chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, fever, fatigue, soreness, muscle weakness, flu-like symptoms, stomach pain, shoulder pain.
Pt. reported 'flu-like' sxs after PCV-13. Fever, chills, aches in joints and tenderness in (R) arm. Began 5-6 hrs after administered. Much better the following day.
Ringing/"fizzing" sound in both ears upon waking, with the noise becoming quite loud when I stood up. Visual effects also present (seeing spots, then vision fading). If felt like I was going to faint. I suspected dehydration. I sat on the floor while drinking water (~12 oz), and symptoms began to resolve. I drank an additional 12 oz of fluid, and symptoms more mostly gone within 30 minutes.
Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 62 years old female patient (also reported as 63) who was accidentally vaccinated with twice dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 11-Feb-2019 and again today in error (date not reported) but should had received TRUMENBA. The patient's past medical history included splenectomy in November and Immunodeficiency. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was also a case of actual medication error due to inappropriate age at vaccine administration, extra dose administered and wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. 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 and Module VI of the 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. Documents held by the sender: none.
Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023).    Concomitant medication details not reported by the reporter. Vial size was reported as 2.5 ml. Vial was initially stored in the refrigerator on 14-JAN-2023. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716944, US-MODERNATX, INC.-MOD-2023-716965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716944:Patient 2 US-MODERNATX, INC.-MOD-2023-716965:Patient 3
Muscle aches all over; Extremely horrible headaches; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches and muscle aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20-2A) for prophylaxis of COVID-19 infection.  On 01 Jan 2021, after receiving Moderna COVID-19 Vaccine the patient experienced extremely horrible, awful, debilitating headaches for two and a half days followed by muscle aches all over as if  someone beat with a baseball bat.  Treatment for the events included 2 pills of paracetamol every 6 hours.  Action taken with mRNA-1273 in response to the events was not reported.  The events, headaches and muscle aches, were considered resolved on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
itching; malaise; chills; urticaria on trunk and other extremeties; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced pruritus, malaise, chills and urticaria. The patient was treated with cetirizine hydrochloride (Cetirizine) and naproxen. On an unknown date, the outcome of the pruritus, malaise, chills and urticaria were unknown.   It was unknown if the reporter considered the pruritus, malaise, chills and urticaria to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician 6 hours after injection developed itching, malaise, chills, urticaria on trunk and other extremeties. The physician took Citerazene and Naproxen with some relief. The physician consented to follow up.
pt recv vax 7JAN97 & devel gen aching, t102.7 on 8JAN97 Am; CBC on 8JAN97 WNL;
I had and am continuing to have a severe injection site reaction on my arm. My vaccine was administered in an incorrect position very low on my arm. I am unsure if it even got into the deltoid muscle. The facility where I received the vaccine does not answer the phone and has not returned any of the e-mails, Facebook messages, or any other correspondence when I have attempted to reach out to them. My arm continues to swell more each day and it getting worse instead of better. I am on day 13. I am happy to provide pictures.
Information has been received from a physician concerning a male with no adverse drug reaction (ADR), who on 25-APR-2003 was vaccinated by injection with a 0.5 ml, dose of Varivax. There was no concomitant medication. Subsequently the patient recently developed a mild case of chicken pox-10 to 20 lesions. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
pt recvd vax;lt eye itch & hurt (bloodshot),felt irritable 5feb;woke up w/ rash all over body on 6feb;felt joint pain in hands & knees;all joints painful & swollen,hands & ankles
pt recv vax 22JAN97 & 23JAN97 pt exp flu-like sx which included nausea & vomiting;by 24JAN97 pt recovered;
This spontaneous report was received from a registered nurse and refers to a 47 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 27-SEP-2006, the patient was vaccinated with the first pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot umber 652093/1099R, expiration date 31-MAR-2008 (route was not provided). ON 27-OCT-2006, the patient was vaccinated with the second pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot number 652093/1099R, expiration date 31-MAR-2008 (route was not provided). Then, on 23-JUL-2007, the patient was vaccinated with the third pediatric/adolescent dose of RECOMBIVAX HB, 0.5 ml, lot number 653788/0610F, expiration date 14-NOV-2008 (route was not provided). Also on 23-JUL-2007, there was an inappropriate schedule of drug administration as the third dose was administered almost 10 months apart from the first dose. In 2011, the patient had titers drawn and the results were positive for Hepatitis B. No adverse event was reported. It was unkonwn if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
I always have some type of reaction similar to having an all-over body ache. I usually sleep for two to three days. I usually ache all over and go to bed for two to three days because I cannot normally function.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
I then tested positive 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset 12Oct2023, outcome "recovered" (Oct2023), described as "I then tested positive 2 days later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient's husband tested negative on 10Oct. Patient was negative and went to get the COVID vaccine, the first date that it was available, which was weird. Patient then tested positive 2 days later, and then took paxlovid. 5 days later and tested negative. Patient had paxlovid treatment from 12Oct2023 to 16Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335918 same patient, different drug and event;
03/08/2007 Received call that child's leg was red approx 2 1/2" in diameter, area was hard and warm to touch. Mother used cool cloth and acetaminophen for comfort. 03/09/07 talked to mother, stated area was still red but not as hard lump.  .25 size. No redness notes.
The patient received a COVID 19 booster  overdose. The pharmacist administered the  0. 2 ml of the concentrated solute. She  didn?t mix the solute with the normal saline solution. The patient presented weakness, sleepiness and left arm pain.
can't smell or taste; can't smell or taste; nose congestion; tested for COVID-19, which came back positive; real fatigued; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) administered in the arm as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included hypertension from 2011 and ongoing; and high blood pressure. Concomitant medication included High Blood Pressure Pills (unspecified) 20 mg from 2011 for hypertension. She reported that on 05Mar2021 she felt real fatigued but did not think the vaccine could cause this. She thinks she had the symptoms of COVID-19 before getting her first dose of the vaccine. On 06Mar2021, three days after the patient was vaccinated, she tested for covid-19, which came back positive. The patient did not get any nose congestion until Sunday (07Mar2021), she had nose congestion; she had it until Tuesday and that only thing she have left is that now (unspecified date) she cannot smell or taste. She further stated that she have no other symptoms just fatigue, congestion but off course she lost my sense of taste and smell, since then and do not have anything after that, "it is very little smell". She would now like to know if it is safe to take her second dose of the vaccine which was due on 24Mar2021. She was concerned that because she had COVID-19, she may need to restart the vaccination series. The outcome of events " can't smell or taste" was not recovered; the patient recovered from nose congestion on 09Mar2021 and recovered from fatigued from unspecified date; and outcome of COVID-19 was unknown. Patient took OTC for the nasal congestion.   Information regarding Lot/Batch number has been requested.
Vomited several times bit. 7 & 10:30 PM on 8-20, vomited 1X during noc., once AM of 8-21 & once eve. of 8-21, + once on 8-22.  Was "hyper" + laughing.  Never has acted like that.  (8-22) sund. temp. R 100 degrees, 8-23 101 degrees 8-24 102 degrees, 8-25 103.6 degrees 8-26 99 degrees.  Irritable on 8-23 - 8-25.  Wouldn't eat solids, only would nurse.
Temp 99.5 degrees, dizzy, throat is tight, some hoarseness but didn't last past a few sentences, injection site on arm red and hard about the size of an orange, mild headache, mucus in throat - symptoms are very mild, still having symptoms today Jan 7, 2014.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, these patients was vaccinated with improperly stored doses of M-M-R II (lot # K016153 with expiration date 24-SEP-2016 and lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. Follow up information has been received from the medical assistant concerning the 4 years old male patient on 27-JUL-2015. On 17-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151, expiration date 02-NOV-2016, rHA) (incorrect product storage). Additional information has been requested. Patient demographic, product, adverse event and narrative were updated.
7/16/2022 pt went to ER due to recent fall/back pain. Patient states he was diagnosed with Covid 7/11/2022 with a home Covid-19 testing kit. Denies c/o SOB, denies fever, denies N/V. Lives at home and takes Eliquis. Patient has been Covid + approximately 6 days. Pt tested Covid-19 + per PCR test at Hospital.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unspecified date in 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, frequency, route, lot # and expiration date were not reported).         On an unknown date, the patient was treated by physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffered such losses, and damaged in the future. The outcome of event was considered as not recovered. The reporter considered event to be related to Zoster Vaccine Live(ZOSTAVAX).
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non serious.
This case was reported by a sales representative and described the occurrence of a sore gland on side of neck in an 18 year old female pt who received Twinrix. The reporter is the pt. On 1/13/05, the pt received the 2nd dose of Twinrix in the "upper left arm". At an unspecified time following the administration of Twinrix, on 1/13/05, the pt experienced soreness at the injection site. On 1/14/05, the pt experienced, "an inflammed nodule or gland on the neck". The injection site reaction resolved on 1/19/05 and the inflammed gland resolved on 1/29/05. The immunization series with Twinrix was discontinued. The sales representative considered the events to be related to vaccination with Twinrix.
Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still upset stomach and weakness today but getting better
This is a 78 year old male with a PMH/PSH as noted below. The patient lives with his family who are all ill with Covid, the patient and most of his family are vaccinated. The patient had been running a low grade fever of around 99 and had a mild cough. Today he went to the bathroom and his legs were weak causing him to fall to the ground where he was unable to get up prompting EMS call. He denies any SOB or CP at this time. In the ED, CT brain negative, CXR negative and sat 94 to 95% on RA. Patient complains of weakness only with no focality. IGG/IGM/spike and PCR pending. Patient will be admitted to medical for ID consult, IVF, PT eval and further monitoring.
I am unsure of the exact date adverse events began, but I did call my MDs office to report problem on 11/14/03. The problem consisted of pain and numbness of the left arm,elbow,and hand. Vaccine was administered in left arm. I felt two tracts one down the front of my arm into 1st and 2nd fingers which became numb. The other pain radiated behind my arm near elbow and to pinkie finger. I had pain at the injection site radiating down. Doctor recomended OTC anti inflamitories. I visited 3 chiropractors. He did spinal adjustment and recomended oral echinacea. The other doctors did adjustment and Massage to effected areas. Doctor did adjustment on two occasions which finally yielded relief of numbness of the arm hand. I continue to experience pain at the elbow especially when I lift my arm away from my body and at top of the forearm. worsening this week. (menstral time) for which I am taking 600-800mg ibprophen every 4-6 hours.
swollen glands/(swollen glands) hurt; it hurts to swallow/affecting her whole neck; headache/headache (on and off); tired/fatigue/tired(on and off)/fatigue (on and off); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen glands/(swollen glands) hurt), HEADACHE (headache/headache (on and off)), FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)) and DYSPHAGIA (it hurts to swallow/affecting her whole neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M209) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache/headache (on and off)) and FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)). On 03-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen glands/(swollen glands) hurt) and DYSPHAGIA (it hurts to swallow/affecting her whole neck). On 19-Feb-2021, HEADACHE (headache/headache (on and off)) and FATIGUE (tired/fatigue/tired(on and off)/fatigue (on and off)) had resolved. At the time of the report, LYMPHADENOPATHY (swollen glands/(swollen glands) hurt) and DYSPHAGIA (it hurts to swallow/affecting her whole neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Three days of nausea and diarrhea, minor itching  all over for seven days with extreme localized itching, heat and inflammation just below injection site.
Systemic: Generalized Body Aches -Mild, Systemic: Other- injection given in left arm and patient complained of muscle soreness of right thigh.  Patient had also reported side effects to previous vaccines but did not note it on the consent form.