chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy; temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8; has a fatty liver and that now is even more sensible to fats; patient hasn't received the second dose and it has been more than a month; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8), CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats), PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8), CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats), PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) and NAUSEA (nauseated). At the time of the report, DIZZINESS (dizzy), BODY TEMPERATURE DECREASED (temperature between 37°c and 37.4°C/time to time gets lowered to 36.7 36.8) and NAUSEA (nauseated) outcome was unknown, CONDITION AGGRAVATED (has a fatty liver and that now is even more sensible to fats) had not resolved and PRODUCT DOSE OMISSION ISSUE (patient hasn't received the second dose and it has been more than a month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment: For the temperature a pill that was recommended (doesn't remember the name).  Concomitant medication was not provided
tightness in throat, hard to breathe then extreme chills then hives/ rashes /facial swelling on lip
I have always has a mild case of tinnitus for years. Seems like with a few days after the 1st shot my tinnitus skyrocketed. Very loud ringing in the head.  The ringing has been so loud that kept me up one complete night with no sleep and hard to sleep since then. I have gone to the family doctor end my ENT specialist. I wear hearing aids and have seen the ENT before. Hoping they could tell me why this has suddenly gotten so much worse. This has been going on  over 3 weeks now. I never thought it could be related to the vaccine and may not even be. Just too coincidental that immediate issues shortly after vaccination. I just want officially report in hopes of gathering data and possibly helping others.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19May2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Jan2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for Covid-19 immunization. The patient's relevant medical history included: "Asthma (controlled)" (unspecified if ongoing), notes: Other medical history: Asthma (controlled); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. Other medication in 2 weeks reported as no. 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: Unknown Result, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of Covid-19. It was reported that, rebound effect of symptoms after 10 days. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment was started on 18Jun2022 and stopped on 23Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchy rash started at forward, spread to upper, then lower back; hips & buttocks started 4 or 5 days after shot & still have it over 3 months later.
Information has been received from a registered nurse concerning a 24 year old female who on 19-DEc-2007 was vaccinated with a first dose of GARDASIL and on 18-JAN-2008 was vaccinated with a second dose of GARDASIL. On 03-MAR-2008 at 15:24, the patient was inadvertently vaccinated intramuscularly with her third dose of GARDASIL in place of hepatitis B virus vaccine rHBsAg (yeast) (MSD). There were no adverse symptoms. This is not a case of product confusion. Additional information is not expected.
Arm and shoulder soreness  1/11 day one arm soreness and painful shoulder. Day 12 appearance of red / hot patch on arm. Resolved with Benadryl.
he had a little pain; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "Pfizer flu shot", "pneumococcal shot" also reported as "Pulmonary Flu Shot"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for imminization. The patient medical history included "exposed to that flu". Concomitant medications were not reported. He said one of the things he did before anything else was he took the pneumococcal thing, the over 65 flu type, he took that, then after 3-4 weeks from there took he took the Pfizer flu shot and he was wondering if he should wait a bit longer than three months or three weeks for the second. He says after the pneumococcal shot he had a little pain, he thought before that he must have been exposed to that flu, he didn't know have it now, it had subsided. The outcome of the event was unknown.  The lot number for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), was not provided and will be requested during follow up.
Patient reported abdominal cramps & vomiting 2 hrs (10-11-11) after vaccine administration. Arm swollen & red at administration site with slight bruising. On 10-13-11, patient reported abdominal cramping & vomiting again.
patient received expired Ipol vaccine; Initial information received on 23-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19 years old male patient who received vaccine IPV (VERO) [IPOL] and reported that patient received expired Ipol vaccine (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).  On 02-Aug-2019, the patient received 1st dose of suspect 0.5 ml IPV (VERO) lot N1F181M and expiry date: 23-Jun-2019 via unknown route in the left deltoid.  It was reported that the vaccine was approximately 5 weeks expired when it was administered.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  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.  List of documents held by sender: none.
10/20 15 min after injection - redness, swelling of site - Ice packs applied, BENADRYL 25 mg po. 10/21 - Called on day off - said she was much better. Redness and swelling subsided. 10/22 - Swollen lymph node (L) side of neck. Saw primary care Dr. - SOLU-MEDROL, Clindamycin, BENADRYL and PEPSID ordered.
First dose, about a year ago, never got second; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago prior to the reporting).   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: 04-OCT-2022 Reporter's Comment: The reporter was a physician. The reporter reported that the patient received first dose of Shingrix vaccine about a year ago and never got a second dose. The reporter did not ask about follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
The same night of the injection, I experienced shortness of breath and I had to concentrate on my breathing in order to breath. That right short hurt. A day or two this continued. After the next few days I was fine. The following week, I noticed under my right breast and right arm, I had limited moving and a lot of swelling. That arm from the deltoid down also was red and swollen. I contacted my doctor a week after my vaccination. My doctor recommended not getting the second dose due to how it affected my breathing more so than anything. There is still some swelling under my right armpit where my lymph node is but it is not anywhere as bad as it was, and my doctor is not concerned.
administered Flublok to a 15 year old, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was administered a 0.5 mL once dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2014 expiry date: 30-Jun-2021) via an intramuscular route in the right arm as prophylactic vaccination on 17-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  It was an actual medication error due to inappropriate age at vaccine administration on same day.  It was not reported if the patient received any corrective treatment.  At the time of reporting, 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.
Injection area (RD) turned red, swollen and lg lump approx 3"x3" circular appeared 24 hrs later.
Breakthrough pain; Anemic; Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021; Low grade fever; Headache; Fatigue; Welts; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH PAIN (Breakthrough pain), ANAEMIA (Anemic), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started  (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Low grade fever), (Headache), (Fatigue) and URTICARIA (Welts). On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021). On an unknown date, the patient experienced (Breakthrough pain) and(Anemic). At the time of the report,Breakthrough pain) and ANAEMIA (Anemic) had not resolved, PYREXIA (Low grade fever),  (Headache), FATIGUE (Fatigue) and URTICARIA (Welts) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna on 08-Mar-2021, second dose on 05-Apr-2021 and third booster dose on 30-Aug-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.   The reporter's causality with Humira for the events of breakthrough pain, fatigue, low grade fever, headache and large welt like fluid gathering under skin at injection site/ down to arm to elbow was a reasonable possibility and for the event of anemic was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I did not have an adverse reaction to the vaccine. In 01/2023, I developed a pain in my upper right arm. In 02/2023, I contacted my doctor and got an appointment with her on 03/10/2023. It was determined that I have arthritis in my shoulder. I also have pain in my hand, wrist and thumb but it is not associated with the pain in my shoulder. I have a printout of exercises I have to do to help with motion and pain in my shoulder.
HAD NUMBNESS AND TINGLING DOWN THE ARM THAT LASTED <24 HOURS
This spontaneous report was received from a Registered Nurse referring to a 2 month old male patient with fatty acid oxidation disorder and no known allergies. On 26-MAR-2013 the patient was vaccinated with the first dose of ROTATEQ (lot number H013164, expiration date 01-MAR-2014) (2mL, oral). No other co-suspects were reported. Concomitant therapy included riboflavin. The Registered Nurse reported that on 26-MAR-2013, within 10 minutes of administering the dose of ROTATEQ, the patient developed a visible blister on the inside of the right lower cheek. The patient was reported as recovering at the time of the report. The reporter stated that no treatment was given for the blister on the inside of the right lower cheek. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a 44 year old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with single dose of each of the monovalent vaccines for Measles, Mumps, and Rubella when he was a child. On 11-MAR-2013, the patient was vaccinated with 0.5 milliliter (ml) of M-M-R II (lot number and expiry date reported as H012571 and 29-JUN-2014 (also reported as 29-JUL-2014) respectively), subcutaneously. Concomitant therapies included TWINRIX and poliovirus vaccine inactivated (unspecified). Both were administered on 11-MAR-2013. On 19-MAR-2013, the patient experienced achiness and fever (103.0 Fahrenheit). On 23-MAR-2013 the patient experienced full body rash. The patient sought medical attention (office visit). On 23-MAR-2013, blood tests were performed and Measles (Rubeola) IgG antibody level was found to be 1.31, Rubella IgG antibody level was found to be 39 and rubella IgM antibody level was found to be negative. On an unknown date in 2013, the patient had recovered. The relatedness for all the events was unknown for M-M-R II. Additional information has been requested.
"Covid toes" - purple, blistery toes persistent for over 5 weeks, persistent headaches at back of head (cerebellum area) for over 3 weeks (not getting better), hearing loss in right ear, tinnitus ringing in right ear, fatigue, intense brain fog
Abdominal pain, cramping and constant. Associated with nausea and vomiting. Hospitalization.
Headache, Myalgia, Fever, chills, soreness at injection site Narrative:  Other Relevant History:
Raised rash at site of injection, approx 3 inch diameter.  Very itchy
States that 2/8/22 felt tired and general body aches. Also reports had severe heartburn with no change in dietary intake. 2/9/22 at 1:00 AM awoke from sleep with sever nightmares and heartburn, was diaphoretic and felt anxiety. Fatigue continues today, 2/9/22. Received initial vaccine series 3/18/21 and 4/8/21. He reports he had COVID-19 in November 2021 with mild cold symptoms, loss of taste and smell and low grade fever. Unable to confirm this as no report on file in database. Recommended he follow up with a physician re: the heartburn.
This spontaneous report was received from a registered nurse referring to a 61 year old male patient with an unspecified immunocompromising condition. The patient's drug reactions/allergies and concomitant medication were not reported. On an unknown date in 1994, the patient was vaccinated with the first dose of PNEUMOVAX 23 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). Then in 2001, he was revaccinated with the second dose and in 2014, he received a third dose. Additionally on an unknown date in 2015, the patient received a dose of PREVNAR 13 (strength, route, dosage schedule, indication, lot number and expiration date were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA012952.
This spontaneous report as received from a licensed practical nurse refers to a 59 year old male patient. Concurrent or medical conditions were not reported. On 20-NOV-2015, the patient was vaccinated with VARIVAX (Merck) (dose, strength, route and lot number were not reported), instead of ZOSTAVAX due to a human error. No adverse effects reported. Additional information has been requested.
Swelling of eyelid; eyes red; eyes infection; This case was reported by a consumer via call center representative and described the occurrence of swelling of eyelid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling of eyelid, eye red and eye infection. On an unknown date, the outcome of the swelling of eyelid, eye red and eye infection were unknown.   It was unknown if the reporter considered the swelling of eyelid, eye red and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient asked if there been any reports of eye lids swelling, eyes red and infected after receiving this injection. The patient also asked this problem could be related to this medication. The patient had never had the events before.
Patient was given Moderna 0.5mg 1st dose instead of Pfizer 0.3mg. No s/s of any adverse reaction noted during 15min wait time. Family aware of vaccine error.
pt recv 3ml of typhoid instead of 0.5ml & 11FEB98 info recv indicated that 1 day post vax pt exp muscle aches, felt faint & devel an inj site rxn characterized by redness & swelling which extended to the elbow;
Patient has been referred for coronary artery bypass grafting.    On November 11 the patient underwent CABG . The patient was extubated shortly following surgery.  The mediastinal chest tubes were removed on POD #POD1 and pleural chest tubes were removed when the drainage was sufficiently low. The patient was weaned off vasoactive drips as tolerated.  He was stable to be transferred to the floor. Discharged after 8 days.
p/vax pt devel a mild case of varicella w/more than 100 lesion on scalp, face, back, & genitals;
shoulders, kneels, hands and neck flared up more that it normally does; A spontaneous report was received from a consumer concerning herself, who is a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event shoulders, kneels, hands and neck flared up more that it normally does  The patient's medical history was osteoarthritis and rheumatoid arthritis. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event shoulders, kneels, hands and neck flared up more that it normally does.  Treatment details included acetaminophen, tropical methyl salicylate extra Strength.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event shoulders, kneels, hands and neck flared up more that it normally does was unknown.
In the first 36 hours: high fever, intense nerve pain in entire arm, shoulder, and left side of neck, and inability to lift or move left arm. In the following 6 months (and continuing): daily migraines, daily intense pain in one tooth but no source found by dental experts, intense intermittent nerve pain in different parts of the body, brain fog/confusion, daily deep fatigue, blurred vision, occasional episodes of dizziness. Migraines are often paired with an intense emotional reaction (crying, anger) that does not connect to life circumstances, is not a reaction to pain, and subsides immediately when pain medicine (tramadol) takes effect.
Low-grade fever; marked swelling of lower extremity 16" in diameter vs 12" in diameter of opposite lower extremity; significant pain beginning roughly 20 post injection.
Patient developed cellulitis as a result of Fluzone or Pneumovax vaccination. He required hospitalization and antibiotic treatment.  11/06/2007 MR received for DOS 10/12-14/2007 for D/C DX: Cellulitis of the L Forearm, markedly improved. Pt presented to PMD with c/o swelling and redness of the L forearm.  Treated with po abx with no improvement.  Admitted for IV abx. TXd with IV abx with good response.