chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (batch/lot number: unknown) at the age of 60 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 as dose 2, single (batch/lot number: unknown), in left arm, on 06Apr2022 as dose 3 (booster), single (batch/lot number: unknown), in left arm and on 14Oct2022 as dose 4 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid as COVID 19 treatment with start date 16Dec2022 and stop date 21Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The night of the vaccine I woke up around 1am with chills and a lot of pain on the vaccine site I could not sleep that night. The next day when I tried to work I couldn't go down the stairs because my legs where hurting a lot. I also had a huge headache I couldn't eat I felt very nauseas. My worst symptoms were my headaches it was a sever headache. On 4/12/2021 & 4/13/2021 I had diarrhea. On 04/1 4/2021 I went to the ER they did blood work they did a heart exam everything came out good and they just said it was just a reaction to the vaccine. I kept drinking Tylenol for my headache. On 4/17/2021 is when I did not feel the headache anymore. Now I just feel very fatigue.
Has redness on right outer upper arm x 7 days. Warm compress to site: Hydrocortisone cream TID x 1 week
At first i was simply tired and my arm was very sore for the first 12 to 24 hours. Then the entire length of both legs began to ache and hurt so badly i found it difficult to walk. It ached from my hips down to my feet and it was so uncomfortable I  was  not sleep the entire night, I simply moaned and groaned in pain.  The  next morning the aching and pain had subsided somewhat so I was able to walk. I never went back for the 2nd injection because I was very fearful the reaction would be worse as I had heard possible and was very concerned as to why I experienced the reaction that I did.
Pt reports hives over face and body (but not at injection site) & possible lip swelling approximately 1 hour post administration. We informed pt to seek medical attention to determine if the vaccination was from the vaccination or not. Pt declined and wanted to self treat with OTC medication. Pt was concerned with the rash but not concerned enough to seek a physician. We offered pt 1 box of generic Benadryl and provided dosing directions for an allergic reaction. She was concerned with the likelihood f drowsiness from diphenhydramine and asked about use with caffeine (so she can be alert for class and studying). Overall, pt was calm and understood the situation and her options for treatment, such as seeking medical attention.   We've attempted to reach out to the patient twice to follow-up but received no answer. Pt's voicemail had a male's voice, so a generic voice mail was left to omit patient identifiers.
fever; pain; hot; burning; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning). At the time of the report, PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.
gave booster shot with 0.5mL , when it should have been 0.25mL spoke with patient and patient stated they are ok
muscle cramp that gets worst the higher when raise the arm; Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine; numbness in fingers especially pinky fingers of injected arm; tingling in fingers especially pinky fingers of injected arm; Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side; Under arm was very swollen after the vaccine but the swelling has since went down; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Oct-2022, 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 an unknown date, the patient experienced MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine), HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm), PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm), AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down). At the time of the report, MUSCLE SPASMS (muscle cramp that gets worst the higher when raise the arm), LIMB DISCOMFORT (Patient did not have full strength in that arm/ experiencing this discomfort since getting the vaccine) and AXILLARY PAIN (Patient experienced pain in underarm of the arm injected, especially when patient extend arm out from side) had not resolved, HYPOAESTHESIA (numbness in fingers especially pinky fingers of injected arm) and PARAESTHESIA (tingling in fingers especially pinky fingers of injected arm) outcome was unknown and AXILLARY MASS (Under arm was very swollen after the vaccine but the swelling has since went down) had resolved.            No concomitant medications were reported.  Patient experienced discomfort since getting the vaccine and it had not gotten any better.  No treatment medications were reported.
Brain fog (forgetfulness, wondering what I needed to do), unsteadiness when walking and on stairs; normally walk quickly and on stairs, vision was off a bit more. Reactions started 12 hrs. after receiving shot and the 2nd day. 3rd day was fine.
On 1/19/01, complained of hives, progressing from 1 to many over body, neck, thighs and left breast. Treated with Atarax. On 1/22/01, complained of temperature of 103F and still has hives. Complained of sore throat and was referred to MD. Z-pak/cough syrup. On 1/23/01, temperature increased and still has hives and are leaving scars. Went to ER X 3.
About 4-5 hours after injection I had pain and swelling at the injection site which was high on my left arm. Severe pain in shoulder and arm for one week then continued with moderate pain, weakness and limited range of motion due to pain. Crepitus with motion. Had orthopedic evaluation 10/4/19. Normal Xray
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter    Reporter did not allow further contact
AFTER VACCINATION AT PHARMACY IT WAS DISCOVERED SHE HAD RECEIVED THE INFLUENZA VACCINE AT HER PRIMARY PROVIDERS OFFICE ON 10/30/2023
I had a slightly sore arm after receiving the vaccine. I also had a fever and fatigue for about four hours after the vaccine. I started feeling unwell on 05/20/2023. I believe I was exposed to COVID-19 while having dinner with friends. I tested positive on 05/23/2023. I contacted a provider and got a prescription for PAXLOVID. I had back surgery in June 2022, and I have had swelling in my feet, ankles and knees. After I started taking PAXLOVID, the swelling has gone away. I did not have an adverse reaction to the medication and tolerated it well. As of today, I still have fatigue and slight sore throat.
Narrative:  86 y/o male who was administered the first dose of COVID-19 (Pfizer) vaccination on 3/2/2021. Patient had been transitioned to a rehab facility and never returned for the second dose.
26JUN92 12 noon elevated temp sudden onset 103 R; 1230PM approx grand mal seizure;
Diaphoretic, syncope, unresponsive, evaluated by EMS, transported to ER
Allergic reaction after vaccination approximately 1 hour after receiving-developed difficulty swallowing, rash, itching. This 13 yrs old male presents to ER via walk-in with complaints of Allergic Reaction. The patient presents with difficulty swallowing, itching, rash, redness of skin. Onset: The symptoms/episode began/occurred suddenly, 1 hour(s) ago, after getting 4 injections at Dr's office: HPV, Tdap, meningococcal, Hep A vaccines. Associated signs and symptoms: Pertinent positives: hives, swelling, Pertinent negatives: chest pain, dysphagia, shortness of breath. Possible causes: At home the patient or guardian has treated the symptoms with nothing. Severity of symptoms: At their worst the symptoms were moderate in the emergency department the symptoms are unchanged. The EMS care prior to arrival includes: none. The patient has not experienced similar symptoms in the past. The patient has been recently seen by a physician. Dr., earlier today.
Pt complained of dizziness about 10 minutes after receiving the BOOSTRIX vaccine. Pt fell down and ambulance was summoned.
Acute bilateral pulmonary emboli without known risk factors for this condition. Onset of symptoms consistent with acute pulmonary embolism started 2 days after vaccination. Formal diagnosis made on CT chest on 4/13/2021 after worsening symptoms of shortness of breath with exertion prompted evaluation in ER
Approx 1.5 days after vaccine: Headache followed by pronounced brain fog, inability to focus, spaced out feeling. Empty head feeling. Lasted about 10 days before starting to improve. Resolved after 12/13 days.
received a "full" booster dose prior to FDA approval; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval). At the time of the report, ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
8/26/2004 Mom came to health dept to report that pt developed a temp of 104. 12 hrs after injections. Mom took her to ER where tests were performed. Mom was told symptoms were viral and not due to vaccines. Pt also has had diarrhea. Treated with antipyretic and Pedialyte. 8/27/04 Feeling fine, asymptomatic.
It was not documented by parent that child has Reactive Airway Diseaese. Should not have received Flu Mist. MD instructed parent to give him Vitamin C and to go to bed early.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 24th adult patient out of 190 reported who was received the vaccine   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
No adverse event occurred. Patient received a booster dose (0.25mL) of the Moderna vaccine but was actually due for a full second dose.
Flu-like symptoms: fatigue, chills, body aches (all over), pain at injection site, headache (but not flu with fever). I took (2) naproxen sodium. I am waiting out the symptoms.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-JAN-2018, the patient was vaccinated with an expired dose of M-M-R II lot # L032044 expiration date of 24-AUG-2017 (dose, route, anatomical place of vaccination and concentration were not provided), for prophylaxis. No adverse effects were reported.
Less than 24 hours from administration of the vaccine, a high fever 103+ degrees.  Extreme body aches especially the lower back.  The body aches were completely debilitating. Tylenol or Motrin taken every 4-6 hours which would subside the fever to about 100 until the fever reducer wore off.  These symptoms lasted a full 2 days.  In addition, a sore arm and red-hot patch where the shot was administered.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805431 was crossed linked to original cases 201804863 due to same reporter.
Vaccine error- vaccine was administered past its beyond use date. The vaccine had been stored in the refrigerator beyond the time frame recommended by the manufacturer.
22 y.o. male asthma presenting to clinic with chest pain.  Chest wall: Left sided chest wall tenderness. Lymph nodes: Cervical, supraclavicular. Mild pain with palpation of axillary nodes   Chest Pain | Acute Pericarditis secondary to vaccination - ECG ordered. Normal sinus rhythm. Diffuse ST elevation. - Naproxen 500 mg BID x2 weeks ordered.  - Colchicine 0.6 mg once daily x3 months ordered.    Follow up in 2 weeks.
pt recvd vax; devel blister like red rash around inject site;devel cluster of blisters w/ redness & swelling of skin tissue of face, arms neck & legs; in f/u: md reported pt was dx w/ allergic rxn;
Pain/swelling on the site that radiate to the armpit and underneath the injection site, redness, warmth on the site, feeling that arm will fall off, heaviness, generalized body aches/malaise/pain/soreness, unable to walk or stand up due to feeling of heaviness, headache, after 2-3 days itching on the site.
2 patients received unspecified doses of VARIVAX that was improperly stored; No adverse effects reported.; This spontaneous report as received from a registered nurse refers to two unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number R009820, expiration date 03-APR-2020 (dose and route of administration were not provided) for prophylaxis, that was reconstituted with properly stored sterile diluent. The vaccines were stored in temperature -9 degree Celsius to 8 degree Celsius for 7 hours 25 minutes. Previous temperature excursion was reported as temperature -9 degree Celsius to 8 degree Celsius for 24.5 hours and -14 (units not provided) to -10 degree Celsius for 1 hour. Digital data logger was involved. No adverse effects were reported.   This case is non-valid due to the lack of the patients' identifiers.
Inability to move arm day after administration, missed one day of work, shoulder pain with certain movements, limited range of motion, diagnosed by occupational health doctor with subacromial bursitis of left shoulder joint.
The day after receiving the shot his arm was very painful, and lasted 5 days.  It was painful to lift his arm.  The day after the vaccine he developed a productive cough which he still has.  Monday after the shot he developed a fever, chills and bodyaches and coughing would cause his "head to pound".  To date he has a painful cough.
Child given wrong vaccine for age group.  Child was complaining of headaches. Her cycle became very heavy and it came twice. Dizziness and short of breath.  Went to dr.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated at an urgent care for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
skin cancer; site has never healed. It scabs over, then the scabs fall off and it bleeds again; site has never healed. It scabs over, then the scabs fall off and it bleeds again; This is a spontaneous report from a contactable consumer (patient) reported for self that forwarded as an adverse event by the epsilon escalation team on 18Aug2021. A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Mar2021 as dose 2, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), on unspecified date as dose 1, for covid-19 immunisation with no reaction. The patient got the 2nd covid shot on 20Mar2021. The site has never healed. It scabs over, then the scabs fall off and it bleeds again. This has happened multiple times. The patient had a punch biopsy and it came back as skin cancer in 2021. The patient never had any sign of skin cancer before got the second shot. Patient was never one of those people who had crazy ideas about the vaccine but what has happened to patient was too strange to ignore. The patient underwent laboratory data and procedures which included biopsy showing skin cancer in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a consumer referring to her son, a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of MMR II (dose and expiration date unknown, lot# was reported as K00815, injection). About a week later (date unknown), the patient became very sensitive to certain sounds and started to hit himself in the head when he could hear some of them. The reporter also stated that the patient previously was given a dose of DTaP (unspecified) and he became slightly sensitive to some sounds, but nothing like he was now. The reporter also stated that after the patient was given his 3rd vaccine (the reporter did not know which vaccine it was), he began walking on his toes and flapping his arms. The reporter did not specify if this vaccine was given before or after the DTaP (unspecified). The patient eventually started walking normally again but he still waved one arm when he was nervous. The patient spoke with doctor for medical attention. Sound cancelling headphones were given as the treatment. The patient recovered from walking on his toes on an unknown date. The final outcome of the other events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.