chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; The next day after vaccine, I started abnormal vaginal bleeding 10 days before my period; My breasts are swollen and hurt; My breasts are swollen and hurt; Cramping all over my body and in my uterus; Cramping all over my body and in my uterus; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 09May2021 at 11:30 (at the age of 21-years-old) as single for COVID-19 immunization. The patient did not had medical history and did not receive any concomitant medications. The patient previously received the first dose of BNT162B2, administered in arm right on 24Apr2021 at 11:30 for COVID-19 immunization. It was unknown whether the patient was pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10May2021 at 09:00, the patient experienced abnormal vaginal bleeding 10 days before her period, her breasts was swollen and hurt, she had terrible cramping all over her body and in her uterus, she had an ongoing fever and chills. She was still bleeding it was day 11. No one was helping her and she was in so much pain. The events did not led to prolongation of hospitalization. The patient did not receive any treatment for the events. The outcome of all the events was not resolved.  Information on the lot/batch number has been requested.
Severe chills at first. Sweating, feverish. Body aches. Nausea.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient's arms doesn't feel well at all/started not to feel well and legs starting to have a rash. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
received a dose Intramuscularly; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number YH345, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 12th August 2022, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 12th August 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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: 12-Aug-2022 Reporter's Comments: The physician reported that a 4-month-old patient received a dose of Rotarix Intramuscularly. The reporter gave consent to follow up. Additional Supportive Information: The patient received a dose of Rotarix Intramuscularly, which led inappropriate route of vaccination.
Headache, Myalgia, Fever, NauseaVomiting, injection site pain and swelling Narrative:
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male child patient (age was not reported) was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ000AB, expiry date: 28-Mar-2019) the left deltoid instead of who FLUZONE QUADRIVALENT on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was also a case of accidental overdose. It was not reported whether the patient experienced any adverse events. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 21-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
>1wk (L) arm swelling, 3cm, c/o if she has infected wound. Similar Rxn to Flu vaccine in 2020.  TxT Antibodics, steroid, antihistamines
Client returned to clinic on 10/26/00, 2 days post vax. Left anterior upper arm was notably flushed to elbow and warm to touch. Client states it has gradually progressed from injection site over the last 2 days. Encouraged her to use anti-inflammatory (like ibuprofen) po and apply ice to arm; and to call clinic if problem persists.
Nausea, upset stomach, gas, chills/shaking, fever, skin sensitivity, injection site pain, body aches, loss of appetite, tiredness
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 26-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Outcome: Live, pre-term birth) from July 2013 to 28-May-2014, Pregnancy (Outcome: Live full-term birth) from January 2017 to 09-Oct-2017 and Alcoholic (1 drink/day) from 22-Feb-2021 to 26-Feb-2021. Previously administered products included for an unreported indication: COVID-19 VACCINE (1ST DOSE) on 19-Jan-2021. Concurrent medical conditions included Penicillin allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021 at 11:43 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Jan-2021 and the estimated date of delivery was 30-Oct-2021. On 16-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 16-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment and concomitant medications were provided.
High fever between 102 and 106.1, chills, nausea and vomiting, headaches, and body aches. Treated with Tylenol and ibuprofen, fluids, and cool rags. Symptoms began 1/4/21 around 8pm with a fever of 102 that increased through the night to 104 after vomiting.
Pt reports feeling very nauseated after her flu shot on 09/30/16 but did not vomit.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA077920 and 2019SA077907, same reporter. This case involves a 4 years old female patient who received vaccine IPOL. The patient's past medical history, concomitant medication and family history were not provided. On 15-Feb-2019, the patient received injection of suspect IPV (VERO) lot number-N1J451M, expiry 05-Oct-2019 via unknown route in unknown administration site. It was an actual medication error due to product storage error. It was reported that there was a power outage and the opened MDV IPOL vaccine was administered to patient that reached a temperature of 34-33 degrees F. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: EM9992) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Factor v Leiden" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (13Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (14Jul2022) Negative, notes: I was symptom free and tested negative for Covid 12Jul,13, and 14; (Jul2022) Positive, notes: Tested positive 15Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient reported that she had no known allergy. The patient received other medication in 2weeks was No. Antiviral details, The patient received Paxlovid for COVID 19 Treatment, from 06Jul2022 to 10Jul2022.  No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B vax & titers wer checked 6 months p/last dose & titer result was 2.6, indicating a low pos response;
J and J booster shot--I lost my sense of smell and taste on 11/13, and still don't have it back, in addition to flu like symptoms
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Profuse vomiting after Covid injection, painful abdomen. This AM prior to vaccine vomitis continued, stated feels like severe gas. Profuse sweating, pain in upper abdomen, pain in mid back after vomiting. HR 112, SaO2 99% with 4l via NC.
Right arm erythematous at upper arm surrounding injection site. Non Tender, Increased skin temp. Benadryl and Tylenol given.
5/22/03 two days post vaccine pt developed transverse myelitis, confirmed by MRI C2-C6 with dense quadriparesis. Gradual improvement in progress. All cultures negative. Presumed viral etiology. Inf. disease specialists do not believe it is vaccine related.
Jan. 29,2021 My left arm is red and swollen in a round ball with fever in it ! This was the first shot suffered for 6 days! I used ice and Tylenol! The second shot Feb  26 2021 24 hours after the same knot appeared and its red ,swelling, and has fever 24 hours after the shot! I have fatigue and the pain from the shot site radiates down to my finger! The whole arm is in pain!
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2018 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805456 was crossed linked to original cases 201804863 due to same reporter.
Rec'd Flu shot at about 115 p 10/14/09. Returned to clinic @ 245 p c/o itching (generalized) and red rash on upper chest & bilateral cheeks. Denied difficulty breathing. No SOB. Lung sounds clear, at 3 pm BP 150/98, P-108. Says she hasn't seen her Dr in along time and has no ph # nurse recommended visit to nearby urgent care. Pt declined. Reported that she has taken BENADRYL for previous allergies and would agree to take. She took BENADRYL 50 mg po. at 315 p BP 151/102 P - 97. At 335 p redness & itchiness diminished significantly: felt better. Agreed to call her Dr. Coworker to drive her home.
24 hours post vax, the pt experienced swelling, erythema, warmth and induration was noted at the injection site, erythema 6cm x 13 cm. Non-tender, induration approximately 1 cm in diameter. Area affected is the left thigh.
eight days after the vaccine, i noticed small bumps near the injection site. within a few hours hives developed. overnight this turned into a large red patch that is swollen and hot to the touch. It is growing in size and is now about 4 inches long and two inches wide
Information has been received from a nurse concerning patients who were vaccinated with ROTATEQ vaccine live (human-bovine) (dates not reported). It was reported that "some" patients have regurgitated the ROTATEQ vaccine live (human-bovine). It was known not to re-dose. The nurse felt that the reaction of regurgitation was not related to the vaccine and was a natural response. No further information is expected.
Pt c/o redness, swelling, and itchiness at injection site 5 days post injection. Pt returned to clinic, RN supervisor noted 10 mm of induration. Pt sent to PCP for evaluation.
Swollen arn where injection was and redness still two day later. Some pain at the injection site. Cramping/stomach issues lasted abut 23 hours.
It was my 3rd does, I had returned to my truck to sit with my son while my wife attened a doctors appointment next door. While browsing the internet on my phone, all of a sudden I lost control of my right arm which I had revieced the injection in. Then about 30 to 60 second later I regain some control of my arm but but fingers/hand was tremoring uncontrolably. As of today 11/16/2021 I had again tremoring in my fingers on my right hand. These symptoms come and go.
On 2/14 started experiencing heart palpitations, tremors, sweating    No previous history of anxiety or depression
swollen left hand; itchy throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 at 15:45 as dose 1, single (Lot number: fj4989) at the age of 22 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing), notes: Other medical history: depression. Concomitant medication(s) included: WELLBUTRIN. Past drug history included: Novocain, reaction(s): "Known allergies: Novocain", notes: Known allergies: Novocain.  The following information was reported: THROAT IRRITATION (non-serious) with onset 27Apr2022 at 15:45, outcome "recovering", described as "itchy throat"; PERIPHERAL SWELLING (non-serious) with onset 27Apr2022 at 15:45, outcome "recovering", described as "swollen left hand". Therapeutic measures were taken as a result of peripheral swelling, throat irritation.
BODY ACHES; VOMITING; HEADACHES; NAUSEA; This spontaneous report received from a patient 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: 1808980, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced headaches. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, vomiting, headaches, and nausea on APR-2021. This report was non-serious.
urgent care visit post immunizations.  Dx cellulitis. Tx warm compress cephalexin 500mg BIDx10days
A red spot appeared on my back. I thought it might be ring worm but it was gone in a week. Also my shoulder was sore for about a week. After my second shot a lump formed in my arm pit that was extremely sore. It was gone in two weeks
BLOOD CLOTS; This spontaneous report received from a consumer via social media through a company representative and concern a male 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, expiry date: Unknown) dose, 1 total dose, start therapy date were not reported for prophylactic vaccination. 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 blood clots. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-blood clots.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
I have not had a monthly mensural period since my last Covid Shot.  As of todays date, I have missed two period cycles, remarkable because I was very regular.  I am not menopausal.  I have had tubal ligation, I am not pregnant.
serum sickness - diffuse urticaria (pt states 80% of his body), arthralgias of bil hands, wrists, knees, neck, shoulder. fever 100 Symptoms started 12/29/21 Treatment: Zyrtec, Aleve, benadryl at home,  1/1/2022 - Rx prednisone and triamcinolone. Within a few hours of starting prednisone, pain/swelling, itching subsided.
same day recvd vax had fever of 103+; next day called MD & fever 100; MD said cont APAP & call if worse APAP q 3 hrs; fever subsided 2-3 days later;
Approximately 5 minutes after receiving IPV patient noted to be dusley.  Mother attempted to pick child up at which time, hand/arms and legs became stiff and rigid- child laid down on floor.  Benadryl 0.3cc administered IH, within 30 seconds child crying - able to move all extremities independently.  Patient seen 10/17/2005 for flu vaccination of brothers/sisters - no concerns or unusual behavior noted.
Chills, nausea, vomiting , headaches, sweats,  frequent urination,  over all joint pain  started at 0400 this morning.
felt mushy; feeling tired; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt mushy"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021294001 Same reporter and drug; similar events and different patient
Covid19 breakthrough.  1st vaccine received on 12/23/2020.  88 y/o male with PMHx of alzheimer's dementia, prostate CA, Colon CA s/p colectomy/colostomy with revision of colostomy due to ileostomy prolapse, DM, HTN, HLD presents to ED via EMS from ALF for respiratory distress and severe metabolic acidosis. Pt admitted to ICU and placed on BIPAP 2/13, covid test at the time was negative.  Pt retested on 02/22/2022 as standard for return to ALF and test was postitive.  Pt on IV ABX, no further covid treatment ordered per ID as pt on room air and asymptomatic.