chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2011US52731 is an initial spontaneous report received from a health care professional (medical assistant) on 10 Jun 2011. This report refers to multiple patients who were vaccinated with MENVEO (batch number: 100023) intramuscularly, which was stored between 30 F and 35 F (outside recommended temperature range) for 30 days prior to vaccination.
weakness, pain lower extremities,  GBS vs myopathy secondary to Zocor;thought to be GBS more than Zocor myopathy;? r/t vax;
2 hours after administration of the vaccine she got body aches, night sweats, fever and chills.  She reports she got up on 11/05/2021 and went to work at the school.  She reports that she was nauseated and felt miserable.  She reports that she felt crappy all weekend until Sunday morning.  She reports she woke up, took a shower and went to church and that she felt much better.
After first shot began experiencing tingling in feet and hands.  I also have numbness in feet and hands.  The doctor also confirmed my inability to feel temperature changes in these same areas.
Patient first experienced bleeding at time of vaccine administration, later that evening patient stated arm began to swell and was red in appearance. The next day, bruising occurred on arm, and bruising on arm has continued to darken and is now a purple color. Patient stated swelling has somewhat improved, but bruising has gotten worse.
Low grade fever w/ knot in left thigh, erythema to thigh 3cm X 8cm, itch, warmth.
Pt returned to the clinic 2 hours after administration of vaccines with hives on her Right thigh/leg. No fever, no respiratory distress noted. PA in house at the time assessed the patient and instructed the pt's mom to give Benadryl and zyrtec. Also instructed pt's mom to take pt to nearest ER if symptoms persist.
Information has been received from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of Gardasil vaccine (lot# unknown) IM injection. Subsequently, on an unspecified date after receiving the Gardasil vaccine the patient experienced "flu like symptoms (fever, vomiting, nausea and body aches) for about 5 days. Medical attention was sought. On an unspecified date the patient fully recovered. On an unspecified date the patient received a second dose of Gardasil vaccine but did not experience any AE related symptoms. No further information was provided. Additional information has been requested.
patient came in today for 2nd dose and said her arm was sore for 1 week after 1st dose vaccination and red for 3 weeks; said she saw her doctor for an unrelated appointment and doctor looked at arm but was not concerned
Vomiting; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vomiting (Verbatim: Vomiting) and fever (Verbatim: Fever). The outcome of the vomiting and fever were resolved (duration 1 day).   It was unknown if the reporter considered the vomiting and fever to be related to Shingrix.     It was unknown if the company considered the vomiting and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter was the mother of the patient. The patient received first dose of Shingrix and experienced fever and vomiting for only one day. The reporter did not know the vaccination date but reported that it was provided at a pharmacy facility. The reporter was not sure if it was administered in the left arm. No additional information was provided. Lot and expiration date were unknown. The reporter did not want to provide personal information or demographics. Consent for follow up was not obtained.
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
Beginning morning after vaccine (4/23/2021) had mild headache and sinus pressure.  At noon, suddenly extremely tired and weak, went to bed, headache increased to a "10".   Body aches waist down began, ("10") sinus pressure increased to a "10", chills and shaking were so bad my spouse had to put 5 blankets on me and hold me in bed for 2 hours, dizziness and vertigo caused walking by myself without support of some kind, impossible, fever began about 2pm started at 100.3 and quickly went to 103, subsided after Tylenol to 101 about 2 hours after began.  Blood pressure elevated from 127/74 (my normal) to 167/85 for 3 hours, then stayed high at 145/85 for 24 hours more.  Called Urgent care who told me to go to ER if Blood pressure elevated more or temp stayed at 103 for very much longer.  Could not take Sudafed due to elevated BP, so had to suffer through sinus pressure, worse I have ever experienced.  I was so depressed from the chills and feeling so badly I cried.  I felt as though I were dying.  This sounds dramatic, but it truely was how I felt.  I had the flu 2 year in a row even though I had been vaccinated and these Moderna side effects were worse than the flu.
3:40 4/10/2021  itchy throat, hot tingly feeling and headache... 4pm throat felt tighter .. felt anxious...  took benadryl 10ml liquid about4 30.. was feeling very hot... no fever.. Woke up 4/11 around 3-4 am.. worst headache ever, my ears hurt, teeth like every individual one were infected,freezing, shaking, dizzy, nausated, whole body itching, not able to stand up without help because I couldn't balance.. took pain medication to help take the edge off the pain and bendryl.. couldn't stay awake,  next day throat feeling like it was swollen, icy hot feeling similar to contrast put in me, cramping in my lower left leg, monday.. same conditons except not the constant headache, blured vision better, still dizzy  monday at 5 am chest feels slight pressure.. lower back pain like labor pains, sharp pain in stomach like the injection they give you to thin blood before surgery painful sharp pain.. later in day.. headache again, itchy body, throat sore, continual stoache pain, tuesday same.. wed.. my neck slightly swollen and sore
Sharp/shooting pain from her L butt to ankle (same side of body as vaccine), used Tylenol with no relief, started 2/23 night
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Massive heart attack due to blood clot.  Heart Cath putting in a stint with over night stay in hospital
sweating, fever, lightheaded at first. I thought it was just a reaction to the shot. 5 or 6 days later I ended up in the hospital with a bad infection (Sepsis) and while in the hospital went into fibrillation that would not stop.  They rushed me down to the OR to shock my heart back to a normal rhythm.  I was in the hospital for 8 days. Now I am on blood thinners and a drug to stablize my rhythm so it can't happen again. I have a new heart doctor who is doing much testing. I have never had a heart problem before I took the shot.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. It was unknown if patient had any acute illness at the time of vaccination and up to one month before.     On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 68 years and 8 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.  Patient had reported no adverse reactions after the administration of vaccine.  No treatment medication were reported.
Injection felt to be very high up.  Immediate pain deep in the joint.  Very stiff arm.  Weakness and inability to lift arm progressively got worse in subsequent days until pain and lack of range of motion was very limited.  Evaluated by an orthopedic surgeon for definitive diagnosis and treatment.  X rays completed.  Diagnosed with subacromial bursitis of the L shoulder from incorrect placement of flu vaccine.
Information has been received from a 20 year old female patient with parakeratotic cells evidenced in previous PAP test, who on 20-APR-2009 was vaccinated with the first dose of GARDASIL. On 29-APR-2009 the patient vomited after receiving the vaccine. The patient further stated that she was still feeling weak, tired and dizzy. The patient did not seek medical attention. It was reported that GARDASIL was discontinued. At the time of reporting the patient had not recovered. No further information is available.  7/13/09 Medical notes received DOS 4/28/09 to 6/30/09. Patient presented on day of immunization for follow-up of abnormal PAP. Abdomen tender on palpation. Subsequent visits:pelvic pain, irregular 'bleeds' with thick white discharge, burning urine. Vaginal infection, UTI.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. No demographic information was provided. VAQTA (lot number not provided) was improperly stored. The improper storage started on 29-DEC-2012. The improperly stored VAQTA may have been administered to an unspecified number of patients on unspecified dates. No adverse event reported. This is one of several reports received from the same source (other case IDs 1306USA008658, 1307USA008944, 1307USA008945, 1307USA008946, 1307USA008947 and 1307USA008948). Additional information has been requested.
fever to 106.1 mild redness & swelling of inject site; no treatment x/something for fever;
Day one : fever, fatigue, muscle aches and pain - from the shot to four days later. Fifth day: Chest pain and jaw pain- Hospital ER  -Sunday-  They monitored my vitals while I was there;  They did some tests but nothing to treat. Within a week and a half I was feeling better. I didn't go to work the following Monday. Tuesday my fever was gone. By Wed or Thursday, I started feeling myself again.
Nurse administered Monovalent vaccine instead of Bivalent.  Patient had previously received her Primary Series and a Bivalent booster was due.
Tachycardia, numbness in extremities, dizziness, shortness of breath.  All intermittent for about 8 hours following shot.  Intense for a 2 hour period 4:30-6:30.
I started to feel bad and decided to take a home test. I tested positive on 12/18/22. I had a sore throat, chest pain, fever, cough, and fatigue. I went to an urgent care, and they tested me, and they told me that I was negative. I was prescribed azithromycin from the urgent care. I decided to take another home test because I didn't believe the test result at the urgent care, and I tested positive at home again. I decided to go to the emergency room, and they tested me again and that is when I tested positive at the doctor office. They prescribed 5 days' worth of PAXLOVID.
severe anxiousness; Irritable; agitated that she could not go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.   On 24-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep). On 25-Feb-2021, ANXIETY (severe anxiousness), IRRITABILITY (Irritable) and AGITATION (agitated that she could not go to sleep) had resolved.            Treatment details included the patient drink Chamomile tea and a shower and symptoms subsided after 5 hours.  Action taken with mRNA-1273 in response to the events was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
This case was reported by a pharmacist and described the occurrence of nonspecific reaction in an adult female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced a nonspecific reaction. At the time of reporting the outcome of the event was unspecified. It was reported that due to this reaction in the past, the subject has had health care providers divide subsequent flu vaccine doses and give as two half doses in an effort to prevent a reaction. This was considered to be a drug administration error. No further adverse events were reported.
mom states a couple of hrs p/vax pt became very fretful & running fever; mom took infant to ER & was released; mom kept giving pt APAP w/o any relief; mom took pt to PMD & was adm to hosp x 4 days later w/t105 & very fretful
Allergic reaction; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I am having a serious  continuous tingling Sensation in my legs and arms. The tingling sensation has caused my legs to go numb, making it difficult to walk. Feels like poor  circulation. And tighten. Nerve pain in my jaw . It?s causing me to lose sleep.  Neck cramping
Patient developed hives approximately 4 hours after receiving Tdap. She has been taking Benadryl OTC since hives began.
Erythema multiforme and fever/chills, cellulitis requiring AUGMENTIN. Amoxicillin/clavulanate 1000/62.5 mg BID.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. On 18th September 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 19th September 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness in the left arm in which the SHINGRIX dose was administered. The onset of the event was after a few hours. The patient had denied permission to contact their physician.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001691 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *41-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 41-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 41-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Gentleman received his 1st Moderna dose on Thu. 2/11 at 0849.  Vaccination protocol was completed. Pt reported feeling fine, no fever, and that he had no allergies which would prevent him from getting the vaccine.  Pt played cards with friends later that day 2/11, but left at 1930 (normally plays late into evening) telling his companions he didn't feel well and his neck hurt.  A welfare call was completed on Sat. 2/13, and the patient was found deceased in the bathroom by his son.  It appears patient fell off toilet and hit his head on the tub. Pressure ulcer present under injection site. The presumed time of death was Thur. evening.
Soreness, tiredness, fatigue, headache, fever, chills, muscle pain.
On 10/3/17 I received the flu shot while on duty. I immediately developed a hematoma at the injection site. One and half hours later I started experiencing vertigo and nausea. By the time I got home around 4:00 PM I had to lie down due to my symptoms getting worse. I had difficulty keeping my balance when ever I was working. Getting up one flight of stairs I had SOB. I ended up going to bed early without dinner as my nausea was worsening. The next day symptoms continued. I had to fly on 10/5/17 and while there all my symptoms remained. I had vertigo, nausea, loss of balance. I had to limit my activities 10/5/ to 10/10.  I also starting noticing I was having trouble hearing conversations.  Upon my return my symptoms were slowly improving. I attended a dinner function on 10/11/17 and realized I was having trouble hearing conversation from my R ear. When I awoke yesterday 10/12/17 and I lost all my earing in my R ear.  I managed to get myself into Dr office for a 9:45 AM apt. He assessed me and then I had a audio test down which confirmed a servere loss of hearing in my R ear.  Dr. started me on Predisone 60mg x 10 days and then a taper plus zofran. I then went to Employee Health Center and reported this work injury and was also assessed by a NP.  I absolutely believe the flu shot caused my loss of hearing and all my other symptoms. I have never had any of this kind of thing prior to the this flu shot. I don't believe it is a coincident. My prognosis is the following. 33% chance full recover, 33% chance some improvement without full recovery and 33% chance this is permanent. Today my vertigo and nausea are improving slowly and I have lost my hearing in my R ear. Needless to say I will never take this vaccine again and I have had many in the past with no issues. I have selected disability or permanent damage but I don't know the outcome of my treatment and I don't see a choice that address this. It is a disability right now pending result of treatment which I am on day 2.