chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1627: Wife approached table. Stated "My husband feels like he is about to pass out." Instructed patient to sit on floor, in fowler's position, against wall. Patient pallor in color. Assessed VS BP88/60, HR51, SPO2 99%, BS81. Applied damp cloth to neck, patient diaphoretic.  remained at patient side. Patient instructed to wait 30 minutes before departure. Will continue to monitor. 1624: BP113/58, HR52. Patient. Able to communicate. Will continue to monitor. Patient regaining color in face. 1649: Patient has no c/o pain or dizziness. BP131/80, SPO2 98%, HR59. Patient skin color WNL. No longer diaphoretic. No s/s of acute distress. Patient ambulated independently at 1659
This is a spontaneous report received from a contactable consumer or other non-HCP (parent); program ID:. A child female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the  COVID-19 vaccine (primary immunization series completed; manufacturer unknown), for immunization. The patient experienced urticaria/reporter's daughter took Pfizer booster shot and ended up with hives, lip swelling and face swelling, with outcome of not recovered. The events required a physician office visit. Therapeutic measures were taken as a result of urticaria, lip swelling and face swelling. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Administered 0.2 mL of Pfizer 6mo-4yrs without diluent. No adverse reactions occurred,  no fever, just fussy.
Area around the injection site very red; Area around the injection site very, very itchy; Lymph nodes under left arm swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 015E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) outcome was unknown.            No Concomitant medication reported. No treatment medication reported   This case was linked to MOD-2021-335046 (Patient Link).
episode of transient global amnesia (TGA) lasting approximately 3.5 hours1 resolving after  Observation no treatment.   symptoms included amnesia to events leading up to vaccination and post vaccination, disorientation to time and place and situation
Pt stated had head itch about 1 hr after vaccination.  She stated calm  .  She took BENADRYL after advised from another RPH which helped some.  After I discussed she talked to PLP who gave her ATARAX, ZANTAC, and CLARITIN which she stated helped her.
only a little pain; 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 Pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient experienced only a little pain. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   At the time of this report, the outcome of the event pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
p/vax pt ran fever up to 102;seen in ER & given Ibuprofen on 9/9/99;also states had prolonged crying & would not eat;GM states fever now down but legs are floppy & child can't stand;referred to ER;no PMD; Annual follow up states that the pt has pain and weakness in both legs, severe at times. Also the left foot is deformed (turned outward) causing walking deformity.
Right upper arm redness and whelp the size of a dime was present below the injection site of the varivax vaccine. Advised to apply ice and to affected area and give oral antihistamine to reduce swelling and redness.
The patient received his first dose of the Moderna CV19 vaccination thirty (30) hours after the first vial puncture. The vaccine had been stored in the manufacture vial the entire period. The pharmacist made a mistake and administered the dose after the 12 hour window. The patient was contacted the next morning upon discovery of the error and only reported a sore injection site. Pt stated he felt fine otherwise.
Midnight - I got a fever - my face was very, very hot. Fingers and toes were very, very cold. Unable to regulate body temperature. So fever and chills. Those lasted for a good four hours before it let up and then it happened again the next day and the day after that. I had about four days straight where I was not well and I don't remember a lot. On the fourth day, I was okay until the evening and I had really painful diarrhea. I couldn't keep anything in my body and I was in the restroom for about four hours. I was scared as to what was going on. I ended up calling telemedicine. The nurse I talked to over the phone and she said wait 7 days and that I should be okay. I was still slow and lethargic for the following week after but I did feel significantly better on the 8th day after the vaccine. In February, (before the vaccine) I had an UTI that I didn't go to doctor for. I drank a bunch of cranberry juice and I was fine afterwards. I do have an IUD- and on July 12th, I noticed the presence of a UTI and I had painful and really constant urinating. I was unable to hold on to anything at all and I went to Urgent care of the 14th. And they told me that I had deteriorated my bladder walls until I had come to a point where I couldn't hold on to anything. I had collapsed for lower back pain on the 16th of July and made an appt to go to doctor. I ended up speaking to someone on the 17th, and I got the medication that day for a kidney infection due to the lower back pain that I was having. And they said that the UTI had gotten so bad it had gone to the left kidney. I was first prescribed (on the 14th)  - Cephalexin and had me take something called Uristat - an OTC cranberry aid and then on the 17th - they told me to stop taking the Uristat so it wouldn't be stressful on the kidneys and they gave me a different antibiotic  - Ciprofloxacin and Extra Strength Tylenol. That helped with my symptoms. I had to go back in to the doctor today because for the past three days I have been having the same kidney pain again. I will get the lab results back sometimes this week. I either have another UTI or I didn't get rid of the kidney infection yet completely.
This spontaneous report was received on 12-JUL-2017 from a pharmacist (Pharm D) and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist reported that the patient was administered a dose of PNEUMOVAX 23, intramuscular (Site of administration not reported), on 04-MAY-2015 for prophylaxis and another dose of PNEUMOVAX 23 intramuscular (Site of administration not reported) on 05-JUL-2017 for prophylaxis. No adverse effects reported. No further information was provided. Additional information is not expected as reporter did not consent to follow-up.
It was noted later that no new vaccine vial was removed that day; presume that vial from previous day was used. The vial was kept at appropriate refrigerated temperature but punctured on 1/17/23 (more than 8 hours prior). Patient was notified and agreed to schedule a follow up vaccine dose appointment.
I am currently lactating and breastfeeding for 11 months. The afternoon that I got the vaccine I got a fever, lethargy and extreme fatigue. I was nauseous and I had diarrhea.  My fever was 102. I started to feel better after three days. I also got aa headache that was similar to the Migraines I used to have. I hadn't had a Migraine for 18 months and I had  a Migraine daily for five weeks. I went to the care facility eight days after the vaccine because I thought I had a UTI. The UTI was positive and I was told I had some Streptococcus B at the time. I was also experiencing confusion, and tiredness.  One month after the vaccine I went back to the care facility because I was have having cramps in my lower abdomen and circulating to my lower back as well as my legs. All tests were negative but I was given multiple antibiotics. After eight weeks I still have lower abdominal cramping, vaginal discharge and headaches. Some of the symptoms were relieved by the antibiotics but they have returned.
Information has been received from a licensed vocational nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lot # L033545, expiration date 30-MAY-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 35F. Time frame: 12 hours. There was a call because of a data logger. There was no a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Diarrhea times one on December 30, loose stool times one on December 31, Loose stools January 1.
Ischemic, middle cerebral artery stroke, with cerebral edema and brain compression.  Required a right decompressive hemicraniectomy, with partial frontal lobectomy.  He required transfer to a rehabilitation facility.  Severe residual symptoms include left sided hemiparesis, left sided neglect, cognitive and speech deficits.
Administered a booster dose of Moderna Vaccine, however resident had already had a booster approx a month earlier
Received influenza vaccine and PNEUMOVAX at primary care physician office 10/23/13 about 1400. Started feeling poorly about 4 hours later. Fever, chills, shaking. Reported to Emergency Room. B/P 159/72. Overtime BP dropped to 81/53. Also noted to have wheezing, flushing, generalized hives. Temperature 103.6.
Patient reports obtaining the first dose of Moderna vaccination on 10/5/21. She states she obtained it in the evening and felt some subsequent nasal congestion and sore throat but went to bed and those symptoms resolved when she woke up. She states when she woke up the next day (10/6/21), she felt like she had a sore on the right side of the tongue which was quite painful. She states as time has gone on, she feels as if her tongue is swollen stating she keeps biting it because it feels like its in the way. She states her throat also feels "different" and mildly swollen.
None Reported to us, I called the patient confirmed all the information matched so we had the correct patient and confirmed he had no adverse reactions
Caller is a nurse calling to report that an expired dose of ROTATEQ was administered to the patient; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies.  On 22-MAR-2022, the patient was vaccinated with an expired Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered at a dose of 2 milliliters (mL) (lot number reported and validated as 1707460, expiration date reported and stablished as 14-MAR-2022) (strength, route of administration and anatomical location and vaccination scheme were not provided) (expired product administered).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA008972: US-009507513-2203USA008707:
Developed chicken pox lesions (few and scattered) one week after Varivax. Advised Tylenol and supportive measures.
pt recv vax & exp malaise;2 to 3 wk p/vax devel a scaly rash, consisting of small red papules, that covered whole body, excluding face;lab revealed ASO positive & a skin biopsy indicated psoriasis;
Swelling, inflammation and pain of entire left arm. Nausea and fatigue. Muscle stiffness, erythema, at injection site.
Pt vacc. w/Engerix-B developed intermittent pain and numbness in arm & radiating into neck Diagnosed as nerve irritation, possibly secondary to vaccination. Recovered 7/30/90.
p/vax pt was afebrile, had sz; upward rolling of eye balls; jerking movements of extremities; lethargy; admit for dec suck & activity; also had UTI; spinal tap nl; grp B strep; tx w/IV ATB
The leg where the shot was done was very stiff and swollen, she had a hard time walking and was painful if not on drugs, around the shot it got red for 2", we had to give her Tylenol and Iboprufen for 4 days. Still swollen and sensitive to touch after almost a week.
Received Covid 19 vaccine 2021, diagnosed in April 2021 with crohn dz, put on April 2021 Humira every other week, October 2021 for blood work - Humira not working, then started having bleeding from rectum, switched to stelara, three doses later may 11, 2022 hospitalized had to get emergency blood transfusion, bone marrow biopsy May 16, 2022 indicated cancer, placed in hospice may 18, 2022, passed June 18, 2022
Dose # 2 NOT administered on 3/20/21 d/t pt reporting anaphylaxis reaction after receiving the first dose of Moderna COVID vaccine on 2/22/21. Pt reported symptoms of tongue swelling, throat closing and tachycardia within 30 minutes of receiving the first dose. Pt reported being given Benadryl after reaction w/ resolution.
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 82.42 years.  Concomitant products were not provided.  On 08-Jan-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-Jan-2021, 9 vials were moved to the clinic. On the same day between 09 AM and 02 PM, vials underwent temperature excursion with temperature of 34 and 35 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Pt died. Autopsy revealed Giant cell myocarditis. Pt received H1N1 vaccine 2 1/2 months prior. Unsure if related.
Patient received Maderna vaccine at high school on 1/20/21  He then tested positive for COVID 1st week of February at high school  2nd dose of Maderna vaccine 2/21/2021 at high school  He then tested positive for COVID at hospital on 4/4
Caller received first dose- got covid shortly after; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN; Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose and got COVID shortly after that, on an unspecified date in Mar2021. He still in quarantine and symptoms were gone. Second dose scheduled on 06Apr2021. He asked whether he was able to go, if not what was the time frame- Cold transferred to D and S. The outcome of event was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
24-36 hrs p/recvd vax noticed pimples on lt shoulder & neck; seen in office dx w/herpes zoster;
Preauricular lymphadenopathy and tenderness initially noted on the R side. Progressive bilateral tenderness prompted symptom reporting.
Chills; Aching; Headache; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was unknown), via an unspecified route of administration on 27Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunisation. It was reported that I had my second shot yesterday morning and then last night before bedtime I started to get chills, aching, headache and a low-grade fever on an unspecified date in 2021 and then it got a little bit worse the night, but it is little bit better now. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
in a wheel chair due to Guillian Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (in a wheel chair due to Guillian Barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug was reported. Reporter mentioned having acquaintances who had the beginning shots of Moderna vaccine that experienced neurologic consequences to that. Reporter further mentioned that patient was her neighbor, who was now in a wheel chair due to Guillian Barre. No treatment drug was reported.  Company comment: This is a spontaneous case concerning a adult female patient with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) AESI event of Guillain-Barre Syndrome. The event's exact occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, the patient is on the wheelchair due to Guillian Barre syndrome. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-675058 (Linked Report).; Sender's Comments: This is a spontaneous case concerning a adult female patient with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) AESI event of Guillain-Barre Syndrome. The event's exact occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, the patient is on the wheelchair due to Guillian Barre syndrome. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-675058:Patient 2
10032018 left upper arm pain with injection of flu vaccine; 10212018 left underarm blister observed. 10222018 red blisters on back near left underarm. 10232018 physician prescribed Valacyclovir for shingles treatment. 10242018 additional blisters appear on left side back and left breast.
Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEADACHE (Really bad headache). At the time of the report, HEADACHE (Really bad headache) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter.
On 7/29/02, pt reports arm swelled to twice it's normal size the day after shot. Had fever and was unable to eat over the weekend. Eyes hurt and had itchy face. Slept OK last night (7/28/02) and back to eating normally. Right arm no longer swollen but still a bit warm to the touch. No fever. Eyes and face feel normal now.