chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown demographics. Information regarding the patients' pertinent medical history, and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly doses of VARIVAX which had a lot # M042495 and expiration date 19-OCT-2018 (dose, anatomical location and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored DILUENT MRK injection. The doses of VARIVAX were exposure to a temperature excursion from -14 Celsius degree to -10 Celsius degree, during a time frame of 1 hour 19 minutes, which was called by a data logger. There was not previous temperature excursions. No adverse effects reported.
Loss of conscious, we called emergency services and they came and evaluated the patient she had a drop in blood pressure they gave her juice and waited 30 mins and evaluated her again and her blood pressure returned to normal level and she went home
Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (R.N.) concerning an 17 (previously reported as 18) year old female patient with a history of 0 pregnancy.  On 15-MAY-2007 was vaccinated with a dose of Gardasil Lot # 655205/1426F.  On 15-MAY-2007 concomitant suspect therapy included a dose of MMR II (MSD) lot #654893/1029F.  Other concomitant therapy included Tdap and MENACTRA.  Patient was found to be pregnant on 19-JUN-2007 and she had a positive urine lab test on that day.  Patient took PHENERGAN for nausea.  She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason.  It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties".  On 17-AUG-2007, maternal serum alpha-fetoprotein (MSAFP) test were done with normal result.  On 12-SEP-2007 an ultra sound was done with normal result.  Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/18/2007. Initial and follow up information has been received for Pregnancy Registry for GARDASIL from a Registered Nurse (RN) concerning an 17 (previously reported as 18) year old white female patient with a history of 0 pregnancy. On 15-MAY-2007 was vaccinated with a dose of GARDASIL Lot # 655205/1426F. On 15-MAY-2007 concomitant suspect therapy included MENACTRA. Patient was found to be pregnant on 19-JUNE-2007 and she had a positive urine lab test on that day. Patient took PHENERGAN for nausea. She took TYLENOL and ibuprofen therapy (OTC) for unspecified reason. It was reported that "patient experienced 4 days of heavy alcohol use in June 2007 at graduation parties." On 17-AUG-2007, maternal MNAFP test were done with normal result. Patient's last menstrual period was reported as 26-APR-2007 and expected delivery date would be 01-FEB-2007. In follow up telephone call to doctor's office the physician reported that patient had a vaginal delivery in early February 2008. She did not know the exact date becasue she did not deliver the patient. The physician said that there no compications and the baby was healthy. On 04-MAR-2008 the patient was seen for her post partum visit and she received her second dose of GARDASIL at that time. No further information was available. Additional information is not available..
3:30 At home, exerienced tachycardia, palpitations, headache; Drove self to hospital ED; Had hypertension, monitored for several hours.  Was diagnosed with Adverse reaction to vaccine and to follow up with PCP on 3/15/2021
pt recv vax; woke up on 31may95 w/ diffuse hives fr neck down & a low grade fever of 99.8;broke out w/ more lesions;seen by MD & advised to take dph;
On 4/14/2021 at about 4:00PM, I started experiencing painful muscle spasms in my left calf. I tried to get rid of the pain by walking it off and scratching my leg, but the more I walked, the worse it got. I don't like taking a lot of medicines, so I took 81mg of aspirin. I waited and the pain eased a bit. I also had hot ginger tea with lemon and honey and hoped it would help me relax a bit. I then prepared dinner and later went to bed. I woke up at about 3:00-3:30AM on 4/15/2021 to go to the bathroom and noticed the pain was returning, so I took a hot shower and hoped it would help the muscles relax. I then went back to bed and woke up at 8:30AM. I went to get breakfast and noticed the pain had returned and was even worse than it had been at 3:00AM, so I took some more aspirin. The pain eased a bit and I was able to go on with my day. On 4/16/2021, the pain returned and was so bad that I could hardly walk. I tried to find someone to take me to the ER, but I couldn't find anyone, so I made do by taking aspirin every 6-8 hours to help ease the pain. On 4/17/2021, my sister called me and asked if I was still in pain. I told her I was, so she took me to the ER at Memorial Hospital. The ER staff told me I had probably pulled or injured a muscle, though I hadn't done anything to injure my leg. They wrapped my leg in a tight bandage and advised me to rest and to try to refrain from using my leg as much as possible. However, I found that the bandage made the pain worse, so I removed the bandaged and tried elevating my leg. Over the following 2 weeks, I continued to experience leg pain and swelling. On 4/30/2021, I went to Health for an upper endoscopy. They noticed my leg was swollen and asked if I was in pain, and I told them I was. They decided not to perform the endoscopy and had me wheeled over to the ER. At the ER, I underwent tests, and they found a blood clot. I was promptly given Eliquis and was kept until about 5:00 PM, so they could monitor me and ensure the medicine was working. They gave me a week's supply of Eliquis and told me to go to my PCP to get another prescription for Eliquis when I ran out. I tried to get in to see my regular PCP, but he was booked solid, so I switched to another doctor, who has been following my case ever since. I am currently still taking Eliquis, and I no longer experience the pain I did before I started taking it. I am scheduled to see doctor on 12/1/2021, and he plans to check to see if the clot has dissolved.
Hives all over the body. Redness on the whole right thigh (site of injection). Hives manifested a few hours after vaccination . Fever of 102 degrees on 2nd day. Hives on and off, that are itchy. Treated with Tylenol, cold compress and Atarax.
the HCP conducted "blood tests against the new born blood tests and found that it was quite different"; the consumer was "very lethargic"; "lost his speech until seven years old"; MRI done and the results showed "some brain damage"; the consumers "eye color changed from bright blue to gray"; temperature of 104 F for three days; had the exact side effects that are listed at all intervals of two, four, and six weeks; This spontaneous report was received from the patient's mother, referring to a 1-year-old male patient. It was reported that the patient had drug reaction or allergies to Augmentin. The patient did not have other pertinent medical history or concomitant medications.  On 28-NOV-2005, the patient was vaccinated with his first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (human serum albumin (HSA)) (M-M-R II) at a dose of 0.5 milliliter (mL), by injection route in the left thigh as prophylaxis recommended by the doctor (exact route of administration and vaccination scheme frequency were not reported; lot number 0378R has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported and but upon internal validation established as 24-MAR-2007).  On an unknown date in 2005, the patient had the exact side effects that are listed at all intervals of two, four, and six weeks (vaccination complication) and ending with a temperature of 104 degrees Fahrenheit (F) for three days (pyrexia). The patient was treated with Tylenol and Ibuprofen.  On unknown date in February 2006 (reported as "at 18 months of age"), the patient eye color changed from bright blue to gray (eye colour change).  On an unknown date in 2007 (reported as "at three years old"), the patient had an magnetic resonance imaging (MRI) done and the results showed "some brain damage" (brain injury).   On an unknown date, the healthcare professional (HCP) conducted "blood tests against the new born blood tests and found that it was quite different" (blood test abnormal). After the initial event the reporter stated that the patient was "very lethargic" (lethargy) and "lost his speech until seven years old" (aphasia) only gaining it back after extensive speech therapy.  It was reported that the patient sought medical attention.   Under the recommendation from the HCP, the patient did not get the second shot. The outcome of the events brain injury, eye colour change, lethargy and blood test abnormal were not reported. The outcome of the events vaccination complication, pyrexia and aphasia was reported as resolved. The causal relationship between the event vaccination complication was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (HSA) (M-M-R II). The causal relationship between the event brain injury, eye colour change, lethargy, blood test abnormal, pyrexia and aphasia and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (HSA) (M-M-R II).   Upon internal review, the event brain injury was considered to be medically significant.
Patient husband stated that patient was in the ICU for 2 days and had to have surgery.
Patient says that she was feeling lightheaded , dizzy, and that she couldnt see or hear.  Rph, took her blood pressure. It was normal  She also gave her some water. Patient persisted with she couldnt see or hear even though she was talking to us. Patient was placed in a supine position in our counseling area and given an ice pack and fan. Emergency services were called. Store management was notified and patient walked out of here
36 year old female airport employee with medical history signficant for chronic focal seizure (diagnosed for 15 years, taking lamotrigine, gabapentin, and pregabilin daily), transient hypertension, and food allergies who presents for Johnson and Johnson vaccine.. She was given vaccine to her left arm and was sent to the observation area. Approximately 10 minutes after vaccination, patient was seen slouched over and slightly shaking. She was responsive with nods and simple yes/no questions. Pt reported ?feeling hot?, ice pack applied to back of neck until she felt more comfortable. No loss of consciousness.   Patient began to displayed anxiety approximately 5 minutes after being vaccinated. Patient was given water and ice, which seemed to ease her anxiety.  She was able to respond to simple questions with nods/yes/no, but had difficulty producing full sentences. However, she made out the words ?I?ll be fine, just give me a moment for my body to reset?. Patient was able to let us know this is normal for her, after an epileptic episode. She said she was diagnosed with epilepsy 15 years ago, but recently more frequently while working at the airport although no known cause of onset. She denies that stress is a trigger for epileptic episode and that these episodes seems to happens ?randmly. Her symptoms gradually improved in 10 minutes after onset and patient was able to communicate in complete and proper sentences. Vitals stable. She requested to go back to work and reports her coworkers at airport are mostly nurses and ?felt 100%  safe? going back. She was observed for approximately 35 minutes total before being discharged.  Vitals: BP 125/65, HR 85, O2 100%   Assessment: focal seizure / epilepsy, fully recovered at time of discharge
"tingling" in her face; face felt numb; having a bruise underneath her chin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 08Mar2021 (at the age of 43-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "tingling" in her face and face felt numb on 08Mar2021, having a bruise underneath her chin on an unspecified date in Mar2021. Patient reported having a bruise underneath her chin that was not there yesterday, before the vaccination. She also stated that she did not remember hurting herself. She also reported that last night she felt a "tingling" in her face. She states that her face felt numb and "tingly" for about a half hour and then this subsided. She said she spoke with two of her colleagues who reported feeling the same thing. Patient was requesting a list of the ingredients of the vaccine, as she may be concerned she had a reaction to a certain ingredient. The outcome of "tingling" in her face and face felt numb was recovered on an unspecified date in Mar2021 while bruise underneath her chin was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, cough, nasal congestion, runny nose, sore throat, body aches, chills, fatigue, headache; with COVID positive PCR on 08/04/2021.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: 320308D), in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Mar2021 as dose 1, single (Lot number: 007M20A) and on 20Feb2021 as dose 2, single (Lot number: 011A21A), in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "hypothyroidism" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing), notes: Dose3 Pfizer, Dose 2 an 1 Moderna. Concomitant medication(s) included: LEVOTHYROXINE (100MCG); VITAMIN C [ASCORBIC ACID] 1000; VITAMIN D3 (2000 IU); VITAMIN B12 [CYANOCOBALAMIN](5000mcg); ZINC (50mg); MAGNESIUM (250mg); CALCIUM CITRATE (600mg); SELENIUM (200mcg); PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]; COLLAGEN + BIOTIN 6000mg.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Covid-19 treatment included Paxlovid from 04May2022 to 09May2022 of lot number GA1519 for the indication treatment of COVID-19.
Pt to ED 10/18 for numbness and tingling in R leg. Pt COVID+ 10/19. 10/20 pt to complete 3 d course of remdesivir. 10/21 pt is intubated, hypotensive. 10/23 Pt lethargic, oriented x4. 10/27 Pt is alert and oriented x4; able to follow commands, on RA with no respiratory difficulties noted. 10/29 pt on bedrest, aox4, room air. 10/30 Pt A&Ox4 and VSS on room air. Pt discharged 11/1.
Patient complained that she have been experiencing muscle tenderness and painful to touch in her upper left arm where.
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N028258, expiration date on 30-MAY-2019, oral for prophylaxis (dosage schedule was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012292: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513- 1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012293.
Moderate headache, fever 100.3, moderate mussel aches, mild soreness at injection site, coughing up thick mucus, moderately lethargic.  Mussel aches started about 11:45am 6/6/21 and progressed. Other symptoms emerged between 11:45 and 4:30pm when temperature was taken, revealing fever.
23 y/o complaining of anxiety. Patient states experiecing anxiety. Patient refused further treatment
Tingling & numbness in arm. Patient said don't worry about it as he doesn't want any repercussions.
history of bells palsey on right side of face.     Numbness and tingingling on right face - bells palsy returned.    she is also a cancer patient (multiple myloma - currently in treatment)    contacted MD - is going to receive steroid therapy.       initially had numbness on right side of face the day following injection - droopiness,  slurring of words began 3 weeks following 2nd injection.
Information has been received from a physician assistant concerning a 41 year old male who on 04/11/1997 and 09/15/2000 was vaccinated with a first and second dose respectively of hep A virus vaccine. Concomitant therapy on 04/11/1997 and 09/15/2000 included a first and third dose respectively of hep B vaccine. this schedule also does not comply with the recommended administration schedule. Subsequently, on approximately 05/15/2001, the titers drawn did not detect seroconversion to either vaccine. The pt sought medical attention. Additional info is not expected. The pt also experienced a lack of effect while on therapy with hep B vaccine recombinant (WAES01052970).
Fever of 104, chills, aches, mild nausea over night, low fever next day.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot # N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Patient was discovered sitting  on the ground conscious and responsive.  The  patient experienced light-headedness  and dizziness approximately 15 mins post injection as she was walking through the store.  EMS was called and while we waited she  was given some water and she reported skipping breakfast.  When EMS arrived they examined her and her blood pressure and blood sugar were both in normal ranges.  The patient was feeling better by the time the EMS responders arrived and they released her.
pt recived janssen covid vaccine on 3/12/21. Then came got Moderna covid vaccine on 7/13/21 (1st dose). Insurance was not billed at that time so were not able to see if he got Janssen vaccine. Today (8/10/21)he came to get the 2nd dose of Moderna and we found out that he got Janssen back in 3/12/21 per insurance decline. He did not report any side-effect from Moderna
not pain but,felt different; the right arm was sore/still sore after 4 month/right arm still hurts/still sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination.      Medical history was not provided.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore). At the time of the report, FEELING ABNORMAL (not pain but,felt different) outcome was unknown and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-355773 (Patient Link).
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-APR-2016, the patient was inadvertently administered an expired dose of RECOMBIVAX HB (lot # J014855, expiration date: 16-APR-2016, dose, route of administration and injection site were not provided). This was supported. Product quality complaint (PQC) was not involved. Additional information has been requested.
potassium was low went from 4.2 to 3.2; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of Blood potassium decreased (potassium was low went from 4.2 to 3.2).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event potassium was low that went from 4.2 to 3.2.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.