chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON 02/08/2021 AROUND 0600 RESIDENTCOMPLAINED OF MOUTH PAIN AND RECEIVED OXYCODONE. DURING THE COURSE OF THE MORNING, RESIDENT EXHIBITED A FEW EPISODES OF LABORED/SHALLOW BREATHING AND SOB AT RESTING. 0XYGEN SATURATION RATE WAS 93-98% ON ROOM AIR, LUNG SOUNDS CLEAR IN ALL LOBES AND PULSE AND TEMPERATURE WITHIN NORMAL RANGE. AS THE DAY PROGRESSED, VITAL SIGNS REMAINED STABLE BUT RESIDENT CONTINUED TO HAVE PERIODS OF SOB/LABORED BREATHING.FAMILY AND NURSE PRACTIONER UPDATED AND THE ORDER WAS RECEIVED TO SEND PATIENT TO MEDICAL CENTER ER FOR EVALUATION PER AMBULANCE. RESIDENT TRANSPORTED AT 1425. RESIDENT RETURNED FROM THE ER AT 1830 ON HOSPICE CARE WITH THE DIAGNOSIS OF: ACURE RESPIRATORY FAILURE  WITH HYPOXIA AND END OF LIFE DECISION MAKING. RESIDENT WAS MADE COMFORTABLE AND MONITORED DURING THE NIGHT AND EXPIRED AT 0630 ON 02/09/2021.
I had a running nose and lots of congestion. I had trouble breathing. These symptoms are ongoing. I tested positive for COVID-19. I went to a clinic about this. They gave me the antibodies fusion.
6/4/03 pm mom noticed sl. rash around inj. site of lt. thigh. Area was hard and red and swollen mid thigh to just above knee. Today 6/5/03 rash is gone/site looks pink and is still hard, swollen, has not spread. Child is not in pain, no fever. 6/4/03 mom iced leg. 6/5/03 am bath given. 6/5/03 getting better.
Patient experienced chest tightness, difficulty swallowing. Patient took a BENADRYL and felt okay.
57-year-old male with PMH of DM 2, paranoid, seizures unspecified, autism presents to the emergency department due to a fall from the patient's bed.  Patient states that he woke up on the floor after falling out of bed, does not remember the fall itself.  Patient remembers getting off up after unspecified amount of time and getting himself back into bed.  Patient denies losing continence or biting his tongue.  Last known well time was this past Friday.  Patient is reported to be altered, unstable gait, and incontinent.  The weekend of event patient had hard time ambulating and had to be carried back to his bed.  Patient states that he does not have a caregiver.  He states that he completes his ADLs on his own Diagnosis:  Metabolic encephalopathy, Likely due to COVID19 infection in the setting of baseline cognitive dysfunction, Drug induced tremor likely from anti-psychotic medications and depakote.        Plan:  Limited MRI brain w/o contrast to evaluate for stroke given reported left sided weakness Further stroke work up depending on MRI brain results Recommend reducing Depakote dose to 750 mg BID given mildly elevated level.    Currently in hospital on 01/05/2022 in COVID stepdown unit.
burning and pinching in injection site, move down arm ito hand, took tylenol, pink, itchy
Initial phone call was approx 2 hours after admission. C/O fever, nausea and headache.  Parents called again approx 1 hour later c/o worsening symptoms and going to the Emergency Department. Patient checked into the Emergency Department at 1:15pm. Vitals at the Emergency Dept: Temp 39.1 C, Heart rate 118, Resp 28, Blood Pressure 79/58, SpO2 94%. Patients was flagged for Sepsis and received a Sepsis workup to include CBC, CMP, POCT Lactic acid, blood cultures x 2, IV fluids x 3 liters, Resp PCR panel, Chest XRay, Urinalysis and PO Tylenol. Patient was discharged from the Emergency Department at 6:22pm.
On 04/2021, I started having menstrual irregularities. It could have happened after the 1st vaccine, but it is hard to say, until it was repeated several times. On 04/2021, I was having periods initially separated by 10 days, then more frequently, they were coming 2 or 3 days in between. I was bleeding more days than not bleeding. I was prescribed progesterone 100mg every night, and that did not work. They raised the prescription: progesterone 200 mg and that stopped working after 2 months. 11/2021, I had a DNC. 12/2021 I had an ablation. It has only been a month, but I have not had any bleeding at this time, so I would say unknown at this time.
Persistent, nonstop tinnitus of varying levels. This is my main complaint, going to an ENT soon. No related events (loud noises, concerts, etc.).  Also some cold sweats and trembling 12 hours out or so. Went away by the following morning.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 05Apr2021 as dose 2, single (Lot number: ER8734), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 45 years (as of dose 1 and dose 2), in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medications included: MONTELUKAST; ALBUTEROL HFA; MOMETASONE; CLINDAMYCIN. The following information was reported: COVID-19 (medically significant) with onset 20Jun2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive; (21Jun2022) Positive; (24Jun2022) Positive; (26Jun2022) Positive; (27Jun2022) Negative; (29Jun2022) Negative; (30Jun2022) Positive; (01Jul2022) Positive; (02Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included: nirmatrelvir; ritonavir (PAXLOVID). Clinical course: tested positive on 20Jun2022. Took nirmatrelvir; ritonavir from 21Jun2022 to 25Jun2022. Significant symptoms initially that improved and then resolved with nirmatrelvir; ritonavir. Tested positive on 21Jun2022, 24Jun2022, and 26Jun2022. Tested negative and symptom-free 27Jun2022 and 29Jun2022. Symptoms returned late in the day on 29Jun2022. Tested positive 30Jun2022, 01Jul2022, and 02Jul2022. Mild symptoms so far in second round.
neck stiffness; headache; swelling in the arm; This is a spontaneous report from a contactable physician via Sales Representative.  An adolescent female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) and influenza vaccine (FLU), both in via an unspecified route of administration in right arm on 2019 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date in 2019 the patient experienced neck stiffness, headache and swelling in the arm. The events were non-serious with outcome of unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine at 12:30 p.m. on Thurs., 4/15. By bedtime, I was experiencing body aches quickly followed by severe chills and a splitting headache.  Was awful. Lasted all evening. At 9:10 a.m.  on Fri, 4/16, I had a seizure that I believe was caused by the vaccine since I haven't had a seizure for over a year (and the last one was triggered by a med change). After the seizure, my symptoms increased to include vomiting and nausea along with a severe headache. The vomiting stopped around noon. My headache lasted until Saturday morning. I felt okay Saturday, just a slight headache.
Cardiogenic shock; This literature-study case was reported in a literature article and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension, Congestive heart failure, Atrial fibrillation, Chronic kidney disease, Chronic obstructive lung disease and Type 2 diabetes mellitus.    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 CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cardiogenic shock. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CARDIOGENIC SHOCK (Cardiogenic shock) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  Company Comment: This case concerns an 82-year-old female patient, with medical history of hypertension, congestive heart failure and atrial fibrillation, who experienced the fatal event of CARDIOGENIC SHOCK. The event occurred on an unknown date after receiving a dose of unknown number of the Moderna COVID 19 vaccine. Date of death was not reported, and it is unknown if an autopsy was performed. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, congestive heart failure and atrial fibrillation remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from SARA team and  contains significant information. Added correspondence contact in general tab; medical relevant history in patient tab.; Sender's Comments: This case concerns an 82-year-old female patient, with medical history of hypertension, congestive heart failure and atrial fibrillation, who experienced the fatal event of CARDIOGENIC SHOCK. The event occurred on an unknown date after receiving a dose of unknown number of the Moderna COVID 19 vaccine. Date of death was not reported, and it is unknown if an autopsy was performed. The rechallenge is not applicable considering the outcome of the events. Patient's medical history of hypertension, congestive heart failure and atrial fibrillation remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: Cardiogenic shock
Very sore arm at site, then I got very very cold, chilled to the bone cold. Then headache and restless legs for about three hours, nausea, woke with a very bad headache.
The patient complained of swelling at the injection site and had seen a doctor who prescribed Augmentin.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Patient reports headache ( pain scale of 6/10) and nausea, no other symptom. BP :99/61, pulse: 72, Spo2 :100% Patient was seen and cleared by EMS.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information included ibuprofen.
Pt admitted to hosp 28SEP91 x 5 days p/vax recvd; dx perirectal abscess; asthma w/rt middle lobe synd;
Pounding headache; Chills; Body ache; Mild nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:30 (at the age of 46-years-old) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (lot number: EL9266) via an unspecified route of administration, administered in the left arm on 23Feb2021 13:30 for COVID-19 immunization. On 14Mar2021 03:00, the patient experienced pounding headache, chills, body ache, mild nausea, and fatigue. The patient did not receive treatment for the events. The events lasted for about a day and a half. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
I had my Moderna booster at 3:00pm. At 2:00 am, I was woken up because I started to feel shortness of breath and my heart was pounding quickly. I also was achy and had a fever. The racing heart/shortness of breath lasted for approximately 3 hours. The fever and aches remain today (approx 11 hours since the vaccine). The symptoms were troublesome but I waited them out. Thankfully, they got better. I did not have any bad reaction to my first or second dose of moderna except pain at the injection site, some fatigue and a headache. This experience was completely different.
started getting bad headaches as she speaks she feels throbbing pains, when walking she has to walk slowly and if she does to much she gets pain in the base of her neck then pains goes to the right side of her head and ear
Havrix adolescent dose administered intramuscularly in left arm on 05/15/2005.  Father called on 05/07/2005 indicating she has sore throat and swollen nodes in neck since 05/06/2005, no fever.  Father called 05/08/2005 - temperature 101 with worse throat pain.  Sent to ER - diagnosed with strep throat, put on an antibiotic.  05/12/2005 much improved, no pain.
Contact Dr. for vaccine information. left side of head hurts. Headache ever since taken vaccine. 11/15 weak arm
Ec'd HPV dose 1 L deltoid on 7/20/17; Hurt a little off and on since got the vaccine, improving  and now only sore to touch right where she got the shot; Noticed swelling L upper arm yesterday, can see it most if abducts shoulder a little; Since noticed, staying same size; No paresthesias; R handed for writing, L for sports; Otherwise well, no recent illness; No rash; Feels well overal, no changes in appetite, activity; No fever; Approx 1 cm area induration at injection site L deltoid, no erythema, mod tenderness, surrounded by 5 x 6 cm area boggy swelling, no erythema, nontender (most noticeable with shoulder abducted approx 45 degrees); No fluctuance throughout; Normal cap refill, motor, sens no pain to active or resisted should ab- or ad-duction nor to internal or external rotation strength 5/5 thoughout B shoulder movements.
pneumococcal vaccine given left deltoid --> site swollen and red. next day more swollen and red.
Lung cancer; B-cell non-Hodgkin's lymphoma; Breast cancer female; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4148979-00 (AbbVie).  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 76 years as dose 2, single and intramuscular, administration date 26Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 05May2021 for ankylosing spondylitis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BREAST CANCER FEMALE (medically significant) with onset May2021, outcome "unknown", described as "Breast cancer female"; LUNG NEOPLASM MALIGNANT (medically significant) with onset 05May2021, outcome "unknown", described as "Lung cancer"; B-CELL LYMPHOMA (medically significant) with onset 05May2021, outcome "not recovered", described as "B-cell non-Hodgkin's lymphoma". The action taken for adalimumab was unknown.  Additional Information: The reporter's causality for the event(s) of breast cancer female and lung cancer with Pfizer BioNTech Covid-19 Vaccine was a reasonable possibility. The reporter's causality for the event(s) of basal cell non hodgkin's lymphoma was  not provided. AbbVie's opinion is that the events of breast cancer female, lung cancer and basal CELL NON hodgkin's lymphoma  are not assessable. The reporter's causality for the event(s) of breast cancer female and lung cancer with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of basal cell non-hodgkin's lymphoma was not provided. AbbVie's opinion is that the events of breast cancer female, lung cancer and basal CELL non-hodgkin's lymphoma are not assessable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patients mom stated child broke out in whelps at 8:30 am 10/30/03.  Mom states allergies severe in family, instructed to go to clinic if worsens.  Mom wanted to try bebedryl first, refused to go to clinic after offered to make appt for her.
Nausea, dizziness, dry heaving started 10-20 minutes after receiving flu vaccine for 1st time. Sent to ER, given 4 mg ZOFRAN and 25 mg BENADRYL. Symptoms improved after ZOFRAN but then increased again after BENADRYL given IV. No SOB, swelling of lips or difficulty breathing.
3 hours after receiving the FLUZONE injection she developed flu like symptoms, aches, chest tightness, mouth swelling, cough and phlegm and sinus drainage. Appt 845 am 10/21/10.
Passed out twice after receiving shot and began seizing while unconscious. Experienced uncontrollable shaking after coming to.
Pt had a vasovagal response to vaccine immediately following vaccination. Pt stated that she was about to pass out from vaccine then proceeded to lose consciousness and present seizure like symptoms with eyes open unresponsiveness for approximately 5 - 10 seconds. pt regained consciousness and recovered completely immediately following incident. She then and only then reported that she has a hereditary vasovagal condition and this had happened previously as a child.
Pt was hospitalized with covid on 6/10/22 and died on 6/25/22
Rectal bleeding; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm, on 25Feb2021 at 15:00 (at the age of 69-years-old) at a single dose for COVID-19 immunisation. Medical history included Waldenstrom's macroglobulinaemia and internal hemorrhoids. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified medications taken within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: GL9269), in the left arm, on 04Feb2021 at 15:00 (at the age of 69-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced rectal bleeding on 28Feb2021. The clinical course was reported as: The patient noticed rectal bleeding and reported that he occasionally experienced this due to internal hemorrhoids, but it is normally caused by either taking nonsteroidal anti-inflammatory drugs (NSAIDs) or by not chewing food properly or undue stress. This time, though, the patient thought it may be related to the vaccine, as none of the other causes appear to apply. The patient did not receive any treatment for the event. The clinical outcome of rectal bleeding was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Child presented with a fever of 101 which eventually went up to 102.5, right arm was red, swollen and sore at injection site (PREVNAR).  Tylenol was given at 5pm with no effect, Ibuprofen given at 8pm which reduced fever and the child then had a temperature of 96 with chills and sweats.  Within 24 hours the fever was down to 99.  Arm remained red, swollen and sore at injection site for two more days.
Several hours after the vaccine was injected, I developed a large red welt on my right arm. It grew about 20% overnight, and is still growing. My arm is quite sore and stiff, and the welt is red and hot to the touch. About 24 hours later, I'm developing very mild wheezing. (Oops. I forgot to add in the 'allergies' section that I get a similar reaction to getting 30+ mosquito bites at once.)
flat rash on arms & head, no fever, mom states pt is restless;tx w/DPH as per nurses noted 10JUL96PM;
Pt stayed 30 min for monitoring d/t hx of allergies. 2 hours after admin developed wheezing, chest tightness, diarrhea. Went to ED, had severe diarrhea, throat swelling, chest tightness, DIB, n/v; pt received IV doses of steroids, benadryl, IM epinephrine, racemic epinephrine breathing treatments x2; and duoneb tx's every 2 hours. Pt required overnight admission to the hospital for monitoring as had some persistent symptoms.
Severe nerve pain and burning upon administration. Unable to use arm due to significant pain and burning. Wearing a sling due to pain.
Swelling of upper arm, redness of upper arm, itching, bruising, lasted 3 weeks. Took BENADRYL - didn't work.
At 10:20 AM on 10/17/2001 had swollen lips, vision problems, throwing up and dizzy. Called mom. Said she would take her to Dr. Cannot get call back from mom now.
I had woke up at 2:00 AM, had seizures (myoclonal?), I think it went on for about 30 minutes. Okay since
Sore arm, chills, fever, aches, fatigue, nauseous - began to feel relief 49 hrs after shot.
Headache, sore throat, nonproductive cough, chills, and body aches. All starting 1/8/22.
Pain, redness, raised red area that was hot to the touch, diarrhea, overall yuck feeling.
Rash, red and raise , intense itch on arms and legs and the body.  Pt was prescribed zyrtec and used steroid cream.  It has been continuous since the first dose on 2/27.
Moderna COVID-19 Vaccine EUA: Patient was underage. Moderna COVID-19 Vaccine EUA: Vaccine recipient was 16 years, 0 months, and 24 days old when they received their first dose of Moderna vaccine. Vaccine recipient was 16 years, 1 months, and 22 days old when they received their second dose of Moderna vaccine.