chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm both vaccines.; experienced Raynauds disease in my right hand on 3 fingers; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 34-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203 and Expiry date: not provided), dose 2 via an unspecified route of administration, in the left arm, on 20Feb2021 at 16:00, as single dose for COVID-19 immunisation. The patient's medical history included hashimotos disease. The patient was allergic to shellfish allergy and bees. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN9581 and Expiry date: not provided), dose 1 via an unspecified route of administration, in the left arm, on 29Jan2021 at 18:45, as single dose for COVID-19 immunisation and got the sore pain. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. On 23Feb2021 17:00, the patient experienced sore arm both vaccines and raynaud's disease in her right hand on 3 fingers. The patient did not receive any treatment for adverse events. The patient did not receive any other vaccine in four weeks. The patient did not test for COVID-19 post vaccination. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Patient here for  Pfizer booster.  Reported a headache, monitored for 30 minutes. Headache continued denied any other signs or symptoms.  A&Ox3, respirations even and unlabored. Skin pink, warm and dry.
Influenza vaccine administered 2pm.4:45pm began to itch all over. 9pm took Benadryl 50mg. Worse in morning. Took Dph 50g at 9am.
It was reported that a 72 year old male received a Fluzone '99-'00 vaccination on 10/22/1999. Reportedly on 10/30/99, the pt developed a red area on his left arm that looks like a rash. The rash was noted 4 days, post vax of the Hep-B shot.
I received the Pfizer Bivalent COVID-19 booster on 9/21/2022. On the evening of 12/14/2022, I noticed that I had scratchy throat and a feeling of a viral onset. On the morning of 12/15/2022, I underwent a PCR test, which yielded a positive result. I was prescribed PAXLOVID and I started taking it that day. I experienced aches and chills the first night, and I had a cough that lasted until about 12/22/2022. I took DELSYM and albuterol for the cough, and they were moderately helpful. My symptoms began to improve 12/17/2022, because the body aches and chills went away and the cough diminished.
No adverse effect reported; patient received first dose 2017 and received second dose 2019; Information has been received from a physician referring to a 15 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and and drug reactions/allergies was not provided.   On an unspecified date in 2017, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were not provided) for prophylaxis at age 14 years old. On 09-JUL-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)  (lot number, expiration date and route of administration were not provided) for prophylaxis at age 16 years old (inappropriate schedule of product administration). No adverse effect were reported. No product quality complaint (PQC) was identified.
Pt. C/O  Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairment of her airway, complaint improved with swallowing water. She also developed an itchy rash (very faint) on left arm.  which resolved over about 10 minutes.
Less than 48 hours after recieving the vaccine, my son woke up with excruciating abdominal pain. The pain was localized on his right side. He vomited so violently, that he actually started vomiting blood. I was afraid his appendix was on the verge of rupturing. I was unaware that he had received the vaccine until we arrived at the Emergency room. The doctor stated that this event could have been caused by a virus or from inflammation triggered by the vaccine. He was also told that the blood may have been a result of a blood vessel rupturing induced my violent vomiting. He was given Zofran and IV fluids while in the emergency room. NO record was made of this statement and the discharge papers did not include anything about the vaccination. He was discharged and sent home. He began to feel better within 2 hours of being sent home. He slept most of the next 24 hours. After this initial attack, he seemed to be doing well. Until 9/2/2021. He woke up this morning with the same symptoms and pain. He decided not to go back to the emergency room because they were unable to do anything for him the previous time. The pain and sickness subsided within 2-3 hours of onset.
Fluctuating heart rate. Shortness of breath. Chills with low pulse  but no fever. Pulse in low 50?s at rest and up to 130 with activity.
hard lump size of egg at injection site, mild erythema, itching, sore to touch, continued swelling at injection site for 6 days
Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diarrhea.  She started getting ill after receiving her second dose of the Pfizer Covid vaccine. Admitted to hospital for 2 day stay.
Redness and slightly swollen injection site. Patient reports having some itchiness at injection site.  Was seen by Dr. this morning (3/31/08).  MD recommended to just watch and observe injection site for now.  Is using TAC cream that was given by MD previous visit.
Swollen arm; very tired; strong headache; strong pain in the arm; arm difficult to move; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (strong pain in the arm), MOBILITY DECREASED (arm difficult to move), PERIPHERAL SWELLING (Swollen arm), HEADACHE (strong headache) and FATIGUE (very tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (strong pain in the arm), MOBILITY DECREASED (arm difficult to move) and HEADACHE (strong headache). On 19-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and FATIGUE (very tired). On 21-Jan-2021, PAIN IN EXTREMITY (strong pain in the arm), MOBILITY DECREASED (arm difficult to move), PERIPHERAL SWELLING (Swollen arm), HEADACHE (strong headache) and FATIGUE (very tired) had resolved.        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.   Concomitant medications Lisinopril. Treatment details were not provided.    This case was linked to MOD21-032007 (Patient Link).
Face swelled and eyes swelled - child was given standard peds dose of diphenhydramine and stayed home from school. By later that day - around 6:00 pm child was back to normal.
achy, chills, cold sweats, severe fatigue, dizziness, nausea - 48 hours
It did my whole body turned blue; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: FC3180 and expiration date: not reported), via an unspecified route of administration, on 04Oct2021 (at the age of 70-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included vitamins and other unspecified drugs. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date, as DOSE 2 and DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in 2021, after 3rd dose, the patient whole body turned blue. The patient would like to know if side effect was dangerous or if it was going to get worse. Therapeutic measures were taken as a result of the event included Benadryl. The outcome of the event was unknown at time of report.  No follow-up attempts are needed. No further information is expected.
18 days after the first dose, I had a flurry of eye floaters, light sensitivity, headache and dry eye that made it difficult to work. My eye doctor said my eyes and retinas were normal and had no explanation for my symptoms. These symptoms continued until a few days ago, when I had acupuncture, which remedied most of the issues. The acupuncturists said the vaccine destroyed my immune and blood system, which was confirmed with a blood test which showed my ferritin levels at 9, which are considered "dangerously low". I've never had any issues with my eyes or iron levels prior to the vaccine, and now I have to live with some remaining eye floaters.   After the second dose, I had immense fatigue that made me miss work for almost 4 weeks, along with continued eye floaters and eye problems.
Erythema, swelling, itching 6 inches x 6 inches at the injection site, occurred within 2  hours of injection. Applied cold packs only. No other treatment reqd. Issue has resolved except a little itching persists.
Bright red flat patch measuring 3.5 by 4 cm where vaccines were given. Patient had MMR and DTAP.
When come in the counseling room for vaccinate, patient was scare and nervous.  Dad had to hold her hand to calm her a little.   About ten or fifteen minutes after the shot, she complaint that her vision was blurry and that she cannot see.   She also complaint of nausea and about to pass out.  Patient seem to get anxiety attack in a moment.  I stay to monitor patient for about 10 minutes.  Dad believed she got anxiety over the shot that's why she experience all this symptoms.  Patient sat another 5-10 minutes and was resumed to normal
Pt rec'd ZOSTAVAX 10/30. Called to report 11/3 index-card sized raised, red, pruritic area that developed over the weekend. No other symptoms. Used home care/local therapy on the area. Improving today.
pt recv vax & c/o sx 3 days p/vax;pt exp sweating w/ c/o h/a & localized rt shoulder discomfort & confusion followed by chest pain upper rt side w/SOB;presently rt upper chest tightness;rt temple h/a;RLQ discomfort (pressure);
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299794 and 2018SA299809 (same reporter). This case involves 68 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
On 10/12/11 PNEUMOVAX 23 was administered onset on pain same day & into next AM, gradually worsened around site, down to elbow, cross collar bone & shoulder (R).
This spontaneous report as received from a registered nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown dates staring on or after 28-MAY-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L039660/expiration date-04-FEB-2018 (incorrect product storage). No adverse event was reported. No concomitant medication was reported. Excursion temperature was 33 F and timeframe was 1 hour. There was prior temperature excursion of 64F for 4 hours. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
PATIENT WAS ADMINISTERED HER FIRST DOSE OF MODERNA.  AFTER ABOUT 5 MINUTES THE PATIENT STATED SHE DID NOT FEEL WELL.  SHE STATED SHE WAS NAUSEATED AND WEAK INITIALLY.  AFTER A FEW MORE MINUTES SHE STATED SHE WAS SHORT OF BREATH.  AMBULANCE ARRIVED AND GAVE HER OXYGEN AND TOOK HER TO THE HOSPITAL.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011321A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 15-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. On 29-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with NAPROXEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 16-MAY-2014, the patient was vaccinated with VAQTA INJ, lot K000943, expiration date 26-EP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Flu, temperature on and off 101, 99.8, 100, Body soreness so painful  Headache and muscles in neck and back  Extreme pain in left arm
Redness around site about 5", eventually went around arm. No fever, SOB, pain. Later felt hot and headache, arm sore. Reported 10/29/03.
Developed nausea and headache the day of the appt. The night of the vaccine developed a 101 degrees temperature with worsening headache and nausea
Patient passed out a couple minutes after vaccine was administered. She was disoriented when she came to. I give her some Gatorade and she seemed ok for a couple minutes then she passed out again for 30 or 40 seconds.  She was disoriented and confused when she came to.  She laid on floor for 15 minutes with her elevated and then sat in waiting area with her dad for 20 minutes.  She said she felt fine and color returned to her face.
HepA-ped dose #1 given on 09/25/2001/recall bad lot # pt notified RTC/HepA-ped dose repeat given on 01/22/2002. Pt's mom called on 01/24/2002 stating that the pt had rash on both hands, diarrhea, and nausea. On 01/24/2002 mom also stated the same reaction with first shot which she forgot to report. It only lasted for a day and disappeared.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Poly cystic ovarian syndrome" (unspecified if ongoing), notes: Other medical history: Poly cystic ovarian syndrome; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Jun2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative twice on days 6 and 8; Negative, notes: after testing negative twice on days 6 and 8; Positive, notes: Positive rapid test on day 10 post initial symptom. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Positive rapid test on day 10 post initial symptom onset after testing negative twice on days 6 and 8 post initial symptom onset. the patient received treatment with Paxlovid from 22Dec2022 to 27Dec2022 for COVID-19.  No follow-up attempts are possible. No further information is expected.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
The patient is a 46 y.o. male with history of brain tumor, feeding tube, PEG dependence presented to Hospital with nausea and hematemesis.   Covid-19 Virus Infection Date of onset of symptoms: 12/22/22 Symptoms present on admission: Malaise, nausea, and vomiting Date of covid positive test: 12/25/22 Vaccination status: vaccinated Imaging: CXR clear Oxygen requirements on admission: room air Current oxygen requirements: room air Medical therapy: not indicated   Hematemesis Nausea and Vomiting (resolved) Possible acute GI bleeding Hgb 15.3 at sending facility,  Hgb 13.1 (12/27) No known history or risk factors for varices Continue BID IV Protonix Continue NPO General surgery consult-see below Check guaiac here Type and screen CTA at sending facility nonacute, but essentially useless for assessment of GI bleeding because he had PEG placement confirmed using enteral contrast prior to CTA Start scopolamine and continue PRN Zofran, can add additional if needed Start D5, 0.45% normal saline with 20 mEq potassium chloride as maintenance fluid   PEG tube malfunction Placement and function confirmed with contrast injection at sending facility General surgery consult-PEG tube likely causing obstruction at pylorus and was pulled back.  Have discussed with general surgery and this is likely cause of patient's nausea and vomiting which is now resolved Keep PEG tube at 2 cm depth, secured on skin with stat lock Dietician consulted- Resume tube feed, can use patient's home regimen/formula Tube feed continued without incident and no nausea or vomiting   History of brain tumor s/p resection History of stroke Continue seizure prophylaxis, convert Keppra and Phenytoin to IV while vomiting Craniotomy, aphasia and LUE deficits noted on admission, all at reported baseline Resume Aricept as able in cognitive deficit ASA held for stroke prophylaxis in setting of GI bleeding as above  Hyponatremia (resolved) Sodium 134 at sending facility Suspect secondary to dehydration IV fluids Sodium 138 (12/28)  Hypokalemia, POA (resolved)  Moderate Likely secondary to persistent vomiting Potassium lowest at 2.7 (12/26) Potassium 3.8 (12/28)
Persistent frontal/temporal headache not responsive to OTC or prescription analgesics Neck pain and stiffness Severe body aches NO FEVER, CHILLS
Moderna 1st dose administer Friday morning 11/19/21 around 9am. Friday afternoon patient reported a knot developing where the injection was administered. On Saturday morning 11/20/21, she reports her arm being swollen, hot, red, painful, and itchy. She reports being seen on 11/22/21 by a provider. Provider note reviewed and stated left arm swollen following COVID vaccine Moderna 1st dose. Itching and redness at the site of injection. No systemic symptoms. Left arm red and warm. No induration or fluctuance. Adverse reaction to vaccine. Prescribed Triamcinolone 0.1% and discharged.
Pt developed arthralgia, swelling and myalgia involving hands, fingers, elbow joint, toes and ankle joints in 2x hrs after vaccination.  Also pt developed sore throat 4 days after immunization. This is in follow-up to report (s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a registered nurse concerning a 17 year old female, with no pertinent medical history who on 23-Feb-2007 was vaccinated with the first dose of GARDASIL (lot # 656049/0187U). On 07-Feb-2007 patient developed arthralgia, myalgia and sore throat. The patient was seen by a pediatrician on 01-Mar-2007. The patient will not receive GARDASIL in the future. NSAID therapy was recommended. No blood work was performed. The patient was advised to return in 1 week if not better. The patient had not returned to date. Patient's outcome was unkn own. Additional information has been requested.