chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of feeling itchiness over the legs and body trunks. No rashes was found, mild localized redness around the injection site left lower forearm and above the eyebrow. No swelling or difficulty breathing noted. Benadryl Oral 25 mg adult dosing administered.  Vital signs at time of administration BP: 140/90, pulse 80, O2 99%.  After 7 minutes of administration client verbalized feeling better and the redness above the eyes resolved. No other distress noted. Full education provided on adverse effects and side effects before leaving the site.  Patient was advised to seek out emergency or healthcare provider if symptoms reappear. By time of leaving, patient was in stable condition and vital signs within normal range. No dizziness, no difficulty breathing, no rashes.
Starting feeling very foggy about 2 months after vaccine. Also started having random skin rashes on shoulders, neck, back and face. Also feeling hyper and exhausted at same time. Hot flashes.
Myalgia Narrative: Per nursing report: "received injection on 2/10/2021 ; c/o muscle soreness"
Patient was given 0.5ml instead of correct dose of 0.3ml.  No adverse events experienced.
presented to urgent care 11/3/99 w/over all weakness;adm hosp,  blood transfusion for ongoing anemia then dx w/GBS;had ascending paralysis;tx w/plasmapheresis;has gross muscle movement back but unable to ambulate d/t weakness;hosp again;60 day follow-up dated 09/26/00 provided no additional data. Annual follow-up dated 01/22/01 provided no additional data.
Information has been received from a physician concerning a 17 year old female who on 07-FEB-2007 was vaccinated with her first dose of Gardasil.  In August 2007 the patient was vaccinated with her third dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  Since the first dose in February 2007, the patient has experienced an irregular menstrual cycle.  The patient was placed on birth control pills to regulate her menstrual cycle, but it is still abnormal.  The patient's irregular menstrual cycle persisted.  The patient sought unspecified medical attention.  Additional information has been requested. 02/10/2010 The patient received two more doses of GARDASIL without side efftects. She was referred to a gynecologist.
Hospital report of cardiac arrest at home/ family cpr; pt had prior  nausea/vomiting/ ? choked/arrested/ aspiration pneumonia;  medical center - transferred to another medical center for cardiac catheterization.
I developed a chronic cough. It was causing a lot of problems. I was unable to sleep. I was having coughing spells. It wasn't only at night. I would also have coughing spells during the day while I was standing up. It was usually relieved by drinking water and taking cough drops. I also took cough syrup. It just seemed like nothing was really helping. When I went to my doctor on 10/11, she determined that the cause of my cough was acid reflux. She advised me not to eat tomatoes or chocolate. Since I've been basically following her advice, my condition has improved. Now, when I start coughing I can get relief by getting a few sips of water. If I don't have water then I take a cough drop and that relieves it. The diagnosis was that it was caused by acid reflux. It is better. She only did a physical exam and checked my vitals. It is much better than it was a few days ago. I am still recovering. I was able to rest normally in my bed the past few nights.
The pt developed varicella on 1/7/02. She was vaccinated on 6/22/00.
Fever the evening of 5/7/2021 and vertigo/extended dizziness the evening of 5/8/2021
This case was reported by a pharmacist via call center representative and described the occurrence of pain in hip in a 68-year-old male patient who received HAVRIX adult. On 18th July 2016, the patient received HAVRIX adult. On an unknown date, less than a year after receiving HAVRIX adult, the patient experienced pain in hip (serious criteria other: serious as per reporter), pain in thigh (serious criteria other: serious as per reporter), stiffness hip (serious criteria other: serious as per reporter) and limbs stiffness (serious criteria other: serious as per reporter). On an unknown date, the outcome of the pain in hip, pain in thigh, stiffness hip and limbs stiffness were not recovered/not resolved. It was unknown if the reporter considered the pain in hip, pain in thigh, stiffness hip and limbs stiffness to be related to HAVRIX adult. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in his deltoid and not in the hip or thigh, which was the area of complaint. In 2016, the patient went to the doctor a few weeks after the pain and stiffness began. No other vaccines were administered during the visit. The lot number and expiration date of the vaccine were unknown. The healthcare professional had no other information to offer. The healthcare professional does not want to receive any follow up about this event.
"PCR stool test was completed on an unspecified date and the results showed "rotavirus"; mucus and blood in their stool; mucus and blood in their stool; This spontaneous report was received from a nurse prescriber via a field employee, referring to a 6 weeks old male patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.  On 06-JAN-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot# and expiration date were unknown) orally for prophylaxis in the series.  On 08-JAN-2020, the patient began experiencing mucus and blood in their stool within 48 hours of administration. The nurse prescriber switched the patient to a hypoallergenic formula. On an unspecified date, a polymerase chain reaction (PCR) stool test was completed and the results showed "rotavirus". The patient sought medical attention by seeing at nurse prescriber's office. There was no intervention to prevent serious criteria. The outcome of the events was reported as not recovered. The causality assessments between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the events were not reported.  Upon internal review, blood in stool was determined to be medically significant.
Patient received J&J vaccine on 4/2/21. COVID positive on 1/4/22 and presented to ER on 1/14/22. Presented to outside hospital for abdominal pain and shortness of breath found to have perforated bowel, b/l pleural effusions, and afib RVR.Then transferred to a HCF.  Admitted for peritonitis. Incidentally covid positive. Patient had episode of emesis while on ventilator 1/18. Patient extubated to Optiflow and required re-intubation likely secondary to aspiration pneumonia from emesis. Extubated to optiflow 1/25. Placed back on BiPAP 1/30. Stable thereafter. Discharged on 2/18/22
Body aches, tired, nausea and bilateral hip pain, constant since 04/11/2021.
Sharp/throbbing pain in left underarm/breast area.; Sharp/throbbing pain in left underarm/breast area.; Sharp/throbbing pain in left underarm/breast area.; This is a spontaneous report from a non-contactable consumer (patient) via. This 32-year-old female patient received the second dose of COVID-19 vaccine (TRADE NAME UNSPECIFIED; lot number ER2613) via an unspecified route of administration in the left arm on 17May2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient previously received the first dose of COVID-19 vaccine (lot number ER8733) in the left arm on an unspecified date for COVID-19 immunisation. On 18May2021 the patient experienced sharp/throbbing pain in the left underarm/breast area. She reported it started on day two after getting the second dose. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of sharp/throbbing pain in the left underarm/breast area were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Chills; 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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), outcome "unknown".  Additional information: Caller got the Pfizer booster shot and she's having chills. She would like to know the reason. Caller stated, "Off and on I'm still having them and they're terrible". Caller confirmed that she received the Pfizer BioNTech Bivalent vaccine but unable to confirm if she received the formulation for ages 12 and older. Caller mentioned that she had chills after receiving the Pfizer Booster. Caller wanted to know how long her chills may last. During the conversation, caller mentioned that she was 69. Caller accepted transfer but caller disconnected during the transfer. Call back was done to gather the information however it was unsuccessful. Further probing could not be done as consumer hung up the call abruptly. Thus, product details (NDC#, UPC# and expiry date) and purchase details were unknown. Hence, limited information was available over the call. Reporter type could not be probed over the call. Hence, captured as consumer and other non- health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/25/07 pm started feel achy - high fever 102, next day aches fever continue 102 start muscle aches Saturday 10/27 - more pain trouble writing - Sunday 10/28 - couldn't walk toe - toe. Went to ED - when seen by physician peers felt "like a turtle" - couldn't roll over. 10/30/07-records received without DC Summary. Admitted 10/7/07-C/O 3 day history of increasing motor weakness associated with fever and diffuse myalgia. Flu shot received 5 days ago. Grip strength was significantly decreased, unable to life up a carton of orange juice. Fevers up to 102.9. Joint pain and ambulatory gait dysfunction. PE: generalized motor weakness significant decrease in grip strength, unable to lift legs more than 6 inches.  Also C/O photophobia, sore throat and headache and difficulty breathing, neck pain, joint pain, numbness and weakness. No rash. No dt changes or ascending in nature. HX of migraine like scotoma. Impression: viral syndrome. 10/31/07-DC Summary received: DC DX: Probably myositis, probably viral in orgin. Recent acute febrile illness. Per 60 day follow up report: Still gets intermittent tingling & numbness both hands & feet. Gets headaches weekly-did not have headaches before-had excessive fatigue-tested has lowered testosterone level. Continues to have. Annual follow-up Information 16-DEC-2008: Still having sig. muscle fatigue and weakness with numbness in foot.
Note: lot number could also be 087B21A - difficult to read it. On the 1st of October, I noticed a weird feeling in my left calf. It felt Like I was going to get a cramp. It felt like a little stitch or pull. I wasn't dehydrated. It didn't seem like I had hurt it. It stayed that way over the weekend.  I made a doctor's appt 09:45 Monday, Urgent Care visit - Clinic - the 4th, they sent me for an ultrasound. It was a clot in my left calf. They prescribed Xarelto blood thinner - 15 mg twice a day for 21 days and then need to switch to 20 mg for 72 days after that. That stitch in my calf cleared after about four days on the blood thinner. I met with my doctor on the 6th.
On the evening of March 16, 2021, I developed an itchy rash (and possible hives) from my elbows down to the tips of my fingers on both arms and from my knees down to my feet on both legs. On March 15, I had taken a long walk outside, so the rash seems to have followed exposure to sunlight, which is the same allergic reaction I have had to sulfa drugs in the past. So this made me think that potentially my itchy rash/hives could be an allergic reaction to the vaccine, but I'm not sure. I'm just reporting it out of an abundance of caution. I am taking Benadryl and using an anti-itch lotion and cold compresses. The rash/hives are still present more than 24 hours later, but even though the itchiness is bothersome, I don't think it's a severe problem. I am hoping it will go away soon. I plan to let my primary care person know via email, but I don't currently plan to see her about this unless it doesn't go away after a few days  or gets worse.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA002182: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
72 yo Male admitted for elective TUR incision of bladder neck contracture.  Procedure accomplished w/o difficulty on 4/13.  Postop course was complicated only by a temp spike to 101.3 following pneumovax injection, which as associated with swollen, painful erythematuous left arm.  That seemed to improve with time and cool packing and patient was discharged to outpatient follow-up on 4/16.  Pneumovax lot number not documented in nursing mar.  07/18/2007 MR received for DOS 4/13-16/2007 for TUR of a bladder neck contracture during which pt received Pneumovax on 4/14/07. Pt spiked a temp up to 101.3 and developed a swollen, painful erythematous L arm which improved over time.
I had low-grade fever, SOB, body aches, severe fatigue, and congestive. These symptoms are still ongoing. I went to my primary care on Dec. 30th for a Covid-19 test, positive result. They also did a flu test, negative result on those.
Moderna COVID-19 vaccine vial exposed to potential temperature excursion used; Moderna COVID-19 vaccine vial exposed to potential temperature excursion used due to lack of digital thermometer and a temperature log in the facility; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used due to lack of digital thermometer and a temperature log in the facility) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used due to lack of digital thermometer and a temperature log in the facility). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine vial exposed to potential temperature excursion used due to lack of digital thermometer and a temperature log in the facility) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was unknown if the vials used undergone a temperature excursion because of lack of digital thermometer and a temperature log in the facility.
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender were administered doses of GARDASIL (Lot# unspecified) dose, route, frequency and location unspecified that was stored outside the recommended temperature range as noted in the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to (Patient Link).
felt feverish and a little achy; felt feverish and a little achy; This is a spontaneous report from a contactable consumer (patient's brother). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at left arm at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 at left arm for COVID-19 vaccination. The patient felt feverish and a little achy. No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovering. Information on the lot/ batch number has been requested.
Patient received dose 1 and dose 2 of the COVID 19 vaccine, 2/2/21 (Lot EL9265, Pfizer)  and 2/24/21 (Lot EN6202, Pfizer), on 2/28/21 patient presented to the Emergency Department at our facility. CBC lab test was abnormal, possible Leukemia, patient transferred to Medical Center for further evaluation and treatment. Patient expired on March 2, 2021.
Around 9 AM, my daughter came downstairs and said her legs felt heavy. She sat down and then she said she was really hot. She was also sweating and pale. She said that she felt like she was about to pass out and that she couldn't see. She also said she couldn't focus, that she was seeing stars, and everything looked black. My husband and I told her to lay down on the couch. We gave her a rag to put on her head to cool her down and we got her some water to drink. She said she had a headache and we gave her some Tylenol.
Palpitation; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 27Feb2021 at single dose for COVID-19 immunization. Medical history included AFib (atrial fibrillation). Concomitant medications included apixaban (ELIQUIS) as blood thinners, had been fine with apixaban, had not got no problem with it; carvedilol (the patient took carvedilol and apixaban before got vaccine and at night of 27Feb2021 when the patient went to bed). Patient got a shot in the afternoon of 27Feb2021, and the night the patient had some palpitations, she was wondering about that because they didn't ask the patient anything about the heart. The patient did take blood thinners apixaban and carvedilol. The patient's question was should she get the second shot, well do the first vaccine have the same ingredients as the first? She was just concerned because she had history of AFib. Outcome of the event was unknown.  Information about lot/batch number was requested.
This spontaneous report was received from a pharmacist, via a company representative, referring to a 56 year old male patient with unspecified chronic medical condition. The patient's pertinent medical history was not provided. The reporter did not know the patient's concomitant medications neither his drug reactions/allergies. On an unspecified date in 2017, the patient received his first vaccination with PNEUMOVAX 23 0.5 ml, for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). Due to the patient chronic condition, he required to get vaccinated annually. Thus, on 16-SEP-2018, reported as "yesterday", the patient was vaccinated with a PNEUMOVAX 23 0.5 ml for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). One day after, on 17-SEP-2018, the patient called the pharmacy and said he was experiencing, since on an unknown date, pain, bruising and itchiness at the injection site. Also, he was experiencing swelling and as the patient explained it to the pharmacist, the swelling had gone beyond the injection site. All previous information was given to the pharmacist over the phone and the pharmacist did not known if the patient received any treatment for the adverse experiences, if any laboratory study was performed or if the patient sought medical attention. At the reporting time, the patient was not recovered from injection site pain, swelling, injection site pruritus and injection site bruising (outcome also reported as unknown). The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided.
body aches; fever; This is a spontaneous report from a contactable physician and non-contactable consumer (patient's parent) via Pfizer sales representative. A patient of unspecified age and gender received second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, fever on an unspecified date with outcome of unknown. Patients parent called doctor's office to report after second dose patient had body aches and fever.  No follow up attempts are needed. No further information is expected.
Vaccine received on 06/01/2020, 10am. No Adverse reaction until 06/04/2020. Localized reaction at the injection site. Injection-site pruritus and rash.