chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 09 November 2006.  A 46 year old, female patient developed "blister-like lesions), 24 hours after she received Fluzone (lot number U2251AA) intramuscularly in the right deltoid on 07 November 2006.  The "blister-like lesions" appeared on the opposite forearm, upper arm and trunk.  At the time of the report, it was unknown if the patient recovered.  Follow-up information received on 15 December 2006.  The patient did not have any illness at the time of vaccination.  The patient stated the lesions resolved approximately 2 weeks after the vaccine was given, but she did experience moderate URI symptoms with fever for 3 days after the vaccine which also resolved.  The patient recovered - approximately 21 November 2006.
Severe pain upon injection.  Over next 2 days - Development of 5 inch swollen area at injection site, hot to touch and painful (pt rates 6 on pain scale).
This spontaneous report as received from a mother via company representative refers to a male child patient of unknown age. The field representative states a Local TV news show on 28-MAY-2014 referenced GARDASIL safety concerns. The representative investigated the information on 29-MAY-2014 and found an article, on the website. The article includes adverse event information from a mother, reporting her two children (related sibling case 1406USA000479). On an unknown date the patient was vaccinated with GARDASIL (lot number and dose not reported). No other concomitant medications were reported. On an unknown date the patient experienced grand mal seizure (medically significant) after administration of GARDASIL. No product quality issue involved. The outcome of grand mal seizure is unknown. The causality of grand mal seizure is not reported. Additional information has been requested.
Pt called to our clinic on 4/28/00 at 14:30 with complaint of rash on stomach and some on chest area. States rash is very itchy. Instructed to go to Urgent Care. She leaves for travel in 3 days.
Caller states that he had his first Moderna vaccine on Tuesday 4/5/21.  Since getting the vaccine, has notice swelling in both calves.  Denies pain or redness or tenderness to touch in legs.  He states the swelling has decreased over the past 3 days, but is still present.  Encourages to rest and elevate legs as often as possible and to notify his PCP regarding this new occurrence.
PAIN DOWN  LEFT SIDE OF BODY FROM NECK TO WAIST; PAIN LOCALISED; PAIN ON LEFT UPPER ARM WHERE RECEIVED VACCINE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced pain down left side of body from neck to waist, pain localised, and pain on left upper arm where received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain down left side of body from neck to waist, pain localised, and pain on left upper arm where received vaccine. This report was non-serious.
extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (extreme aching on left arm /excruciating pain on left arm so that he cannot lay affected side, Left arm.) outcome was unknown.            Patient had no known allergies.  Treatment also include Hot and cold compress and massage.  No concomitant medications were reported.
Body aches; Nausea; Chills; Headache /dull headache; pain was so bad that she would gasp; excruciating pain in her lower back around her ribs and the pain was constant; and around her ribs; midway down to the tip of her spine; pain was so bad that she would gasp and could not sleep all night long; felt horrible; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020 11:23, the patient received the 1st dose of Shingrix (inhaled). On 11th February 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 11th February 2020 19:30, the patient experienced back pain, rib pain and pain in spine. On 11th February 2020 21:30, the patient experienced general body pain, nausea, chills, headache and gasping. In February 2020, the patient experienced feeling abnormal. On 13th February 2020, the outcome of the back pain, nausea, chills and headache were resolved with sequelae and the outcome of the general body pain, rib pain, pain in spine, insomnia and gasping were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the back pain, general body pain, nausea, chills, headache, rib pain, pain in spine, insomnia, gasping and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and in the evening started excruciating pain in her lower back around her ribs and the pain was constant by 9:30pm that same evening, she started having nausea, body aches, chills, and headache.  The patient said that what bothered her the most was that initial excruciating pain in lower back, midway down to the tip of her spine, and around her ribs.  The patient said that pain was so bad that she would gasp and could not sleep all night long. The following day, that excruciating lower back pain subsided but she still felt horrible because she continued to have dull headache, chills, and body aches.  The patient said that by the following Thursday (same week), all the symptoms had resolved, she felt fine and she was back to normal again. Reporter did not consent to follow-up.
This is a spontaneous report obtained from a contactable pharmacist. A 67-year-old female patient received, on 26Jan2018, PREVNAR 13, (Lot. S92740, Expiration date: Dec2019, NDC number: 00005197105) at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 02Feb2018, the patient experienced a slight feverish feeling, redness, and swelling in her arm at the injection site. On 05Feb2018, she was still having aching in her hands and feeling like she's swelling. The patient did not recover from the events at time of this report.
Arthralgia, Fever, NauseaVomiting chills, fatigue Narrative:  Other Relevant History:
This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered M-M-R II (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 at 15:00 as dose 5 (booster), single (Lot number: 6J2524) at the age of 55 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "testicular cancer" (unspecified if ongoing), notes: (40 year survivor); "severe vertigo" (unspecified if ongoing); "VACTERL syndrome at birth" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; AMLODIPINE; EZETIMIBE; SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose:03; Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose:04; Manufacturer unknown), for Covid-19 Immunization. There were no other vaccines received in four weeks. The patient did not have Covid prior vaccination. The following information was reported: OFF LABEL USE (hospitalization), IMMUNISATION (hospitalization) all with onset 14Sep2022 at 15:00, outcome "unknown" and all described as "dose number: 5"; NEPHRITIS (hospitalization), SEPSIS (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "Sepsis/nephritis"; URINARY TRACT INFECTION (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "UTI"; DYSURIA (hospitalization), FATIGUE (hospitalization) all with onset 16Sep2022 at 05:00, outcome "unknown" and all described as "difficulty urinating and tiredness"; PYREXIA (hospitalization) with onset 16Sep2022 at 05:00, outcome "unknown", described as "fever of 103". The patient was hospitalized for off label use, immunisation, nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection (start date: Sep2022). It was reported that the patient experienced fever of 103, difficulty urinating and tiredness. Went to urgent care where UTI was diagnosed. Sent to emergency room for further evaluation where IV antibiotics were started. Sepsis/nephritis are suspected, and patient is being admitted. The events "dose number: 5", "sepsis/nephritis", "fever of 103", "difficulty urinating and tiredness" and "UTI" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (16Sep2022) 103; SARS-CoV-2 test: (17Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of nephritis, sepsis, pyrexia, dysuria, fatigue, urinary tract infection.
A few hours after my younger son received the HPV vaccine he felt light headed, dizzy, disoriented and nausea
Information has been received from a physician and a medical assistant concerning a 13 year old female patient who on 06-MAY-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # 658282/0929U) concomitantly with a dose of MENACTRA (Lot # UF389AA). On 04-AUG-2009, the patient was vaccinated with the second dose of GARDASIL (Lot # 658282/0929U) and on 19-JAN-2010, the patient was vaccinated with the third dose of GARDASIL (Lot # 658282/0929U). According to the physician, after the patient received her third dose of GARDASIL, she reported that she was extremely sore and weak. The medical assistant reported that the patient had a physician's note to be out of school on 25-JAN-2010 and remained out of school for the rest of that week (until approximately 29-JAN-2010) for symptoms of being extremely sore and weak, it was also reported that the patient had another note to be out of school for symptoms of extremely sore and weak from 01-MAR-2010 to 12-MAR-2010 (also reported by the physician as "missed 2 months of school"). The physician also mentioned that the patient had "mild symptoms" following the first and second dose of GARDASIL (dates not reported). The medical assistant stated that the patient had not recovered. The patient sought unspecified medical attention. Diagnostic laboratories test were performed (not results provided). Upon internal review the patient remained out of school for symptoms of being extremely sore and weak, was considered disabling. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a "baby" male patient of unknown age. Patient's medical history and concurrent condition were not provided. On 27-NOV-2015 the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional Information: The caller stated that, with the first two doses had some headaches and the normal things that were told she would have.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 45 minutes post injection I experiences the sensation of heat all over my body, my heart rate increased rapidly and I had tingling in my mouth.  This passed after about 10 minutes, since then I have been experiencing exhaustion and feeling foggy.  No additional reactions at this time.
Woke up at 3:36 am on May 27th. I was feeling lightheaded when I got up to pee. Laid down and the feeling didn?t go away. Went into another room to put my head between my legs and the feeling did not go away. And then began to feel a pressure sensation in my chest and feeling clammy. Woke up my family and I went to the ER. When I arrived at the ER my heart rate was 32 bpm.
felt soreness in his arm afterwards; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt soreness in his arm afterwards) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis and Eczema.    The patient's past medical history included Cough in 2020, Productive cough (phlegm) in 2020 and Intentional dose omission (last dupilumab injection was scheduled for 27-Jul-2021, but he was one day late with it) on 27-Jul-2021. Concurrent medical conditions included Smoker, Skin haemorrhage since 2021, Skin infection since 2021, Scratch since 2021 and Skin disorder (scratches so bad that his skin breaks, bleeds and it's caused infection in his arm and hands) since 2021.   In 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 09-Oct-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 04-Jun-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PAIN IN EXTREMITY (felt soreness in his arm afterwards). At the time of the report, PAIN IN EXTREMITY (felt soreness in his arm afterwards) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Since the fourth dose of dupilumab, patient reported that he has a cough and phlegm productive cough. On an unknown date in 2021 the patient reported that he still experiencing bleeding along with an infection on his skin, due to excessive scratching. Patient said that he scratches so bad that his skin breaks and bleeds and it's caused infection in his arm and hands. Patient also stated that he will be taking antibiotics in the near future for relief. Patient reported that he picked up 2 medications that he was going to start from 03-Jun-2021 including hydroxyzine for itching and sulfamethoxazole, an antibiotic because he scratches so bad that his skin breaks, and bleeds and it's caused infection in his arm and hands. It was reported that patient stated that he began therapy with dupilumab in January 2021 using samples from the doctor, and he got three doses using the samples, but then there was an interruption in therapy for about a month and a half before he was able to get on a program that pays for the dupilumab for a year, so then he re-started therapy after that interruption. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
24 hours after vaccination, complained of fatigue and took a nap (which he had not done in 6 months).  9 hours after that, went to bed with a fever of 101.5 degrees.  90 minutes later, woke up crying and screaming.  He would not open his eyes when I asked.  When I asked what hurt him, he would not say.  Head hurt?  Yes.  Stomach hurt?  Yes.  Fever now 102.4 degrees.  Eventually stoppped crying in 10 minutes, and returned to sleep.  Slept fitfully all night, waking to have a cool cloth applied.
As a condition of my employment every new employee is required to get a Influenza shot before they can start work. Well. I this is what I thought I got until I was diagnosed with Shingles in the ear in Dec. 2017. Up to this point, about two weeks to 30 days I got a rash on my stomach. I thought maybe it was something I was allergic to so I just bought antifungal cream from the store. The second rash about maybe two a month later showed up on my chest below my collar bone but above my chest. This lasted a while and then the third rash sometime in Sept. 2017 on the back of my neck around my hair line. When I look at my chart it shows that I had a varicella zoster vaccination instead of a influenza vaccination. So now it is all adding up. Just looking back on the symptoms; rashes, dizzy spells, headaches, and muscle aches I can conclude that I've had Shingles for some time now. It just progressed until it ended. The second vaccination I got in Nov. I'm not sure if that was the wrong vaccination or not. I have requested my records. Well, due to having Shingles, the pain and inflammation my nerves on my right side of my face are paralyzed. I believe I am sick because I was administered the wrong vaccination., I was not scheduled to have a varicella zoster shot it was supposed to be the influenza shot. Considering I've never had chicken pox before this shot should not have been administered without my consent. I was told I was getting an influenza. Now I'm not feeling well and my face on one side does not work because I was given the wrong vaccination in error.
I feel my left side of body especially my neck and shoulder and a little part of my jaw or cheek numb. It is not that severe but still I feel it is not like my right side of the body.
30 minutes after receiving her first dose of COVID-19 vaccine patient experienced vertigo, nausea, diarrhea, pallor and tachycardia.  No associated rash or shortness of breath.  No lip or tongue swelling.  No itching.  Seen in ED where he VS were normal, she received meclizine and saline and improved to discharge.  Dx dizziness due to anxiety.  Over the next 24 hours patient experienced chills, sweats, fatigue, nausea and aching.  Temp max 99.0.   These resolved completely within another 24 hours.
Information has been received from a nurse concerning a 16 year old female with no medical history or drugs allergies, who in September 2008, was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL on an unspecified date. The patient experienced nausea, fever and vomiting 6-9 hours after both doses. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had recovered. Additional information has been requested.
devel a rash w/red blothes on both thighs & legs arms & 4 hrs p/recvd vax; mom called MD & was instructed to give DPH; rash subsided in 30mins;
got covid19 virus from someone at work.; got covid19 virus from someone at work.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced got covid19 virus from someone at work. (COVID-19) on an unspecified date. patient was asking when she can receive the second dose of the vaccine. she said one of her doctors told her 20 days after recovered while her other doctor said 1 month and the other 3 months. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started feeling dizzy, dizziness progressively worsened to the point were any movement was making me throw up violently.  This lasted 2 days, then my husband took me to the emergency room. I could not walk with out help due to the dizziness and being unbalanced.  The gave me IV fluids, and medications for vertigo and nausea.  The ER doctor recommended physical therapy for vertigo.
Patient received 3 immunizations on 10/12/17. Patient went to the hospital emergency room, the day after she received immunizations, because she was running a fever and had pain and swelling in her left arm. Dr. prescribed her two antibiotics to treat any infection he felt may have been caused by the immunizations. When I counseled her about her antibiotic prescriptions, her arm looked flushed and she said it ached. She stated that she felt ill but was mostly concerned about missing a day of work on Friday 10/13/17. We filled her prescriptions on 10/14/17. I proceeded to tell the patient I would check in with her again on Monday to make sure she was feeling better.
74 yo male diagnosed with COVID 19 4 days prior presented for Monoclonal antibody infusion but found to have Pulse Ox 91% and disqualified for said therapy. Patient states he received series #2 Pfizer vaccine 03/24/2021. He has an intermittent non prodictive cough and reports having chills earlier. He denies having chest pain or shortness of breath. He denies having headache or abdominal pain. He reports having an episode of loose stools previous day.
The day after (Sunday, November 28th) the second vaccine (Saturday, November 27th), while I was resting (watching a movie), I had one hour were my heart was racing uncontrollably and I had difficulty breathing/shortness of breath. I also was sweating and clammy, felt like I was going to pass out, and I was very pale in color in my face. On (Wednesday, December 1st this same situation occurred again when I was teaching; this time it lasted 30-40 minutes. I felt very weak after each episode. In addition to these two episodes I also felt flu-ish for 7-10 days. *NOTE: after my first vaccine I felt very sick (flu-ish symptoms) for 7-10 days; more than the typical 3-5 days that is noted.