chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Body ache / generalized aching; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Articular calcification, Joint range of motion decreased and Ankylosing spondylitis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body ache / generalized aching). At the time of the report, HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) 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 considered HEADACHE (Headache) and MYALGIA (Body ache / generalized aching) to be possibly related.    No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and contains no new information.
2 patients received ACT-HIB vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown age and unknown gender patient's and reporter reported 2 patients received Hib (Prp/T) Vaccine [Act-Hib] vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot number: UJ797AA/ /UJ801AA; Expiry date: 09-Oct-2023) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter reported 2 patients received Hib (Prp/T) vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) with no reported adverse event (product preparation error) (latency: same day).  It was reported, nurse who asked if 0.9% NaCl diluent can be used to mix ActHIB. She has already reported two patients who received ActHIB mixed with 0.9% sodium chloride to VAERS. Additional Description of event Adverse events :Nurse reported 0.9% NaCl diluent was used to mix ActHIB. She has already reported two patients who received ActHIB mixed with 0.9% sodium chloride diluent to VAERS.  Action taken: not applicable.  Outcome: Unknown   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 the 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.
Patient underwent right lower lobectomy and thoracic lymphadenectomy for lung cancer.  Postoperation with her standard surgical floor where she had chest tubes to suction.  She had some borderline blood pressures with her thoracic epidural, which did respond to fluid resuscitation.  Once her chest tube outputs dropped and her airleak stopped her chest tubes were sequentially removed.  On the day of discharge she was breathing easy. Hospital admission within 6 weeks of receiving the COVID vaccine.
Started with left arm pit had a red spot and pain. Left side of neck swelled up. Arm pit went back to normal left side of neck is still swollen.
Patient reports waking up at 4am morning after receiving the vaccine with body aches, vomiting, diarrhea, and ear pain. Utilizing acetaminophen and hydration with water to ease symptoms. Still experiencing symptoms. She is currently awaiting call back from oncologist to rule out other causes.
8/14/02 shot given. 8/15/02 new temp max 101, sore throat, headache, body aches, and neck stiffness. 8/17/02 symptoms resolved.
Swelling of the right upper arm, 10 cm x 10 cm. Hot to touch, no pain, some itching. Rx: Motrin PO, Atarax PO, cold soaks.
Dizziness, cold sweat, near syncope. Water provided to patient called the paramedics. Patient walked out without assistance  45 minutes after vaccine was administered,
2 weeks after injection, developed red, indurated, painless, warm lesion at injection site (induration 2 cm). No fever. No treatment.
Extreme fatigue (lack of ENERGY) with minimal movement such as walking three steps; resultant shortness of breath (SOB) and occasional dizziness.
inconsolable crying for 6hrs 1230PM-645PM;mom phoned MO & MD inc APAP dosage;no further events;
Patient presented today 10/6/17 to report S/S after flu vaccine on 9/29/17 during employee flu clinic. Verbalized feeling itchy and scratchy throat about 1hr after vaccination. Verbalized hives started in abdomen, then (R) side of body and quickly spread all over. Pt didn't report or go to MD. Took antihistamine and applied lotion. Some hives still visible today on abdomen today 10/6/17. Reported today and instructed to notify MD regarding next year flu vaccination if concerned. Pt. aware will be reporting.
Abdominal pain, nausea and dizziness started two hours after shot. Following day flu symptoms with tenderness to all lymphnodes, especially abdominal and groin area.  Abdominal pain and nausea persisted for 10 days. Still experiencing some tenderness and nausea.
She reports having severe headache, dizziness, nausea , body aches & fever 101.0 for a day.  Loss of appetite. Sore arm & redness at injection site.
The next day after I received the Pfizer vaccine I started feeling sick and lightheaded it had a headache. I think nothing of it and then my menstrual cycle started early and it started off being heavier than usual. Then I notice when I went to wipe myself or use the bathroom blood clots was falling out. Being that I work in the medical field I know like if is not bigger than 1/4 there's nothing to really worry about. So as the day went on and the following days I noticed that the blood clots kept on getting bigger and bigger and coming faster and faster. At this point I started getting concerned, that's when I decided to go to the hospital. At the emergency room at Hospital  they really didn't do nothing for me but gave me an ultrasound and gave me some birth control told me to follow up with my OBGYN. But I already made an appointment with OBGYN cuz I just feel like if something was going on and I can't get in to see them till June 30th. They did give me some birth control and tell me your help with the bleeding and for me to take some ferrous sulfate. They said they'd never heard of this reaction before. So I went on May 1st to get my second vaccine. Before I received it, I talked to doctor there and they told me it would be fine for me to get it. Now my symptoms and reactions are starting all over. I'm so concerned about what's going on with my body. I just need somebody to explain to me what's going on. I cannot afford another hospital ER bill again.
My son had his 1st round of several vaccines at once, so I do not know which one caused him some encephalitis like, and maybe a little of meningitis like, symptoms, and fever and lethargy.  Maybe the MMR as it is grown on chicken embryo, maybe the Tdap, maybe the Hib flu set off strep/pneumococcal pneumonia.  I really do not know what the problem was/is.  Please just get the list of vaccines from the doctor's office, for the record.  He became either unresponsive or hyper-responsive, and was just not himself.  So, we gave him megadoses of Vitamin C and got him out in the sun for UVB-Vit D3 via skin, kind of like they recommend when an infant not processing bilirubin and has jaundice, as either sun or the bili-lights had to be done for several of my children right after they were born.  So something to do with the liver, I guess.  I was told acetaminophen ok if vaccine reaction, but no this actually was hard on his liver and made his vaccine reaction worse.  He eventually got better.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 88 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tuberculosis" (unspecified if ongoing), notes: at age 19. No other significant history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Feb2023 to 21Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: On the 10th day of Covid. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment Paxlovid (lot number 1917018A) from 07Jun2022 to 12Jun2022. No other medication received in 2weeks. Patient had no known allergies and medical History. On the 10th day of Covid, symptoms returned with more mucus in upper chest and slight fever.  Clinical Course: The patient did not receive other medication in 2weeks. The patient received COVID 19 Treatment, (Paxlovid) from 07Jun2022 to 12Jun2022, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3, (booster) single (Lot number: EW0187) at the age of 62 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE; LISINOPRIL. Past drug history included: Bactrim, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound Initially testing week negative on antigen test now testing strongly positive since 5/28 with persistent congestion through 6/2; positive, notes: Paxlovid rebound Initially testing week negative on antigen test now testing strongly positive since 5/28 with persistent congestion through 6/2. Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
A non-serious spontaneous report of "H1N1 LAIV given to an 11 month" was received from a registered nurse/health professional in the concerning a 10-month-old male. The patient has been healthy, has not had any symptoms of the flu and has not had any reactions to the vaccination. No other relevant medical history and no concomitant medications have been reported for this patient. On 16-Oct-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore treatment and reporter causality assessments were not applicable, and the event was considered as resolved. Additional information was received on 24-Nov-2009 and incorporated this information into the narrative about the patient's past medical history, concomitant medications, prior use of vaccine and reporter's address in detail.
Swelling to Right Deltoid and shoulder in general.  Pain increasing in severity over the course of 4 days.  Pain and swelling reached point that patient reported to the ER for further evaluation.  Imaging of involved area completed and draining of fluid from involved area completed.
Joint pain in hips and knees. Seeing chiropractor for event. With no relief, I am seeing my primary on July 19.
7/9 Immunization MENACTRA developed temp to 100. 7/10 Temp to 103, nausea, diarrhea. 7/11 Temp to 100, nausea, diarrhea. 7/12 No temp, nausea, diarrhea. 7/13 diarrhea, nausea. 7/14 nausea, diarrhea.
The following month after the 1st vaccine. My hair had stopped growing. A few months later, I went to see my dermatologist. I received labs. I received a prescription of fluocinonide and I thought my hair was improving after taking it for 1 month. after the booster the same thing happened. My hair stopped growing. After trying another prescription that did not work I was put back on fluocinonide.
She is calling for her son, who had the COVID vaccine but has COVID now and has a horrible cough; She is calling for her son, who had the COVID vaccine but has COVID now and has a horrible cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent (patient's mother).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She is calling for her son, who had the COVID vaccine but has COVID now and has a horrible cough". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient on Paxlovid therapy, and would like to know if he can take a cough medication that wouldn't interact with the medication.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tongue Swelling, Fever, Redness around injection and swelling, dizziness
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:09 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
In 15 minutes, post vax, silver dollar-sized area of erythema appeared along with a 50 cents-sized raised lump. Ice pack applied and given Benadryl 50mg PO.
Adolescent patient was given Moderna. Currently Moderna is only EUA for 18+ patients.
sore arm; This is a spontaneous report received from a contactable consumer. This consumer (patient mother) reported similar events for four people. This is the first of fourth reports. A patient of unspecified age and gender received BNT162B2 (COVID19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that her three kids were complaining of sore arms. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433726 same reporter/drug/event, different patient;US-PFIZER INC-2021433725 same reporter/drug/event, different patient;US-PFIZER INC-2021433880 same reporter/drug/event, different patient
Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain  scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues.   Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021.  Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen
Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 hours after. Next day generally just cold and body tired. No arm pain.
Covid vaccine given within the 90 days of patient having passive antibody therapy. No adverse reactions were reported. Patient stated they had a fever of 102 F on 1/5/21 and muscle aches.
she had no side effects, no nothing from it; received Prevnar and Pneumovax 13 on the same day; This spontaneous report was received from a licensed practical nurse and refers to a 16-year-old female patient. The patient's medical history included tonsillectomy. Her current conditions included recurrent strep throat. Her historical drug included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR). She had no prior vaccinations (within 4 weeks), no adverse events following prior vaccinations. No information regarding the patient's drug reactions or allergies and concomitant medications was provided. Her last office visit was on 16-JUN-2020. On 19-JUN-2020, the patient had pneumococcal conjugate vaccine (PCV) 23 titer test performed, which showed that she had no immunities built up and the physician recommended that she should be vaccinated.  On 08-JUL-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 (unit not provided) intramuscular injection, once, in her left deltoid, lot # S0005856 was confirmed to be not valid, expiration date 03-DEC-2020 and the second dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) 0.5 ml intramuscular injection, once, in her left deltoid, lot # CK0843, expiration date on an unknown date in March 2022, both for prophylaxis (reported as "was due and doctor felt like she needed it"). The patient had no side effects (reported as "no nothing from it"). The reporter stated that the suspect vaccines were administered on the same day according to the physician instructions. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S0005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Soldier received anthrax on 11 Aug 03 and presents to the clinic on 13 Aug 03 with 7 cm circular area of erythema and mild swelling.  Benadryl 25 mg 1-2 cap q6 hours prn and ice to decrease pruritis (having hot temps outside, increasing pruritis)
The pt experienced tingling in legs, which increased to shooting nerve pains with memory loss. Treated with Amoxicillin for 6-8 weeks. The annual follow up states, "I still have nervous system shooting sensations and muscle pain. My joint pain is controlled by Voltaren. This is eventhough I was on IV antibiotics x 12 weeks."
p/2nd dose 2SEP91 pt devel acute MS, 2 wks later bilateral visual blurring MD felt visual loss & myopia; hospitalized 14OCT91 exp neurological deficit; also dysphasia & hemiparesis, walked w/limp, clumsy rt hand, demyelination, encephalomye
Case number PHEH2015US020300, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 524 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular at a dose on 07 Oct 2015. It was reported that the patient received FLUVIRIN vaccine that was out of temperature range at 47F before administration. No adverse event was reported.
TEETH FELL OUT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced teeth fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of teeth fell out was not reported. This report was non-serious.