Injection site reaction- circumferential thigh swelling, redness, tenderness. Inconsolable crying for 2 hours.  Given Tylenol and cool compress.
A spontaneous report has been received from Health Professional concerning a patient of unknown gender. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving nasal FLUMIST quadrivalent started on an unknown date. The reporter stated that a patient was showing influenza like symptoms and the provider would like to test them for the flu. They received the FLUMIST and would like to know how long after receiving that vaccine they were able to complete a nasal swab for influenza testing without the FLUMIST altering the results. The outcome of the event of influenza like symptoms was unknown. The reporter considered the event of influenza like symptoms to be non-serious.
Rash at injection sight. Extreme dizziness, tiredness, sweats/chills for two days. Late on second day, I was prescribed meclizine, third day the dizziness was greatly reduced, other symptoms gone. By third day  rash has continued to grow and blisters on injections have developed
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BLOATING; GAINED WEIGHT; WEIGHT LOSS OF 5 OR SO POUNDS; This spontaneous report received from a patient via other company (AbbVie) concerned an elderly female. Initial information was processed with additional information received on 29-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient had felt the side effects such as bloated and fatigues and gained weight when the patient started Skyrizi and had never felt sick. The patient tested positive for covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and afterwards received a negative result. In 2022, the patient had a weight loss of 5 or so pounds. Laboratory data (dates unspecified) included: COVID-19 virus test negative, and had positive (the physician thought it was a false positive result). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with risankizumab was not reported. The patient recovered from suspected covid-19 infection, bloating, and gained weight, and the outcome of suspected clinical vaccination failure and weight loss of 5 or so pounds was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complain: 90000238693.; Sender's Comments: V0:20220658464-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
L shoulder area is erythematous, mild swollen & not Tender skin feels hot to Touch.
The next day the lymph node under left arm felt like a lump; Dose number: 3; The dizziness was so significant could not even drive a vehicle; Was in extreme pain after booster; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 at 11:45 (batch number: unknown) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Allergy NOS" (unspecified if ongoing), notes: Known allergies: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Left arm; Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Left arm; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 at 11:45, outcome "unknown", described as "Dose number: 3"; DIZZINESS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "The dizziness was so significant could not even drive a vehicle"; LYMPHADENOPATHY (non-serious) with onset 24Dec2021, outcome "recovering", described as "The next day the lymph node under left arm felt like a lump"; PAIN (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Was in extreme pain after booster". Therapeutic measures were not taken as a result of dizziness, lymphadenopathy and pain. Additional information: Some symptoms were minor. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Flu like symptoms including body aches, exhaustion, and fever (100.8 F).
feeling sick after second dose; achy after second dose; flu-like symptoms after second dose; tired after second dose; fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose). At the time of the report, ILLNESS (feeling sick after second dose), PAIN (achy after second dose), INFLUENZA LIKE ILLNESS (flu-like symptoms after second dose), FATIGUE (tired after second dose) and PYREXIA (fever after second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test: positive (Positive) COVID in Oct 2020.         Concomitant medication was not provided.  Treatment information was not provided.
An improperly stored dose of GARDASIL 9 was administered to the patient; No adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drugs reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date: 14-JUN-2020 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. The vaccine was under a temperature below 36 fahrenheit degrees (F) of 32.1 F during a time frime of 8 hours as recorded by a data logger. No previous temperature excursion was reported as well as no adverse effects.
This spontaneous report was received from a registered nurse regarding a multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates following a previously reported excursion, the patients were vaccinated with improperly stored VARIVAX (therapy type digital data logger) (lot # L001332, expiry date 13-JAN-2017 and Lot # L041207, expiry date 20-OCT-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature of 20.1F for a time frame of 3 hours and 27 minutes. It was reported that the vaccine was administered, since there was a previously reported excursion, with a temperature excursion of 13.5F for 3 hours and 3 minutes. Product quality complaint was not filed. No adverse effects were reported. On the other hand, the reporter stated that M-M-R II appears on the product list as temperature stability questions were asked, however, no doses of improperly stored M-M-R II were administered to any patients. This is one of the three reports received from the same reporter (MARRS #1606USA000381 and 1606USA000382). Additional information is not expected because the primary reporter did not want to be contacted.
TDAP administered IM to (L) deltoid on 9-1-2010. Student presented 9-3-10 with 24 hours hx edema, erythema, tenderness at site of administration. Ice applied, BENADRYL 25mg po q 6 hours prn & Ibuprofen 400mg po TID prn.
Developed "bump" on left side of nose near left brow/eye that developed surrounding swelling on 23 Jan 02. No fever, chills, nausea, vomiting, malaise or other systemic symptoms reported. Seen in ER and treated with one dose of unknown IV antibiotics. Advised to follow-up as outpatient and received 2nd dose 24 hours later.
Pt hospitalized with fever of unknown origin, drop in platelets and hematocrit. Probable diagnosis was ? but subsequent ? testing negative. Serums (acute-convalescent) sent to lab. Acute: o convalescent: 1:1600.