chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient received "two injections" of ZOSTAVAX (lot #, dose and route not provided). It was unclear as to whether these two injections of ZOSTAVAX were given at the same time or not. No side effects were reported at this time. Additional information has been requested.
PATIENT RECEIVED INITIAL COVID VACCINE YESTERDAY AT NOON. STATES SHE HAD A MILD REACTION  WITH ARM REDNESS APPROXIMATELY 30 MINUTES AFTER VACCINE, THEN 3-4 HOURS LATER FACE WAS HOT,RED, BLOTCHY, & TINGLY. APPROXIMATELY 12 HOURS AFTER VACCINE, THE REDNESS SIGNIFICANTLY INCREASED FROM BLOTCHY TO FULL REDNESS, & ALSO HAD HIVES ON NECK, CHEST AND BOTH ARMS, AND THROAT SWELLING STARTED. PATIENT TOOK BENADRYL 50MG AT 3-4 HOURS POST VACCINE AND 25MG AT ~12 HOURS POST VACCINE.
Excruciatingly Painful headache; nausea; face is "white as a sheet"; Feeling very hot and cold; hands "curled in on themselves"; soreness at the injection sight; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea) and SKIN DISCOLOURATION (face is "white as a sheet") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection sight) and HEADACHE (Slight Headache). On 29-Mar-2021, the patient experienced HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves"). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About 5 mins after vaccine administration patient passed out. She came back to a few seconds later. 911 called EMS examined her & she went home
pt recv vax & @ 11PM seizured-taken to ER-another sz @ 115AM;
Starting about 2 inches below injection site, arm swollen, red, hot.  Swollen area 4-5 inches in worst part-with vivid red outline pain.  Whole arm and hand swollen by day 2.  Major site of swelling and redness moved progressively lower on arm.  Pain-especially when it  progressed to elbow-5-6 days duration.
pt recv vax & pt exp bronchitis w/a cough & body aches;pt was treated w/erythromycin;pt recovered;
I experienced body aches with a heavy sensation all through my body and all the way down to my feet. I felt chills and my face was hot. My head hurt so much, my throat was inflamed and I had difficulty swallowing and passing saliva. I also felt super sleepy throughout my days and my sleep was so profound that I had difficulty waking up in the mornings.  I got tested for strep throat and I also got tested for Covid-19.  I also received my second dose injection today 01-28-2021 but I have not felt any symptoms yet.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: muscle cramps in leg-Mild
I know Shingrix causes a lot of side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The staff of state health department made the generalized statement that the Shingrix causes a lot of side effects, that's to be expected. The staff of state health department did not elaborate or provide any additional details. The reporter did not consent to follow-up. No further details were provided.
Dizziness, Myalgia, fatigue, chills Narrative: missed work following second dose of vaccine
She had 4 vaccines, the following night developed pain and swelling with redness in the left deltoid. Has body aches that she expected from immunizations but the pain in the deltoid is unusual. Has never had this type of reaction in past.
they used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent with no reported adverse event; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 15 months old female patient who reported they used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Vaxelis) and pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 15-May-2023, the patient received a 0.5 ml once (dose 1) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot:UJ807AA, expiry date: 01-Oct-2023) (Strength: Standard) via intramuscular route in unknown administration site for Immunization.  On 15-May-2023 the patient had used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent with no reported adverse event (product preparation error) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash Narrative: developed ovoid ~1x3in rash over injection site 7 days after vaccination, resolved in 3 days. Warm to touch, erythematous, indurated. No sloughing, hives, or other adverse effects noted. No therapies tried or applied.
Vaccinated 10-8-09. Developed arm pain and fever. Went to hospital. Diagnosed w/ cellulitis per doctor.
On 10/20 reports a "bump" on the site of the varicella vaccine, together with a rash that is the size of a quarter coupled with itchiness.   On 10/19 night time, had headache 6 out of 10, woke up on 10/20 still with headache; on 10/21, headache is 3 out of 10 that comes and goes.  No fever reported.
Headache the day of the vaccine and the following day. Sore arm starting on the day I received the vaccine and lasting for 2-3 days.
A spontaneous report has been received from a consumer via Medical Rep concerning an 8 year old, male. The patient was receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 13-DEC-2014. Action taken was unknown. The outcome of the event of got the flu was unknown. The company physician considered the events got the flu as non-serious. The events got the flue has been identified by the company physician considered the events of got the flu, was considered to be non-serious. Based on the information in this report, and awaiting the reporters assessment, the company physician considered the events got the flu, was unrelated to the FLUMIST Quadrivalent . The reported causality was no.
day 1-little light headed, tired   day 2-arm hurt, light headed, day 3-feel week light headed, day 4-week foggy, day 5- little week  foggy
Patient reported to the pharmacist that when she received her first Shingrix dose 3 months before, that she broke out in a rash all over her body. She described the rash as red bumps. The patient alerted her PCP to the issue and the rash resolved. Patient could not remember the exact date the rash started or how long it lasted.
One hive on each thigh below injection sight. Benadryl 12.5mg PO ordered and ice packs applied to sites.
hypotonic, hyporesponsive collapse-dec of muscle tone, turning pale, perspiration
Pt received injection 4/19. Had pain in arm at site. Woke up 4/20 with erythema from elbow to shoulder. Mild swelling right elbow above injection site.
Chief Complaint: shortness of breath. COVID x5 days ago.  COVID pneumonia.  IV Decadron, IV remdesvir.  Oxygen, duo nebs.  admitted to Hospice.
received pneumovax 23 on oct 14th at 9:41 at approximately 12:00pm noticed extreme tenderness down to wrist and underneath arm. Patient came into pharmacy to oct 16th and arm is red above elbow and some swelling under arm above elbow bend. Area is warm to the touch.
This patient began feeling faint approximately 2-3 minutes after vaccination. She did not lose consciousness at any point but was very clammy, sweaty and lethargic and feeling very weak and faint. We called 911 right away and EMS came and took her vitals which they reported as normal but took her to the ER to be evaluated.  After speaking with mother that evening and the next day she reported it took her " a while" to feel better at the ER and the ER noted her blood sugar was also low.  They ran some other tests but nothing else was remarkable according to mother. By the next day when we spoke 7/11 patient was feeling much better and back to normal according to mother.
Hives and bruising on legs. Hives on arms - back - breast - face. Eyelids and lips had some swelling. 3 time on prednisone 10 mg. - 1 ZANTAC - 1 all day allergy pill in A.M. and 1-2 BENADRYL in P.M. Saw dermatologist Dec. 30/15. Said hives were from shot. Prescribed - fluocinonide cream .05%. Ongoing.
fever, headache, body aches, fatigue, my skin felt like it was sunburned, and of course, my arm hurt. Those symptoms lasted about 36 hours, except my arm, which continues to hurt and has a 2 in by 2 in swollen patch of red where the shot was given.
About 2 hours after receiving the Moderna Booster (3rd dose) I experienced aphasia for 2-3 minutes. I was unable to form words.
a little sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 13:40 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: She states she is allergic to penicillin and ACE inhibitors - has an anaphylactic reaction to both of those medications and additionally has allergies to various antibiotics. There were no concomitant medications. Vaccination history included: Bnt162b2 (she receive the first dose of the Covid-19 Vaccine 07Feb2021, First dose Lot: EL9262, Expiration unknown, Time the Vaccination Was Given: 07Feb2021 13:40), administration date: 07Feb2021, when the patient was 77 years old, for Covid-19 immunisation; Flu shot, for Immunization, reaction(s): "redness", "Swelling", "makes a hard lump in her arm"; Flu shot, for immunization, reaction(s): "hot to the touch". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On Jan2021, Covid-19 test Result: Negative. Caller said that she had a little bit of a sore arm and nothing else.  Any shot that she gets, whether in her arm or butt, she said that it swells, gets red, and hot. The caller said that with her Covid-19 Vaccines she got a little soreness and iced her arm in preparation thinking that she was going to have her usual reaction like she does with the flu shot, but she got nothing. Second dose lot number said that the Lot number for the second dose was written messy. She said that it looks like EN62N, but stated that the numbers are mixed together. She can not read the last 2 digits for the second dose lot. Description of Product Complaint: Description of complaint: Caller is a consumer that was calling about the Covid-19 vaccine and reported that she got the first and second injection and got the second one on 28Feb2021. Caller said that she had a little bit of a sore arm and nothing else. The caller said that when she reads about this, the reactions are showing the vaccine is making protection for her body. Does it mean that since she did not have any reactions did her body not make the antibodies anymore?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 3 hours after the injection I had numbness and tingling in my hands and down my left side.  It was similar to the response I had to the first injection in the series.  It was significant enough that I had to concentrate to grip something firmly.
Pt recvd 3 doses Hep B vax & on 23OCT91 called & stated p/each vax exp severe abd pain, diarrhea (lasting about 3-5 days) w/in 24hrs;
51 yo patient. Pfizer booster on 10/11 Monday, then Tuesday SOB and chest pain by Thursday 10/15 with severe SOB admitted at the hospital for large pulmonary embolism, saddle embolism. Case reviewed with Hematology and felt should be reported, pls investigate further with patient
PATIENT RECEIVE A PFIZER COVID-19 VACCINE BEYOND  USE TIME OF 6 HOURS BY MISTAKE. NO ADVERSE EFFECTS HAS BEEN REPORTED AFTER RECEIVING THE ABOVE INVALID DOSE.
patient developed cough, fatigue, body aches, headache, sore throat, and a fever on 07/25/21.  He tested positive for COVID on 07/26/21
Pt was administered Tdap and Menactra in left deltoid with separate syringes on 7/29/09 without apparent difficulty.  Pt returned to Clinic on 7/30/09 with c/o headache/backache and pain and swelling to left upper arm.  On exam, pt noted to have raised red area at injection site approximately quarter-sized.  Also large localized swelling to upper arm.  Pt was treated with Tylenol 1000 mg at clinic and instructed to continue q 4 hours for 24 hours.  Pt also given icepack and ace wrap with instructions to use for 24 hours for twenty minutes at a time with rest in between.  Pt was prescribed a Medrol dosepack and atarax 25 mg to take  q 8 hours when not driving.  Pt was instructed to go to Emergency Department if symptoms worsened and to return for follow-up visit on August 3, 2009
Broke out in itchy bumps (hives) on upper back, neck, shoulders, face
The patient came in to get a Novavax vaccination and was given a Janssen vaccine instead.  This was a booster dose and she did not want an mRNA vaccine.  Pharmacist pulled the Janssen instead of the Novavax.
Experienced syncopal episode following vaccine. Epinephrine 0.3mL administered by EMS at site.
Patient had #3 dose on 04/28/2022 and received #4 dose on 06/15/2022, less than 4 months required between doses.
Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.; Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 as dose 3 (booster), single (Lot number: FM7553) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0191), administration date: 26Jun2021, when the patient was 15-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0179), administration date: 03Jun2021, when the patient was 15-year-old, for Covid-19 Immunization. The following information was reported: BREAST SWELLING (non-serious), BREAST PAIN (non-serious) all with onset 10Jun2022, outcome "recovering" and all described as "Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.". The events "started to swell and developed a right breast on 6/10. the breast got larger and larger abs began to cause pain." required physician office visit and emergency room visit.  Additional information: Started to swell and developed a right breast on 10Jun. The breast got larger and larger abs began to cause pain. Went to the ER on 12Jun and was referred to an endocrinologist.the patient was not diagnosed with COVID-19 and not been tested for COVID-19, Since the vaccination. No known allergies. the patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Diarrhea. I had diarrhea in the form of soft stools that started one week after dose 1 of Covid-19  Vaccine. Then I found out I had Giardia Infection. I got the second dose and the diarrhea got much worse. I just started to take the antibiotic for treatment of the Giardia.
Arm pain that is not the same as the injection site soreness.  Arm pain starts in upper arm and runs down to the hand.
patient experienced lightheadness, followed by passing out for approximately 2-5 minutes, during which pulse was weak and patient difficult to arouse. pale color. ems and pharmacist contacted and watched patient. Patient fine after 15 minutes more of observatio
Woke up in the middle of the night after getting the shot: body aches, chills, fever  Throughout the day after the shot, had body aches, chills, fever  Two days after the shot, the above symptoms cleared, but headache was most painful it?s been
Client received half dose of Moderna Bivalent Covid-19 Booster shot at age 5 years, 9 months old.  At that time, Moderna Bivalent was EUA approved for Age 6+
Information has been received from an 82 year old female patient with allergies to VICODIN, Erythromycin, and Penicillin and a history of gall bladder surgery who two or three years ago was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin, paroxetine, levothyroxine Na, VESICARE, Leflunomide, oxycodone and "Hormone Patch" (once a week). On 12-SEP-2009 the patient experienced shingles. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of the report, the patient's shingles persisted. Follow up information has been received from a health care professional concerning an 82 year old female patient with erythromycin allergy, penicillin allergy and no illness at the time of vaccination and history of chickenpox when she was a child who on 15-MAY-2007 at 14:06 p.m. was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 652966/0623F) 0.65ml, intramuscularly into left deltoid. On 16-SEP-2009 she had shingles with severe symptoms painful (8 in score 1-10) itchy, tingly with an itchy/ painful rash on the left flank. Lesion type was dry lesion. She had not recent exposure to chickenpox or herpes zoster. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 27-OCT-2009 sample was obtained and on 04-NOV-09 was sent to the laboratory. On an unspecified date she had rheumatoid arthritis and was treated with ARAVA per rheumatologist. At the time of the report the patient had not recovered. Shingles and rheumatoid arthritis were considered to be disabling by the reporter. Additional information has been requested.
1-14 hours post shot: rapid/heavy heartbeat, Nausea and chills  7 days post shot: rash and itching at injection site
I tested positive for COVID-19 on 03/12/2023. I took Paxlovid medication prescribed by my doctor. for one day only because it made me sicker.  I got really tired and exhausted, flu like symptoms.  My symptoms lasted about ten days.  I tested negative ten days afterwards. I did a telehealth with my doctor.
I am a Pfizer employee. My mother received the second vaccine shot and told me her face got swollen afterwards.; This is a spontaneous report from a contactable reporter reported for a 64-year-old female consumer. A 64-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Apr2021 (at the age of 64-years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergies to penicillin. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021, the patient experienced her face got swollen. Reporter stated that mother received the second vaccine shot and told me her face got swollen afterwards. Patient did not received treatment for events. The outcome of the events was recovered on unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the seasonal influenza vaccine (unknown type, GSK P7HK7) on Tuesday 10/20/2020 around 3:15 pm as part of a requirement  for employment by Hospital.  Around 12:30 am on 10/21/2020 I woke up to use the restroom.  When I went to stand up I became weak and lightheaded.  I made my way into the restroom, and sat down by the toilet as I was feeling nauseous.  I began to have the cold-sweats and became very confused and disoriented.  I also became short of breath. The episode woke my boyfriend up who came to my aid.  He described me as pale, confused, and incoherent.  I do not recall some of the events that took place during the episode, but my boyfriend described it as something similar to patients running low blood sugar.  The episode lasted about 1 hr.  I returned to bed at this point with a terrible headache, which lasted into the next day.  I also felt weak for most of the following day.