chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of my injection I got a bad headache.  After going to bed I had severe chills (I could not seem to get warm no matter how many blankets I used) along with increasingly worsening muscle aches and a worsening headache.  In the morning I felt like I had been  hit by a truck. Everything hurt. It felt like a bad flu type muscle aches and pains. I had a low grade fever all day (99.3-101.7) , was very tired and my arm (injection area) felt like it was hit with a hammer.  It felt sore, swollen and bruised although it wasn't.  The headache was bad and continued without letting up even when taking Tylenol or Motrin.  These symptoms continued all day.  I could not do anything but continually change positions to try and get comfortable enough to sleep.  One time when I laid down to take a nap I got the same chills as the night before.   That evening was  another rough one although I was warm all night instead of getting chills.  Upon waking, day three,  I still have a bad headache, muscle aches and pains though they are less than yesterday.  I am able to do things for myself today as long as I rest in between.  NOTE: I have no reaction to the first vaccine at all
Administering the 2nd dose of the moderna vaccine to patient, needling splattering occured; Needle splattering occurred; A spontaneous report was received from a heath care professional in the concerning a patient who and had administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection  Physician stated that in the course of administering the 2nd dose of the Moderna vaccine to a patient, needle splattering occurred. She did not know how much of the vaccine went into the recipient's arm.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Underdose and Device connection issue without any associated adverse events.
It started in the morning I had an itchy throat and sore throat with a cough. I tested that day, and it was negative. Two days I had a fever of 101.9 and tested again, and it was positive for COVID-19. I contacted my doctor and did a tele visit on that Monday and prescribed me PAXLOVID. I had taken it for five days and it makes my mouth taste bad. I still have a cough, but it was by the five days the sore throat and fever was gone. I have had drainage for years though, could be why I cough.
GARDASIL 9 (R017624, 3/17/2021); seizure; syncope; incontinence; This spontaneous report was received from a registered nurse via a company representative referring to a 16-year-old male patient. The patient's concurrent conditions included history of seizure. The patient's drug reactions or allergies were unknown by the reporter. No information was provided regarding the patient's medical history and concomitant medication.  On 24-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location were not reported). The registered nurse reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot number R017624 and expiration date of 17-MAR-2021 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). However, lot number R017624 was valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).   On the same day, post vaccination the reporter experienced syncope, seizure, and incontinence. No laboratory diagnosis or studies were performed. The patient did not seek for medical attention neither received treatment to the events.  The outcome of seizure, incontinence and syncope was reported as resolved on an unspecified date in June 2019. The reporter did not provide causality assessment between the events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   Upon internal review, seizure and syncope were determined to be medically significant events.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 at 15:00 as dose 1, single (Lot number: EN6206), in right arm, on 24Mar2021 at 15:00 as dose 2, single (Lot number: ER8727), in right arm and on 23Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) included: PRAVASTATIN TEVA, start date: 01Nov2021, stop date: 31Jul2022; EZETIMIBE ZYDUS, start date: 01Oct2021, stop date: 31Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 treatment from 01Aug2022 to 05Aug2022.
arm was a little sore at the site of injection; This is a spontaneous report received from a contactable consumer or other non hcp. A 56-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 24Feb2021 at 09:15AM (age at vaccination 56years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity. On 24Feb2021 the patient experienced arm was a little sore at the site of injection. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
pt had dose 1 of moderna vaccine on 9/2/21, dose 2 on 9/30/21 at the  health Center.  At 1201 AM on 10/3/21 pt began to have stabbing L chest pain worse when lying flat, better if sitting or standing.  It was associated with neck coldness and "bumping from the inside" pain in the L arm alternating from proximal bicep area to distal arm (not forearm).  Sx persisted for 1 hour and pt consequently presented to the hospital.  Sx resolved spontaneously at 3-4 AM.
This spontaneous report as received from a nurse refers to a patient of unknown age. Nurse reported that on 27-OCT-2014 the patient was vaccinated with GARDASIL lot number J014295 (expiry date : 11-AUG-2016), intramuscular which underwent an unsupported temperature excursion. No adverse effects reported. Additional information has been requested.
DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patient).   A 60-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 04Feb2021 08:30 (Lot Number: EL1283), at the age of 60-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included osteoarthritis, asthma, fibromyalgia. Historical vaccine includes first dose of BNT162B2, Lot number: EL1283, on 14Jan2021 08:45 AM in left arm at the age of 60-years.  The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included etodolac (LODINE); montelukast; amitriptyline; acetylsalicylic acid (BREOPRIN), all were taken for unspecified indication, start and stop date were not reported.  The patient previously took Vioxx and experienced allergies.  The patient experienced DVT on right leg on 21Feb2021 with outcome of recovered.  The event required physician office visit. The patient has not been tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of DVT in right leg which includes Eliquis.
11 cm x 8 cm induration/reddness at injection site- Left upper arm, deltoid
has trouble sleeping; weakness; body aches; felt fatigue; has had migraines just about everyday after vaccine; This case was reported by a consumer and described the occurrence of migraine in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced migraine. On 6th June 2021, the patient experienced weakness, general body pain and fatigue. On an unknown date, the patient experienced difficulty sleeping. Shingrix was discontinued. On an unknown date, the outcome of the migraine, weakness, general body pain and fatigue were not recovered/not resolved and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the migraine, difficulty sleeping, weakness, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced migraines just about everyday after vaccine and had trouble sleeping. From 6th June 2021 until the morning of reporting day patient felt fatigue, body aches, and weakness. The patient did not get her second dose because of the side effects she experienced with first dose. The reporter consented to follow up.
He had a sore mouth. Vomit about 4 to 5 times and also had diarrhea.
rash; felt like rope burn; fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Shingles once" (unspecified if ongoing); "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer/BioNTech Covid-19 Vaccine Details: , Dose: 1, Date: 08Mar2021, Time: Noon, Site and Route of administration: Right arm, Route of administration: Intramuscular, Batch/Lot Number: EN6199), administration date: 08Mar2021, for Covid-19 immunization, reaction(s): "throat was closing", "couldn't swallow". The following information was reported: RASH (non-serious), outcome "unknown", described as "rash"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "felt like rope burn"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: I provided all test dates/times on Pfizer website. 1st vaccine in (City, State). Felt like throat was closing pulled over onside of road. I was driving could not swallow that was after waiting 15 min in the Pharmacy. 2nd vaccine (Name) ended up with a rash photo enclosed. Felt like rope burn. Had a fever and chills. Contacted my Physician(Name). 3rd vaccine Booster same types of hives on head. Hair fall- out on the top of head- went to derm. Prescribed foam topical steroid. My hair was always extremely thick- no gray. Before getting booster I asked my GP/FP an Internal medicine to take blood and let me know what my levels were. I believe he said 380, (Name), My affiliated with (Name) Hospital. Before going in May I am supposed to get another booster. I didn't see to do well with mRNA.  Follow-up attempts are completed. No further information is expected.
Pt states sudden onset of chills, required 3 blankets to get warm.  Felt very weak, legs so "rubbery" had to call son to come walk him to the bathroom. Continued through the night and next day.  Is feeling better today (9/30/10). Does have several (10-14) erythemic macular lesions approx 1cm in diameter on back, several as in pairs. Do not follow dermatomes, no pattern, c/o itching. No lesions anywhere else on body. States thinks they came at the same time as "rubbery legs", but can't really say. Seen by his PCP here at our facility, MD says not Guillain-Barre, but thinks it is some kind of viral that happened at the same time of the shot. Does not feel it is a true "reaction".
Child developed a rash after receiving vaccines on 7/5/12. Right thigh with induration at site of vaccinations. Both anterior thighs with fine raised rash.
pt recvd vax; red, swelling DTP site; had similar episode oct78;
This vaccination was the booster after Pfizer-BioNTech vaccines received on 12/31/20 (EK5703) and 01/22/21 (EL3248).   Covid breakthrough with mild illness lasting approximately ten days. Symptoms included upper respiratory congestion, occasional coughing and sneezing, and fatigue.
10/09/2005 back to school after receiving shot developed severe headache, took 500mg Tylenol after school and again at HS. 10/10/2005 headache lessened went to school, headache continued, nasal congestion, felt bad, During night woke drenched with sweat, but no elevated temp. wrong sweat from sheets, pillowcase and PJ's. 10/11/2005 woke feeling ok and 10/12/2005 feeling normal.
have taken the shot every year and  had gotten the flu.; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a female patient (unknown demography) who have taken the INFLUENZA VACCINE every year and got the flu (influenza).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that she had to take the flu shot as she had work in a close environment of people.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown at the time of reporting.  There will be no information on the batch number for this case.
Itchy rash, patches all over foot, elbow and legs. Healthcare provider prescribed Benadryl.
Whether the adverse events were caused by the vaccine is to be determined.  We are available to discuss more details if this information can be used to help others from experiencing these reactions.  The morning after getting the vaccine, patient discovered that she could not swallow.  As her condition worsened, she was taken to the emergency room.  Over the past month, patient went to the emergency room 4 times.  The last time resulted in extended hospitalization that continues to this day.  In addition to the swallowing problem, two other major adverse events need to highlighted.  First, on 27 March, while in the hospital, vaginal bleeding started.  On 29 March, her doctor, performed a hysteriscopy/DNC finding "  "an unexplained blood clot (hematoma)."  The second major event was when patient demonstrated significant confusion and lack of memory.  On 7 April, she was diagnosed with Metabolic Encephalopathy.  Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back.  But as of 10 April, she was still having issues including hallucinations.  Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility.  She still does not remember much of the last 37 days.
Swollen Lymph Nodes in armpit of injected arm Fever Chills Fatigue
Swelling; Distorted arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm) in a male 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) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm). At the time of the report, PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Admitted with SOB, cough, weakness, fatigue. Newly dx Afib w/ RVR. Increasing O2 requirement. He received 7 days of dexamethasone, 5 days of remdesivir, s/p tocilizumab 12/5, ceftriaxone X 6d, azithromycin X 3d, s/p cefepime 12/2
Administered 1st dose to a patient who was underage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose to a patient who was underage) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-123474 (Patient Link).
Injection (Trihibit) 02/24/2004, right thigh.  Hot, red, swollen approximately 4 inches from mid thigh to crotch.  02/25/04: cool pack.  02/26/04: Seen MD, steroids and antibiotics.
Severe muscle aches and pains prohibiting sleep. Arm pain at injection site hard and sore preventing sleep as well. Muscle aches and pains subsided within 48 hours.
10 days after first shot, I had fever, diarrhea, headache, weakness, and swollen neck for two days. 17 days after the first shot I still had fever, weakness and started having palpitations. The fever lasted for 3 weeks until the emergency department doctor gave me ivy fluids. The weakness and palpitations are still occuring (more than 40 days after first shot).
arm sore; arm stiff; arm red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm 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 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 PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm red). At the time of the report, PAIN IN EXTREMITY (arm sore), MUSCULOSKELETAL STIFFNESS (arm stiff) and VACCINATION SITE ERYTHEMA (arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD21-091000, US-MODERNATX, INC.-MOD-2021-137978, MOD21-091050 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-may-2021 does not contain any new information; Sender's Comments:  MOD21-091000: US-MODERNATX, INC.-MOD-2021-137978: MOD21-091050:
It was reported that a pt rec'd vaccination and developed inflammation and induration at the injection site. She was evaluated by the physician and treated with motrin and benadryl and compresses.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # 672652/0022AE; expiry date 28-SEP-2014) on 15-0CT-2012. Route was unknown. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received GARDASIL that was improperly stored at 28 f for 8.5 hours. No adverse effect was reported. This is 1 of 2 cases from the same source (other case number 1210USA013616). Additional information has been requested.
The day I got it I had Headache body aches fever, chills, urine smelled like sewer fever went up to 104 in the night my legs couldn't hold me up I was hallucinating and thought I was going to die. Next day Tylnol kept fever to 101. still had Headache and body aches no energy Saturday was washed out n no energy n headache. Sunday a headache n today Monday a headache still and urine still smells bad
Severely weak, struggling eating and drinking, sleeping 75% of the day, achy body.
I noticed a humming in my ears. I thought it was something in my house. I didn't notice it because if there's another noises in the house, I can't hear it. I can just hear it when it's quiet. I went outside to see if it was something maybe inside the house or if it was something outside. It seems to have gotten louder recently, and I didn't think much of it at first. I asked my doctor for an audiology exam, but I haven't gotten that done yet. I noticed the humming and I talked to my doctor about it when I went to visit her for something else. I haven't gotten the test done because I haven't been able to get in for that exam. The only time where it's the most bothersome is when it's night time and I'm sleeping. It's woken me up a few times. Others in my family haven't been about to hear anything humming so I'm assuming it is my ears. I'm unsure if this tinnitus is in relation to the vaccine or if it's too much ear wax or if it comes with age.  I have been using airpods for a while and I didn't have a problem with them before, but I have stopped using them recently and switched to headsets.
Patient complained of having left anterolateral arm with marked swelling, erythema and mild warmth noted by school nurse on 1-24-11.
3"X1" AREA OF PAIN, REDNESS, WARMTH, INDURATED ON 12/30/20 LASTING 48 HOURS; STATES HEADACHE FROM 12/29-12/31/20; REDNESS SUBSIDED BUT HAS RETURNED IN PAST 2 DAYS WITH PRUTITUS, REDNESS AT INJECTION SITE TO LEFT DELTOID.