chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 3 weeks following my 2nd dose of the Pfizer vaccine, I experienced two days of diarrhea (April 29-30). On May 1, I broke out into hives for seemingly no reason, starting at my joints (knees, elbows, wrists, ankles, cervical spine) which quickly spread to the rest of my body, covering approximately 80% of my skin. I have never had a rash like this in my life (aside from Chicken Pox as a child), and am not aware of any allergens that could have caused me to breakout in this manner. I do not have seasonal allergies. My only food allergy is to bananas, which causes a mild tingling sensation in my mouth/throat and upset stomach, but does not cause anaphylaxis. I did not knowingly ingest or was exposed to bananas at the time my rash presented. The hives were extremely itchy and although I have been medicating with Zyrtec and Benadryl, the rash has only started to recede today (Day 4).
This spontaneous prospective pregnancy report has been received from a pharmacist referring to a 23 years old female patient. Information about concomitant medication and medical history was unknown. On 31-JUL-2017, the patient was vaccinated with VARIVAX (dose was not reported), lot # M043581 with expiration date 28-OCT-2018 and M-M-R II (dose was not reported), lot # M039914 with 26-SEP-2018, subcutaneous for prophylaxis. On 03-AUG-2017, the patient presented at another pharmacy complaining about rash. On the same day, the patient's mother explained that "the patient was 7 weeks pregnant and had pustules in mouth and vaginally, was a little feverish and  uncomfortable from the rashes, but otherwise, she's fine". The last menstrual period (LMP) and estimated date of delivery (EDD) were approximately 15-JUN-2017 and 22-MAR-2018. The pregnancy outcome was outcome pending. The outcome of rash, pustule in mouth and vaginally, little feverish and uncomfortable from the rashes was reported as not recovered.
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization(EUA): Patient received the third dose of Covid Vaccine on 10/12/2021. Diagnosed with new onset Afib with RVR on 112/19/2021. 69-year-old female with history of paroxysmal atrial fibrillation now on Eliquis, actinic keratosis, asthma, elevated homocysteine, hypercholesterolemia, hypertension, hypercholesterolemia, nephrolithiasis, OA, renal mass, alpha gal allergy
sore right arm; cold sore on her lips; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips). At the time of the report, MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Applied Abreva Cream
Dizziness, Headache, NauseaVomiting, achey, lightheaded
Vaccinated 4/10/21, fully vaccinated 4/24/21.  Case became ill on 4/29 with "cold like symptoms" and tested C19+ on 4/30.
MY tinnitus had been an afterthought after a few years when it first occurred in 2004.  Soon after the 2nd moderna vaccine, it has gotten progressively worse.  Met with my ENT a few days ago and he informed me he has had numerous patients complain about tinnitus after receiving a COVID vaccine.  Some of my friends and relatives have also mentioned the same thing.  The ringing in left ear is constant and is getting worse.  Since a hearing test on 5/26 showed I have "Asymmetrical sensorineural hearing loss, unilateraL, with restricted hearing on contralateral side", he has ordered a "MRI BRAIN+INTERNAL AUDITORY CANAL, W/WO CONTRAST.  My MRI appt is 6/3.
Pt with a history of prostate cancer and currently on radiation therapy.  Presents with lightheadedness and dyspnea on exertion.  Admitted for hypoxic respiratory failure secondary to COVID pneumonia.
Shortness of breath and I kept getting shorter breath everyday, little tighter; My arm was sore; Irregular heart rates; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 10:00 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus syndrome" (unspecified if ongoing), notes: Verbatim: Lupus syndrome; "Arthritis" (unspecified if ongoing), notes: Verbatim: Inflammatory arthritis; "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Tracheomalacia" (unspecified if ongoing), notes: Verbatim: Tracheobronchial malacia; "Low Immunoglobulin" (unspecified if ongoing), notes: Verbatim: Low immunoglobulins/I have low immunoglobulins so I get IV IG; "Rare Lung Pain" (unspecified if ongoing), notes: Verbatim: Rare lung pain; "Hypogammaglobulinaemia" (unspecified if ongoing), notes: Verbatim: Hypogammaglobulinemia; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemia; "Inflammatory arthritis" (unspecified if ongoing); "lung surgery" (unspecified if ongoing), notes: I have had lung surgery, it didn't feel like any of that it was just shortness of breath. Concomitant medication(s) included: CIMZIA taken for arthritis; IVIGLOB-EX; PLAQUENIL S; NAPROXEN; SYMBICORT; ALBUTEROL HFA; TRAZODONE; ZOLOFT; POTASSIUM; MAGNESIUM; VALTREX. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Location: Left arm, Time of administration:10:00am), administration date: 12Feb2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath and I kept getting shorter breath everyday, little tighter"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm was sore"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Irregular heart rates". The patient underwent the following laboratory tests and procedures: cytomegalovirus test: they were fine; full blood count: they were fine; heart rate: irregular; investigation: they were fine. Therapeutic measures were taken as a result of dyspnoea.  Addittional information: Additional information: Patient took steroid Medrol (Methylprednisolone) as a treatment received. Time of vaccination: Nurse Practitioner stated, It was like 10 o'clock in the morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slight headache this morning; sore arm; felt a chill last night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (felt a chill last night) and HEADACHE (slight headache this morning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (felt a chill last night). On 05-Mar-2021, the patient experienced HEADACHE (slight headache this morning). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (felt a chill last night) had resolved. On 05-Mar-2021, HEADACHE (slight headache this morning) had resolved.            No concomitant medications provided. Treatment included 2 doses of Excedrin and increased water intake.   Reporter did not allow further contact
Breakthrough case.  Covid positive results on 9/8/2021 by PCR test
Fever 102F. Occurred after 2 doses of APAP taken for musculoskeletal pain. Fever brought under control by alternating ibuprofen with acetaminophen. Fatigue and musculoskeletal pain for 4 days after vaccination.
This case was reported by a healthcare professional and described the occurrence of urticaria on both feet in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included needle stick injury. At the time of reporting, there were no concomitant medications or relevant medical history. The subject may have "had a reaction to NOVOCAINE." The subject had a needle stick injury previously which was the reason for the ENGERIX B pediatric. There were no reported adverse reactions to previous vaccinations. On 28 January 2014 at 17:00 the subject received 1st dose of ENGERIX B pediatric (20 mcg/ml, unknown route, left arm). Per the reporter, the subject received 2 pediatric ENGERIX B vaccinations (to equal the adult dose). On 30 January 2014, 2 days after vaccination with ENGERIX B pediatric, the subject experienced urticaria on both feet (described as urticaria on feet, armpits and scalp). Per the reporter, the urticaria began on the subject's feet then moved up to her armpits and then her scalp area. It was unknown if the immunization series was delayed or discontinued. At the time of reporting the event was unresolved and ongoing. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B pediatric.
Approximately 2 days after receiving vaccine, the patient developed a sore throat, low grade fever, and muscle aches. All symptoms resolved on their own;within another 72 hours.
nurse gave a patient the DPT and Polio component of Pentacel, and did not reconstitute the HIB portion,no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case involves a 6 months old female patient who received 0.5 ml dose vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U6615AB via unknown route in unknown administration site., on 05-Dec-2019 was inappropriately reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that nurse gave a patient the DPT and Polio component of Pentacel, and did not reconstitute the HIB portion.  It was unknown whether the patient had any adverse reactions.  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.
POTS; develop shortness of breath; chest pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 11:30 (Lot number: EW0196) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM; LEXAPRO; SPIRONOLACTONE. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 28Oct2021, outcome "recovering", described as "POTS"; FATIGUE (disability) with onset 18Jul2021 08:00, outcome "recovering", described as "fatigue"; DYSPNOEA (disability) with onset 20Jul2021, outcome "recovering", described as "develop shortness of breath"; CHEST PAIN (disability) with onset 20Jul2021, outcome "recovering", described as "chest pain". The events "pots", "fatigue", "develop shortness of breath" and "chest pain" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (28Oct2021) pots; sars-cov-2 test: (21Jul2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, fatigue, dyspnoea, chest pain included: propanolol and physical therapy. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After many visits with different specialists patient was diagnosed with POTS on 28Oct. Never had any problems like this until got the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
2nd dose has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The pharmacist reported that the second dose has not yet been administered to the patient. The reporter declined follow-up from Safety for now due to wanting to ask if the patient if it was okay first. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Exp loss of conciousness, diaphoresis, nausea. Onset 2 minutes after immunization. Hyptensive.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL. On an unknown date, the patient experienced anaphylactic reaction immediately after receiving first dose of GARDASIL (hospitalization). On an unspecified date, the patient's white blood count dropped experienced anemia. The patient sought medical attention and was treated by an unspecified hematologist at the hospital. The company representative was unsure if the patient was hospitalized or if treatment was done in an outpatient setting. The outcome of the events were reported as recovering. Additional information has been requested.
Within about 10 minutes experienced heart thumping and light headedness.  Felt overall as though I was hyperventilating, but breathing was normal.  By that evening, I was feeling "not right".  By the next morning, started chilling, temp was elevated, over all "sick" feeling.  Experienced that until the next afternoon.  Arm was very sore (still is, but better).  Please note that I had Covid starting November 8, was very ill 2 weeks and continued feeling extreme weakness and fatigue for several weeks after.
had hives on both legs that phased in & out the evening of shot on 28MAy96;the hives were gone by the next morning;
70 yo man with multiple severe medical comorbidities received his first dose of Moderna COVID-19 vaccination without incident. 8.5 hours later, he was noted by his family to be in his usual state of health. 9.5 hours after the vaccination, he was found down by his family in cardiac arrest. Resuscitation attempts were not successful, and the patient died.
I do NOT know that this was a reaction to the vaccine.  I am reporting this because it was a new problem which occurred after the 3rd vaccine (no problems after the 1st and 2nd vaccines) so that you have the data. Approximately 3 weeks after the vaccine, the patient noted increasing pedal edema and over the next 2 weeks developed "stabbing" pain in her legs, left more than right leg.  She was also noting that her lower legs felt tight, as if there were bands wrapped around them.  This affected her walking and interfered with sleep.  She does have severe venous stasis of both lower extremities, left worse than right, with h/o thrombosis in a superficial vein in the left thigh.  She did follow up with her PCP, and LE doppler was negative for current clot, and xray fibula/tibia and ankle were negative except for mild degenerative changes in the left knee.  Then 2.5 weeks later, she had an episode of afib with RVR with nausea, weakness -- this is probably not related.
180cm X 110 cm area of induration and cellulitis on L thigh.  Treated with Keflex 250/5 ml 4 ml TID for 10 days.  Benadryl 12.5 mg/5 ml 7.5 ml po q6hours prn.
tingling/numb feeling down left arm and hand. My pointer and thumb had sensation while my middle, ring, and pinky would go cold and numb. I frequently massage my hand/arm to circulate blood and now wear a brace, given to me by my PCP to reduce stress on my wrist for 6-8 weeks. Though im sure this is a nerve issue rather than carpel tunnel.
Rash chest and arms appeared after few days. Pruritus using Benadryl. Rash resolving per patient.
Arm hurt by that night pretty bad.  The next day a very hard lump, that could be felt about 5 inches across my arm.  Severe burning at shot site.  Turned very red, hard hot swollen and I felt like I had the flu.  Worse at night. Burned too much to sleep. Hurt too much to touch it.  Cold wash cloth on it at night so that I could sleep some.  Took 4 Motrin to relieve the body aches etc. Still the same 2 days later at 10 P.M.  I have had bad reactions two other times. None last year.  The year before 2008 had fever of 104.  Once before had arm not as bad as this time.
"Covid arm" -- marked redness, swelling, and pain in affected arm which lasted 5 days. Also: malaise, headache.
Site was painful and red. Then a large ball; spread with a red circle around the hard ball area where the vaccine was administered, by Sunday. Provider instructed client to take Claritin for an allergic reaction and to apply ice to the area. Client took Benadryl instead of the Claritin. Site still was "itchy" yesterday. Site is clear today, March 15, 2013.
Fever (101 F), Body aches, Malaise, Exhaustion, Poor appetite, Chills, Sweating, Dizziness, Nausea
5/3/21-Contacted by individual to report that she has tested positive for COVID-19 test result with the following symptoms: cough, chills, headache, sore scratchy throat, congestion, runny nose, loss of smell, and fatigue. She has been Vaccinated x 2 with Pfizer COVID vaccine and denies any chronic conditions or medications.
Faint, feverish, vomited twice, diarrhea, blurred vision, ringing in ears, numb arm, disoriented and difficulty communicating.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema, injection site warmth and injection site swelling to be possibly related to SHINGRIX. Additional information was reported as follows: The case was reported by the registered pharmacist (RPh). The patient received SHINGRIX in left deltoid.
Patient called to verify her appointment for this week and mentioned that her arm was still sore from the last injection on 08/27/2021. I told her that is usually long to have that side effect. I told her she should try using a muscle rub to see if that would help.  She said it wasn't a big issue, but it was just still sore.  I told her if it doesn't improve, she should go get it checked out.
stomach pain, vomiting, pancreatitis, severe pain in stomach and back, liver count went up
C/O red leg, no pain. Apply cool compress. Call DR on Monday am. Per DR on call.
PATIENT REPORTED "FEELING FLUSHED" AND "A LITTLE NAUSEOUS" IMMEDIATELY AFTER INJECTION
Almost fainted the day after getting the vaccine, after lunch.  Ears ringing, sweaty, legs weak, had to sit down.  Lasted a few minutes before symptoms went away.
ABOUT 1 HOUR AFTER RECEIVING MODERNA BOOSTER, PATIENT REPORTED PERIOD BLEEDING, VERY HEAVY BLEEDING, BAD CRAMPING, AND WAS ABOUT 10 DAYS FROM THE START OF REGULAR PERIOD START DATE. PATIENT REPORTED THIS ALSO HAPPENED WITH HER 2ND DOSE OF MODERNA SERIES.
severe diarrhea is reported in pt who recvd flu vax last year; pt ate eggs 24 hrs following vax & exp above sx; pt has no h/o allergies to eggs;
Patient received vaccine at 1015 am. While waiting in the store for observation, she began to feel a racing heart, shaking from the inside out, and difficulty catching her breath around 10:30.  911 was called.  She stated her throat started to feel tight, dry mouth, and metallic taste and was given an epi pen.  The patient stated she started to feel better after the epi pen was administered and declined medical transport when emergency services arrived.  Per emergency services, notable negatives include: no hives/rash, no localized reaction, no wheezing, no angioedema, no hypotension, no flushing.
Received full dose of Moderna vaccine and reported breakthrough covid positive case on 8/16/2021, verified by PCR test.
Mother reported that pt "can't hold his head up." She stated she was taking him to ER because pediatrician told her to. See ER record and nurse's notes. (ER visit unremarkable. Advised mother to "keep an eye on the child.") Pt never had a fever.
Shortness of breath Chest pain Pain in my jaw Pain at the roof of my mouth Hive on my right forearm, which was raised & red
Janssen COVID-19 Vaccine EUA: During the post-observation period, vaccine recipient developed pruritus, fine raised rash on face, itchy throat, swollen under left eye. She was treated with diphenhydramine by EMS. She was monitored for additional 45 minutes. Then she continued to have itchy throat and felt that throat was swelling. She was transported to the emergency department.
I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I woke up to a ramped up ringing in my ears that has not subsided. The noise level increased at minimum 50% and it causes brain fogginess I have not previously experienced.
Went for routine checkup; bloodwork showed elevated fasting blood glucose and elevated alkaline phosphatase. Also have occasional muscle aches. Alkaline phosphatase has been elevated before (prior to vaccine). I reported all of this on the Check-in and received a follow up call from the CDC encouraging me to fill out a VAERS report.
High fever, severe chills, extreme nausea, vomiting, mild joint aches came on  all at once 13 hours after injection; severe nausea subsided after 9 hours, but continued mildly for rest of the day after the shot and patient was unable to eat; one bout of vomiting at 3AM; fever subsided to 100.5-101 for the entire day after the injection, though tylenol and aspirin were taken every four hours throughout the day.
devel fever same eve p/vax; given Tempra 29DEC92 slept til 6AM-30DEC fever 102; given Tempra; pt keeps jumping like hallucinating & falling; alternating between crying & sleeping; t101;