chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 16-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. It was unknown whether the patient had any complications or acute illness during this pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received contains non-significant information.
3 days after vaccines given in (L) deltoid, pt dev a small "lump". Noted to have small dermal cyst to (L) axilla at time of visit today.
Patient complained of fever, loss of appetite, body aches, dizziness, intermittent left chest pain, dyspnea, and weakness after receiving Janssen vaccine. He was seen by a medical provider on  12/18/21, and his vitals were within normal limits other than a low BMI 17.83.  He received Ibuprofen for costochondritis and myalgia. Advised to continue fluid intake and avoid rapid change in position.
28MAY93 pt recv vax & devel atrophy of fatty tissue, & some atrophy of rt deltoid muscle;on going pain, & problems mostly in area of inj;going inc into shoulder & dec arm into hand;a lot of MD seeked, tests, etc;
Very high heart rate/ heart beating very fast around 160bpm.; Blood pressure did also drop very low a few times; had the common flu like symptoms; Is Pregnant: Yes; This is a spontaneous report from a contactable consumer. This 31-year-old female consumer (patient) reported for herself that: A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 301308A), via an unspecified route of administration, administered in right arm on 01Oct2021 13:00 as DOSE 2, SINGLE and dose 1 received via an unspecified route of administration, administered in right arm on 10Sep2021 13:00 (Lot Number: FF8841) as DOSE 1, SINGLE both doses taken for COVID-19 immunization (at the age of 31-year-old). Medical history included allergies: Sulfa and allergies: Bee stings (honey bee, yellow jacket, wasps) from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid], cetirizine hydrochloride (ZYRTEC) and iron. The patient previously took amoxicillin and experienced allergies: amoxicillin. No other vaccines within 4 weeks prior to the COVID vaccine. Patient received following medications within 2 weeks of vaccination: Prenatal Vitamin, Low Dose Aspirin, Zyrtec, Iron. The patient did not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. On 01Oct2021 23:00 after the second dose of vaccination, the patient experienced very high heart rate/ heart beating very fast around 160bpm, blood pressure did also drop very low a few times, had the common flu like symptoms and patient was pregnant. Seriousness of the events reported as non-serious. The patient did not receive any treatment for events. The mother reported she became pregnant while taking bnt162b2. The mother was 29 Weeks pregnant at the onset of the event. The mother was due to deliver on 13Dec2021. On 01Oct2021, the patient underwent lab tests and procedures which included blood pressure: very low, heart rate: 160 bpm (High). On 03Oct2021, heart rate: little higher than normal. The patient required to visit physician office, and not hospitalization prolonged. The outcome of the events was recovering.
breakout on her shoulder; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. Caller was a patient reporting an adverse event on behalf of another patient.  The patient states that she was in the pharmacy and a woman in the pharmacy told her that after she received the 1st dose of Shingrix, she developed a breakout on her shoulder. Caller did not have any additional details regarding the event or patient. This case has been linked with US2020075700, reported by same reporter.
Pt stated she has been having one migraine headache per day since receiving the shot as of 8/19/19.  Stated she had one migraine on 8/17, 8/18, and 8/19.  She stated the migraines cause her head to hurt and her vision to blur.  Pt is not sure if it is the shot or not, but has had a total of 3 migraines since receiving the vaccine.  Pt stated she has advised Dr., but no treatment has been given as of yet.
Tachycardia, low blood pressure, near syncope, tremors, numbness, lightheadedness, severe weakness, fatigue. Dx'd with postural tachycardia syndrome. Came on suddenly and without warning within  a month of vaccination.60 day follow-up / no additional data. Follow-up: 2/8/00 - 1440 - Call to pt to ask if she had received, signed, and mailed consent form back to us. Could not leave message - house keeper does not speak English. 2/9/00 - 8:20 - Call to pt - left message on answering service requesting a call back. 2/11/00 - 1005 - Call to pt -She had misplaced consent sheet, but has now found it and will sign and return it now.
No additional effects noted; Patient may have accidentally received an MMRII vaccine intramuscularly as opposed to subcutaneously; the pharmacist however gave the MMRII vaccine to the patient in the deltoid and utilizing a technique for intramuscular administration; This spontaneous report was received from a pharmacist referring to a 43-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-MAR-2020, the patient was accidentally vaccinated intramuscularly as opposed to subcutaneously (incorrect route of product administration) with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) in the deltoid left arm for prophylaxis (strength was not provided, lot # S005251 had been verified to be a valid number; expiration date reported as February 20201, and upon internal validation established as 20-FEB-2021). Also it was reported the pharmacist utilized a technique intended for intramuscular administration (Wrong technique in product usage process). No additional effects noted.
Syncope instantly after injection. Questionable seizure. 24 hrs later, patient complained of numbness at injection site, unable to verbalize or move for several minutes. Persistent arm pain.
Bull's eye rash, rash has continued to spread to most of upper arm, arm is hot to touch and compared to opposite arm much warmer in temp. Pt also reported feeling tired and joint pain day after receiving ZOSTAVAX.
This spontaneous report was received from a pharmacist refers to an unknown age and gender patient. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, lot# H013020 expiration date 10-SEP-2013 strength, dosage and route were not reported. No adverse effects were reported. Concomitant therapy was not reported. Additional information has been requested.
Patient reported itching, hives on neck and arms and headache within 20-25 minutes of receiving her vaccine. Patient was evaluated in the EC and treated with Benadryl, Pepcid, Prednisone and Tylenol. Patient was discharged from EC at 4:45pm.
24hr post vax pt devel local swelling redness, itching & pain @ inj site-eventually involving arm from upper arm @ inj site to the elbow;joint pain in fingers & knees-mild h/a, nausea x 3-4 days;subsided w/o sequellae;no temp recorded;
Excessive swelling (large bump on back of my arm around injection area). Small knot still persists. Swelling lasted 4-5 days.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 16-AUG-2018, the patient was vaccinated with expired PNEUMOVAX 23 lot # M040804, expiration date 20-MAY-2018, for prophylaxis (route of administration and exact dose were not provided). No adverse event reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA009711.
Patient signed up for a flu shot but instead received a dose of Pfizer Covid-19 vaccine. Nurse vaccinator grabbed the COVID-19 Pfizer vaccine, which was placed next to the flu vaccine, inevitably incorrect vaccine was given to the patient. Patient has completed 2 doses of Pfizer Covid-19 vaccine on 4/15/21 and 5/11/21. Patient has received the booster dose of Pfizer COVID-19 vaccine outside of CDC recommendation for an immunocompetent person as a result of this incident. Patient later gave consent to receive COVID-19 Pfizer booster dose and a dose of flu vaccine.
The patient received 0.3 ml of undiluted Pediatric Pfizer (orange cap) vaccine instead of the Pfizer (gray cap).
Pt experienced severe sore throat, headache, body aches and high fever the next day, post vax. Symptoms lasted for 3 days.
Initially, as expected - mild fever, soreness. Then developed diffuse rash over body - none on face. Slightly raised and intermittently pruritic. Concentrated to arms and lower legs. Plan: Monitoring.
patient experienced syncope within 5 minutes of receiving vaccination. was in a seated position. no injuries were reported. moved patient to left side after gaining consciousness/
Patient ID:  MRN:   Name:   Age: 49 y.o.  Birthday:  Admit Date: 8/15/2022  3:08 PM  Discharge Date:  8/18/2022  Unit: 3A125/3A125A  Admitting Physician:   Discharge Physician: M.D.     Discharge Diagnosis:  Principal Problem:    Facial cellulitis  Active Problems:    Type 2 diabetes mellitus, with long-term current use of insulin    Morbid obesity    Acute parotitis    COVID-19 virus infection           HPI: "The patient is a 49 y.o. female morbidly obese, with type 2 diabetes mellitus, fibromyalgia. Patient reported that for the past 2 days she noted worsening swelling and erythema on the right lower face associated with fever. Her significant pain especially when opening the mouth. She was seen at ER and was diagnosed with facial cellulitis and was advised admission but she refuses. She was treated with Augmentin. Her condition worsened today does she came to our emergency room. She was seen by ENT and diagnosis was parotitis with facial cellulitis. She is edentulous with no gum swelling. She was started on IV antibiotics and steroid and will be admitted."     Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.         * Facial cellulitis  ?Right Facial cellulitis/parotitis. Failed outpatient treatment with oral antibiotic therapy. CT of the head and neck results reviewed. Continue IV Unasyn and Decadron per ENT recommendations and start Decadron Taper. Patient admits to history of MRSA infections in the past. Vancomycin added. MRSA swab is negative, transitioned IV vancomycin to by mouth doxycycline. Continue supportive/symptomatic treatment and pain control. Continue hydration with IV fluids. Continues with leukocytosis likely due to IV steroids. Continue to monitor with daily Lab. Pro-calcitonin trending down. Advanced to soft diet and tolerated well. Leukocytosis trended down with steroids taper. Cleared for discharge per ENT to follow up on patient. Transition antibiotics and steroids to oral.   ?Covid 19 virus infection. Remains asymptomatic from respiratory standpoint. Oxygen saturation within normal limits on room air. No IV Remdesivir . Continued to monitor. Ambulatory care manager referral on discharge.   ?Diabetes mellitus type 2. Continue with same home regimen/equivalent and adjust Levemir dose. Monitor blood sugar and cover with insulin sliding scale. Diabetic diet and A1c ordered.                  Physical Exam on the Date of Discharge:  Stable and improved.            Consults:    IP CONSULT TO SEPSIS NURSE NAVIGATOR  IP CONSULT TO OTOLARYNGOLOGY  IP CONSULT TO SOCIAL WORK     Significant Diagnostic Studies:     labs, microbiology, radiology, and cardiac graphics: per chart.        Disposition:  home     Discharge Condition:  good
Soreness in arm, rash near injection site. Heating pad on arm for soreness.
started spotting blood; A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am; Full body aches; exhaustion; menstrual like cramps for several days; This is a spontaneous report from a contactable consumer (patient), who is also an other Health Professional.   A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of , administration, at age of 25 years, administered in Arm Left on 30Mar2021 11:00 (Lot Number: EP7534) at single for covid-19 immunisation.  Medical history included Hashimotos , adhd (as reported), allergies to: Latex, corn, mint, morphine , beets, tobacco.  Concomitant medication(s) in two weeks included lisdexamfetamine mesilate (VYVANSE), levothyroxine, liothyronine (NP THYROID) and levocetirizine dihydrochloride (XYZAL), all taken for an unspecified indication, start and stop date were not reported. Reported that "A few hours after i had an unbearable headache that was not relieved until I took 800mg of ibuprofen and then 1000mg of Tylenol an hour later at about 1am. Full body aches and exhaustion. I also got menstrual like cramps for several days. Now I just started spotting blood when my period finished two days before I received my vaccine, which is extremely abnormal for me." Events onset date reported as 30Mar2021 15:00. Treatment drugs received for event headache, and no treatment received for other adverse events, The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  Outcome for events was recovering.   No follow-up attempts possible. No further information expected.
Headaches started after the second Pfizer vaccine. The headaches are on both sides of the  back of my head and  go up to the top of my head. I have had them daily now since the second dose . I had the shot in may and it is now august. I also recently had an autoimmune test come back positive. I think this shot triggered an immune response.
Shortness of breath, headache, rash in the injection area, sore throat, trouble swallowing after injection,
Febrile Seizure lasting about 5 min evaluated in ER then DCd. No known family hx of seizure. Given Motrin in ER and seizure info in office.
I got the flu shot from my work.  They brought in some nurses. About 1 week after the injection, I started to have severe allergic reaction.  Throat, chest and eyes were burning. My lymph nodes under my jaw swelled. I made an appointment with my Allergist.  Then, a few days later, I developed bronchitis. My symptoms had no phlegm but bronchial spasms.  I had a very low grade fever. My spams lasted about 4 weeks.  I went to my allergist, regular doctor.  They thought it was asthma which I don't have. The inhaler they gave caused heart palpitations and my low back to go out.  But, my concern was the bronchial spasms.  I've never had that for that long.  I ended up in the emergency room on 11/7/2012.  This all happened 1 week after the flu shot.  They said it was preservative free. I've had sickness before when I had the Preservative based flu shot so I always try to use the preservative free.  I've never had lung issues with any of the flu shots in the past. It's 11/26/2012 and I feel I've just gotten over all my symptoms.  I wanted to add that the emergency room doctor on 11/7/2012 said it was a virus and he couldn't do anything for a virus except give me more inhalers.
Immediately after I felt a little confused and light headed.   I remained at site beyond the 15mins I felt I could a least walk but still felt off.  As the day progressed I became lethargic and tired. I pretty much stayed in bed.  the following day I felt cold and body aches. After taking 2 500mg of Tylenol and sleeping I felt normal again. Regained energy and not sore.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions or drug allergies were not reported. On 25-MAR-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength and dose were not reported) administered subcutaneously (lot # M033904 expiration date: 20-JUL-2018) for prophylaxis. A sterile diluent (lot # and expiration date were unknown) was used to reconstitute the dose. According to the reporter, VARIVAX was exposed to the following temperature excursion: 2 hours between 6 degrees Fahrenheit (F) and 14 F. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA014489:
1st day: Swelling, redness,  pain in upper right arm, site of shot.  Swelled area measures 3x3?.  2nd day:  Swelling, redness & pain continues with migraine, chills, slight fever, body aches, extreme tiredness, slept most of the day, upset stomach, unable to eat much.  3rd day: Not as tired, fever & chills gone, redness, swelling & pain continues at injection site but now extends under my arm into the armpit area,  diarrhea started in the morning, continued throughout the day, face flushing, pain & swelling under my right arm, migraine returned.
I stated to the nurse after the vaccine was administered that I felt very dizzy; after a couple minutes the dizzy spell went away and I ask if it was okay to leave to which she replied yes. As I was walking out of the office I had to sit down in the waiting room because I had another dizzy spell. Once I sat down the dizziness was overwhelming and my last thought was to get a nurse, (although I don't remember exactly) when I got up to walk to the nurses door I passed out then had a seizure. The nurses and Dr. came out and took me back to put me under observation... I felt better after about 30 minutes. Once I left the Dr.'s office I read the take home care instructions given and it stated that if a patient advises to the nurse she/he is feeling dizzy to have the patient wait 15 minutes which my nurse did not; just thought that could have been related to why I had the reaction I did. Seek Advice Details: I have a primary care physician appt. tomorrow to follow up about side effects from the vaccine. The patient was taking HPV vaccine for: Per nurse request and based on age range.
Headache, Myalgia, Fatigue Narrative: Arm pain night of injection. Took Tylenol.
Fever, chills, body aches, swelling of the entire left upper arm with redness.
10 mins after first dose, pt reports feeling lightheaded, dizzy, SOB, and chest tightness. Pt denies numbness/tingling, sore throat, throat swelling, hives or fever. SBPs around 150s (normally in the 90s). Feels like she is going to pass out. Symptoms resolved and pt discharged at 2325.
swelling & erythema around inj site; total length of 15cm-rt upper arm;
Pt called and left a message with the clinic messaging service. She reports red painful right arm. ?Unable to move arm much? and ?shooting sharp pain? down to her hand and up to her neck
I started getting pain in my right wrist and was unable to do simple tasks like opening doors, holding cups and cutting food. Within a month, I was unable to move my wrist. I had an MRI which showed damage to the cartilage, tendon, ligaments and bone of the right wrist. I was then referred to a rheumatologist, who diagnosed me with psoriatic arthritis.
pt adm to ER 2 blisters loose abd & chest & thigh;no itching, one blister broken;described as varicella-like rash by MD;pt had vax on 9OCT for low titer;4NOV97 re-admit to ER w/many more blisters (20+);given rx for Vorivax;
Pt received Moderna vaccines on 01/28/21 and 02/25/21. During hospital admission, pt was tested for COVID and was found to be positive on 10/07/21
30 MINUTES AFTER DOSE PATIENT C/O DIZZINESS, NAUSEA, EPISODE OF VOMITING, DIFFICULTY SWALLOWING & HEADACHE. REFERRED TO PEDS OFFICE W/ BENADRYL AND SENT HOME.
Patient was given the product twice in a 1 month timeframe with no reported adverse event; Initial information was received on 15-Jan-2021 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient (of an unknown age and gender) who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] twice in a 1 month timeframe with no reported adverse event, [lot number and expiry date not reported) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error due to extra dose administered. (latency: at the time of vaccination).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
10 days after my injection, I developed an erythemic, itchy rash, slight induration,  @ 6-8 CM at the site of the injection. No other symptoms. The secondary reaction was not painful, mostly itchy & is resolving each day.  Initially, I got a typical reaction of erythema, induration,  & pain at site, which resolved after 23 hours. After some research/reading, there are documented cases of 'Covid Arm'....a' delayed cutaneous hypersensitivity' reaction,  after 7-10 days.'.