chrisvoncsefalvay/vaers-outcomes huggingface dataset:
couple of days of not feeling well; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (couple of days of not feeling well) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 031A21A and 030M20A) for COVID-19 prophylaxis.     Patient had no any allergies to medications, food and other products.  The patient's past medical history included Angiogram coronary (4 years ago) and Stent placement (6 heart stents). Previously administered products included for Product used for unknown indication: INFLUENZA VACCIN (given within 1 month prior to Moderna COVID-19 vaccine) in September 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCIN. Concurrent medical conditions included Hypertension, Endometrial cancer and Thyroid cancer. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, ATORVASTATIN, ISOSORBIDE and LEVOTHYROXINE SODIUM (UNITHROID) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (couple of days of not feeling well). At the time of the report, MALAISE (couple of days of not feeling well) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had problems with the thyroid medications.  It was reported that after the First, second and First booster patient  had a couple of days of not feeling well. Post first dose patient developed the event on 25-FEB-2021. Post second dose patient developed event on 25-MAR-2021.Post first booster patient developed event of 19-NOV-2021.  No treatment medications were reported.   This case was linked to MOD-2022-655145 (Patient Link).
A cluster of hives (small red bumps) developed on the palm and wrist of the left hand within 2 days of the flu vaccination. The vaccination was administered on December 8, 2003. As of today, December 16, 2003, the cluster of hives is almost gone.
08Sep2021: Iron 20; Iron Sat 8; 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; This is a spontaneous report from a contactable consumer(patient).   A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ZW0153) on 30Jul2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included multiple myeloma: in remissions since 2017 and allergy to Sulfa and Omnicell. Concomitant medications included thyroid (ARMOUR THYROID) 60 mg, 1x/day since an unspecified date and metoprolol at 25 mg, 1x/day from an unspecified date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ECUO153) on 07Jul2021 at 08:00 at single dose on right arm. The patient was found to have decreased hemoglobin, decreased hematocrit and Iron saturation decreased. Treatment received included started on FE supplement.The patient underwent lab test which included 30Jul2021: HGB 14; 26Aug21: HGB: 12.1; 08Sep2021: HGB: 10.8; 30Jul2021: HCT 40; 26Aug2021: HCT: 35.8; 08Sep2021: HCT: 31.9; 08Sep2021: Iron 20; Iron Sat 8. At the time of the reporting events outcome was unknown.
stroke; cerebral palsy; low vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "deaf" (unspecified if ongoing), notes: Caller is deaf, and using a speech relay service. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; CEREBRAL PALSY (medically significant), outcome "unknown"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "low vision".  Clinical course: Caller is deaf, and using a speech relay service, she had a massive stroke, she had the first dose of the Pfizer vaccine sometime in mid of Feb2022, she would like to know if she could still take the 2nd dose or had to start over. She had Cerebral Palsy as well and low vision.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an adult male. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The patient experienced full blood count decreased when treated with first dose of covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose number in series 1) and risankizumab (Skyrizi) for moderate to severe chronic plaque psoriasis.  The patient previously received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220152014 (Dose number in series 1).
RASH AROUND INJECTION SITE, APPROX. 2 TO 3IN LASTING 4 DAYS. RASH ON CHEST ON 3RD DAY (LASTING ONLY ABOUT 8 HRS),  HEADACHES AND VERY SORE THROAT CONTINUING, DIZZYNESS (3RD DAY), MUSCLE ACHES IN INJECTION ARM CONTINUING. VERY TIRED, LIKE FIGHTING OFF A COLD
Case number PHEH2014US009951, is an initial spontaneous report from the health care profession on 13 May 2014, and with a follow up report received on 28 Jul 2014. This report refers to a 11-year-old male patient. Concomitant vaccine included BOOSTRIX (batch number: 3T549, other manufacturer) at a dose of 0.5 ml intramuscular into right deltoid on 08 May 2014. On 08 May 2014, he was vaccinated with an intramuscular dose of Men A lyophilized component of MENVEO (batch number: A13015) reconstituted with sterile water instead of being reconstituted with MenCYW-135 liquid component. He was advised to re-immunize with full dose of MENVEO. The child had received full dose of MENVEO (batch number: unknown) on 08 Jul 2014 with no complaints. No adverse event reported following this medication error (wrong solution used in drug reconstitution). No further details provided. Follow up report received on 28 Jul 2014. Updated the vaccination details.
Patient's mother brought patient in to receive a COVID-19 Pfizer vaccine on 09/14/2021.  The patient?s mother filled out a consent form on behalf of the patient and listed the date of birth as 05/24/2009 and signed and consented on the official Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s mother. Clinic guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions. . Upon entering the vaccine into the Immunization Information System it was discovered that the patient's true DOB was 05/24/2010  and therefore this was an unauthorized vaccination.  The date of birth was then confirmed and verified in the National System.  The Health Department Chief Medical Director was notified.  In addition, the patient's parents notified per protocol.
Hospitalization for COVID PNA 2/20/22-3/1/22.  Treated with dexamethasone, baricitinib, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily. Expired 3/1/22
Pfizer-BioNTech COVID-19 Vaccine   Patient described immediate jaw clenching/tightness within first 10 minutes after vaccine, that only now subsided about 72-80 hrs later.  Along with this severe body aches, soreness, chills.
Blurry vision and( flashing light in peripheral vision )right eye the next day after receiving the second dose on April 27,2021.   Flashing light lasted for a week. Afterwards just blurry vision until May 30th vision became distorted and dark.  Visited eye specialist 06/04/2021 and was advised to report to the CDC that blood clot was found in right eye. Treatment is now needed that involves injections to the right eye . (3 treatments in span of 10 weeks)  with possible laser treatment if injections are not as effective.   Eye Specialist -
Same day post vax, the pt complained of nausea, dizziness, headaches, flushing, dry heaves, and erythema to face and arms. She was taken to the ER and treated with steroids and Atarax. Sent home on 10 day dose pack of prednisone.
Flu like symptomss; congestion; runny nose; body aches; sore throat,; sinus pain; POPPING EAR; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) as unknown dose on 20Mar2021 at 10:15am for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 21Mar2021 at 08:00, the patient experienced flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the reported events. The clinical outcome of the events flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears was not resolved. No follow-up attempts are possible. Information about lot number cannot be obtained.
Initially had sore arm starting 12 hours after receiving shot and lasting about 48 hours. Slight redness at injection site.  12 days after injection injection site became hard, red, hot and small red dots appeared, some which bled minimally. This condition has continued for the past two days. Additionally have experienced nausea, Diarrhea, headache and fatigue.
Swelling of all joints, very painful; Swelling of all joints, very painful; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Mar2021 17:00 (Batch/Lot Number: EN6201) as dose 1, single; on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for covid-19 immunisation; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 17:00 at 60-years-old (Batch/Lot Number: EN6201) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for COVID-19 immunization. Medical history included ankylosing spondylitis (AS) and osteoarthritis. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA); tramadol. The patient previously took statins and experienced drug allergy. The patient experienced swelling of all joints, very painful (disability) on 29Mar2021 with outcome of not recovered. The patient was given Injections in knees, back and 3xs pretizone. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Events reported as serious due to disability.
day after, was severe nausea, body aches,  low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.
Case number PHEH2015US007728, is an initial spontaneous report from a consumer (also patient) received on 20 Apr 2015. This report refers to a 42-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Prior to vaccination the patient was healthy. The patient was vaccinated with FLUVIRIN (batch number: 1103001) intramuscularly in his shoulder in Oct 2011. The patient does not remember needle breaking skin and no band aid was needed after vaccination. In Oct 2011 after vaccination, the patient went to the emergency room with aching pain all over the body. The patient reported that after the vaccination he had weakened immune system. Further, the patient had experienced fatigue problems, memory problems, tinnitus, weight gain and gray hair. In Jun 2013, the patient was admitted to the hospital for 10 days due to rectal bleeding, swollen colon and inflamed small intestine. The patient's lab results revealed bacteria in intestine. The patient was treated with cefadroxil and minocycline. The patient was also treated for low testosterone. The final outcome of the events was unknown. Causality was not reported.
Student c/o nausea, weakness, and dizziness aprox 10 min after receiving vaccine. No SOA, LCTA bilat. vs WNL. Placed in supine position with feet elevated. Began c/o sleepiness. Pt mom notified by PC of pt condition. Left with dad @ 13:25.
Information has been received from a registered nurse concerning her 22 year old daughter with a history of a seizure disorder who "recently" (date unspecified), was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  Two hours post vaccination, the patient developed pain and redness at the injection site.  About four hours post vaccination, the patient had a seizure and seemed confused for the next 24 hours.  The patient sought unspecified medical attention.  The patient has since recovered.  No product quality complaint was involved.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Left shoulder - Pnuemococcal injection site became so painful I could not sleep on that side. Left shoulder - Pnuemococcal injection site was red, hot and swollen.  The redness and swelling was 5" in diameter. Extreme fatigue that persisted for 48 - 72 hours. Body aches and chills that persisted for 48 - 72 hours. I felt like I had the flu.
Soreness arm at site of injection, swelling and 2 1/2 square redness still present at day 3; extreme soreness x 2 days; getting better. Recommend to ice; pt mobility of arm is not affected! Call MD or pharmacy if redness persists. No fever reported.
Fever, diarrhea, dizziness, nausea, headache, loss of appetite, pain, severe low back muscular pain, testicle cyst, increased cholesterol level.
This spontaneous report was received from a registered pharmacist via a company representative concerning a 60 year old (also reported as 61 year old) female patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) by accident instead of ZOSTAVAX. No concomitant therapy was reported. No side effects were reported. Additional information is not expected.
Narrative: COVID infection following COVID vaccine series 03/16, Pfizer, dose #1 04/05, Pfizer, dose #2 09/06 pt cc: fatigue, rhinorrhea, sore throat exposure: unknown 09/07 COVID swab, result: detected 10/13 COVID swab, result: not detected
Chills; Fever; doesn't feel comfortable reporting his details; felt like crap; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had fever and chills too and felt like crap after getting the vaccination. Reporter stated she was not with patient or anything and has no further information to provide; did not feel comfortable for reporting patient's details. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Loss of energy/stamina for 20 days. Listless, sore arm, out of breath with simple daily activities
About an hour or less after receiving vaccine I lay down and the room started spinning for a minute or so. This continued with position change but not as frequently.
Initial report was received on 23 October 2013 with additional information received on 03 November from a health care professional. A 13 month-old male patient who had no illness at the time of vaccination and no reported past medical history had received on 18 October 2013 at 1045 AM an intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an unspecified amount of time later was found with no chest movement and blue. The patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the child who was found with no chest movement and the child was blue. Cardiopulmonary resuscitation (CPR) was performed with no response. An "autopsy done: gross examination unrevealing; no obvious cause of death identified; results of cultures, toxicology pending (will take up to ~6 weeks for results to come back)." No further information was available at the time of the report. The patient's outcome was fatal. Documents held by sender: none.
headache, persisted for 12+ hours, relieved by ibuprofen nausea and loss of appetite, persisted for 12+ hours dizziness and weakness, persisted for 12+ hours severe chills, persisted for 1 hour all resolved within 24 hours
11-7-12 Left upper arm is red and swollen down to elbow, warm to touch, somewhat painful. Gave BENADRYL 2 tsp. po in office. Started sulfamethoxazole suspension. Mom started antibiotic on 11-8-12. Arm not as swollen on 11-8-12 and not as red in color. 11-9-12 Arm looking better today, is itching. Pt went to school today. Pt with questionable egg allergy as well.
Patient was found on the ground laying on the right side. Patient stated she fainted about 5 mins after the vaccine and hit her head. Denies pain to head and back. C/O dizziness and lightheadedness. History of fainting with blood draw. VSS. BG 114. Patient stated she felt better after laying down so we sat her up and gave her a snack. As soon as she finished snack, patient c/o dizziness and lightheadness. Patient was laid back down on the ground. EMS was called.
Information has been received from a health professional concerning an 8 year old white male with no allergies or medical history who on 4/29/97 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot # 619268/1336D). On 6/23/04 the patient presented for a well child exam and had a varicella rash. There were no labs or diagnostic tests done. The recovery status was unknown. Follow up information indicated that the patient recovered with no problems. Additional information is not expected.
a minor child has received vaccine at age 7; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On an unknown date, the patient received Infanrix (right deltoid). On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a minor child has received vaccine at age 7). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Oct-2023 A minor patient had received Infanrix vaccine at age 7. It was not reported if patient received any other dose of the Infanrix series. However, the reporter reported that patient's parents were against vaccines due to their beliefs and were not receptive to recommended vaccination schedules.  Transferred to medical information for further guidance.  The reporter consented to follow-up. The patient received a dose of Infanrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration.
Pertinent history of hypoplastic left heart. Patient died; ER resuscitation attempted with intubation. 5 doses epinephrine after acute episode collapse. Nurse follow up on 10/07/04 states: "Cyanosis." Autopsy Report received on 1/07/2005 states congenital heart disease.
Extreme pain, swelling and warmth at injection site, accompanied by a headache. Patient received KEFLEX 500mg BID x 7 days and triamcinolone cream from Dr.
On day of shot, soreness at injection site. Next day, extreme fatigue, flue-like symptoms, fever, sweats, chills, shooting pains in all extremities.