chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cellultis; left lower leg turned stop-light red; swollen; itchy; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine and who developed cellulitis, her left lower leg turned stop-light red, swollen and itchy.  The patient's past medical history included cellulitis.  No relevant concomitant medications were reported.   On 19-Feb-2021, approximately 2 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the day of vaccination, the patient reported that her left lower leg turned stop-light red and that it became swollen and itchy. The patient was admitted to the hospital 20-Feb-2021 through 22-Feb-2021 where she was treated with intravenous vancomycin.   Treatment for the event included intravenous vancomycin.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis, her left lower leg turned stop-light red, swollen and itchy,  was unknown.; Reporter'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.
Ropey-looking rash or welt on the back; Ropey-looking rash; Feeling out of breath; Feeling rapid heartbeat; Feeling chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat), CHEST PAIN (Feeling chest pain), URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 in March 2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson COVID-19.    On 17-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat) and CHEST PAIN (Feeling chest pain). On 17-Dec-2021, the patient experienced URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash). On 18-Dec-2021, URTICARIA (Ropey-looking rash or welt on the back) and RASH (Ropey-looking rash) had resolved. At the time of the report, DYSPNOEA (Feeling out of breath), HEART RATE INCREASED (Feeling rapid heartbeat) and CHEST PAIN (Feeling chest pain) had not resolved.            No any concomitant medications were reported.  No any treatment medications were reported.  Patient took Johnson & Johnson COVID-19 vaccine as their primary dose in March 2021 and received the Moderna COVID-19 vaccine as their booster shot on 17-Dec-2021.   Reporter did not allow further contact
Unilateral leg pain/right leg throbbing; Fatigue; Sluggishness/felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness/felt sluggish), PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced SLUGGISHNESS (Sluggishness/felt sluggish) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing). At the time of the report, SLUGGISHNESS (Sluggishness/felt sluggish), PAIN IN EXTREMITY (Unilateral leg pain/right leg throbbing) and FATIGUE (Fatigue) had not resolved.            No concomitant medications were reported.   On an unknown date, the patient experienced right leg throbbing. In 2021, the patient experienced felt sluggish and fatigue. Moderna vaccine was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
aching in rt arm began 2 mons p/vax recvd, & still aches @ noc, p/writing/baking; hx of arthritis, rx past 10 yrs Seldane "this is not an arthritis-like pain;
Deceased 11/13/2021; Hospitalized 11/11/2021; COVID-19 positive 11/11/2021; fully vaccinated.  BRIEF OVERVIEW: Admission Date: 11/11/2021 Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Lower GI bleed COVID-19 HOSPITAL COURSE: 88 year old female that presented on 11/11/21 for severe covid-19 infection. Patient was initially intubated in the ED for Acute hypoxic respiratory failure 2° COVID.  However during the day 11/12/21 family meeting was held and patient's family decided to withdraw care. Patient was initially placed on Venti mask after extubation. However during the night of the 13th to 14th patient developed terminal restlessness. Morphine drip was started and family was contacted. Patient passed away on 11/13/21 at 9:29pm. Daughter was at bedside. Patient had no response pain, no heart/lung sounds over 2 mins, no carotid pulse over 2 minutes, and no pupillary reaction to light.  Time of death was called at 9:29 pm.
About 5 minutes after administration patient responded with itching. I gave her a 25mg Benadryl and watched her. At that time she called MD and MD told her to go to ER. She did not feel ambulance was necessary. She had no trouble breathing when she left. Vaccine was administered at approximately 11:40am and she left for ER at approximately 12p.
sore shoulder , tired, light headed, neck pain, shingles on neck, oozing from ears, eyes, mouth, covid toes
The first shot, I got it on 4/17/2021 around 3:30 pm and I felt only my arm for couple days. For the second shot, I got it on 5/7/2021 around 10:10 am, I wakeup around  4:30 am feeling sick, all my body weak no energy, headache and diarrhea. It's know 2:00 pm and I still feeling sick.
This spontaneous report as received from a 37 year old smoking female patient with asthma and unspecified allergy to latex refers to herself. On 17-MAY-2013 the patient was vaccinated with "one shot" of PNEUMOVAX23 0.5 ml, batch number reported H022064 valid number 0291AE expiration date 25-JAN-2014 dose and route not reported. The patient reported that she was prescribed PNEUMOVAX23 because of her asthma. Concomitant therapies included SINGULAIR (formulation not provided), albuterol, FLOVENT and unspecified hydrocodones, all of which she has taken for 10 or more years. The consumer called to find out what vaccine she had received during the call she paused to call her doctor and verified the vaccine as PNEUMOVAX 23. During the call the consumer started that PNEUMOVAX23 out her on her death bed, the vaccine was not safe. The caller used some profanity and became so distraught that she cried. Afterwards she calmed down and apologize for losing her temper. On 18-MAY-2013, the following day after onset of therapy the patient experienced an adverse reaction that includes feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up to the point that (she was) barely able to walk', coughing so severe that it felt like her 'brain busted out on her head'. wheezing, being unable to breathe and she feared she will die. The patient reported that she has never been sick like this before had any kind of serious reaction to any vaccine before. The patient had screening x-rays for pneumonia performed on 23-MAY-2013 but results were not provided. The patient sought unspecified medical attention and was given a treatment which included penicillin, ZITHROMAX and unspecified steroids. The outcomes of feeling like she is 'on her death bed', headaches, coldness, paleness, muscles 'locking up the point that (she was) barely able to walk', coughing so severe that it felt like 'her brain busted out of her head', wheezing, being unable to breather and she feared she will dead adverse events were reported as not recovered/not resolved, and the outcomes of crying and abnormal behaviour were recovering/resolving. The patient claimed that she was 'getting worse.' The reporter considered feeling like she was 'on her death bed'/PNEUMOVAX23 put her on her death bed adverse events to be related to PNEUMOVAX23. The patient also reported that an unspecified neighbor died from PNEUMOVAX23. (MARRS # 1305USA015672) This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 20-MAY-2015, the patients was vacinated with a dose of improperly stored VARIVAX (Merck) lot number K010441 (dose and route were not reported) and a dose of improperly stored M-M-R II lot number reported as 002528 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid lot number for stored M-M-R II. Additional information has been requested.
stated nurse gave inj too high on lt arm causing what pt is sure is nerve damage; had funny sensation go up arm & neck w/puncture; has had cont pain since which is not relieved w/Ibuprofen; has not yet seen MD when event reported in 19OCT95
I tested positive for COVID-19 on 4/28/23. I had congestion, irritated throat, fever, body, headache, and joint aches. I contacted my doctor and was prescribed Paxlovid and Zofran. I am still dealing with nasal congestion, but I feel much better now.
Client due for DTap and Hib immunizations on 8/10/21. Instead of giving ActHIB, Menveo was given.  Client's mother reports that he has not suffered any adverse reactions as of 8/12/21.
Throat swelling later in evening. Went to ER & they treated with BENADRYL, PEPCID & prednisone.
Arm is more sore on day 7 after it had been fine. On day 8 it is itchy and burns and there is a large red rash in a circle shape.   I feel fine otherwise.
temperature dip, throwing up, all flu like symptoms.  Lasted from 4pm til morning In the following months, i noticed handfuls of hair falling out.  Clumps of hair, not just individual strands.
Body aches, runny nose and hoarse voice, felt warm for 3 weeks after flu shot same received on same day. Patient had 500mg tylenol prior to receiving flu shot
Initial misuse report received from a healthcare professional on 22 November 2013. A '2-month-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE 2 month old was given 0.25ml dose and given another dose 30 days later with no adverse event, i.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Soreness in my arm and neck. developed a headache and had fatigue. Got chills, achy, and nauseous. Really bad muscle pain. Took Tylenol and Gatorade. Woke up to body aches that were so bad I couldn't move
NO ADVERSE EVENTS- PT PRESENTED FOR 2ND COVID SHOT. HE SCHEDULED HIS APPT ONLINE AND FILLED OUT HIS PAPERWORK ONLINE. HE FILLED EVERYTHING OUT FOR MODERNA. HE PRESENTED AND STATED HE WAS HERE FOR HIS SECOND MODERNA VACCINE. WE BILLED THE INSURANCE AS HIS SECOND DOSE AND IT WAS ACCEPTED. AFTER I GAVE HIM THE VACCINE, I ASKED FOR VACCINATION RECORD CARD. WHEN HE GAVE IT TO ME- IT WAS MARKED AS PFIZER FOR HIS FIRST DOSE. I QUESTIONED HIM AND SAID HE BELIEVED HE RECEIVED MODERNA INITIALLY. I RESEARCHED THIS AND WAS ABLE TO VERIFY THAT HE DID GET PFIZER AS HIS FIRST DOSE. HE WAS GIVEN MODERNA AS HIS SECOND DOSE TODAY. HE REPORTED NO ISSUES AND STATED HE WOULD CALL US IF ANY OCCURRED. I DOCUMENTED THE CORRECT VACCINE INFORMATION ON HIS VACCINATION RECORD CARD.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported as 1) 24-OCT-2016 [Date as reported. Further clarification needed.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
headaches; flu like symptoms; joint soreness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) on an unspecified date (at the age of 38-year-old) for covid-19 immunisation. On an unspecified date in 2021, the patient experienced headaches, flu like symptoms and joint soreness. They also wanted to know if it was okay to take tylenol or ibuprofen or will it interfere with antibody production. The event was reported a non serious. The outcome of all the events was unknown.   No follow-up attempts are possible; information about lot batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366793 same reporter/drug/AE with different patient
THIS LOCATION WAS INSTRUCTED TO PICK UP PFIZER VACCINE FROM HUB STORE FOR USE 3/24/21 AND 3/25/21.  THERE WAS NO EXPIRATION DATE OR SIMILAR INFO ON THE PACKAGING IN WHICH WE RECEIVED THE VACCINE AND DILUENT.  SINCE WE WERE TOLD TO USE THE VACCINE ON THESE DAYS ONLY (WE NORMALLY USE MODERNA), THE ASSUMPTION WAS THAT THE VACCINE WOULD BE WITHIN ITS BUD/TIME.  OUR STORE MANAGER WAS INFORMED AT END-OF-DAY ON 3/25/21 THAT VACCINE HAD EXPIRED AT 11:00 AM THAT DAY. CONSULTATION WITH PFIZER INDICATED THAT THE DOSE DID NOT HAVE TO BE REPEATED FOR PATIENT.
Pt vac w/ DTP/OPV had norm 4 mo well baby exam; Next day found limp & cyanotic. Brought to ER by paramedics, no signs of life after usual resuscitation measures. Possible SIDS.  06FEB91:  AUTOPSY REPORT RECEIVED FROM SHC; DX = SIDS
Administered vaccine in right thigh. When removing the needle, the needle and syringe separated. No vaccine was noted on thigh skin or in syringe. Discussed with parents and MD on call. No additional vaccination needed/given. No signs of adverse effect/injury.
Patient received second dose of Moderna on 4/15/2021 at 1:30  PM. Woke up in the middle of the night with a headache andfwver of 101-101.3. Felt achy. Started to feel better but then yesterday had a headache and stiff neck.
Headache, nausea, vomiting, joint pain. All symptoms began between 7 and 12 hours after injection
Within minutes of vaccination lips tingling, blurred vision, dizziness/vertigo, sweating. Was able to walk to a chair. Vertigo persisted less than 1 hour. Patient reported vaginal spotting after urinating. Was able to ambulate out of clinic.
Pt hit smallpox while in shower on the wall and the scab tore off. Pt cross-inoculated self with 6-7 identifiable locations. Pt has severe itching, bandaid irritation and localized blisters around the smallpox sites.
Patient left facility after shot, even though she signed to acknowledge that we recommend a 15 minute wait.    Patient had an episode of syncope when being driven home by her husband.
Erythema Multiforme Rash, No Stevens Johnson, no Toxic epidermal Necrolysis.  Treated the itch with Atarax.
patient known to have mild, intermittent, chronic leukopenia. now with significant worsening, ANC down to zero. patient started sulfasalazine about 6 weeks prior to worsening of leukopenia which might be the reason.
Constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose Covid vaccine), for COVID-19 immunization.   The following information was reported: CONSTIPATION (non-serious) with onset 2021, outcome "unknown", described as "Constipation". Therapeutic measures were taken as a result of constipation.  Additional information: The people have experienced the side effect of constipation with second shot of the vaccine. She said she (50 years old female) her boyfriend (52 years old male) and sister (60 years old) are experiencing bad constipation after the Pfizer covid vaccine. Her doctor has prescribed laxatives and they are taking 8-9 prunes a day..   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510559 Same Vaccine/event, different  patient
pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication were reported. No treatment medication were reported.
At first my entire upper left arm became red, hot, and tender within a day of receiving the shot. After a few days, it became an isolated red bump (~2 inches diameter?) that is still red, hot, and tender. It is only sore if I touch it. This bump hasn't changed for the past 1.5 weeks.
Messed up periods, after two decades of none, now I?m suddenly having 10+ days periods and horrible cramps.  Short version.
Mother reports the start of a rash at the site of injection on the right arm where varicella vaccine administered on 11/18/19 that got worse and spread. Also reported visible lymph nodes in neck. Rash has gotten better as of today 12/3/19. Lymph nodes still visible per mother.
Information has been received from a nurse concerning a female who on 07-Aug-2008 was vaccinated with a dose of GARDASIL. On the same day, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 104, 33 and R; 72, 29 and R; 112, 30 and R; 16, 31 and R; 24, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Neck pain; Headache; Arms and legs are painful; Hoarse voice; Fever; This is a spontaneous report received from non-contactable reporter (Nurse) from a sales representative.  An 11-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 02Mar2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; hpv vaccine (HPV VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 03Mar2022, outcome "unknown", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2022, outcome "unknown", described as "Arms and legs are painful"; HEADACHE (non-serious) with onset 04Mar2022, outcome "unknown"; DYSPHONIA (non-serious) with onset 04Mar2022, outcome "unknown", described as "Hoarse voice"; NECK PAIN (non-serious) with onset 04Mar2022, outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3-4 day following inject, exp discomfort like a weight on upper rt arm in muscle; no numbness, weakness, tingling or loss of feeling in extremity; sought treatment by MD;
I started feeling off and tired that afternoon. Then the next day I didn't feel too well the whole day. I started feeling feverish and by afternoon I was running a temperature of 101 degrees. On Friday I started feeling better Friday night. I had fever congestion, and mouth pain. It was difficult to eat or chew.
I had Covid, then got the vaccine I had an antibody test and it was very high before the 2nd dose, so I did not need the vaccine, you approved something that not everyone needs. I had heart problems with surgery, throwing up, muscle cramping, severe headaches, legs falling asleep and more, which I still have some problems with. You need to let the people know about the side effects of these vaccines every other drugs come with pharmacy info on them this should as well as it causes death as well. I had the modern vaccine. Never will I ever be able to get another or I was told I would most likely die.
Patient received varicella vaccine on 1/28/98 (had severe adverse event at time of vaccination). 11/27/06 Diagnosed with chicken pox.
Noticed small area of burning sensation at right side of wrist and the vein there was very enlarged and sticking out.