chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain in joints; chills; fever; migraine; swollen lymph nodes in underarm and groin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 15:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "Allergies: Walnuts" (unspecified if ongoing); "Allergies: latex" (unspecified if ongoing); "Allergies: Bees" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; SINGULAIR; NASONEX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovering", described as "Extreme pain in joints"; CHILLS (non-serious) with onset 2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "fever"; MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "migraine"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "swollen lymph nodes in underarm and groin". Therapeutic measures were not taken as a result of arthralgia, chills, pyrexia, migraine, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient did not test positive for COVID-19.  No follow-up attempts are possible. No further information is expected.
splitting headache; This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), intramuscular, administered in Left Arm on 25Feb2021 (Batch/Lot Number: R78322) as SINGLE DOSE for immunisation. Medical history included patient had shrunk he used to be 6 foot tall, this had happened over a lot of years, and has nothing to do with the vaccine. There were no concomitant medications.  Patient said he had a splitting headache on 25Feb2021, his wife of 30 years remarked that this was the second or third time he had ever mentioned a headache. He said it started a half hour after he got the shot, it was half strength by the time he went to bed, and he still had some this morning then it dissipated. He said he was fine, hale, hearty, and healthy. He said he had no vascular problems. The patient experienced splitting headache on 25Feb2021 with outcome of recovered on 26Feb2021.  No follow-up attempts are needed. No further information is expected.
3cm area of erythema; warm to touch at injection site. Being treated as cellulitis. Follow-up in 3 days.
Red welt in area of injection site that occurred about a week after initial injection. Reporting itching x 1 day, swelling, redness and some pain at injection site. 10 days. As of 4/12/21, no itchying, red swollen area is still present. plan to take an antihistamine.
2/7/08-4pm-Injection site became red (when mom noticed) - large area of erythema, about 3x3 in. - warm to touch - no fever - Rx with Cephalexin 250 mg tid x5 days.  Area was all clear within couple days.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No information regarding their concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, injection (lot# L012034, expiration date: 07-APR-2017; lot# L013825, expiration date: 21-APR-2017; doses and routes of administration were not provided). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of -13.5 degrees Celsius for 1 hour and 13 minutes. There was no previous temperature excursion. Digital Data Logger was involved. This is one of two report received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1612USA001155:
Patient reported feeling dizzy a few minutes after the vaccine administration.  He began sweating and became extremely pale.  The patient reported hearing "static" and then lost consciousness.  He was held in place in his chair for a moment, and then came around.  We offered him an ice pack for his neck and monitored him for the next 30 minutes.  His blood pressure was 86/44 at that point.  Over the course of the next half hour his blood pressure recovered, but he still reported feeling strange and thought if he stood up he would pass out.  The patient's father had arrived and they decided to go the the local ER via ambulance.
Patient reports arm soreness limiting mobility of his shoulder. OTC treatment (pain relievers and hydrocortisone cream) was recommended along with watching for any worsening of the problem.
16OCT98 malaise, 14OCT rash, runny nose, fever 103, conjunctivitis;
Warm, red swollen area the size of soft ball approx. 3" below injection site".
About 3-5 minutes after the shot I started to sweat profusely from my forehead.  My throat felt like someone was blowing a balloon up in it.  I could not breathe.  I was given an EpiPen by the pharmacist to stop my throat from closing.  EMT was called to the scene following by a medic who performed an ekg in the ambulance.
I had flushing; hives in my head; due for 2nd dose yesterday. pharamacist refused to administer; rashes on face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (I had flushing), URTICARIA (hives in my head), PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) and RASH (rashes on face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (I had flushing), URTICARIA (hives in my head), PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) and RASH (rashes on face). At the time of the report, FLUSHING (I had flushing), URTICARIA (hives in my head) and RASH (rashes on face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was reported. No treatment medication was provided.
Patient received his COVID "booster" shot on 11/09/2021 on the advice of his cardiologist who diagnosed him with new onset CHF. Two days later, on 11/11/2021, patient suffered a stroke caused by a clot in his brain. Patient was taken by ambulance to Hospital. In the Emergency Room, a number of tests- including a CT scan and angiogram were performed. At this point, patient was experiencing complete left side paralysis but was able to speak and to understand speech. One day later- on 11/12/2021 patient's brain began to swell. He was put on comfort care because his family and medical team did not think that patient's heart and body would be able to withstand the surgery. Patient passed away on 11/13/2021- just 4 days after his last COVID shot.
Pallor, Lethargy, Tachycardia, Fever to 38.1 C, Poor Feeding.
Post vax, the pt experienced upward rolling of the eyeballs, tonic posturing, followed by shaking then a postictal lethargy.
a nurse rpt a pt inadvertently recv 0.1 mL of TD, purogenated intradermally, rather than PPD, 2 days later pt developed 5-cm area of induration & redness at the inject site. pt saw m.d. & recovered.
Moderna COVID-19   Slight swelling at site of shot  Rash and slight itching along upper arm eight days after shot.   Now four days later - no worse and no hindrance
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers not route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Oka/Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 19-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route not were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Information has been received from a physician concerning an 8 year old white male with a hx of a rash due to BACTRIM who on 29MAY2003 was vaccinated IM in the LA with the first dose 0.5ml of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. At 16:30 on 30MAY2003, within 48 hours of being vaccinated, the pt developed a temperature of 105 degrees and a very large, warm, tender reaction locally at the site. The pt also had nausea and had vomited at least once. Upon examination, there was no indication of respiratory infection or other cause for the patient's elevated temperature. The physician also reported that the pt had low pneumococcal titer levels. The pt was treated with Tylenol 500 mg q 6 hours, ibuprofen 200 mg q6 and short course of prednisone 20 mg twice daily for 48 hours. It was noted that the pt had an uneventful course. Subsequently, the pt recovered from his events. Additional information is not expected.
Patient felt faint after receiving Gardasil injection, was observed for 15 minutes until faintness passed then discharged to family member.
Fever, pain in the shot place, bodyaches and fatigue  and also the site of the shot is swollen and red
02/03/2022 at 20:00 - Severe Chills, Severe Headache, Backache, Fever 101.9, High Heart Rate, Mild Difficulty Breathing  02/04/2022 all Day - Shallow breathing, Cough, Headache, Backache, High Heart Rate 02/05/2022 - High Heart Rate, Cough, Mild Difficulty Breathing
(L) arm swelled up, pain, tenderness, and redness on injection site. Pain rated at 0 on 0-10 scale. Felt like it hit a nerve. Shooting pain down left arm, unable to lift much above waist without severe sudden pain onset. Pain intermittent rated and 6 to touch. Shoulder joint has crepitation on movement.
Mild muscle soreness around injection site; Swollen lymph nodes in left armpit; Hives at major joints.; Severe fatigue day of, for about 24 hrs.; This is a spontaneous report from a contactable patient. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: EN6208) via an unspecified route of administration in left arm on 10Mar2021 (at the age of 45-years-old), as an unspecified single dose for COVID-19 Immunisation. The patient's medical history included G6pd enzyme deficient, diabetes mellitus. The concomitant medication included Lisinopril, Pioglitazone. The patient was allergic to Sulpha drugs, NSAIDs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced Mild muscle soreness around injection site, severe fatigue day of, for about 24 hours on an unspecified date. On 15Mar2021, five days later broke out in hives at major joints/lymph node areas that went away after about 8-10 hours. The patient also experienced swollen lymph nodes in left armpit on an unspecified date. The clinical outcome of the event muscle soreness around injection site, swollen lymph nodes in left armpit was unknown, fatigue, hives at major joints/lymph node was recovered. No follow-up attempts are possible; No further information is expected.
p/vax pt arm sore then went away for few days then started back hurting @ site of immun;now can't lt arm up-no redness or swelling;advised take APAP & apply warm compresses;
Following day after receiving Pfizer vaccine, my arm was so sore, I?m lethargic. I?m a breastfeeding mother and my 4 month old is lethargic as well. I?m tired.
Dizziness Narrative:  Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.
Chest pain approximately 24 hours after injection. Pain varies from internal burning sensation to feeling like inside of left side of chest is being compressed. Chest pain continued after sore arm and other common injection symptoms faded. Workplace nurse checked pulse and confirmed it was normal shortly after chest pain developed. Urgent care confirmed vitals normal after other symptoms faded and the chest pain continued. EKG also came back normal. Put on Ibuprofen regime.
Pt has a Very itchy, red,  pimple/bump rash over most of her back, front, hips and arms.  NOTE: I also have a similar rash but not nearly as bad as my wife on my rt shoulder and arm. It began two weeks ago. I ALSO had the J&J shot on 5/9/2021 batch 204 A21 A at a pharmacy
p/vax pt devel edema & erythema of 85% of upper arm from shoulder to elbow;painful & pruritic;
Patient has an extremely red, swollen arm. Patient does not exhibit pain to move the arm. Patient stated no fever, no problems breathing and no problems swallowing.
I got COVID,  I had a fever, body aches, nausea and low energy. My family doctor prescribed Paxlovid and I took the full treatment.  I felt bad for about 5 days and then felt better for 2 days and then got sick again for about a week.  My doctor said I had "rebound" COVID. I still had low energy for another 2 or 3 weeks but am feeling back to normal now.
3 days of fever reaching 101.8 degrees F, with body aches. skin sensitivity to touch, and fatigue. When those symptoms first started there was a soreness under my sternum during inhalation that has since progressively gotten worse.
Throat felt funny, unable to explain. Denies itching, cough, chest pain, SOB BP: 189/98 Pulse ox: 100% HR: 80  Seen and cleared by EMS
This spontaneous report as received from a physician refers to a 65 year old male patient. On 06-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot/batch number, expiration date and route were not reported). On 06-SEP-2014 (reported as since receiving ZOSTAVAX), the patient experienced severe reaction clarified as arthralgia, myalgia, diarrhea and fever with temperature 101 to 102F. There was no treatment given for the events. The patient sought medical attention. The outcome of the events was not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
ear ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ear ringing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 TINNITUS (ear ringing). At the time of the report, TINNITUS (ear ringing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Began with rash on upper back and grew to rash on right and left arm, rash on middle and upper back, rash on right thigh with constant itching. Apply Tramcinolone Acetonide Cream 2x day; Methylprednisolone DosePack
Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea; Vaccine exposure via breastmilk; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) outcome was unknown and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  CC: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred  on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-356031 (Parent-Child Link).   See case MOD-2021-356031 for details regarding the Parent case.; Sender's Comments: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred  on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 4 months old male patient who received vaccine ACT-HIB. The patients past medical history, and family history were not provided. Concomitant medications included DAPTACEL on 28-Nov-2018. On 28-Nov-2018, the patient received a first dose of suspect HIB (PRP/T) VACCINE lot UI820AA, expiry date 18-Nov-2018 via unknown route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that 4-month old male received expired ACT-HIB vaccine. The patient did not experience 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.
Arm is kind of sore; Pretty tired; This is a spontaneous report from a contactable consumer (parent). A 21-year-old female patient received bnt162b2 (BNT162B2, lot no. and expiry date was unknown), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer vaccine, the new Covid vaccine yesterday (17Dec2020). The consumer reported that her daughter's arm is kind of sore and she is pretty tired on unspecified date in Dec2020. The patient was given the vaccine because she interacts with Covid patients, she works in the Intensive Care Unit, so they provided the vaccine to her. The patient gets a Covid test every three days and she has been always negative on Covid test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Within 15 minutes of received the vaccine, pt. became lethargic. Blood pressure dropped to below 70/50. Pt began sweating and was nauseated. Pt. began vomiting and experiencing diarrhea.
Immediately after shot, arm began to hurt badly where it hurt to move it and it began to itch. A few hours after that I felt really tired and began to get strong cramps in my uterus, when I went to the bathroom to urinate, I noticed blood and blood clots coming out. I have been bleeding and have blood clots still coming out after 12 days now and the bleeding is increasing.