chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: 059F22A) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 12Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 02Sep2021 as dose 3 (booster), single (Lot number: FC3180), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "mild asthma" (unspecified if ongoing), notes: mild asthma; "hypothyroidism" (unspecified if ongoing); "Breast cancer Stage 1", start date: 01Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "vaccine brand other=Moderna Booster, vaccine dose number=4/vaccine  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive; (22Dec2022) Negative; (24Dec2022) Negative; (26Dec2022) Negative; (28Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. Hospitalization prolonged was reported as no.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Case number PHEH2013US015399, is an initial spontaneous report received from a nurse on 18 Jul 2013: This case refers to an 18 years old male patient. He received only Men C, Y, W-135 liquid conjugate of MENVEO vaccine (batch number: M12128), intramuscularly without being reconstituted with Men A component on 15 Jul 2013. No adverse reaction was reported following this administration error.
Only the liquid portion of PENTACEL was administered to patient. Staff member did not grab both liquid and powder vials. Vaccine was not reconstituted with powder (HIB).
Febrile reaction, hospitalized for 2 days after receiving vaccine. Patient discharged with no limitations after 3 days. Highest temperature 104 degrees F.
no adverse events at this time.  Vaccine was given in error for the patient's age of 14.
The pt woke up crying on Friday night with a red raised rash over both legs and thighs on her stomach and in between her fingers. This rash itches. Mother gave topical Benadryl and an aveno bath. Rash is subsiding but still is present.
Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:  Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.  The case is classified as Off-Label Use (Product use in unapproved population).  Due to the nature of the event, the causality between the events, "Product storage error", "Product use in unapproved population" and "no adverse event" and Vaxelis is not applicable.  No further information is expected.
Chicken pox from the chicken pox vaccine.  May complicate her MCADD disease, but too early to tell..
Chills and nausea for 2 hours; night sweats for 2 nights; body aches for 48 hours; fatigue lasting 48 hours.
Developed nausea, dizziness, hives, swollen throat, hoarse voice a few minutes after receiving vaccines. Kept for observation and given Benadryl.
I started to develop a rash on my wrist. It started to get worse and then it spread to the other arm. Really itchy, bumpy, welts.
swelling; redness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SWELLING (swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (swelling) and ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications provided. No relevant treatment information provided.
She initially experienced febrile illness after COVID-19 vaccination with increased swelling in legs, arms, head and face. She presented to the ER with generalized edema, hypoalbuminemia and elevated inflammatory biomarkers.
About 2 hours after receiving shot, I was feeling very run-down and sore. My neck had pressure building at the base. Left work early to get rest. My next day entire head and shoulders were pressurized and shooting pains down neck, through arms, numbing left side of body  cramping feet and arms, all triggering anxiety /panic attacks. By Friday I sought help. Urgent care sent me ER because they?d be able to run better tests.  ER gave me an Ativan and sent me mental health referral.  After a couple more days of trying to rest and get ease, went to different urgent care. Received muscle relaxer for cramping, and appointment for primary care provider.  Saw ENT dr for throat, referred to neurologist, had MRI for neck pressure and painful spinal release sensation I feel every morning. Follow-up is end of June. Brain in fog, pressure in head building still daily.  Acupuncturist gave me info for this  Reporting. Been to acupuncture twice, not improving yet.
After recieving her first dose of the Pfizer Covid 19 vaccine, patient reported she experienced a "covid arm". She showed pictures of her arm being red, swollen, & enlarged at site of injection. She stated it lasted about 4-5 days long & went away on its own.
Hx of vertigo, migraine associated, 5 days after 1 vaccine 1/4/2021 had an episode of vertigo 1/18, later in January had another episode of vertigo. Last night was the 3rd episode. #1 Moderna 12/30/20. Reports acute episode of vertigo 1/4 (5 days post vaccine). A second episode 1/18 (19 days post vaccine). Decided to delay getting #2 Moderna by one week. Received #2 Moderna on 2/3. c/o mild fatigue 24-48 hrs post vaccine. Reports a 3rd episode of acute vertigo 6 days post #2 Moderna on 2/9. Each episode of vertigo lasted 2-5 hrs associated with n/v/diarrhea. No meds taken to treat sx. vertigo following a URI 11/2017. Complete w/u by physician 3/2018 with audiology testing and brain imaging. Found to have some sensorineural hearing loss in left ear. Poss vestibular migraines vs Meniere's Disease. Remote hx headaches and ocular migraines with aura. No episodes of vertigo since 2018 until these recently described episodes in the 1-2 week period following vaccine administration.
Numbness & tingling of left arm. Loss of sensation to arm and fingertips. Redness to left palm and fingertips.
Pt. Presented w/ Tingling Tongue + Lightheaddness. Pt. was ambulatory and A/0x4. Pt was moved to private treatment area for observation- vitals were obtained x3 and onsite Dr. Prescribed 50mg Benadryl. Pt. was monitored for additonal 30 min. and released home. Pt was advised TO seek medical attention If needed Further.  Tingling Tongue, light headed. Tongue feels like "someone is pulling on it" PT. was moved to private area was Ambulatory A/ox4 vitals were obtained after 15 min of monitoring Pt. stated her Tongue was still tingling and felt " like someone was pulling on it" so on site Dr. Advised to give 50mg Benadryl. Pt felt better after 30 min monitoring and was discharged home. Pt. was advised to seek medical attention IF needed.
bell's palsy; face was tilted; she felt a little off balance; metal taste; Taste bud changed; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bell's palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009021A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Lupus erythematosus and Blood pressure high. Concomitant products included ANASTROZOLE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BALANCE DISORDER (she felt a little off balance), DYSGEUSIA (metal taste) and TASTE DISORDER (Taste bud changed). On 04-Jul-2021, the patient experienced FACIAL DISCOMFORT (face was tilted). On 06-Jul-2021, the patient experienced BELL'S PALSY (bell's palsy) (seriousness criterion medically significant). The patient was treated with ANTIVIRALS at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (bell's palsy), BALANCE DISORDER (she felt a little off balance), DYSGEUSIA (metal taste), TASTE DISORDER (Taste bud changed) and FACIAL DISCOMFORT (face was tilted) outcome was unknown.            Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-258142 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
pt recv vax & 30min later pt returned c/o puffy/itchy eyes & chest congestion;235PM DPH given pt was advised to seek med attention;refused 911 call;pt did seek medical attention & dx w/acute rxn to vaccine;
Pt Stated that he was not feeling well after the vaccination and wanted water. While getting him a bottle of water pet had Fainted and was out for 10 seconds before he regained consciousness.
pt recvd vax 25NOV94 & on 26NOV94 MD onc call saw pt w/sx of both arms & chest hurt, chills, fever 100.2-102, h/a, since receiving vax;
Recurrent itching of hands, feet and legs. Recurrent heart palpitations, dizziness, fatigue, sleep disturbances, numbness and tingling in bilateral lower extremities. Symptoms started 1 1/2 years ago after initial injection. Has had total of 6 injections.
I gave the patient a Poliovirus vaccine intradermally in right forearm instead of given the patient TUBERSOL. Patient was contacted and returned for a TB injection to be done in the left forearm on 11/13/18. No symptoms reported by patient.
No further AE's reported; improperly stored doses of ROTATEQ and PEDVAX HB; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 15-FEB-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL one time, lot #1742464, expiration date: 20-SEP-2022, administered orally for prophylaxis (strength was not provided); and  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 mL one time, lot #U024089, expiration date: 27-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided).   The administered doses of the vaccines experienced temperature excursions in the range above 47°F (47.5°F) for 20 minutes; above 47°F (46.7°F) for 10 minutes; and above 4 7°F (47.1°F) for 20 minutes. Total time frame: 50 minutes. The vaccines had not had any previous temperature excursions. It was not reported if it was recorded by a data logger. There was no adverse effect reported.
Varicella - Information has been received from a consumer concerning his 10 year old grandson who in 1999 was vaccinated with varicella virus vaccine live.  In 2000, the patient devoleped chickenpox.  Additional information  has been requested.
burning (urination) frequency bladder infl/trouble sitting; tests urine C&S/upr G.I./Sigmoidospy/bone scan; cystoscopy/CT scan;
One afternoon in May 2021, erratic heart beat for approximately 25 minutes.  I was home and working, not engaged in any physical activity.  Also in mid-May, I began to experience pain in lower right pelvic area which increased in severity over several weeks.  I had pelvic ultra sound to rule out anything.  Nothing was detected and the pain resolved within a few weeks.  My doctor stated that he had other female patients who experienced similar symptoms after the COVID-19 vaccine.
No other AE reported; expired dose of MMR II was administered to a patient; This spontaneous report was received from an office manager and refers to a 12-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 22-NOV-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S037501 with expiration date on 20-NOV-2021, therapy type rHA (exact dose, route of administration were unknown) for prophylaxis. No adverse event was reported.
Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm.  Nausea but it passed; feels weak and slept 6 extra hours today.  Joint pain in shoulders and legs. No fever.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a patient who received BEXSERO. Co-suspect products included HAVRIX. In March 2018, the patient received BEXSERO (intramuscular) and HAVRIX (intramuscular). In March 2018, less than a month after receiving BEXSERO and HAVRIX, the patient experienced injection site erythema, injection site swelling, labeled drug-drug interaction medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown. The reporter considered the injection site erythema and injection site swelling to be unlikely related to BEXSERO. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to HAVRIX. Additional details were provided as follows: The patient was given BEXSERO and HAVRIX in the same arm at the same time, which led to labeled drug-drug interaction medication error and vaccine administered at inappropriate site. The patient developed arm redness and swelling around the injection sites. The health care professional had called on behalf of the doctor. The health care professional did not have any vaccine or patient information. Vaccines were given some time last week before the date of reporting. The health care professional was not sure when reaction started or if they had resolved but did not believe these reactions were from the vaccines.
Approximately 36 hours after the first Moderna shot my left arm began to swell and itch, with a 5 inch by 2 inch red blotch. It is now day 9 with no improvement.
Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular marrow space, consistent with aplastic anemia. Patient has received dexamethasone, platelets, and PRBC. Unknown outcome patient has been discharged from the hospital.
Patient became disoriented, light headed, fell backwards hitting head on wall, he complained of feeling sick to his stomach and dizzy when sitting up, wanted to lay down. Symptoms lasted about 20 minutes.
I stated having pain in my left earlobe 5 days after getting my shot.  The pain was pretty severe and eventually worked its way behind the ear and into the back of my head and back and front of my neck.  The pain got so bad that I called the doctor but was not going to be able to get in for a week.  I ended up going to the ER but kept my doctor appointment as well.  The ER diagnosed me with Shingles although the doctor could only find one small lesion on the back of my head.  I did not feel this was a correct diagnosis.  By the time I went to the doctor my eye was watering quite a bit and my mouth was a little crooked.  I was diagnosed with Bell's Palsy on the left side of my face.  I was given steroid treatment for 10 days and was also given a 2 week course of Zovirax.  It took 3 months for the Bell's Palsy to completely heal.
Information has been received from a pharmacist concerning a female patient who on 15-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). After ZOSTAVAX (Merck) was administered, the patient told pharmacist she had shingles and had been having some achy back pain. The patient sought unspecified medical attention. The pharmacist stated that he did not see signs or symptoms of shingles. At the time of the report, the outcome of the patient was unknown. No further information is available.
Fever; swollen lymph nodes; severe headache; body aches; This is a spontaneous report from a non-contactable consumer reported for herself.  A 22-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unknown route at the left arm on 03Feb2021 15:30 (at the age of 22-years-old) for COVID-19 immunization. The patient medical history included asthma, allergies to penicillin and peanuts. The patient was not pregnant. No COVID prior vaccination. The patient had received the first dose of vaccine on 15Jan2021 03:45 PM at the left arm. The patient experienced fever that lasted 48 hours, severe headache, body aches, and swollen lymph nodes, the events occurred on 03Feb2021 11:45 PM. The outcome of the events was recovered.  The patient did not receive any treatment. Patient has not tested positive for COVID-19 since having the vaccine.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I became dizzy, nauseous, sweaty, and rapid breathing about 10 minutes after receiving the vaccine.  I was given an EpiPen  injection and taken by ambulance to a local ER
Within 10 minutes facial numbness to the left lip and cheek area. Felt like rubber and lasted for about an hour.  Reappeared 2 days later and lasted a few hours.
Patient was given an expired dose of Moderna.  She was given the vaccine on 2/18/22 and it expired 2/10/22.
Information was received from an online magazine who reported that a consumer said that on an unspecified date her daughter was vaccinated with GARDASIL. It was reported that late June 2007, her daughter's life changed after GARDASIL. The patient went from a vibrant, active college student, to a bedridden, chronically ill, young woman with seizures, GI tract problems, constant migraines, blurred vision, abnormal pupil reaction, loss of feeling in both legs, heart arrhythmia, TIAs, eye sensitivity, exhausted adrenals and the list just kept growing. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Seizures was considered to be an other important medical event and bedridden was considered to be disabling. No further information is available.
Loss of consciousness  Client was said to have  passed out while sitting at the waiting area about 5 minutes after vaccination. He was brought to the First Aid area  on a wheelchair. Client was noted to having urinary incontinence immediately he arrived at the First Aid area. His head was repositioned and ice pack applied to his forehead and client  recuperated and started talking. Duration of witnessed episode lasted for 15 seconds . Patient claimed having similar episodes with last episode occurring 6 years ago while at work. Vital signs was taken, monitored for  additional 30 minutes and was driven home by his significant other.  Vital signs recorded Temp: 96.9deg. F; BP: 102/62 MAP: 76; H.Rate: 78; Oxygen sat: 97%.  (Vasovagal syncope).   Neurologic: Loss of consciousness (Comment: Patient had Vasovagal reaction with patient having urinary incontinence, lasting for 15 seconds 5 minutes after vaccination. Patient claimed having similar episodes 6 years ago. )
Severe headaches; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: not provided), via intramuscular route of administration, on 29Dec2020 07:45 AM (at the age of 53 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included multiple sclerosis (MS) and is a breast cancer (CA) survivor. The patient has known allergies to seafood and diazepam (VALIUM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dimethyl fumarate (TECFIDERA), tamoxifen, and acetylsalicylic acid (ASPIRINE). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 06:00, the patient experienced severe headaches for a 1 month with no relief from acetaminophen (TYLENOL) or ibuprofen every 6 hours. The patient had to go to emergency room (ER) to get migraine treatment. The event severe headache was reported as non-serious and did not require hospitalization. The event severe headache required a physician office visit and an emergency room visit. The patient received treatment for the event severe headache which included acetaminophen, diphenhydramine (BENADRYL) toradol, prochlorperazine (COMPAZINE), and sodium chloride. The outcome of the event severe headaches was recovered on an unspecified date in 2021. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Jan2021 which was negative.
On 4/5/21 my armpit started hurting and is swollen. The pain goes down into my arm and a little into my pec. Same side as injection site.
This case was reported by a physician via sales rep and described the occurrence of pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain and sleep disturbance. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the pain and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was in her 70s. The patient experienced pain for 3 days and interrupted her sleep. This case has been linked to the case US2018GSK198403, reported by same reporter. The reporter agreed to be contacted for follow up.
Swollen, red, itchy, inflamed face (starting 1 1/2 days after vaccine injected).