chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female with depression who in November 2007 was vaccinated with her first dose of GARDASIL intramuscular in her deltoid. Concomitant therapy included LEXAPRO. The patient was vaccinated with all three doses of GARDASIL (lot numbers not available) intramuscular into her deltoid. The patient received her first two doses of GARDASIL along with MENACTRA, Tdap (manufacturer unknown). Three or four months after receiving her third dose of GARDASIL intramuscular (in approximately August 2008 or September 2008), the patient experienced absent seizure. The child became non-reactive, non-responsive and distant. She did not received any other vaccines along with her third dose. She received an electroencephalography and an magnetic resonance imaging which were normal. The outcome of the patient was not reported. The patient was currently seeing a neurologist who felt that the seizure was caused by stress rather than from the vaccine. Upon internal review absent seizure was considered to be an other important medical event. Additional information has been requested.  10/19/09 Neurology consultation records received, service dates 4/7/09 to 10/5/09. Assessment: Partial epilepsy. Witnessed seizure with vocalization, elbow flexed, hand clenched, turned head to right side, incoherent. sweating and drooling.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 21-JUL-2014, an unspecified patient was vaccinated with a dose of ROTATEQ (lot # H020558, expiry date: 17-APR-2014, oral) that was expired. Pertinent medical history and concomitant medications were not reported. No adverse effect reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
The avccaine was expired on 19-May-2023, and the vial was initially stored in the refrigerator, thawed and injected on 31-May-2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The avccaine was expired on 19-May-2023, and the vial was initially stored in the refrigerator, thawed and injected on 31-May-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The avccaine was expired on 19-May-2023, and the vial was initially stored in the refrigerator, thawed and injected on 31-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The avccaine was expired on 19-May-2023, and the vial was initially stored in the refrigerator, thawed and injected on 31-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The avccaine was expired on 19-May-2023, and the vial was initially stored in the refrigerator, thawed and injected on 31-May-2023).    No concomitant medications were reported. They were all in intact carton. Vial size was 2.5 ml and the vial did not underwent any temperature excursions. No adverse reactions were reported. All the patient were qualified the age and or immunocompromised. No treatment medications were reported.   This case contains information for the 12 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20 (master)
Eight days after the shot I woke with an itchy rash that circular and about 3 inches in diameter.    Based on what I read, it was "Covid Arm."      It is now 7 days since the rash started and it is mostly gone.   There is just a little redness at the bottom of the area where the rash was.    It largely stopped being itchy after 3 days.
I had left flank pain, so I went into the emergency room. I had a really red area on the left side where my lung is that was very painful. They did run a CT scan to rule out a kidney stone, which came back negative for kidney stones. I was given prescriptions to help with what I was told was pyelonephritis. I am feeling much better now.
pt recv vax 13MAY96 & 26MAY96 pt devel about 40 lesions on rt hand & face;27MAY96 pt to MD & was dx w/chickenpox;MD felt chicken pox w/not d/t vax but rather to natural exposure since there were children in the pt class w/chickenpox
Patient experienced near syncope immediately following first dose of vaccine. Patient reports that this is a common occurrence following any procedure involving needles. Patient recovered quickly and refused any further treatment prior to leaving the vaccine POD.
Learned of child's death from mother. It was 10 days after Hepatitis B immunization. Death certificate: otitis media and hyperthermia.  Nurse follow up on 06/18/04 states: "complete."
Rash of small red bumps on rear end, legs, feet, hands, arms, stomach, back, face, ears. Loss of appetite.
Moderate arm pain, immediate, lasting 4 days; moderate body aches, starting about an hour later, lasting 2 days; nausea, starting about 30 min later, lasting 1 day.
Rash that appeared about 5 weeks post vaccine. It was not itchy or blistering, just a raised pink rash allover my neck and torso. My PMD said it looked like a reaction to the RSV vaccine.
This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the right arm on 18Oct2021 at 20:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hypertension (HTN). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN)); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 30Sep2021 at 20:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced shingles on the left side of the abdomen. On 08Nov2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The event 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 event. Since the vaccination, the patient had been tested for COVID-19.  The clinical outcome of the event shingles on the left side of the abdomen was resolved on an unknown date in Nov2021.
COVID mRNA Vaccine linked Antiphospholipid Syndrome; This is a literature report. A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANTIPHOSPHOLIPID SYNDROME (medically significant), outcome "unknown", described as "COVID mRNA Vaccine linked Antiphospholipid Syndrome".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Lethergic/very tired two days post injection, and on 1/5/2021 golf ball size warm to touch red area at injection site.
Patient is pregnant (14 weeks), Nausea, Fatigue and achiness. Began 3am 10/13/2008 and is ongoing . Patient also experiencing headaches. (Onset prior to vaccine)
lt arm w/9x9 erythematous, severe tenderness since inj;fever day p/inj to 102, chills, dizziness, stiff neck, sx x 2 days, x/erythema lt arm remains;placed on ATB;
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated on 31-JUL-2012 with lot # (670542/0619AA) ZOSTAVAX that expired on 26-JUL-2012 and not experiencing any known symptoms. Additional information has been requested.
Stomach and chest felt uncomfortable. Next chills and shaking for about 30 to 45 min. Approximately a hour and half later had fever and sweating for about 45 min. Checked temp about 30 min later was weak and not eating for a total  36 hours. Body aches all joints
Approximately 2 weeks after the first dose, I began having muscle spasms in my right forearm...I had just started playing softball again after an extended hiatus so I didn't think anything about.  I went to a chiropractor for Active Release therapy to get the spasming to stop.  A week later I got my second dose (5/5/21) and I went back for a second game and knelt on my right knee and started getting spasms in my right quad muscle.  I switched to my left and it immediately started getting the same spasm in my left quad muscle.   The spasm began in my hip muscle and continued down the front of my leg to the knee. The spasms continued to get worse over the next hour to the point I couldn't walk without significant pain.  Over the next week, I began getting spasms in both legs at the same time - calves, quads, feet.  I would also get spasms in my neck, my upper back and shoulders.   They would hit at all times during the day and there was no warning signs.
Nausea, muscle soreness, injection site swollen, bright red, and hot to the touch, and redness/swelling growing in size daily.
I received my second Pfizer COVID-19 booster on 7/15/2022. On 12/19/2022, I woke up with a heaviness in my body that was centered in my chest. I then took a home antigen test, and I got a positive result. My husband had tested positive two days prior, so I was expecting it. I felt unable to function, so I pretty much stayed in bed the whole time, except the times I would get up to fix food. I had a headache and disorientation. About 6 days in, I had an episode in which my oxygen level went down to 86. I became disoriented, so I had a lie down for about an hour. After about an hour, my oxygen level was normal again, so I got back up and went to the kitchen to do some work. When I went to the kitchen, I felt faint and disoriented again. Not only that, but my left thumb had turned blue! The area from the base of the thumb to the knuckle was purplish black, kind of like a bruise. There was no pain, though. I had another lie down, and I did not get back up. Thankfully, it didn't happen again after that. During my illness, I felt like I had congestion in the chest, but I couldn't cough it up. I avoided coughing, because I was afraid coughing would make it worse. I felt unable to function, because I had really intense fatigue. Despite my fatigue, though, I had trouble sleeping. Most nights, I would be awake until 4 AM. However, I was still able to eat; my senses of smell and taste were not affected by the virus. During my illness, I took echinacea tea, elderberry gummies, manuka honey, and ADVIL. I tested myself on day 8, day 12, and day 16, and it wasn't until day 16 that I got a negative result. At the time of this writing, I sort of still have some residual symptoms. I do my normal pre-COVID-19 activities (e.g. grocery shopping) every other day, and I'm always exhausted on the days in between. Prior to COVID-19, I would sometimes walk for a mile, but I have not been able to do that since getting sick.
This 49 year old male received the Covid shot on  3/28/21    and went to the ED on  4/11/21     and was admitted  on 4/11/21 with the following diagnoses listed below. COVID-19
Client is a 34yo male who received Moderna doses 1 and 2 on 4/23/21 and 5/21/21, and his Moderna booster on 11/30/21.  He states that he had mild systems after his first two doses which resolved within 48 hours.  After his booster dose, 2 weeks ago, he developed pretty marked soreness in his entire left arm where the vaccine was given.  By 2 days after the booster, pain and stiffness extended from his left neck (demonstrates C7 area) to his fingers.  He noted redness and swelling at the injection site in the left deltoid which has resolved.  He noted redness and swelling and stiffness in the left MCP which has improved some but is still present today.  It seemed to improve more over the weekend while away from work (works with hands in shop refurbishing engines). He denies any other joint pain at all, or stiffness.  He has no personal or family history of arthritis or similar inflammation.  He does not take NSAIDS due to history of stomach ulcers so has not taken anything for this.   He denies any injury or other illness.  When asked, he states his arm was a little itchy but denies any rash/hives, mouth or respiratory symptoms.  Felt chilled for about 36 hours after booster but did not check his temperature.  Denies vomiting or diarrhea, swollen lymph nodes or lumps/bumps.
"Moderna Arm"; Arm was incredibly hot; Arm red; Arm swollen; Barely sleep for 10 days; COVID ARM; Itchy; Uncomfortable rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and INSOMNIA (Barely sleep for 10 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE from 01-Jan-2018 to an unknown date for Rosacea.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), INSOMNIA (Barely sleep for 10 days), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm). On 12-Mar-2021, INSOMNIA (Barely sleep for 10 days) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-125639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: ADR form attached on 10-may-2021, new events were added, updated outcome
Knocked him out; when someone was talking to him about something he could not remember what they were talking about; wiped him out mentally/These vaccines are messing with his head so bad; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Knocked him out"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about"; MENTAL DISORDER (non-serious), outcome "unknown", described as "wiped him out mentally/These vaccines are messing with his head so bad"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "takes away his ability to concentrate"; SOMNOLENCE (non-serious), outcome "unknown", described as "He will need to sleep it off over the weekend".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4 of his doses have had exact same thing. He will need to sleep it off over the weekend.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355612 same reporter/patient/drug/AEs and different dose;
Administration of Menveo conjugate only; Administration of Menveo conjugate only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st August 2022) for prophylaxis.   On 3rd May 2021, the patient received Menveo. On 3rd May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 3rd May 2021, the outcome of the inappropriate preparation of medication was unknown. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received Menveo conjugate only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The batch number of Menveo was updated from AMXA419A to AMVA419A as per sales data sheet.
mild chills overnight (may have been low grade fever) began around 9 pm and lasted until about 9 am next day,    Recorded a low grade fever (~100 F) the next morning but it went away once I was up and moving around.  Moderately sore arm (not as sore as first shot) lasted about 36 hours.  Had headache all the next day but not sure it was related - may have been a tension headache. This was my second dose.  I did not report side effects from first dose.  The first dose caused only a sore arm for about two days.
Participant c/o nausea, light-headedness and 'eyes burning'.  B/P 160/102; stated "feeling funny".  EMS called - arrived at 0835, BS 133.  Continued with symptoms; initially refused to go to E.D., but then agreed to be transported to ER at 0848.
Moderna vaccine administered outside of BUD. BUD was 6/3/23 and vaccine given on 6/8/23.
Severe Congestion, diarrhea, cough, body aches, sore throat,  difficulty breathing , Nausea
Case number PHHY2011US85561 is an initial literature report received on 04 Sep 2011. The authors present a case of bulging fontanelle following immunizations in a neonate. This report refers to a three month old neonate of unknown gender (table 3). This healthy neonate was vaccinated with Hib (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB INN), IPV (manufacturer and batch number: unknown, therefore conservatively taken as IPV VIRELON INN), HepB (manufacture and batch number: unknown), PCV-7 (manufacturer and batch number: unknown), DTaP (other manufacturer) and rotavirus (manufacture and batch number: unknown) on an undetermined date. Less than a day after vaccination, this neonate experienced bulging fontanelle and was fussy. The causality was assessed as possible by the reporter. No further information about the outcome of the event was available.
Bell?s Palsy: Left sided facial palsy discharged from ED 4/7/2022 on prednisone, valacyclovir, Systane complete eye drops & eye ointment
Very large injection site reaction. I had a large red spot, covering most of my upper arm. I would say the size of the red patch was about 8x4 inches or so. I also experienced swelling and the spot was warm to the touch and mildly itchy. Treated with ice, ibuprofen and Benadryl for about four days. The injection site reaction got worse over about the first 36 hours from the time of the injection and then slowly improved. From the time of the injection to the time the reaction went away was about 5 days total.
After taking the vaccine patient stated that he felt like he was going to pass out.  Mother stated that this happens every time he gets a shot.  Patient was walked to chair where he was given water.   Patient passed out briefly and was taken to medic station.
Severe cramping in lower left side of my back running thru my buttock on April 19th.  After two consultation with my doctors office, , order X-Rays and was diagnosed with moderate arthritis. Upon researching arthritis I found another person who also had reactive arthritis to the Covid-19 vaccination.  Although I may have had arthritis, I feel the vaccine has intensified the pain. Where I am in pain everyday and am now pursuing Physical Therapy.
Emesis, diarrhea and itchy bumps to neck, back, belly for 4 days.
Vaccine 5/31/22. Tinnitus and intermittent hearing loss the week after vaccine. Didn?t seek care. Noted hearing loss 6/4/22 but resolved. 6/6/22. On 6/24/22 developed acute sensory neural hearing loss Severe surg very Severe vestibular symptoms
Vesicular rash starting in hands and spreading to whole body with itching, burning, body aches, fever. Hospitalized 9/20/16-9/23/16.  Biopsy of rash "spongiotic dermatitis with frequent eosinophils."