chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3X5cm pink itchy area near the injection site (Left arm); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (3X5cm pink itchy area near the injection site (Left arm)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PRURITUS (3X5cm pink itchy area near the injection site (Left arm)). At the time of the report, INJECTION SITE PRURITUS (3X5cm pink itchy area near the injection site (Left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Concomitant medication  was not provided.
Confirmed Covid positive; Confirmed Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: EN6203) at the age of 61 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had no other vaccines in the four weeks prior and no COVID prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Confirmed Covid positive". Patient reported she was confirmed COVID positive on 10Jan2022. The event "confirmed COVID positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: COVID test nasal swab: (06Jan2022) positive. Therapeutic measures were not taken as a result of the event.
MOM REPORTED GOING TO ER THE NIGHT OF 3/23/09 WITH A FEVER OF 105+.  RETURNED TO ER ON 3/24/09 WITH CONTINUED HIGH PEVER.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with a 0.5 ml of GARDASIL (lot number, therapy route and site not reported) "this morning" on 24-JUL-2012 and then passed out. No other co-suspects or concomitant medications were reported. It was not known if this was the patient's first dose or not, so no therapy start date was available. The patient visited doctor's office for medical attention. The outcome was unknown. Upon internal review, passed out was  considered to be a medically significant event. This is one of several reports received from the same source. Additional information has been requested.
On 9/16/99, the pt experienced fever and on 9/17 she developed rash with vomiting.
6 styes on her right eye; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (6 styes on her right eye) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HORDEOLUM (6 styes on her right eye). At the time of the report, HORDEOLUM (6 styes on her right eye) outcome was unknown.            No relevant concomitant medications were reported. The reporter stated that patient had to get her eye drained and seek medical attention. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. The reporter did not provide an assessment for the event (s), HORDEOLUM (6 styes on her right eye).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-significant Follow-up Appended/ Patient's contact information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-156188:Case for dose 2
Increased redness of face, trunk, and extremities. Audible wheezing and restlessness.
~36 hours:  fatigue, muscle aches, joint pain, headache, dizziness
Pt had such severe chills the day after vaccine, that he was shivering uncontrollably, seizure-like.
Patient was slightly nervous before receiving vaccine. After vaccine was administered she became pale, nauseous, complained that she couldn't see, felt dizzy. Her breathing was visibly slow, but she never lost consciousness at any point. She placed her head between her knees, her mother and I coached her to breathe for several minutes. She then had some sips of water. After about 5 minutes she was feeling better. She remained seated and after about 5 additional minutes she was okay to stand up. She explained that she had not had anything to eat yet that day and it was close to 1 p.m. I suggested getting something to eat right away and trying some orange juice to bring up her blood sugar.
Adverse reaction, lump in neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a female 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 local swelling (Verbatim: Adverse reaction, lump in neck). The outcome of the local swelling was resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.     It was unknown if the company considered the local swelling to be related to Shingrix.   Additional Information: GSK receipt date: 04-APR-2023 The reporter reported an adverse reaction experienced by another female patient, after they received the first dose of Shingrix.  The reporter reported being told the other patient experienced a lump in their neck after the first dose and was advised not to receive the second dose of Shingrix.  The reporter reported the lump had resolved. The reporter did not consent to follow-up. This case was linked with US2023049708, reported by the same reporter.; Sender's Comments:  US-GSK-US2023049708:Same report, other patient
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1707USA009901: US-009507513-1707USA009810.
This spontaneous report was received from a nurse practitioner concerning a 16 years old female patient with no pertinent medical history or drug reactions/allergies who on 21-JUN-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL intramuscular (lot # 657737/0522U, expiration date on 08-FEB-2010), on 16-AUG-2007 received the second dose of GARDASIL, 0.5 mL intramuscular (lot # 658222/0927U, expiration date on expiration date on 17-MAR-2010) and on 27-DEC-2007, the patient received the third dose of GARDASIL, 0.5 mL intramuscular (lot # 658558/1061U, expiration date on 14-APR-2010). The nurse reported that on 25-SEP-2012, the patient had an abnormal PAP smear that tested positive for GARDASIL strain. The nurse also noted that the patient did not have sexual contact before start of GARDASIL in May 2007. No treatment was given for the event. At the time of the report, the patient had not recovered from the event. The patient did not seek medical attention. Additional information is not expected.
Headache, fatigue started 8 hours after injection. Arm soreness for 2-3 days. Rash and redness around injection site and all over my back on morning of 4/28/21 with extreme itch and burning lasting 24 hours. Primary doctor recommended bennedryl and Tylenol via telemedicine call.
From information received on 11/1/02, it was reported that a 52 year old male patient was administered TD ADS (lot # U0525AA) on 10/5/02. Within 24 hours he experienced a sore arm and redness at the injection site. Reportedly he now has complete immobility of the arm in which the vaccination was administered.
Received Hep B vax in right deltoid at approximately 2 PM. Noticed 10 minutes post vax, diffuse macular rash to both forearms. At 4 PM, came back to clinic - rash on lower legs also. No swelling. 7 PM, mother states that rash resolved post Benadryl administration. Physician will administer 2nd dose in his office and will monitor pt for reaction for 1.5 hours.
This spontaneous report as received from a registered nurse refers to a 2 years old patient of unknown gender. On 23-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of  the several reports from the same source. Additional information has been requested.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 21-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which has the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received the vaccine 4 days past it's expiration date on 1/22/22. Vaccine expired on 1/18/2022 based on calculated 10 weeks from the date of refrigeration. Unable to reach the patient but upon contacting the manufacturer, patient is to repeat dosing to ensure immune response from the vaccine. Will continue to try reaching out to the patient to communicate. So far, no adverse reaction has been reported by the patient directly to the pharmacy.
Admitted with chest pain / SOB Dx with Pulmonary Emboli / Hematuria / Proteinuria / Hypocomplementemia  Dx with SLE / LUPUS NEPURITIS
My son, age 6 (BD 4/18/2000), had an adverse event to his 2 yr old immunizations in 2002.  Approximately 6 hours post 4 immunizations (MMR, polio, HibB, Dtap) he developed a fine raised rash all over his body for 2-3 day that itched. Mom does not remember any fever, breathing difficulties. He did have a decrease in appetitie for a few days but no problem with fluid intake. He has no medical problems and NKDA, no past vaccine reactions. Neg Family history for asthma or skin diseases. He has the middle child with one brother and one sister.  He continues to have a "darkened" skin area behind his neck, in elbow creases and behind knee's that periodically have a "non-blanching small red bumpy-beaded" rash there.  MD state it is not eczema. He treats the area with Hydrophor and Eucerin cream 2-3x/day with relief of itch and dryness. He is being f/u by Allergy/Imm for skin testing 12/12 and sinus scans.
Receive shot on 11/6/12 first one ever was made to take or no job got shot around 10AM - felt fine (no problems till that night 10:15PM it hit nausea, room spinning couldn't walk dizziness.
Within a few hours of my vaccinations I began having flu like symptoms including leg cramps, skin sensitivity, general fatigue/malaise, and mild fever. The fever lasted nonstop for 48 hours and then was off and on for a week. The fever left after a week but the rest of my symptoms began to worsen over the next few weeks so I went to my doctor and reported this event. She told me that the immunizations did not cause this but I insisted this all started within a few hours of my immunizations. In late November I was mildly anemic and had blood in the urine. I could not concentrate at work or when driving and asked to go out on short term disability in late December. On Oct 1st I had a major left lung collapse. In February I was diagnosed with fibromyalgia. I do not accept this diagnosis and can say with all certainty that my immunizations either caused or triggered this disease. In May I was diagnosed with COPD. I am unable to work as a result of my illness. I often need a wheelchair to get around. I have a resting heart rate that is 85-101 bpm. This was all a result of my immunizations: N1H1, seasonal flu, whooping cough & Tetanus given on October 11, 2010.
5cm x 5cm erythema and tenderness in left arm at site of injection. Treated with keflex 500mg twice daily for 7 days and zyrtec 10mg once daily for cellultis. Student advised to return as needed, no return visits documented.
Patient had headache, rash on neck and back. Was told to give BENADRYL and TYLENOL per MD. Rash went away after giving BENADRYL per mom.
about 18 hours after  getting 2nd shingrix and flu  shot he reported cramps over many muscle groups  , esp upper body.  He had hematuria x 3 that morning as well. He drank copious amounts of water, and the cramps and the hematuria resolved  in 6 hours. Of note,  weeks after first shingrix in February, he complained of hives which have resolved.  Also of note, I had another patient have a similar presentation 3 days before.
I began experiencing dizziness/vertigo when lying down or getting up.  This only lasted 30 seconds or less and improved after a few weeks.  Upon receiving my second vaccination on 3/16/21 the dizziness has immediately gotten a bit worse.  It has only been a few days since my second dose.  I also have a slight runny nose and a little sneezing after the second dose but this is veery minor.
I came down on Dec. 30th 2021 with Covid Positive test, it seemed to last severe symptoms for one day however it took a week for symptoms to clear completely. In February 20th 2022, I began to notice a sense of fullness in my right ear and then had an extreme vertigo episode that kept me immobilized for about 4-5 hours. I went in with the ENT a few weeks later. They did an audio test and balance test and diagnosed me with Meniere's disease. I am taking a prescription that does help out tremendously with symptoms however from time to time I am still getting the sense of fullness in my right ear along with white noise.  Vertigo does come and go very seldom and causes me to sit for about a half and hour and then I am typically able to go about my day.
"running nose, like a cold"; "skin on feet peeled"; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Mother) reported for a 44-year-old female patient (Daughter) that:  A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included latex allergy, and allergy to avocado, bananas over 20 years ago she was also diagnosed, figs, 2 anaphylactic shocks so she knows how to manage. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced nose kept running like a faucet, skin peeled off under her feet, very sick, After the first dose, Daughter had severe reactions: nose kept running like a faucet, skin peeled off under her feet, and was very sick for 3 days. The patient previously took flu shot, every year with no problem. On an unspecified date, the patient experienced "running nose, like a cold", "skin on feet peeled". Caller mentioned she has some food allergies, and the allergist cautioned her about polyethylene glycol (PEG). Caller has an appointment on Monday. She also takes Zyrtec everyday and has no reaction to it. Caller asked if there was another ingredient that people are allergic. The clinical outcome of events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Mother called on 9/23/2008 reporting low grade fever with scattered rash on L leg and chest.  Less than 50 lesions.  Appetite normal. T/C with father as follow up 9/24/2008 rash on leg gone, chest rash decresed but some lesions on back, afebrile.  Parents have opted not to give child Acetaminophen.  Will call RN if no change in 48 hours.  9/29/2008 No further contact with parents.
The pt was considered a high risk (nos). According to the physician, he did not have cancer. The pt received Engerix-B vaccination (date, dose and series unspecified). It is unclear whether or not the pt developed antigenemia or aplastic anemia. According to the reporting physician, the pt needed a bone marrow transplant. Treatment of the adverse event was not specified. It was reported that "all other therapies failed" (nos). The pt died. All of this had occurred within ten days. The most recent information received on 5/24/2000, reports that the pt died (date and causality of death were not specified). Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient received 1st dose of pfizer vaccine. Less than 1 minute later patients mother alerted us that the patient had lost consciousness. She was immediately laid down and gained consciousness within 10 seconds. She stated feeling lightheaded, sweaty, looked pale and felt like she was in a trance. 1st BP reading (111/67), 2nd BP reading done 15 min later (106/59 & HR 65). After 30 min of monitoring patient was able to leave.
This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In  April 2018, less than a week after receiving SHINGRIX, the patient experienced trigeminal neuralgia, facial pain and toothache. On an unknown date, the outcome of the trigeminal neuralgia, facial pain and toothache were unknown. It was unknown if the reporter considered the trigeminal neuralgia, facial pain and toothache to be related to SHINGRIX. Additional details were provide as follows: The age at the vaccination was not reported. The patient was experiencing facial pain like a bad toothache on his left side of face, like trigeminal neuralgia and it was very painful.
rash on my breast-opposite side of the shot, under my arm, and on my back; Rash on my breast has turned into blisters; swollen, painful lymph nodes; The entire area has dull constant ache, sometimes sharp pain; This is a spontaneous report from a contactable consumer (patient) from medical information team.  A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9266, expiration date not reported) via an unspecified route of administration, in left arm, on 26Feb2021 (at the age of 68-years-old), at dose 1, single for covid-19 immunization. Medical history included Parkinson; that was mild and not very serious, glaucoma and had a surgery for it, dry eye. Concomitant medication included carbidopa, levodopa (RYTARY). The patient experienced rash on breast- opposite side of the shot, under arm and on back, the rash on breast turned into blisters, swollen painful lymph nodes and the entire area had dull constant ache; sometimes sharp pain on Feb2021. The patient had no investigation assessment reported. Therapeutic measures were taken included Benadryl and Ibuprofen. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Developed neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot I was very uncomfortable and called the on call physician for my doctor. I was already taking acetaminophen for my symptoms. He recommended adding an antihistamine. I started Zyrtec once daily with a mild transient improvement in my symptoms. Today is day 4 after the shot and I am still very uncomfortable, with neck swelling and difficulty swallowing. On day 2 after the shot I woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. In addition I experienced fatigue, headaches and malaise on days one, two and three after the shot. Those symptoms have resolved by day four.
Sudden pain in shoulder, left breast, and arm pain and left side.  Pain is not getting better ater two weeks and patient can not move left arm with out severe pain.  Has continious pain in Left side of back and left breast.
BLOOD CLOTS IN HER BRAIN, WHICH SPREAD THROUGH OUT HER BODY; This spontaneous report received from a consumer via social media (Twitter) and concerned a female patient of 29 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the patient experienced blood clots in her brain, which spread through out her body, and was hospitalized (date unspecified).The patient was hospitalized for four weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in her brain, which spread through out her body was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210637099-Covid-19 vaccine ad26.cov2.s-Blood clots in her brain, which spread through out her body. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).