chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported a couple hours after vaccination arm became red, swollen, fever of 101.6, and area was hot to the touch. Happened on Saturday morning so on Sunday continued to ice the area. reported on Monday it spread further and after consulting PCP directed her to ER or urgent care. Pt reports that ER md said cellulitis and allergic reaction. Prescribed Bactrim and Keflex to treat the cellulitis.
Information has been received from a physician concerning a 20-something year old female who on approximately 11-MAR-2008 was vaccinated with her third dose of GARDASIL (lot number not specified). On approximately 11-MAR-2008 the patient experienced a severe rash. The patient sought unspecified medical treatment. It is not known if the patient's rash persisted. Additional information has been requested.
About two and half weeks after I received my third dose of the Pfizer vaccine, I started having episodes of chest tightness and heart palpitations. At first it was only a few times a day, but then within a week the episodes were happening 8 times a day and would last from1-5 minutes. The longest two episodes lasted 9 minutes and 20 minutes respectively. I also had an innate desire to cough and if I coughed a certain way, I could get myself out of the irregular rhythm.  The episodes would come unpredictably. Not brought on by exercise or exertion. 90% of the episodes would come on while standing or walking. The other 10% would happen while laying in bed, or exercising. Thankfully since the end of December they have decreased in frequency, but still happen intermittently.
Sudden drop in blood pressure. Shivering. Body stretched. Semi-conscious state/was passing out --> Paramedics were called immediately.
1st dose - body felt heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "1st dose - body felt heavy". It was unknown if therapeutic measures were taken as a result of discomfort.  Additional information: It was also reported that after receiving 2nd dose of vaccine, the patient  experienced bad headache (felt like nerve pain), achy body, body felt heavy, stomach ache, mild fever, chills nonstop, shivering all night, feels weak and sleepiness. Awareness Date was reported as 01Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SEVERE BRUISING ON BILATERAL LEGS  STARTED OFF DARK RED, BLUE GREEN AND PURPLE; FULL BODY NIGHT TIME SWEATING; FEVER; POUNDING HEADACHES THAT COME AND GO; BLOOD CLOTS ALL OVER MY LEGS; This spontaneous report was received from a patient and concerned female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, no known allergies, and born with slight thalassemia. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiry date: unknown) dose was not reported, administered on 02-APR-2021, at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had a fever of 102 Fahrenheit on 02-APR-2021. On 07-APR-2021, the patient noticed severe bruising on her bilateral legs, and stated that they were each about the size of a half dollar they started off dark red, turned blue, purple and noted they kept popping up. She stated that they were now blue and green in color. The patient felt that if she did not do something both her legs would be covered. She stated they were blood clots all over her legs. The patient had a visit to emergency room for the severe bruising on bilateral legs started off dark red and turned blue, green and purple. She also reported full body night time sweating every night and pounding headaches that come and go, especially upon standing.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-APR-2021, had not recovered from severe bruising on bilateral legs started off dark red, blue green and purple, and full body night time sweating, and the outcome of blood clots all over my legs and pounding headaches that come and go was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A female of unspecified age experienced fever the day of vaccine and 5 days later experienced bruising on bilateral legs the size of a half dollar. They varied in color. The patient visited the emergency room but details of diagnosis and treatment were not provided. There was no confirmation of a diagnosed thrombotic event. Based on the information provided, a meaningful medical assessment can not be made. Additional information will be requested, including contact with the patient and/or treating physician for further assessment.
Seizure immediately after the dose was given; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure immediately after the dose was given) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced SEIZURE (Seizure immediately after the dose was given) (seriousness criterion medically significant). On 04-Jun-2021, SEIZURE (Seizure immediately after the dose was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment information was reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Mild nausea and gas after 1st and 2nd dose. Symptoms disappeared after 10 months.
Inc t104 ax in Am following day; activity dec; gave cooling bath & APAP @ home; @ office was given APAP suppository; mom also sick w/throat infect; upper resp infect
Initial medication error report received from a health care professional on 16 April 2013.  A 63 year old patient had received FLUZONE HD, dose, anatomical site of vaccination and date of vaccination was unknown. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Swollen in supraclavicular lymph nodes, soreness, muscle aches, fever,  nausea, skin rash
Patient presented at Hospital for COVID19 Vaccine administration on 04/09/2021 at 1:21 pm. Upon checking in for her appointment, she was provided with COVID19 vaccine screening and consent form in which she denied the following:  ? Having allergies and reactions to any medication, foods, vaccines, or latex.  ? Carrying an Epi-pen for emergency treatment of anaphylaxis.  ? Having had a severe reaction to previous dose of this vaccine or to any of the ingredients of this vaccine.  After the vaccine administration, Patient was guided to the observation area for a 15-minute observatory period.  At approximately 2:00 pm- while in the observation area, approximately 15 minutes from vaccine administration, Patient, began to feel faint after family member was being treated by our medical alert team and sat down while hyper ventilating triggering a panic attack. At this time husband, also in the observation area, was asked by our medical team if patient had a history of panic attacks where he preceded to confirm that patient indeed has a history of panic attacks. Vitals were taken while patient was sitting in the presence of a nurse.  2:02 pm Vitals  ? Blood pressure 130/80 ? Oxygen saturation level 98% ? Pulse 83  2:04 pm-Paramedics were called by Lead Medical Assistant  2:14 pm -Paramedics arrived.  While the paramedic team assessed patient, EKG normal, vital signs normal. Patient was hyperventilating, became rigid, unable to open eyes with a locked jaw while grinding her teeth. Patient never lost consciousness.  At this time, patient?s husband and paramedic began speaking to her, comforting her, and assisting her with breathing exercises. Patient?s husband confirmed that was she was experiencing was one of her usual panic attacks that usually can last 30-45 minutes.  As a precaution, paramedics offered to transport patient to the nearest hospital to which the patient refused.  2:30 pm- patient was fully recovered and deemed stable by the paramedics? team.   At 5:00 pm- Center Administration called patient, she stated that she felt fine. No other symptoms reported.
has four varicella blisters, 2 on lt thigh, 2 on back;
loss of taste, prednisone tasted bad; loss of smell; diarrhea; Received 2nd dose 22 days after 1st dose; jerking and tingling 3 hours after receiving 2nd dose; Felt horrible, Brain fog; Was afraid; could not hold a glass of water; lethargic; back of my neck was hurting; sleeping for 20 hours a day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 22 days after 1st dose), PARAESTHESIA (jerking and tingling 3 hours after receiving 2nd dose), FEELING ABNORMAL (Felt horrible, Brain fog), FEAR (Was afraid) and ASTHENIA (could not hold a glass of water) in a 66-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.     Concurrent medical conditions included Neuropathy, Ligament tear, Thyroid disorder, Autoimmune disorder and Hypertension. Concomitant products included PREDNISONE for Autoimmune disorder, ATENOLOL for Blood pressure high, GABAPENTIN (NEURONTIN) for Neuropathy, LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 22 days after 1st dose), PARAESTHESIA (jerking and tingling 3 hours after receiving 2nd dose), FEELING ABNORMAL (Felt horrible, Brain fog), FEAR (Was afraid), ASTHENIA (could not hold a glass of water), LETHARGY (lethargic), NECK PAIN (back of my neck was hurting) and SOMNOLENCE (sleeping for 20 hours a day). On an unknown date, the patient experienced AGEUSIA (loss of taste, prednisone tasted bad), ANOSMIA (loss of smell) and DIARRHOEA (diarrhea). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 22 days after 1st dose) and NECK PAIN (back of my neck was hurting) had resolved, PARAESTHESIA (jerking and tingling 3 hours after receiving 2nd dose) and LETHARGY (lethargic) had not resolved and FEELING ABNORMAL (Felt horrible, Brain fog), FEAR (Was afraid), ASTHENIA (could not hold a glass of water), SOMNOLENCE (sleeping for 20 hours a day), AGEUSIA (loss of taste, prednisone tasted bad), ANOSMIA (loss of smell) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information includes  Neurontin for 2 days   This case was linked to MOD-2021-071211 (Patient Link).
A 3-4cm erythema spot at injection site. Happened immediately and gone in 20 to 30 minutes.
Pt presented approximately 5 minutes after first dose of vaccine with itching around injection site on L arm. Notice redness to pt's face, L arm. 50 mg Benardyl given an 20 mg Famotidine. Pt vitals and history obtained. Pt stated her R arm and back were itchy. Pt monitored for another 30 minutes, at which time pt stated itching was resolved. Redness had diminished, too. Pt dischrged with advice to folow up wth allergist before next COVID vaccine.
Body Aches; Feverish (Normal 97.0, recorded 98.5); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31H20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     MEDICAL HISTORY (Patient): Concurrent medical conditions included Diabetes.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)). At the time of the report, PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 97 (normal) recorded 98.5.         Patient took Advil as treatment medication for unknown use. No concomitant products were reported.   For mRNA-1273 (COVID 19 Vaccine Moderna ) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: significant FU attached which contain AE outcome
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8733), in left arm, on 30Dec2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: fragrances" (unspecified if ongoing); "known allergies: dust" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 22Oct2022 to 26Oct2022 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201273468 Same reporter/patient, same drug/different dose, different AE;
R arm local swelling                                                                                          Apply Cold compress Prn Return if symptoms worsen
Information has been received from a nurse and later a physician concerning a 15 or 16 years immunocopetent female patient with asthma and allergies to codeine, and shellfish who on unspecified date  was vaccinated intramuscularly with the first a 0.5 ml first dose of GARDASIL (lot# 660620/0571X). On approximately 12-NOV-2008 the patient developed an indent on her arm after receiving the first dose of GARDASIL. The patient sought physician's medical attention. Concomitant therapy included ADVAIR, MSD and ZYRTEC. The physician stated that the patient received the vaccination with out incident but gradually noticed a "quarter-sized" indentation in the area of the deltoid that is obvious to visual inspection. No pain, erythema, limited movement, rash or other complaints were reported. The patient is schedule to be seen in follow-up next week. At the time of this report it is unknown if the patient recovered. Additional information has been requested.  Follow up information was receivied from a physician who reported a 13 year old female (previously reported as 15 or 16 year old) with no medical history, illness at the time of vaccination and allergy history was intramuscularly vaccinated with the first dose of GARDASIL (lot# 660620/0571X) at 16:30 am on 03-NOV-2008 on the left arm. At 14:53 on 14-NOV-2008 (previously reported approximately 12-NOV-2008) the patient developed indentation to the left deltoid area at injection site with no pain. She performed shoulder soft tissue ultrasound but results were pending. The outcome was not reported.  Additional information is not expected.
received dose about 1040am and returned at 1140 stating she had a rash on her chin which progressed to her upper chest area. No difficulty breathing, SOB.  Offered 50mg Benadryl, which she declined due to fasting for Ramadan.  RN instructed patient and daughter symptoms to watch for and to go to the nearest ER. Patient observed for 30 additional minutes with no increase in symptoms.
I awoke the next day, Sunday 5/27/18 with soreness in muscles and joints, and rate them as 7 out of 10 on pain scale. My right deltoid was swollen and very painful (10 out of 10). I was very lethargic, and went back to bed, slept 5 hours, up one hour and back to bed until Monday morning. Same things on Monday 5/28/18. I was not able to do any of my normal activities of living, or my chores. I was somewhat better on Tuesday morning, 5/29/18 and went to work. But was  overcome again by lethargy and ended up laying on the floor there for 3 hours until I was able to drive home. Then slept thru to Wednesday 5/30/18. My joint and muscle pain started to resolve, and I was able to work my regular day. I was normal on Thursday 5/31/18. I am in excellent health, walk 3 miles daily, eat healthy diet, and maintaining normal weight for my height for years. I cannot remember being sick over the last 2 years, including colds. n fact, I do not remember being that sick in years.
Two days post vax, pt developed an injection site reaction characterized by redness, swelling and pain. Pt felt drunk.
Took injection on Wednesday 08/20/2003.  Noticed swelling redness and warmth on Thursday 08/21/2003.  Donor called in was advised.  On Friday 08/22/2003 donor returned to center.  Area on right deltoid approximately 4 inches diameter.  Slight swelling warmth pink, no pain.
Muscle pain all over body, fever, chills, weakness, dizziness, shortness of breath, pain with breathing Cleared up in its own in 48 hours.
Paleness, fast heart rate, weakness, muscle and joint pain, labored breathing, dizziness, nervous, bad dreams, restless, faintness.
Arm swelled, difficult to raise/grab/lift anything, same side knee swelled and painful.
significant right axillary adenopathy, lasting 5 weeks and with intermittent recurrence for 3 weeks
On 11/03/00, HBV #1 Engerix was administered. The patient had a raised, itchy, rash on his back and arms, 24 hours after the vaccine. The patient did not seek treatment. The rash and itch comes and goes.
Pt reports inj. site was raised red and tender to touch. Pt called to report symptoms to provider on 4/27/17 and was told to ice, use Benadryl and mark site and if any problems with SOB or throat tightening she was to go to Urgent Care.  If not improved on 4/28/17 she was to contact provider to be seen.
"Felt great until 36 hours after shot. It just hit suddenly, felt exhausted, chills and body aches. Very bad from midnight to 230am.  Got up a 6am with a very bad headache, at 9am I took tylenol.  I got up at noon and felt great until midnight that night, same symptoms but much less severe.  had fever/chills, no body aches.  when i got up at 7am i had a headache but not as bad as previous."
10/15 Administered at 4:00p 10/16 vomiting x 2 at 8:30 a, localized, erythema, LLE, 2 areas, Top about 1" diameter, bottom 4 cm x 6 cm.
Approximately 48 hours after vaccination developed rash on left side of chest, rash eventually spread under arm to back. Diagnosed as shingles by same practitioner who prescribed SHINGRIX.  Rash is painful, burning.
Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient who was vaccinated po with the first 2.0 ml dose of ROTATEQ at 2 months of age (date unspecified). It was reported that the patient did not return for the second dose of ROTATEQ 4 to 10 weeks later. The LPN reported that the patient is now exactly 7 months old (unspecified if patient received second dose at 7 months). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
pneumonia; flu; Initial information received on 22-Nov-2020 regarding an unsolicited valid serious case received from that consumer/non healthcare professional (patient) via social media.  This case involved a 65 years old patient who got the flu (influenza) and pneumonia, while the patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 1975, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed pneumonia (serious) and flu (influenza) (non-serious) (unknown latency for both events)following the administration of INFLUENZA VACCINE. The event pneumonia was assessed as medically significant.  It was reported that, patient had not taken flu shot since then and did not take COVID shot.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for all reported events.  There would be no information available on the batch number for this case.; Sender's Comments: This poorly document case received from media concerns a patient with unknown demography who experienced pneumonia and influenza, after vaccination with INFLUENZA VACCINE (Flu shot), produced by unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, immune status and lab test ruling out predisposing etiologies were not reported. Based upon the reported information the role of vaccine cannot be assessed.
Arm started getting sore within couple of hours.  Symptoms worsen by evening, patient was nauseous, had stomach upset (4 bowel movements)--she went in her pants while sleeping.    Arm was sore from shoulder to elbow and could not lift it.   Stomach symptoms started to alleviate after bowel movement. Patient took ginger and liquorice tablet to help with stomach.    Patient still somewhat sick to stomach and fatigue.  Arm still is sore but can actually use it now.   Called doctor but has not been able to speak to them yet.
On March 9, I noticed some discomfort in my left arm.  Upon examination, I observed swelling in my left arm around the injection site. There was also redness around the site measuring 4 1/2? long and 3 1/2? wide. It was warm to the touch. I applied ice to the area and took a Benadryl capsule.   The ice brought down the swelling and the redness did lighten some.  Today I still feel some discomfort in the shoulder, the swelling is gone, and the redness, although lighter, has increased in size to 5 1/2? long.