chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L027733, expiration date 13-SEP-2017) for prophylaxis (exact dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursions of 10.73 degrees Celsius for 15 minutes and 10.8 degrees Celsius for 30 minutes. The call was because of data logger. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002466.
have blotch where I received the shot, that got large, and knot under my arm; I don't think it was in Deltoid, it looks like it was lower.; 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 63-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: immunocompromised because I have low immunoglobulin level. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Manufacturer Unknown, Dose 1), for COVID-19 immunization; Bnt162b2 (Manufacturer Unknown, Dose 2), for COVID-19 immunization; Bnt162b2 (1st booster manufacturer unknown), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), outcome "recovering", described as "have blotch where I received the shot, that got large, and knot under my arm"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "I don't think it was in Deltoid, it looks like it was lower.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient stated, "I am losing you. It went out a little bit. I can hear you now. So first I am immunocompromised because I have low immunoglobulin level, I am not treated for it but I do have low immunoglobulin level (Intent: Medical History). I went to get my second booster on Sunday and I use to give shot because I use to do medical assisting many many years ago (Further reporter type not clarified hence captured as consumer) and after I received the shot in my shoulder she have put band aid. I have realized it was not in the deltoid muscle it was a little bit it was lower the deltoid muscle and apparently I had a big reaction, I had a blotch on my arm yet since Sunday each day it has gotten larger but it has, it is gotten larger but the color but the coloring is subsided like it is fading away now at this point and it was swollen underneath but that seems to be getting 'flexes' well. Her concern is if this shot was administered in the wrong spot lower then the deltoid do I , my cells can get its efficiency?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had received my Pfizer Covid vaccine on 8/2/21, between 10 am - 2:00 pm.  Myalgias started around 8 pm. I took Trazadone 50 mg at about 9 pm, at which time I went to bed.  ( I had taken Trazadone previously and had not had any adverse reactions.)  I woke up in the middle of the night to go to the bathroom, as usual.  During the night,  I had myalgias and night sweats. At about 7 am, I awoke,  had significant myalgias, was a bit dizzy, so I sat up and waited a couple of minutes before getting up.  I got up, walked about 10 steps to the bathroom, used the toilet and went to the sink.  I felt very dizzy and next thing I knew, I had passed out, hit my head on the tile floor. When I came to, I was extremely dizzy.  My husband helped me to bed, I took Tylenol, had ice on my head.  I take ASA 81 mg every other day, so my head continued to bleed for 4 hrs.  I went to the local Medical Center Emerg department for evaluation and CT.   The 1st week after my fall I was very fatigued and slept  10-12 hrs at night with 1-2 naps during the day. (This was a stark contrast to my usual 6-7 hrs/ night, with no naps.) I continued to be dizzy at times, lightheaded and sometimes queezy.  I was unable to read much at all, could not tolerate noise or viewing a screen. I started PT on 9/2/21 and the rehab therapist diagnosed me as having a nerve inflammation (neuritis) affecting my vestibular system.  I am improving continually.
pt recv vax & devel Injection site pain with impaired mobility of the arm; pt self treated w/hydrocodone w/o relief;to MD 27OCT97 @ which time pt cont to exp lt arm pain particularly w/movement;pa originated @ inj site & radiated to elbow;
Patient lay down because he felt dizzy per EMS's notes. Per patient, he has this kind of reaction when receives injections. Patient left walking with family member.
FELT LIKE FAINTING; BODY ACHES; BILATERAL HIP PAIN; LIMPING; CHILLS; This spontaneous report received from a patient concerned an 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced felt like fainting. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced bilateral hip pain. On 09-MAR-2021, the subject experienced limping. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from chills, body aches, bilateral hip pain, limping, and felt like fainting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Narrative: The patient received two doses of Moderna COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 5 Jan 2022. The patient was admitted on 5 Jan 2022 with severe weakness, cough, fever, COVID pneumonia, hypoxia, and sepsis. The patient was treated with remdesivir and dexamethasone. The patient's breathing was back to baseline as of 9 Jan 22, but remains in the hospital as of 10 Jan 22.
This literature marketed report was received from the authors of a published article, and refers to 7 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with two doses of MMR vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On unknown dates between 28-DEC-2014 and 08-FEB-2015, the patients experienced measles with rash. It was unspecified if the patients were exposed to measles in one or both of the two theme parks, if there was secondary exposure to measles or the source of measles exposure was unknown. The outcome of the event was not reported. The authors considered the event of measles outbreak despite two doses of measles-containing vaccine to be related to MMR vaccine (manufacturer unknown). This is one of several cases received from the same literature (cross-referenced cases MARRS # 1606USA004609 and 1606USA005686). Additional information has been requested.
I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown.
Joint pain; Low grade fever; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 30Apr2021 at 03:15 (at the age of 46-yeasr-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) and lisdexamfetamine mesilate (VYVANSE); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 21:15, 18 hours after injection, the patient experienced joint pain, low grade fever, chills, headache and fatigue which were severe for the first 4 hours and had been moderate since then. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint pain, low grade fever, chills, headache and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Day after vaccine: high grade fever, chills, joint pain, headache Day 2 after vaccine: headache, nose bleed
at 1128 EMT,  (MD), and (PHN) responded to clt in observation area. c/o mild itchiness at  vaccination site. Vitals taken at 1130 am: BP 110/82 HR 70. PT AxO x4. c/o progression of internal itchiness to left arm and lower body, mild dizziness and confusion/"foggy." 50 mg Benedry PO elixer given at 1135 am. Vitals recheck at 1150 am: 145/90, 80 HR. Clt exhibited s/s anxiety. At 12 pm Pt states feeling better, denies dizziness, states is more focused, denies CP, denies s/s tight throat or swelling. no swelling noted. states itchiness is better. left site at 12 pm, PHN instructed Pt to f/u with PMD in 24 hours.
Fever 101.7 for 24 hours. Welps three inched raised for 4 days.
I carried a fever, and had flu symptoms , with a horrible headache, and  body aches  for over a week. I also had quite a few seizures which is unusual for me. Some trouble thinking at times .( this could be from the seizure activity)  Extreme fatigue.
Rash head to toe, ear pain, stomach pain, swollen face. He was taken to his doctor and he tested positive for Strep. Was given antibiotics.
her arm was red; arm was red and swollen; hurting; hot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. She stated about side effects in February, when she got her 2nd shot she was afraid that she got Moderna by mistake because her arm was red and swollen and hot and was still hurting. She stated that she also called because of an unusual side effect the first time. She thinks it was ridiculous that it took this long to follow up and she doesn't want to spend anymore time on it. The outcome of events was unknown.  Information about batch/Lot number has been requested.
The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with headache. The day after that the flu like symptoms abated, but then were replaced with muscular and joint soreness, especially in the lower legs.  It felt like my calf muscles were going to charlie horse at any moment.  Also, I experienced random muscle twitches throughout my body, but mostly in the calf region.  This muscular twitching has continued for two weeks now, though it has abated to some degree in terms of frequency and intensity.  The muscle twitching is the reason that I'm writing this report.  I expected that I might have flu like symptoms, but not twitching muscles all day and night.
Patient received her 2nd Shingrix shot. She had no adverse reactions to her first shot. Later that night she had severe pain in her arm. She could not sleep in her bed so she attempted to sleep in a chair but was unable to because of pain and was unable to use her arm at all. The next day she still was unable to use her arm. There was slight improvement on the 3rd day. She was able to use her arm but with some pain still. She said that she is slowly improving now and asked us to report for her.
red itchy lump; dizzy; pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain). At the time of the report, INJECTION SITE MASS (red itchy lump), DIZZINESS (dizzy) and PAIN (pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
4/22/2021 suffered a stroke, hospitalized on 4/23/2021 for 3 days! affected right side ,speech was affected. been off work since,Still currently off work  disabilty 9/27/2021
Arm immediately hard/red swollen. No other issues. Went home. Took BENADRYL. Arm swelled shoulder to elbow. Went to ER. Given steroid tx. Pt ok, swelling down.
Patient had pronounced bruising in the arm the vaccine was administered, around her elbow. The bruising is resolving and is not causing pain. It occurred 2 days after the vaccine was administered.
Patient described pain in arm and neck. Face and neck felt hot as well approximately 7 hours after vaccination.  She states she did not sleep well that night and that the next day she said the area that was red and swollen was above her elbow, not where the vaccination was given.  She said it was a golf  ball size lump and she drew around it with a marker to  make sure it did not grow.  It did not but it lasted for 2 days. She said it subsided by 10/16, 3 days post vaccination.  She is now symptom free but wanted to make sure we sent this on to VAERS. She states she did speak with her doctor who confirmed with her that it was not unusual to have swelling, but patient was surprised that it was not at the injection site but lower down her arm.
Patient presented to local ED with complaints of increasing dyspnea, flank pain, and discomfort for 48 hours. History of COPD, TIA, Stage 3a chronic kidney disease, hypertension, Vertigo, Atrial fibrillation, Coronary Artery Disease, AAA, and S/P aortic valve repair. COVID test was negative, however CTA showed acute PE. Previously vaccinated with Pfizer on 2/6/21, 2/27/21, and boosted on 12/11/21. Patient admitted 12/12/21 and discharged 12/20/21.
Patient called today, which is 4 days after her vaccination. For the first 2 - 3 days after her vaccine, she experienced language impairment, "rubber legs", fever, short term memory loss, and fatigue. Patient is feeling better and following up with her PCP.
Patient called 12.20.17 days after vaccine and said her arm was very sore, red, and warm to touch. I called patient on 12.21.17 to check on her and she said it was still sore and starting to itch.
(1) Hard lump vaccine site. (2) Balance problems and tiredness (however patient was on Fexofenadine at the same time). Resolved balance issue in follow up isn't in 2 days after stopping Fexofenadine.
Patient was given Moderna vaccine when she should have received pfizer due to age less than 18 years.
PULMONARY EMBOLISM, UNSPECIFIED. 6/1/2021 ACUTE PULMONARY EMBOLISM CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 ACUTE PULMONARY EMBOLISM PULMONARY EMBOLISM, UNSPECIFIED. 6/1/2021 PALLIATIVE CARE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 PALLIATIVE CARE
Light colored "poop"; Stomach issues progressively increase/has a lot of gas; Severe bloating of abdomen; Got sick; Severe body aches; Felt like head was going to explode; Fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas) and MYALGIA (Severe body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Abdominal disorder (Issues with abdomen), Hiatal hernia, Narrowing of esophagus, Breast cancer, Surgery (32 surgeries for hiatal hernia,), Spinal fusion (Lumbar fusion and neck fusion), Cholecystectomy (Gall bladder removed) and Surgery (Component separation surgery (abdomen)). Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Drug allergy (allergic to Levaquin.), Blood pressure high and Drug allergy (allergic to cipro.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ILLNESS (Got sick). 04-Mar-2021, the patient experienced MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Severe bloating of abdomen). On an unknown date, the patient experienced FAECES PALE (Light colored "poop") and FLATULENCE (Stomach issues progressively increase/has a lot of gas). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Got sick), ABDOMINAL DISTENSION (Severe bloating of abdomen), FAECES PALE (Light colored "poop"), FLATULENCE (Stomach issues progressively increase/has a lot of gas), MYALGIA (Severe body aches), HEADACHE (Felt like head was going to explode) and PYREXIA (Fever 101.9F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature increased: 101.9 (High) 101.9 F.         No relevant concomitant medications were reported.  .
RASH ON MID TO LOWER BACK; TIRED; SLUGGISH; ITCHING  AT THE SHOT SITE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced itching at the shot site. On 31-MAR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced tired. Treatment medications included: ibuprofen. On 03-APR-2021, the subject experienced rash on mid to lower back. Treatment medications included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on mid to lower back on 05-APR-2021, and headache on 03-APR-2021, was recovering from itching at the shot site, and tired, and the outcome of sluggish was not reported. This report was non-serious.
Information has been received from a physician assistant referring to a female patient of unknown age. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and current condition were not provided. On 25-OCT-2018, the patient received an expired dose of PROQUAD (therapy type was recombinant Human albumin (rHA); lot # N010114, expiration date was on 24-SEP-2018) subcutaneously for prophylaxis(expired product administered). No adverse effect was reported.
Pain, swelling, redness, heat, and tenderness to palpation of (R) upper arm starting one day after receiving immunization at time o f well child exam.
dizzy/lightheaded with associated  bradycardia within 5 minutes of injection - rest, elevate legs, water, monitor symptoms.  Resolved after 30 minutes diarrhea within 1 hour of injection - resolved on its own after 2 initial episodes sore arm, muscle aches, chills and low grade temperature began within 12 hours - took Tylenol extra strength, drank fluids and rested.  Resolved after 48 hours
Fever, chills, rigors with generalizeed myalgia, arthralgia, malaise and severe localized pain on the day following vaccine administration.  Fever, chills and rigors resolved the next day, though generalized myalgias still present 2 days after administration.
Swelling and redness of left arm. He presented to clinic 6/3/2017 for the swelling and redness and was daignosed with Cellulitis and given antibiotics and arm was marked. He returned there the next day because the swelling had spread furthur although redness had faded. He was given a different antibiotic to start if the swelling worsened.
LMP 8/22/2020, EDD 5/29/2021 Vaccinated March 11 and April 1.  Isolated prenatal hypertension developed at 36 weeks Early c section due to isolated prenatal hypertension Baby born with unilateral auditory neuropathy
tingling in leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in leg) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (tingling in leg). At the time of the report, PARAESTHESIA (tingling in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Parent state that at 3a patient had temp of 105, parent was giving patient Tylenol which would lower temps but never lower than 101. Parent also stated that patient was breathing fast. Patient presented to the clinic with a rectal temp of 103.1 and RR of 64. Patient was given rectal Tylenol 80mg and was cooled with ice packs. Patient temp came down to 99.3 and RR 54. Patient remained afebrile thereafter.