chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to  School COVID Vaccination Clinic on 7/9/2021 for her 2nd dose of the COVID Vaccination. At this time it was discovered that she had received her 1st dose as a Moderna vaccine, despite not meeting the age requirements. Patient did not report any symptoms  or adverse effects from the first vaccine and was subsequently given her 2nd dose Moderna lot # 001C21A on 7/9/21 to complete her vaccination series.
Chest pain after she got first shot; chest has been really tight and it hurts; chest has been really tight and it hurts; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 20Jul2021) via an unspecified route of administration, administered in left upper arm on 21May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. It was reported that after she got the first shot, on 21May2021 she started having pains in her chest. It didn't last long. She didn't think anything about it at the time. Then she had more chest pains. It scared her. Since then her chest has been really tight and it hurts. Patient stated that she did not think she would get the second shot. She also stated The chest pain started right after/ Chest pain after she got first. Her chest felt really tight. No treatment for chest pain. She was taking any medications within 2 weeks before getting the vaccine, she said she was. Then she said that she was out of time and she needed to go.  Follow-up attempts completed. No further information is expected.
Fussiness the evening following vaccine, perceived abdominal pain, two episodes of bloody diarrhea.
This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug  reactions/allergies and concomitant medications were not reported.      On unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion at an unspecified temperature for an unspecified time frame. It was not reported if there were previous temperature excursions. Data logger was involved. No adverse symptoms were reported. A product quality complaint was not involved.        Additional information has been requested.
Localized injection site reaction with surrounding erythema and one small area of blistering, deltoid muscle.
pt recv vax 2JUL96 & 24OCT97 pt exp chickenpox consisting of 10 spots in groin & scalp;
Lightheaded, dizzy, nausea, right deltoid, red swollen hot.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 82 y.o. MALE with PMH of CKD stage 3, CHF, Dementia, schizophrenia, Afib, Depression, COPD, prostate cancer, Parkinsonism disease, CAD, Psychosis, Memory Loss, lower GI hemorrhage, Orthostatic Hypotension . Patient was resident of LTC with dementia and parkinsonism. Since last few months patient was residing in long term care and his health was declining. Jan 4th note says patient had chest pain, A.fib with RVR alternating with slow ventricular response with worsened weakness causing further impairment in mobility(wheelchair bound) and decline in functional abilities. Per last note from health and Rehab stated that patient passed away on 5.18. There was no further details on cause of death.
Fever 101.5; Lethargy; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, lethargy and chills. On an unknown date, the outcome of the fever, lethargy and chills were recovered/resolved.   It was unknown if the reporter considered the fever, lethargy and chills to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called and reported that the patient had fever of 101.5 degree F., lethargy, and chills for one day. The reporter consented to follow up.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-JAN-2016, the patient was vaccinated with a dose of oral, ROTATEQ lot # L008996, expiration date 01-DEC-2016 (route was not provided). On 04-JAN-2016, there was an incorrect product storage as the patient was administered a dose of improperly stored oral, ROTATEQ. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Headache, swelling and pain in throat and ears. Fatigue. Covid toe on 3/29
viral exanthema and diarrhea, resolving without treatment on 01/24/2022
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 7th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th February 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, injection site pain and upset stomach. On an unknown date, the outcome of the general body pain, injection site pain and upset stomach were unknown. It was unknown if the reporter considered the general body pain, injection site pain and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the husband of the patient. On the morning of 8th February 2019, around 10 am, the patient started to experience upset stomach, pain at the injection site and body aches. The reporter did not give consent for follow up. Patient was present in the background during the call. No further details were provided.
On 2/3 upon rising my vision was blurry for awhile.  At 8PM I had Kaleidoscope Auras in both eyes.  I have never experienced either of these events.
Pt states that a couple days after getting vaccine fingers of both hands swelled up and developed rash on hands, wrists, ankles and hips. Treated with Benadryl and "anti-itch cream".
Red around the vaccine area, in where it was administered. BENADRYL was given at office.
No adverse event noted. Expired vaccine administered. Vaccine expired 4/1/2022. Administered 04/19/2022.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical location: Arm right), administration date: Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Pain in the right shoulder joint and surrounding muscle.", "Pain in the right shoulder joint and surrounding muscle."; Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical location: Arm right), administration date: Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Increased pain in the right shoulder joint and surrounding muscle.", "Increased pain in the right shoulder joint and surrounding muscle.". The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "increased pain in the right shoulder joint and surrounding muscle/ there is also pain when raising the arm overhead, lifting items overhead and performing any activity requiring rotation of the right shoulder"; MYALGIA (non-serious), outcome "not recovered", described as "After dose #3 I again experienced increased pain in the right shoulder joint and surrounding muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, myalgia. Additional information: There was also pain when raising the arm overhead, lifting items overhead and performing any activity requiring rotation of the right shoulder. The left (did not have any injections) remains without any similar symptoms. The patient received multivitamins. The patient did not have any medical history. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was treated with heating pad and used analgesics. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/21/2003, child had swelling and redness with three blisters around injection site of right arm. Seen by MD at Clinic, given antibiotic and creme.  Treated by MD on 11/22/03, given 500mg Rocephin IM. Diagnosis with Cellulitis.  Seen 11/23/2003, swelling and redness improved given 500mg Rocephin.  11/25/03: Improved.  To see again on 11/26/2003.  Still under tx.
receiving 0.5ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 060h21a) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (diagnosis received on Jun 2nd 2019) and Traumatic brain injury. Concurrent medical conditions included Obesity (severe), Cognitive disorder and Memory loss.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
I got the shot at 11am on 3/23/2021. I was completely fine with absolutely no symptoms for most of the day until that night. Around 8pm, after laying down on my sofa for a couple of hours, I felt intense head pressure when I tried to stand up.  When I tried to walk, I realized that my entire body was shaking. I took Tylenol (500mg) and went to bed. Throughout the night, I experienced a severe migraine, chills, fever, sweating, increased heart rate and difficulty sleeping. I took more Tylenol (500mg) around 4:30am (3/24/2021) and went back to sleep. When I woke up around 8am (3/24/2021) all symptoms had resolved and I was completely fine.
Got H1N1 injection on 11/24/09. On 11/25/09 nod periorbital swelling and red papules on arm (x4) and felt itchy but no hives. No medication given and symptoms almost gone by 11/27/09.
Patient received seasonal influenza vaccination about one month ago without incident.  On 11/4/2009 she was vaccinated at work.  Immediately post vaccination she felt flushed and dizzy but continued to work.  The next day she had numbness and paresthesia of the right upper extremity.  This seemed to pass.  The following day, 11/6 she had a stocking distribution numbness of the right lower extremity.  It began distally and ascended rapidly ultimately seeming to stop at the level of the clavicle.  The numbness was completely right sided.  Patient said it interfered with her ability to walk and on occasion her knee would buckle.  However, she had no weakness.  She was seen in the ER and admitted.  She was afebrile in the ER with a normal exam with the exception of the right sided numbness.  An MRI was done of the entire neural axis and was essentially normal for her age.  There was no evidence of cord compression.  Neuro surgical impression was of ascending, transitory sensory polyradiculitis consistent with sensory Guillian Barre but with no motor abnormality and no track signs.  No evidence of CNS involvment.  Patient discharged to home on 11/10/2009.  Symptoms have slightly improved but persist to the degree that it hampers her ability to work. 12/18/09 DC Summary and hospital records received for DOS 11/07/09-11/10/09. Pt. presented with right lower extremity weakness and progressive numbness which started morning after receiving vaccination. States this was causing difficulty walking. Admitted to hospital and neurology and neuro surgery consults obtained. Treated with steroids.Symptoms improved. DX: atypical right lower extremity weakness and numbness 12/10/09 Bone Health Center records for DOS 11/20/09.Presents with mild arthralgias. DX: arthralgia and Raynaud's phenomemon  11/13/09 ED and hospital inpatient records received. Service dates 11/7/09 to 11/10/09. Assessment: Numbness. Patient c/o right arm and right leg numbness. Leg feels 'wobbly'. Admitted as inpatient.
Blacked out, fatigued, sore muscles, vomit mucus one time, 1 squirt of loose stools at time of blackout Fatigue lasted 2 days. All other symptoms only lasted 1 day.
Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On an unknown date in June 2016, the patient was vaccinated with ZOSTAVAX (lot # M005727; expiration date, dose and route were unknown). On an unknown date in 2016, the patient experienced injection site pain and had a rash on her arm. The patient contacted the physician to seek medical attention. Unspecified antibiotics were given for treatment. The outcome of the events was reported as recovered on an unknown date in 2016. The causality was not provided. Additional information has been requested.
Fever for 24 hours.  Treated with Tylenol.  Edema of the right arm, right chest and scapular area.  Severe myalgia in upper right arm.  Mild redness at injection sites at right arm. Presented with severe splinting to the right.
Following the first dose she had a sore arm started later that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, the patient experienced PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night). On 14-Dec-2021, PAIN IN EXTREMITY (Following the first dose she had a sore arm started later that night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-448040 (Patient Link).
Employee complains that he is still having discomfort in the arm where he receive a Tdap injection. No swelling and no redness, but some discomfort and reduction in ROM of right shoulder.
Mild localized reaction to Lt deltoid.  No fever but c/o generalized body aches.  Instructed to ice the area , Take Tylenol and hydrate to treat the symptoms
Patient called today to report that his arm muscle that he received his second vaccine dose in began hurting on 2/21/2021. 9 days after vaccination. He also says it has now began hurting in his "joint." Referred to his PCP.
At 6:30 PM on 4/9/21- approx. 8.5 hours after the injection, I started feeling achy and chilled. At that time my temp was 99.7, and by 10 PM my temp was 102.1. I woke up at 1:30 AM on 4/10/21 and my temp was 102.5 and I was experiencing severe body aches, chills, and a pounding headache. At 2:15 AM I started having an intense pain in my abdomen that lasted for 10-15 minutes until I vomited. The aches, chills, and headache lasted until 8:00 AM, at which time my fever finally went below 100. Aside from being very tired the remainder of the day, my symptoms had subsided. Around 7 PM on 4/10 my temp did go back up to 101.6 and the aches and chills returned. After a full nights sleep, all symptoms were gone on 4/11.
Narrative: Headache, Fever, Sore Throat. All symptoms developed 8 days after Vaccination
Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL: lot number C3397AB was received on 05 October 2009 and again on 09 December 2009, and lot number C3498AA was received on 08 February 2010; and one dose of DAPTACEL, lot number C3473AA received on 17 November 2010 (routes and sites of administration not reported). The subject developed a paroxysmal cough with whoop on 14 September 2012, approximately 21 months after the last dose. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 18 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 October 2012, the subject's cough was still persisting. The duration of cough was reported at that time as 17 days. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Approximately 3 weeks after my second dose of the Pfizer Covid-19 vaccine, I began experiencing hematospermia and other changes in semen characteristics. This was associated with what felt like pain in my prostate and increased pressure in the groin. I was first treated with a course of abx which did not avail the symptoms. Urinalysis negative for any blood cells or bacteria. Bloodwork was normal for CBC and chemistry panels. The blood and pain worsened and I sought a second visit. This time a DRE was performed and minor prostate swelling noted, and placed on a month course of Bactrim abx. This did not diminish the symptoms so referred to urology where a cystoscopy and rectal US were performed with normal findings on both. Eventually the symptoms subsided after ~4-5 months of continual symptoms.  However, after I received my booster dose, this time with Moderna on 12/9/2021, the symptoms returned, again ~3 weeks post vaccine, although severity appears less. Prior to these two episodes, I have never experienced any blood or changes in semen characteristics.
Information has been received from a physician concerning a 15 year old female who in January 2007, was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. In January 2007 within days of the vaccination, the patient developed redish patches on her distal arm near injection site after her first vaccination with Gardasil. Near the injection site was a small abscess with tiny eschar over it. The event was inferior and anterior to the injection site. The physician stated that it could be an infected follicle or low grade cellulitis. The patient also had a sore throat. The patient sought unspecified medical attention and was treated with Keflex. The patient's redish patches on distal arm near injection site, small abscess with tiny eschar over it and sore throat persisted. Additional information has been requested.
Patient received 3 shots in 2017 and received a dose of GARDASIL 9; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On unspecified dates in 2017, the patient possibly received the three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (unidentified Merck hpv vaccine was administered (name and lot number not provided); dose, route, anatomical location, and expiration date were also not provided) for prophylaxis.  Then, on 10-SEP-2021 (reported as today), the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered).
adm to hosp 29SEP92 w/myalgia, h/a & fever from 99 to 101.8; neg blood culture, neg urine culture; 29SEP elevated LDH 190, elevated SGPT 22, GGT 15, SGOT 23; a/discharged LDH-271, SGPT 24, GGT 19, SGOT 31 as outpatient LDH 645, SGPT 414;
Bottom lip swelling with blister along length of bottom lip. 2 Benadryl 25 mg  soft gel taken ice applies and monitored for any other major problems.  After 2 hours lip stopped swelling but remains tender and sore with blister. Lip is very red.
body itching-raised bumps/hives 6hr post vax;pt started methylprednisone w/in 24hr p/vax;
Breakthrough case admission after three vaccines  Moderna 3/26/21 Lot3 017b21a;  mODERNA 4/23/21 Lot# 043B21A;  Moderna 8/18/22 Lot# 011B22A
Pain in upper arm since time of injection. Redness, hard, and warm to the touch around site of injection. Injection received at 5:30PM on 5/25. I had to take off work on 5/26 and 5/27 due to feeling exhausted and sore. Bruise forming at site. Feeling sweaty then chills occasionally over 4 days. Itchy and sore from upper arm to back of neck.  Went to urgent care, afternoon of 5/29 and put on steroids and antibiotic for reaction/infection at site.
Donor had adverse event reported on return to center, donor reported lightheadedness x1 day and aching in joints x 4 days which is still unresolved at time of DAE.
Soreness at site of injection; aches, fever 102 hoarseness, sore throat, cough.