chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Binocular vision loss - Vascular consulted: felt central pathology more likely etiology (Atherosclerosis vs poor cardiac function) rather than focal carotid or vertebral artery pathology alone.  Recommend consider cardiology consultation, antiplatelet agent, high-intensity statin.  Vascular consulted: felt central pathology more likely etiology (Atherosclerosis vs poor cardiac function) rather than focal carotid or vertebral artery pathology alone.  Recommend consider cardiology consultation, antiplatelet agent, high-intensity statin.  In summary suspect his visual symptoms were related to hypoperfusion due to orthostatic hypotension.  The symptoms improved with fluid resuscitation, stopping amlodipine, losartan, Robaxin.  Sodium bicarb was started by nephrology, possibly losing bicarb with his ostomy output. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
RECEIVED BOTH DOSES OF PFIZER COVID19 ON 01/22/21 & 02/12/21. ON 02/21/21 REPORTED COMPLAINING OF RT EAR PAIN AND SORE THROAT. HAD NEGATIVE COVID19 TEST AND FLU. NOT ABLE TO TEST FOR STREP AT THIAT TIME. DIAGNOSED WITH SORE THROAT, EARACHE ON RIGHT, AND ARTHRALGIA OF RIGHT TMJ. TOLD TO GO TO ER IF NOT BETTER IN 1-2 DAYS AND FOLLOW UP WITH PCP IN 1-2 WEEKS.
10/13/2018; patient developed three bumps three inches from the site of administration; few days later few bumps on the toes, then spreading to the legs.
Pt became sore immediately after injection, no redness or soreness at injection site while at pharmacy, nor development after. Worsened pain throughout the day of administration and worsens at night. Extreme muscle pain and discomfort in upper arm, shoulder, and radiating down arm. Pt took ibuprofen and applied ice with some improvement, but is still experiencing pain 72 hours out from vaccine administration.
Patient felt sleepy, blurry vision. BP 131/55 (pulse 62), O2 sat 100%.  After rest, patient felt better.
Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.). At the time of the report, OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed hives on both wrists, biceps, in between fingers, buttocks -- took Benadryl & Claritin -- resolved.
Red, diffuse, macular and urticarial all over body, slightly itchy, started day after injection.  Appointment on 11/20/03.  Gave Orapred 15mg/5ml 4 tsp every day.  Pt has fully recovered.
Pfizer-BioNTech COVID-19 Vaccine EUA: Eight hours following vaccination patient developed numbness of left the lower face. No other symptoms documented. Numbness resolved without intervention within one week of vaccination.
Swelling, redness, pain at injection site and rash over thighs. Fever
This spontaneous report as received from a health care worker refers to a 14.5 year old patient (unknown gender). In 2010 the patient received a first dose of GARDASIL (lot number not reported) (0.5 ml, intramuscular route), a second dose of GARDASIL in 2011 (lot number not reported) (0.5 ml, intramuscular route), a third dose in 2012 (0.5 ml, intramuscular route) and in 2013 a fourth dose of GARDASIL (lot number not reported) (0.5 ml, intramuscular route). The patient did not sought medical attention. No adverse effects reported. Additional information has been requested.
Shot hurt when administered on 8/23/11. She called on 8/26/11 -> arm still really hurt. I call in hear of immun. with RPh and she said could hurt up to six days - On Sat. 8/27/11 I followed up again - was still sore but better.
I've always been very aware of my menstrual cycle as my body gives significant signs. My cycle has always been regular, with only a maximum of three days or less difference. Interestingly, a day after my first vaccine dose, I told those around me the symptoms were very similar to when I'm about to menstruate but worse.   Tonight after about a week, very oddly, my cycle started 10 days early. Additionally, the color also looks different from what it looks like normally. It is usually ranges between dark red and brighter red but today, it has a notable purple tinge to it.   After an internet search, there is article where it seems other women are also experiencing significant shifts in their cycles. And as I'm not one who normally pays much attention to health changes, this was significant enough for me to feel incentivized to report this. It is also quite troubling and is increasing a bit of anxiety on how the second dose may impact the hormones. I really hope there are better studies on how the vaccine can affect hormones as it can cause havoc with the body.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Aug-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were provided. It was reported that patient felt very dizzy. Sometime nauseous, occasionally elevator like feeling and fever. (99.1).
This spontaneous case, initially received from other health professional on 19-Oct-2018, concerns a 1-year-old, infant male patient. The patient had no historical condition. The patient did not receive any concomitant medications. On 16-Oct-2018, the infant patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 252660 and expiry date: 31-May-2019). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
The muscle in my upper right arm has been sore since the date of injection.  The shot was given by the clinic.  After going on leave, 12 September 2022, I was directed to my Primary Care Giver.  I contacted the clinic two times about soreness prior to leave.  Vaccine Manufacturer:  Sanofi Pasteur  /  Dosage:  0.5 ml
Patient called OHS and spoke to doctor on 1/14/08.  After taking 1 Vivotif tablet developed nausea and vomiting and diarrhea.  Did not complete the course prescribed.  Patient stated she had not refrigerated vaccine even though instructed in writing.
Pt reported redness with itching 3 days post vax. She had redness with some swelling noted on front of arm beneath area of injection. She used cold compresses on area. She had two small superficial areas noted on left arm/shoulder on day of injection.
Vomiting; diarrhea; chills; became very I'll; Could not even sip water; This is a spontaneous report received from Pfizer. A contactable consumer (Patient) reported that a 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the she became very I'll after her first shot. Vomiting, diarrhea and chills. Could not even sip water. She was a sixty year old female. Very afraid of second dose. Outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
nausea; stomach pain; This is a spontaneous report from a contactable consumer and nurse, based on information received by Pfizer (manufacturer control number: EC-2021-092476) for BNT162B2.  A male patient of unspecified age received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration on an unknown date as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient's co-suspects included on 09Apr2021, the patient started receiving Lenvatinib mesylate (LENVIMA) with a lot number:1391915 and expiration date: 04/30/2022 at a dose of 18 milligram by oral route of administration, once daily for mal neoplasm of UNSP kidney except renal pelvis. Other medications which were used at or around the time of adverse events were: Bisacodyl (DULCOLAX), Cabozantinib S-Malate (CABOMETYX), Folic acid and Cyanocobalamin (VITAMIN B-12). It was reported that on an unknown date after receiving the COVID shot, the patient experienced stomach upset with nausea and stomach pain. The outcome of the events was unknown.
Medical assistant used normal saline as diluent for Dtap/IPV component and administer the solution IM along with the Hib IM separately
my lips started to tingle and numbness; my lips started to tingle and numbness; my face started to swell; it felt like her heart was racing; This is a spontaneous report from a contactable Consumer. This 69-year-old female Consumer reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 10:00 (Batch/Lot Number: EL9262) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included thyroid cancer, thyroidectomy, COVID-19 Virus in 2020, joint injury, knee surgery from an unknown date and unknown if ongoing she was using the prescription anti-inflammatory for her knee that she had surgery on. There were no concomitant medications. The patient previously took aleve. Reported she has no allergies she is aware of but had an immediate lip tingling after receiving her first COVID-19 Vaccine dose. She said the left side of her face started to swell 5-10 minutes after getting the COVID-19 Vaccine. She said it felt like her heart was racing, too. She said she did not have any tongue swelling. She said her facial swelling went away in about 2 to 2-1/2 hours, and then it was like nothing had ever happened. Reported she may have taken a Tylenol but doesn't know for sure that she did. No further details provided. She was on a prescription anti-inflammatory medication for about a month and stopped taking the prescription 2 weeks prior to getting her first COVID-19 Vaccine shot. She said the prescription anti-inflammatory was for a problem she has with her knee. She said she may have taken some Aleve in between stopping the prescription anti-inflammatory and getting her first COVID-19 Vaccine dose. She said she knows she did not take any Aleve the day she received her COVID-19 Vaccine. She said the prescription anti-inflammatory is a common medication that is prescribed, and she was using the prescription anti-inflammatory for her knee that she had surgery on. Reported she had thyroid cancer, saying she has no thyroid. She said she had the thyroid cancer many years ago and has been on a cocktail of thyroid medicines since then. No further details provided. Reported she is still healing from having the COVID-19 Virus in 2020. She said she is getting episodes with "COVID toes", clarifying her skin is blackened around her toes at times. The outcome of the events was recovered on 28Jan2021.   No follow-up attempts are possible. No further information is expected.
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-10-2022
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-OCT-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-SEP-2016, the patient was treated at clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
I was probably exposed either Friday, or the Saturday beforehand 07/29/2022 or 07/30/2022. I developed a slight cough and headache on 08/01/2022. I felt a bit feverish but was not running a temperature. I took an at home COVID-19 test but it was negative. On Tuesday, I was still feeling badly, so I made an appointment with my PCP for 08/02/2022. I took a PCR test at his office which was positive. I went to a different clinic and was prescribed PAXLOVID which I took for the recommended 5 days. Over those 5 days, I never ran a fever or had breathing issues. I had a slight headache for the first 3 days, a slight runny nose, and some fatigue. Otherwise, the symptoms were very mild. I took an at home COVID-19 test today on 08/08/2022 and it was negative. I was also able to take my dog on a long walk yesterday with no issues.
Day 3 - Extreme Headache, Nausea, head and neck pressure when not lying down continuing for 5 days then becoming manageable and occasional. Day 14 - Occasional Double vision.
I started with a runny nose and a headache. I usually get that with allergies. I think it was a sinus headache that continued for a  day or two. I then started coughing and short of breath.  The coughing brought up a lot of junk but it was clear. The runny nose and sinus headache stopped after two days. The productive cough continues until now. After experiencing symptoms for 5-7 days I came home and took a home COVID test and it was positive. I spoke to my Pulmonary physican who had me speak to my PCP. I have a video call with him tomorrow
a VAQTA pediatric dose was administered today post expiration date; This spontaneous report was received from a medical assistant and refers to a 15-year-old male patient. The patient's pertinent medical history, concomitant medications and previous drug reaction or allergies were not reported. On 30-SEP-2020 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 1 pediatric dose, lot # S019435, expiration date 23-AUG-2020 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness & swelling with streaks below injection site within 48 hours of administration. Cold compress applied, BENADRYL given. Swelling & tenderness by the 4th day.
I was diagnosed with Shingles on 05/11/2022. I started experiencing COVID like symptoms on 05/12/2022 Tested negative on the 12th and 13th. Tested positive on 05/15/2022.
1ST DOSE ON 3/18/2021 2ND DOSE ON 4/8/2021 TESTED POSITIVE FOR sars CoV2 ON 5/10/2021
The patient was seen for a well baby exam about 3:30PM on 03/23/2006.  He was well at the time of exam.  He received DTAP, IPV, HIB, and PCV vaccines before leaving.  About 3-4 hours later, he developed a pink/red rash in patches from head to toe.  A dose of Benadryl was orally administered once and the rash resolved.
Vaccine given at 11:51 AM and within 2 hrs patient had limp upper and lower extremities lasting for 12 hrs.  He was feeding and breathing normally and had no fevers.  After 12 hrs, he went back to normal.
vaccine given from undiluted vial. No adverse outcomes noted. asked parents to watch for any signs or symptoms and report to clinic immediately.
On Saturday, 2/10/18, huge swelling in armpit, lymph nodes, but I felt fine. I took pictures if you want them & my doctor has a set of them, too. On Sunday, 2/11/18, an intense migraine started and lasted for a few days, accompanied by vomiting, sweating, and freezing. I saw the doctor on 2/13/18, she told me what to watch for regarding the lymph nodes and to come back if any of them occurred. She said I should get the second dose, but move it further out in the 2 - 6 mo window. She gave me a script to help with migraine, if I get one on the second dose. I was able to keep down water & broth on 2/13/18 and solid food by 2/14/18. Today, I'm just exhausted.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. An elderly female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3249), in left arm and on 29Nov2021 as dose 3 [booster], single (Lot number: F48027 (as reported)), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Breast Cancer (remission)" (unspecified if ongoing); "Pulmonary Embolism" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE, stop date: 10May2022; ASPIRIN 81, stop date: 10May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "recovering" and all described as "I got Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (COVID-19 test): (22May2022) Positive. Therapeutic measures (Monoclonal Infusion Therapy) were taken as a result of drug ineffective, Covid-19. Additional information: The patient started the Pfizer COVID-19 treatment from 10May2022 to 14May2022 then reported that on day 13, the patient got COVID again after taking the pills. On 02Jun2022, investigation results concluded that: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EL3246 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3246, fill lot EL3229, and the formulated drug product lot EL3222. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Information has been received from a 49 year old female consumer with no medical history and no allergies who in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included doxycycline. In 2002 the patient contracted pneumonia. She reported that she went to the doctor when she contracted this, but the doctor sent her home. No lob studies were performed. No treatment was required. No product quality complaint was involved. Additional information has been requested.
approx 25 mins after vaccination, pt developed numbness to tongue, benadryl administered.  Vitals: 11:05am BP 124/80, P 90, 11:13am BP 98/60, P 82. symptoms progressed to rash, dyspnea, chest pain and pedal edema. Epinepherine 0.3 mg given with Epi pen auto injector., rescue called. 11:36am 145/70, P 118.  Pt transported to hospital vis rescue
Based on the information received on 19 June 2015 the case is now medically confirmed. Initial unsolicited report received from non-healthcare professional on 20 May 2015. A 42-year-old male patient, whose medical history was reported as allergies to azithromycin and IVP dye, had received a third dose of MENACTRA (batch number: U4986CA, expiration date and dose not reported) intramuscularly in left deltoid on 19 May 2015 at 10:00 hours. Previously patient had received MENACTRA vaccine on 17 May 2012 at the age of 39 years. The patient had not received any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and other medication were reported as none. Patient denied receiving any other medication. On 19 May 2015 at 20:00 hours, ten hours after vaccination patient was feeling hot, had chills and body aches. Laboratory investigations were not required. Patient had received MOTRIN as a corrective treatment on 20 May 2015. At the time of this report, patient was recovered from all events on an unspecified date. List of documents held by sender: none. Follow-up information received from physician on 19 June 2015. A patient had received 0.5 ml dose MENACTRA vaccine on 19 May 2015. It was not known if patient experienced any delayed reaction. No additional information reported. List of documents held by sender: none.
It was like an adrenaline rush at first, light headed and felt like i was going to pass out- 04/2/2021 Shortness of breathe last for 2 weeks. Given a Steroid Shot- 04/16/2021 Given an Inhaler 04/16/2021
Patient reporting hip joint pains, and was unable to move due to pain, back pain. Prescribed steroids by PCP, patient still experiencing pains.
pt was transferred from an outside hospital (name not in medical record) to hospital for further evaluation and treatment; admitted to hospital; pt had been seen in their ED for low O2 sats and was given 4L O2 via NC; chest x-ray was abnormal; when got to hospital, pt was not in respiratory distress, suspected possible CHF; found to have a positive COVID test;  was treated with dexamethasone; pt experienced PEA arrest with V Fib; CPR via ACLS protocol, and ROSC achieved; intubated; found to have an acute right lower extremity DVT; Heparin; pt in septic shock requiring vasopressors; family made by DNR and he passed away in the hospital
Born at 39 weeks gestation. Newborn screenings WNL. May have been a twin.
My arm got sore after about 5 or 6 hrs.   Went to bed, at about s 3:00am woke up in a sweat, barely got to the bathroom thought I was having a heart attack, got myself to the floor for the cold tile, next thing I remember waking up on the floor in the bathroom.  Got myslelf back to bed.  My arm was no longer sore, however, the shingle shot went directly to my hip and lower back,  I had shingles on 12/21/21, a bad case where it was on my left hip to my lower back.  After 5 months I asked my doctor if it was OK to get the shot.  Well now it's over 2weeks sufferering and reliving the shingles again.  My doctor said to go on Gabapentin     at bedtime.