chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; A regulatory report was received from a 67 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  flu-like symptoms.  The patient's medical history included Stage 1 adenocarcinoma of the endometrium and orthopedic issues. On 01 Dec 2020, patient was diagnosed with COVID-19. The relevant concomitant medications were baby aspirin and oral lysin.  On 25 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 025J20-2A) through unknown route of administration  for prophylaxis of COVID-19 infection.  On 25 Dec 2020, after the first dose, patient experienced flu-like symptoms. Laboratory data was not provided. Treatment information was also not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event flu-like symptom was unknown.  Follow-up received on 30 Mar 2021 included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever about 4pm on 05/01/2001. Next morning right arm swollen from above shoulder to the elbow, red and hot with rash all over red, faded and returned. Fever 103-105 for about 4 days. Rash started out blotchy, then pinpoint. Doctor was seen on 05/02/2001. Three days later treated in ER for dehydration.
Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored GARDASIL 9(lot #, expiration date, dose and route were not reported) for prophylaxis. Previous temperature excursion was reported as  greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014514: US-009507513-1612USA014512: US-009507513-1612USA014513:
Few minutes after receiving first dose of Covid-19 vaccine, patient had syncope, hyperventilation, and sweat, almost lost consciousness and patient's parent requested paramedics to be called.  She was monitored inside paramedics but did not go to the emergency room after almost 30 minutes.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX. On 8th November 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In November 2018, the patient experienced pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers. The patient was treated with VALTREX, TORADOL and LYRICA. On an unknown date, the outcome of the pain in arm, movement disorder, muscle atrophy, numbness in fingers and vaccine administered at inappropriate site were unknown and the outcome of the weakness of arms was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, movement disorder, weakness of arms, muscle atrophy and numbness in fingers to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe arm pain, the patient couldn't lift arm, about 5 days after vaccination. The patient experienced severe arm pain and weakness. The sharp pains was down arm. They started the patient in VALTREX, did a pretnazone shot, a TORADOL shot and at the time of reporting the patient was on LYRICA. The patient on the day of reporting, said about 3 by 4 pain gone, but still had weakness. The patient was still on LYRICA. The physician said there was some muscle atrophy. The patient had numbness in thumb when the sharp upper arm pain strikes. The patient did mention to her that he thought the injection was given lower on his arm, which led to vaccine administered at inappropriate site. The reporter requested to follow up with the office to know that their adverse event was reported and to discuss. The reporter did agree to follow up from GlaxoSmithKline.
Patient reports left sided hearing loss, beginning hours after injection. He also reports vertigo, nausea and vomiting.
On the afternoon of May 24, I began having a headache and a sore throat.  On May 25th, my sore throat became worse, I began sweating off and on, and I started becoming hoarse.  On May 26, my sore throat was more noticeable in the early morning and late at night, but my voice was not as hoarse as it was on May 25.  On May 27th, my voice was hoarse again and my sore throat was very painful.  I called the County Health Dept. at 10:30AM and spoke with Nurse, who administered my vaccine.  She told me that strep throat was going around and she didn't think my symptoms had anything to do with receiving the yellow fever shot.  As of 10:40 AM on May 27, I have not gone to the emergency room or doctor's office about my symptoms.  If they last over a week, I will seek medical attention.
1 day after injection - Pt c/o rash, swelling, itching @ site.
Child had immediate erythematous reaction on posterior left upper arm after receiving varicella vaccine. 10 days later developed a maculopapular rash surrounding the erythematous area and spread rapidly to trunk and face. Also had fever of 102.9. Diagnosed with Varicella on 4/11/15. Treated with Acyclovir.
I developed vitiligo, and it worsened after the second dose; I developed vitiligo, and it worsened after the second dose; My whole hand just turned white, then it spread all over to other hand and feet; developed depression due to these skin changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "vitiligo". The following information was reported: VITILIGO (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "I developed vitiligo, and it worsened after the second dose"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "My whole hand just turned white, then it spread all over to other hand and feet"; DEPRESSION (non-serious), outcome "unknown", described as "developed depression due to these skin changes".  Additional information: Th patient reported, she had to get the Covid vaccine for work and ended up getting the Pfizer Covid 19 vaccine. She never had vitiligo in her life, and no family history of it. After the first dose, she developed vitiligo, and it worsened after the second dose. Her whole hand just turned white, then it spread all over to other hand and feet. After second shot, it went crazy. She developed depression due to these skin changes. She was interested in clinical trials with product since she developed vitiligo after receipt of the Pfizer Covid 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Five hour after the shot my right arm was sore .   The next day I woke with a headache and was dizzy.  I took Excedrin and Sudafed.  I was tired all day and spent much of it in bed.  By the middle of the day I experienced nausea and had several bowel movements.  By 3 p.m. I experienced stomach pain, began to feel muscle pain (particularly in the low of my back) and got a headache.  At 4 p.m. I started to have a light feaver (98.6) and serious shivers - I couldn't get warm and was shaking terrible.   I took two Excedrin, drank water and used a heat pad and four blankets to stop this shivers.  I also experiences itching on my lower right arm.   By 7 p.m. the fever broke, and most all symptom disappeared.   I remained tired and when to bed early to wake this morning feeling much better.
On 11-12-14 Mother brought her daughter, age 11, into HD for immunizations. Nurse administered Hep A, Hep B and FLUMIST. Mother later that day said to receptionist, that her daughter had a flu vaccine 8 days ago.
Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FALL (Fall). At the time of the report, FALL (Fall) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of FALL was not provided for HUMIRA. No treatment medications were provided by the reporter.
Symptoms  (congestion, runny nose, cough) started May 30th.  Tested positive for COVIC-19 Friday.  Paxlovid for 5 days beginning June 3rd.  Later in June 9th  received Amoxicillin because I also had a sinus infection.
Anxiety; mood swings; Depression; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue). At the time of the report, ANXIETY (Anxiety), MOOD SWINGS (mood swings), DEPRESSION (Depression) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
After shot #1 within ten minutes I felt a wave of nausea, light-headedness, and dizziness pass through my body that lasted about a minute or two. I reported this to the pharmacist and she explained nausea was a symptom of the vaccine and let me go home. That night I had several waves of nausea/dizziness that lasted for a few minutes. I was mostly fine after that. Before shot #2 I relayed symptoms again to the pharmacist and she said to expect something similar for my second shot. After shot #2 I felt nothing except a sore arm until nine days later when I was hit with extreme dizziness, light-headedness, and nausea while driving. The symptoms persisted for several days and I went to my doctor to see if it could be a reaction to the vaccine. The doctor said no because it was too far out from my shot date and believes it's "motion sickness/vertigo" due to my age/gender and prescribed me Dramamine to get by. I'm still experiencing symptoms 13 days out from the date of my second shot.
patient got booster shot, after 2 minutes of getting vaccine. patient reported not feeling good. she became diaphoretic, very brief LOC less than 1 minute per report, became pale, weak and shaking.  She reports seeing spots and ringing in ears. With help she was able to transfer from chair to wheel chair and brought to the observation area where she can lay on a bed. Initial vs 80/42, hr 50, sat 99% on room air. she was given water, juice and crackers. She reports feeling better after 5 minutes. BP up to 99/59, HR 60s. 15 minute vitals with BP 109/69, hR 71. She denies spotty vision and ringing in ears.  After 30 minutes, BP 101/67, HR 61.  She was able to walk without any issues. She was send home.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-OCT-2009, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2011, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
A nurse from center called to notify me that the child was seen by a physician there today a few hours after receiving vaccines at our clinic for swelling from his left shoulder to his fingers and also red streaking to that arm.
Started getting sore again a week after I got the shot. Then Got an itchy arm 2/14 at night around 10pm, but didn?t think anything of it. Woke up in the middle of the night and realized there was a lump right above my collar bone. Then saw the faint rash in the morning and a little bit swollen. Itchiness is nothing too bad. Soreness started to go away, but lump still there.
SWELLING RIGHT ARM FROM DELTOID AROUND UNDER ARM PIT DOWN TO WRIST, STARTED 4/24/09
A non-serious, spontaneous report of temperature 103 degrees Fahrenheit and slightly lethargic has been received from a parent concerning a four-year-old male patient, subsequent to receiving FLUMIST. This case is submitted in accordance manufacturer post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included GERD as a baby, seasonal allergies, and eczema. Concomitant medications included certtirizine hydrochloride and diphenhydramine hydrochloride. The patient received FLUMIST on 19-Oct-2009. On 20-Oct-2009, the patient's temperature had been running 103 degrees F. Parent stated the patient's temperature was 102.8 F with forehead thermometer and 105 F with behind the care ear thermometer. The patient commented that the child looks perfectly fine; no symptoms other than a fever and slightly lethargic, but he does not look sick. The event outcomes ere not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  01-MAR-2010. The patient was treated with ibuprofen and acetaminophen. On 22-Oct-2009, the events of fever and slightly lethargic resolved. Additional information was received on 26-Feb-2010 and incorporated into case: treatment drug and concomitant medication information, event onset/end dates and outcomes, medcial history.
Pt could not lift arm above head. Pain would wake her up at night. Reported to rx on 11/18/13.
Tingle in the arm; Increased heart beat; face became red; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingle in the arm), TACHYCARDIA (Increased heart beat) and ERYTHEMA (face became red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingle in the arm), TACHYCARDIA (Increased heart beat) and ERYTHEMA (face became red). At the time of the report, PARAESTHESIA (Tingle in the arm), TACHYCARDIA (Increased heart beat) and ERYTHEMA (face became red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment medications were provided
No additional AE reported; dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient on 4 AUG 2021; 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 04-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 0.5 milliliter, lot # T029522, expiration date reported as 13-MAR-2022 but under interal validation established as 13-MAR-2023 for prophylaxis (anatomical location and route of administration were not reported).   The administered vaccine experienced temperature excursion of -4.8 degrees Celsius (C) for 20 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA003020: US-009507513-2108USA003288: US-009507513-2108USA003135: US-009507513-2108USA003100: US-009507513-2108USA003267:
pt had swelling & pain @ inject site; also had some lightheadedness w/some anxiety for approx 4 days; no tx needed;
Patient was diagnosed with shingles 31-may-2022; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2022, the patient received the 1st dose of Shingrix. On 31st May 2022, 130 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comments: The patient was diagnosed with shingles on 31st May 2022. The patient had not received second dose. The reporter consented to follow-up.
Low temp general ill feeling after shot for 1-1 1/2 wks. Nine days after shot had mild case of chicken pox for 1 week. Doctor called it varicella rash.
Initial symptoms were bleeding gums. Labs revealed thrombocytopenia (plt < 10), refractory to inpatient treatment with glucocorticoids and IVIg. Hematology consult most highly suspected ITP, as of 2/12/17, she remains on plt drip and has initiated rituximab.
This spontaneous report as received from a nurse refers to an 8 year old female patient with current condition of chronic unspecified lung issue. On 17-DEC-2013 at about 4:30 pm, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J007786, Exp date: 25-SEP-2013), intramuscularly (dose and frequency unspecified). On 18-DEC-2013 the patient vomited once in the morning and was experiencing "sour stomach" at the time of report, but she was able to eat. No treatment was given for the events. Patient's mother called the office for medical attention. The outcome of the events was reported as recovering/resolving/ Additional information has been requested.
first sx noted was facial paleness w/cyanosis around mouth;pt very limp;eyes rolled back (per family) color improving by time got to hosp;this happened 2 more times while in hosp x 48hr;dx hypotonic state secondary to DTP vax;
I lost 95% of my range of motion in my left arm and about 85% range of motion in right arm.  I ended up in an urgent care on 12/15/2022 and they sent me to the Emergency Room Department. The ER gave me an oral steroid (decadron)  in the ER and then a prescription for oral prednisone to take the next day.  They also gave me a prescription for ketolorac.  My right arm is about 95% improved.  My left arm was about 40% improved but now seems to be regressing back as time goes on.  At the time of injection, something did not feel right and I mentioned that it felt like it was going in the bone.  Never felt that before.  It also seems like it was given higher in my shoulder this time.
joint pain and swelling in wrists, knuckles, knees, ankles and some pain in back accompanied with rash (hives), severe fatigue, and just over all not feeling well. 5/14/10 Follow up: Temporary #E-42978 report filled out in regards to my son. Additional information to support my report. In the month following the meningitis vaccine he began having flu like symptoms but tested negative for flu. Had rash, hives, strep like symptoms. Treated with antibiotics on several occasions over the last 15 months. I have taken him to 5 different doctors with symptoms and most recent being an arthritis doctor. I have suggested this vaccine from the very beginning and was told no this was no the cause. After being tested for so many different possibilities I feel this vaccine has contributed to my, prior to vaccine, "healthy" sons medical problems. He has been tested for the following: strep, flu, mono, lupus, arthritis, lyme disease, and had white blood count checked. He was 15 at the time he was given this vaccine "WITHOUT MY REQUEST OR CONSENT", and at this point I am ready to find out if something has happened with this vaccine.
Vaccine inadvertently given outside viable time outside refrigerator.  Vaccine outside of frig for 29.5 hrs-was not used in the 12 hour room temperature time frame.  Upon realizing error- contacted Moderna 5/11/22 to obtain guidance on stability of vaccine and any further action.  Moderna stated it would take 3-5 days to follow up with us with any necessary next steps
client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to the door with staff and husband. Reported feeling fine except still warm.  Steady gate.
Patient received the vaccine in left deltoid and after about 5 minutes reported to me feeling numbness and tingling in that same arm. She did not report any other symptoms that would be concerning in regards to an allergic reaction. She also verbalized feeling "clammy" and sweaty, also feeling a little flush.