chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started having small red bumps on both hands, and both feet and ankles.  This progressed from 6/6/21, to spreading up her arms and legs, neck and upper chest over the next couple of days.  On 6/9/21 the bumps became very evident that she had hives.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: responsive within a minute and recovered within 10 minutes
Breakthrough case after full vaccination, C/O cough, sinus drainage, diarrhea, and abdominal pain onset 12/29/21
Per mother, pts symptoms started approx 9p Mon 8/10/06, HA, nausea, felt hot (did not check tem) flu like symptoms. During the night chills. 9am still with HA, nausea, felt warm 100F. Denied rash and breathing problems.
2nd dose given too early, 1st dose 1/8/21, 2nd dose 1/28/21
Had a dark bruise after the shot, a week later had tremendous pain radiating from the injection site to the shoulder and neck down to my fingers. Continued pain since then. The pain keeps me up at night. Dr prescribed NSAIDS. MRI imaging, and PT. Pain is still bad, and hard for me to move.
Initial non-serious report received from a health care professional on 12 October 2009. A cluster of several unidentified patients experienced large local reactions (not specified), and at least two unidentified patients experienced large local reactions (not specified) and enlarged lymph nodes of axilla after receiving ADACEL (lot numbers and route/site of administration not reported). The reporter indicated that all the patients were vaccinated within the last six months. No additional details were provided. Follow up information received on 30 October 2009 from a health care professional who provided information for a 28 year old male patient who developed pain and swelling at the injection site and left axilla pain three days after (08 October 2009) receiving ADACEL (lot number C3355AA) intramuscularly in the left arm on 05 October 2009. The patient did not have allergies, prior reactions with past immunizations, or receive any other vaccinations within 4 weeks of the administration of ADACEL. The patient recovered. The reporter stated that the cluster involves one other patient who remains unidentified. Follow-up information was received from the health care professional on 19 November 2009. According to the reporter, specific information for each patient was not available, as the events were "usually noted several weeks or months later". No additional information was provided. Documents held by sender: None.
pt feels woozy p/vax;w/in a maximum of 5min mom of child called nurse;pt had arms crossed  was exhibiting signs of sx: convuls became pale then tinged w/blue green;bluish in color & not breathing;sweat;thirsty;resp 15-20;P64, BP 78/50;
RASH, ITCHEY, HEADACHE, A LBIT FEVER, JOINT PAIN, MUSCLE PAIN
his PSA level increased. Caller said he checked his PSA level 8 weeks after the 2nd shot and it's now at 18; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, he received 2 shots of the Comirnaty vaccine last year), administration date: 2021, for COVID-19 immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious) with onset 2021, outcome "unknown", described as "his PSA level increased. Caller said he checked his PSA level 8 weeks after the 2nd shot and it's now at 18". The event "his psa level increased. caller said he checked his psa level 8 weeks after the 2nd shot and it's now at 18" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated he has a Safety Question. Reporter states last year when he had his yearly physical and blood draw, his PSA or Prostate Specific Antigen, test was at a level of 6, which was very good for his age. Reporter states, then a year later when they drew his blood after the 2 shots of the vaccine, his PSA level was 3 times that at a level of 18. He couldn't believe it, so he had them retest and it came back the same. Reporter stated that he went to (PRIVACY) to a Urologist who rechecked his level and gave him advice, but the urologist thinks it is possibly connected to the vaccine and the doctor is going to watch it for a while. The urologist said he could order a biopsy, but that is particularly painful and invasive for him. Reporter stated that he found out from the CDC there are 44 ongoing studies on PSA levels from the Pfizer and Moderna Vaccines if patients experiencing higher levels after the vaccines. Reporter stated  it was very irritating to have his levels suddenly jump up to 3 times the level they were., and he was calling to find out what is going on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients received an unspecified number of dose of improperly stored GARDASIL, injection (lot number 1291AA, exp. date 12-APR-2014, route not reported). The reporter stated that GARDASIL had been exposed to total time out of range a maximum of 60.5 hours at minus 2 Celsius degree. No adverse effects were reported. The outcome of events was unknown. This is one of 4 reports from the same source: 1308USA002370; 1308USA003562; 1308USA3561; 1308USA003560. Additional information has been requested.
Vaccines administered 9:41 am on 3-01-14. Developed hives on face 3-02-14 at 10 am, by evening rash was all over her body. To ER - given oral dose of prelone in ER. ER doctors suspected a virus. No symptoms of illness. Sibling ill with vomiting on 3-03-14 no fever. Rash comes and goes - diffuse. Rash on face 3-03-14 with few patches on body.
5/18/07 patient given first Gardasil(HPV) lot 1447F.  8/2/07 patient given second Gardasil (HPV lot 09270 mfg Merck.   8/17/07 - Patient taken to Tx Hosp Emerg Room for excesssive bleeding related to menstrual cycle.  Blood test reveals platelet level approx 32K.  ITP diagnosed.  Platelet level would go down to 2K on 9/4/07. Treatments given have been Immune Globulin, WinRHO, and Prednisone.  Patient on birth control pills to stop bleeding.  Latest lab taken show level at 232K, first time over 100K since mid-August.  At present, patient still has some itching (all over) and acne on face (from medicines?).  Still monitoring platelet level - hope this nightmare is over.  Sister age 12 (at time) received same HPV vaccinations with no adverse reaction so far.  Not certain about Route in quest #13.    12/18/07 Reviewed hospital ER & Clinic medical records which reveal patient experienced heavy menses with clots & went to ER 8/17/07.  Tx w/tapering steroidsReferred to Heme, GYN & PMD.  Clinic records of 9/20-12/12/2007 indicate patient bleeding controlled w/low dose estrogen. Plts max low 2k on 9/4 w/bruising & petechiae. Received IVIG 9/7 x 1, plts rose to 16k. .  Received WinRho 9/11 & plts rose to 28k.  9/20 plts 12k, tx w/tapering steroids until 10/21.  11/9 plts 232k but restarted steroid taper for 2 more wks.  11/30 plts 203k & plan was to observe off meds.  No labs reported on 12/12 visit.   ER DX: thrombocytopenia & menorrhagia, hemodynamically stable.  2/22/08 Reviewed pcp medical records & vax records.  Corrected lot # in database.  Received initial HPV vax on 5/18/07, IM in left arm, lot # 1447E.  On 8/2/07 c/o nausea & dizziness s/p 1st HPV vax.  Vomiting w/each period & felt dizzy, cramping & heavy periods.  To see GYN if anti-inflammatories not helpful.  Office vs of 8/20 revealed pt w/ very heavy mentstuation & epistaxis.   Seen in ER where plt ct 36K.  Referred to GYN.  Returned to office 9/5/07 s/p dx w/ITP, plts 2K & had received IVIG.  9/14 plts 28K per t/c.  11/7/07 vs for stuffy runny nose, sore throat & urticarial rash on back.  Dx w/URI, urticaria, thrombocytopenia.  Last plt ct noted as 43K on BCP.   FINAL DX: Idiopathic thrombocytopenic purpura.
This spontaneous report was received from a physician and refers to a 14 year old male patient. No medical history and concurrent conditions were reported. On following dates 09-APR-2015, 02-DEC-2014 and 09-APR-2015, the patient was vaccinated with GARDASIL (lot # K006960 and expiry date: 14-JAN-2017), (lot: K006960; expiration: 19-FEB-2017) and (lot: K006960; expiration: 19-FEB-2017) respectively intramuscular injection. It was unspecified whether GARDASIL vials or pre-filled syringes were used for these doses. No concomitant medications were reported. On 18-APR-2015, the patient experienced heat intolerance, exercise intolerance and fatigue. The patient also had fainting episodes following exercise on 18-APR-2015, 15-MAY-2015 and on 15-JUN-2015. On 06-JUL-2015, the patient experienced diaphoresis and hyperventilation. On unspecified dates laboratory tests blood chemistry and complete blood count (CBC), electrocardiogram (EKG), Holter monitor, one month cardiac event monitor, and electroencephalogram (EEG) were performed and reported as normal. It was unspecified how long it took for the patient to recover from these fainting episodes, hyperhidrosis and hyperventilation and recovered in 2015. The action taken with GARDASIL was not reported. The outcome of heat intolerance, fatigue and exercise intolerance was reported as not recovered/not resolved. The causality was not reported. No further information provided. No product quality complaint (PQC) was filed. Additional information has been requested.
contracting COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (contracting COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (contracting COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (contracting COVID) outcome was unknown.        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.   Patient is enquiring how long should be waited to receive booster shot after contracting COVID-19. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
Hospitalization for COVID-19 pneumonia and acute on chronic hypotonic hyponatremia on dates 9/29/2023- 10/2/2023.  Treated with  Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Shortness at breathe and, tightness in chest and wheezing started 1 hour after receiving the vaccine.
Massive heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Bypass surgery.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Massive heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had quadruple bypass surgery 2 weeks after taking the vaccine.  The side effects and deaths are being underreported. Some doctors have said they have tried to report the side effects from the COVID shots online and were Blocked.  Company comment: This case concerns a patient of an unknown age and gender with relevant history of bypass surgery, who experienced serious unexpected MYOCARDIAL INFARCTION in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). Treatment information was not provided and outcome is unknown. The patient's medical history of bypass surgery remains a major confounding factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-445808, MOD-2022-445817 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with relevant history of bypass surgery, who experienced serious unexpected MYOCARDIAL INFARCTION in an unknown temporal relationship to administration of mRNA-1273 (unknown dose). Treatment information was not provided and outcome is unknown. The patient's medical history of bypass surgery remains a major confounding factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
itching like I have lice; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching like I have lice) and MYALGIA (Sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (Sore arm). On 26-Apr-2021, the patient experienced PRURITUS (itching like I have lice). On 25-Apr-2021, MYALGIA (Sore arm) had resolved. At the time of the report, PRURITUS (itching like I have lice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Widespread joint pain-achy.; Nausea and vomiting; Nausea and vomiting; Headache; Fatigue; Widespread joint pain-achy.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 11:00 (Lot number: Ew0173) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DYAZIDE; WELLBUTRIN; LEXAPRO; AMITIZA; PRILOSEC. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin; Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EJ1686, Administration time: 12:00 PM, Vaccine location: Left arm, Route of administration: Intramuscular), administration date: 05Jan2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Lot number: EL9262, Administration time: 12:00 PM, Vaccine location: Left arm, Route of administration: Intramuscular), administration date: 26Jan2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 24Oct2021, outcome "not recovered" and all described as "Widespread joint pain-achy."; NAUSEA (non-serious), VOMITING (non-serious) all with onset 24Oct2021, outcome "not recovered" and all described as "Nausea and vomiting"; HEADACHE (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of arthralgia, nausea, vomiting, headache, fatigue, pain.  Additional information: It was stated that patient did not receive other vaccine in four weeks of COVID vaccination. Patient was not diagnosed with COVID prior to vaccination and not tested with COVID since vaccination. Facility where the most recent COVID-19 vaccine was administered Public Health Clinic/Veterans Administration facility  Follow-up attempts are completed. No further information is expected.
Extreme pain running down both arms and both legs.  Extreme cold and extreme shaking.  Blood pressure high, pulse high.  Called 911 taken to hospital.
Initial and follow-up information have been received from a nurse for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning a 17 year old white female with allergic reaction to CECLOR and a history of one previous pregnancy, one elective termination and no full-term deliveries who on 08-JAN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot # 659439/1267U) and is pregnant. The patient had a pap test on 04-MAR-2008 that revealed atypical squamous cell of undetermined significance (ASCUS). An ultrasound test was performed on 12-MAR-2008 to established pregnancy due date of 15-SEP-2008. A colposcopy was performed on 18-APR-2008 and a biopsy from 30-APR-2008 provided a diagnosis of cervical intraepithelial neoplasia 1 (CIN 1). An ultrasound test was performed on 07-JUL-2008 and revealed an estimated fetal weight of 3 pounds and a fetal measurement of 28-30 weeks. A repeat pap test was performed on 21-JUL-2008 that revealed ASCUS. Pregnancy was reported as normal to date. Additional information has been requested.
achy feeling x7-10 days;inj site hot, red, tender, size tennis ball x approx 7 days;
Patient received Moderna COVID vaccine on 4/12/21 and 5/10/21. On 1/13/22, patient admitted to our med/surg unit for acute respiratory failure with hypoxia and COVID-19 pneumonia (also tested positive). The plan is for patient to be discharged home today (1/7/22).
Arm was immediately sore and that increased as the day wore on. By evening he was not feeling well - tired and feeling a big chilly. By 11:45 my husband began to shake violently, from head to toe,  and that lasted for 1 hr. and 45 min. If he had not been awake and able to speak to me I would have thought he was having a seizure, that's how violently he was shaking. He didn't have trouble breathing per se, but it was hard to catch his breath because of all the violent movement.  When the shaking stopped he was sore, especially in his head and neck area. He was unable to sleep that night. By morning he had a temp of 100.2. He took Ibuprofen and that helped. He felt tired and dragging the rest of that day, but by the third day he was feeling well again.
I initially felt tired.  As the day progressed I noticed discomfort in my joints.  I also noticed what I would describe as discomfort in the lymph system.  Also, I have difficulty thinking clearly.  Tasks that I  usually complete easily such as online banking have been more difficult.  I'm making mistakes.  As I write this I am now three days from the inoculation.  I have burning pain under my right arm.  I have burning pain in tops of my feet.  My hip joints are stiff.  My eyes are sore.  I feel generally fatigued.  This is not my normal level of functioning.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection lot# L027733, expiration date: 13-SEP-2017, lot# L039660, expiration date: 04-FEB-2018, lot# M000442, expiration date: 03-MAR-2018 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005129: US-009507513-1703USA005128: US-009507513-1703USA000842: US-009507513-1703USA005127:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2017, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
reaction was very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose and an unspecified shingles vaccine at the same time, both for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated that he had a reaction when he got the shingles vaccine and another vaccine at the same time roughly a year ago. The patient could not remember if the other vaccine was for the flu or for pneumonia. He did not know the type of pneumonia vaccine that he had received. He said the reaction was very uncomfortable and lasted for roughly 10 hours. Outcome of the event was recovered.  Information on the batch number has been requested.
Dizzy; Fuzzy; Clumsy; Tired; she fell (did not know how); Gash on cheek; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEELING ABNORMAL (Fuzzy), CLUMSINESS (Clumsy), FATIGUE (Tired) and FALL (she fell (did not know how)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING ABNORMAL (Fuzzy), CLUMSINESS (Clumsy), FATIGUE (Tired), FALL (she fell (did not know how)) and SKIN LACERATION (Gash on cheek). At the time of the report, DIZZINESS (Dizzy), FEELING ABNORMAL (Fuzzy), CLUMSINESS (Clumsy), FATIGUE (Tired), FALL (she fell (did not know how)) and SKIN LACERATION (Gash on cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient woke the next morning with pain and swelling in right deltoid area. Seen by primary care provider - prescribed Clindamycin 300mg capsule PO Q8hr x7days & US completed showing soft tissue edema. Patient continued to have discomfort and was seen in emergency department 8-6-2020@1951 - ED provider prescribed Keflex 500mg (10ml) QID x 7 days