chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to 23 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 1 degree Celsius for 1 hour and 15 minutes and of 10 degrees Celsius for 30 minutes. No previous excursion were reported. The temperature excursion was detected by a data logger. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Small red bumps on belly 6/3/98. Increased to lg red blotches on neck and belly with spots on legs and arms 6/4/99.  Pt does not appear to be uncomfortable or irritable. Pt also has red "knot" @ DTAP injection site.
not feeling well; Headache; Muscle pain / muscle ache; throwing up; dry heaves; This is a spontaneous report received from contactable reporter (Consumer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown (Lot Number: Not provided)), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain / muscle ache"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; RETCHING (non-serious), outcome "unknown", described as "dry heaves".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
period was 1 week late; extremely heavy bleeding during last period; extremely heavy bleeding during last period,  3 weeks prior to period had light bleeding for whole 3 weeks. my period was 1 week late. my hemoglobin dropped from 11 to 7.5 after having my period; This is a spontaneous report from a contactable other nurse (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Sep2021 09:00 (Batch/Lot Number: 30145bh) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on 18Oct2021 09:00 (Batch/Lot Number: fe3590) as dose 2, single for Covid-19 immunisation. The patient was non-pregnant 31-year-old at the time of vaccination. Medical history included sleep apnoea syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Levaquin, Advair, Solumedrol, and Benadryl and experienced allergy. On 05Oct2021, the patient experienced extremely heavy bleeding during last period, 3 weeks prior to period had light bleeding for whole 3 weeks. Her period was 1 week late. My hemoglobin dropped from 11 to 7.5 after having my period. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events as reported "not given blood in ER now get iron transfusion". The patient underwent lab tests and procedures which included haemoglobin: 7.5 on Oct2021, haemoglobin: 11 on Oct2021, and PCT test: negative on 19Oct2021. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Menstruation delayed, Heavy menstrual bleeding and Haemoglobin decreased. 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.
Menstrual cycle started early. Previous normal menstrual cycle started 01Jun2021 and occurs every 28 days. I had the first dose of Pfizer vaccine on 14Jun2021 and my menstrual cycle started early on 22Jun2021 and stopped on 28Jun2021. After the second vaccine on 06Jul2021, my menstrual cycle started on 15July2021 and lasted for 8 days. Normal menstrual cycle lasts 5-7 days.   Soreness at injection site for 4 days. The soreness started 06Jul2021 and stopped 10Jul2021.
Chills, cough, low grade fever, soreness, headache like the worst case of the flu I have ever had.
Confusion, Headache, Myalgia,   NUMBNESS ABOVE LIP, BRUISE ON ARM, ITCHING  Narrative:
Approximately at 10:00AM on 12/27/2021, I was exhausted and had extreme fatigue. I had flu like symptoms including a fever.
Two days after receiving vaccination, patient returned to primary care. Right arm was red, warm, and swollen at injection site. No pain in area.
036B21A 4/17/2021 003C21A 5/15/2021 6/26/2023 - 7/1/2023 (5 days) presented to the emergency department complaints of shortness of breath and cough. SHE COMPLETED IV remdesivir, will discharge on Decadron
Localized erythema & swelling of dermis & sub dermal skin at site where VARICELLA & MMR Imm. were given. No fever or skin discomfort.
Day of vaccine and 2 days after fatigue, body aches.  2 Days after vaccine, swollen and painful lymph nodes in armpit on arm with injection.
STOMACH ACHE; DIARRHEA; FELT SO COLD; LITTLE SPOT OF LOCAL INFLAMMATION LIKE A PENCIL CHIP; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included l5 fracture. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced little spot of local inflammation like a pencil chip. On 03-APR-2021, the subject experienced stomach ache. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced felt so cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, diarrhea, and felt so cold on 04-APR-2021, and was recovering from little spot of local inflammation like a pencil chip. This report was non-serious.
Tired; Low energy level; Not feeling well; Ache all over; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, low energy level, not feeling well, ache all over.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events- Tired, Low energy level, Not feeling well, Ache all over.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, low energy level,not feeling well,ache all over was unknown.
She got her vaccine, around 3:00 AM she woke up with read bad chills, she put on warm blankets.  She got up around 5:00 AM and had real bad body aches.  She took 2 Tylenol and then when she got up around 8:30 AM she began to sweat.  She feels light headed and dizzy.  She still feels light headed right now.  She has not called her doctor as she did not know what she needed to do.
BODY ACHES; SLIGHT HEADACHE; LEFT ARM SITE INJECTION PAIN; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On 11-APR-2021, the subject experienced left arm site injection pain. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, left arm site injection pain and slight headache was not reported. This report was non-serious.
pt experienced dizziness, hotflash and heart palpitations, vitals taken, BGL noted low for pt. pt given 2x oral glucose, water and snacks to increase BGL. pt BGL increased to 99. pt accept treatment and refused transport
I'm not sure if this truly is related, but about a week and a half after my first vaccine I started waking up with a little red rash. It started on my arm, then my leg and around my belly button.  It was itchy at times, but not any different to the touch compared to the rest of my skin. The first rash I noticed I can still faintly see on my arm. It is going away very slow. After my 2nd shot I developed a much bigger rash on my left leg. Same otherwise as the others. I made an appointment with my dermatologist, but she can't see me until beginning of June. So for now I put on some Hydrocortisone when it is itchy.
This is a Literature report. This author reported similar reports for 2 subjects. This is the first of two reports. This author conducted an open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2; n=323) VAQTATM (25 U/0.5 mL) (hepatitis A vaccine; HAV) with PROQUAD (measles/mumps/rubella/varicella; MMRV) and PREVNAR (7-valent pneumococcal; PCV-7) in healthy, 12-23 month-old children. Group 1 received HAV/MMRV/PCV-7 concomitantly on Day 1 and second doses of HAV/MMRV at Week 24. Group 2 received MMRV/PCV-7 on Day 1, HAV at Weeks 6 and 30 and MMRV at Week 34. A subject of an unspecified age, race, and gender received on Day 1 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR) and measles, mumps, rubella, and varicella vaccine (PROQUAD); both via an unspecified route of administration on an unknown date at a single doses for immunization. At week 6 of study, the patient also received hepatitis a vaccine (VAQTATM, 25 U/0.5 mL) via an unspecified route of administration on an unknown date at a single dose for immunization. The subject's medical history and concomitant medications were not provided. On an unknown date, on day 52 of study, the patient experienced dehydration and gastroenteritis, which were serious for being medically significant. The clinical outcome of the serious adverse events, dehydration and gastroenteritis, was unknown. The author reported the serious adverse events dehydration and gastroenteritis (Group 2 post-administration of MMRV/PCV-7) possibly vaccine-related.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety valuation, 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. Linked Report(s): US-PFIZER INC-2017007364 different patient/event, same drug.
Pt was schedule for 3rd dose of vaccine Modern for 9/2/21.   Pt stated he had only received his covid vaccine series at North star health clinic. At the time of appointment pt verbally stated he had not received his 3rd dose of moderna. after the fact it was fount that he had received a 3rd dose at another clinic according to vac track.
Took a vaccine nothing happened, soreness at injection site, In March I started having heart palpitations. One day had palpitations and I check my heart rate and my rate was 130 BPM. Later that night after my shower I almost fainted, went to ER. Requested my heart rate received EKG. Heart rate elevated, thyroid was scanned. Monitored me for 3 days prescribed heart medicine and thyroid medicine. Endocrinologist diagnosed me with Graves disease.
The patient received the vaccine 10-30-13 around 11:30am. The patient was asked to remain in the store for approximately 15 min and reported no reaction at that time. She called 11-5-13 and said she hasn't felt well the past few days and has had headaches. This morning her arm is swollen from shoulder to fingers and injection site is very red. Arm is tender. I told her to contact her physician.
Patient called on 9/23/17 to report adverse events to pharmacist. Complaint of stiff neck, sore arms at injection site and cannot move her arms. She received AFLURIA 2017-2018 single dose syringe injection in left deltoid muscle and PNEMOVAX 23 in right deltoid muscle. Not feeling well, shortness of breath, terrible pain and headache. When asked on a scale of 1-10, how bad the pain was, she said 9-10. Pharmacist strongly recommended that she immediately go to the emergency room/hospital. Unknown if patient actually went to the ER or not.
Not need 2nd dose, high IgG levels; This non-serious case was reported by a physician via call center representative and described the occurrence of off label use in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced off label use (Verbatim: Not need 2nd dose, high IgG levels). The outcome of the off label use was unknown.   Additional Information: GSK receipt date: 7-Mar-2023 No further information shared or collected.  The permission for consent to follow up was not asked as adverse event was considered after call ended. The neurologist did titers for the patient (husband) and told him that he did not need a 2nd dose because he had high levels immunoglobulin G, which led off label use. As the neurologist suggested the patient to not to take 2nd dose of Shingrix just because of high level of immunoglobulin G, therefore it was considered that after knowing the schedule of Shingrix even though the health care professional suggest to not to take the dose and event was coded off label use.
Immediately after the shot, I got the feeling of light headed and dizzy. I took a deep breath and felt like a jolt in my body, I chalked it up to nerves. I waited for 30 minutes, I did feel dizzy still and pain in my arm. I sat in my car for another hour before I felt comfortable enough to drive. March 12 that night I felt tired. I woke up Saturday feeling sluggish and exhausted. By that afternoon it was full blown flu like symptoms, fever, chills, shakiness. Monday the 15th I went to work but was foggy in the head, I still felt like crap, complete exhaustion and no energy. I ended up taking sick days Monday the 15th and the 16th. By Wednesday I came back to work but kept noticing brain fog. I noticed shortness of breath, still feeling tired. I started having trouble and with my coordination. I had headaches of and on and still the brain fog. By April I still wasn't better. Three weeks after getting my vaccine I started using a cane. I went to my doctor by the end of April and my walking was getting worse, I felt like all the muscle strength in my body was gone. I have done physical therapy, but not better. I now use a walker. Just walking in my house gives me shortness of breath. I still have trouble with weight movements and shakiness. I have been off of work since May, my doctor took me off of work end of April.
Pt had same symptoms after 1rst dose.  COVID + test 4/20/2020
PRE PROCEDURE SCREENING 08/22/21  8/23/2021  3:26 PM EDT ----- Regarding: Positive COVID-19 test result Hi Dr., I wanted to let you know that you referred this patient for upper endoscopy and she was scheduled to have the procedure done within the next few days..  However her COVID-19 test result came back positive.  I called her.  She is currently asymptomatic.  Because of positive COVID-19 test result, we will have to cancel the procedure for now.
Patient stated 3 days after being given the vaccine, he was hospitalized for 6-8 days with a platelet count of 0. The patient stated he was given several IVs. It may have been due to the vaccine with their diagnosis of ITD and previously RSV.
Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Feb2021 11:00 AM in left arm for COVID-19 immunization. Medical history included HBP (Blood pressure high); thyroid issues; obesity; known_allergies: seasonal allergies; covid-19. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine, losartan, HCTZ, vitamin D NOS, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, tiredness, headache, injection site tenderness, feeling unwell, chills/fever waves on 16Feb202112:00 PM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at 2am (approx 14 hrs after injection), took 1000mg ibuprofen w water, sleep. Woke up w L eye swelling (have photos), appears L sinus inflamed, more ibuprofen. Effects continued into Sunday, relieved w ibuprofen, swelling of eye went down. Remained tired and achy throughout Monday 01/18 and Tuesday 01/19, woke up Wednesday 01/20 w L sinus stuffiness and "full" feeling, feels like a 1 sided sinus infection.
Headache & Sedation Narrative:  tested neg for covid illness  Other Relevant History:
pt c/o abd pain while standing, turned gray fell, eyes rolled up & back in head;unresponsive-10 sec;post ictal in a tonic fashion w/lt arm flexed;rt arm extended, mouth parsed & shouted;t99.6, P84, R28;pt briefly drowsy;
Patient is a 3 year old. Instead of the Pfizer COVID-19 6 months-4 years product, the 5 year-11 year product was  inadvertently administered instead.  0.2 ml of the 5-11 year old vaccine was given for Dose #1 of the COVID series. Parent was notified immediately after this occurred. No adverse effects were noticed after the appointment. A follow-up phone call to the parent was made and parent reported no issues or symptoms.
pt recv vax & exp motor paralysis in the form of a Bell's palsy rxn & sensory loss (paresthesias); @ the time of the report, pt's motor function had returned but complete sensory function had not;
2nd dose on 10Dec2014, has not received a 3rd dose; received a 0.5 mL dose on 10Nov2014; Received a 0.5 mL dose on 10Nov2014; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 62-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On 10th November 2014, the patient received the 1st dose of Hepatitis B vaccine .5 ml. On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On 10th November 2014, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced underdose and adult use of a child product. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the underdose, adult use of a child product and incomplete course of vaccination were unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose in the left arm. The patient received 0.5 mL of 1st dose of Hepatitis B vaccine, which led to underdose and adult use of a child product. Till the time of reporting, the patient did not receive 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The reporter believed it was Engerix B but was not sure. No symptoms reported. The patient did not want to give his real birthdate but the year was correct. He was able to provide his vaccination info from an app from his doctor's office. The reporter consented to follow up.
This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2015 last year, the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscularly (lot number, expiry date and dosage not reported). The patient had intact immune system and in spite of that the physician suggested a second protective dose PNEUMOVAX 23 which was administered on 07-MAR-2016. No adverse effects reported. No further information provided. This case is linked to case#1603USA004161 via same reporter link. Additional information has been requested.
Had mammogram 11/2022 that was normal.  Then presented with left breast enlargement and diagnosed with breast cancer and mets to liver
all symptoms below for about 48 hours:  - Fever 101,21 - Chills - nausea  - tiredness - very painful arm area where vaccine took place
Red itchy and swollen area over the injection site. It started 8 days after the vaccination and has been occuring for 3 days.
Moderna COVID-19 Vaccine EUA  Started about 13 hours after injection Nausea - Severe Vomiting/dry heaves - Severe Exhaustion - Severe Chills - moderate Body aches - mild/moderate Arm pain - moderate (and getting worse and spreading 48 hrs. + later) Headache - mild  Symptoms were as listed above for about 12 hrs.  The next 24 hours I mostly slept from total exhaustion.  The following day (about 36 hrs after symptoms started) was MUCH improved - maybe 85%.  Arm pain is getting worse and redness/soreness is spreading.   This was the first time I can remember EVER staying in bed for an extended period like that.
I started having an irregular heartbeat in March 2021. It was sporadic and did not really cause me any problems until November 2021. In November, I began to have more frequent episodes of tachycardia and bigeminy. I went to my doctor and she referred me to a cardiologist. The cardiologist ran some tests and diagnosed me with atrial tachycardia and started me on Diltiazem 180mg/day and later added metoprolol 25mg/day.
pt recv vax & 24hr post vax pt exp a rash @ inj site in the form of tiny pimples;13APR96 the rash spread to the elbow & was treated w/hydrocortisone;the rash remained dry & bumpy p/tx w/hydrocortisone;
The pt developed a rash, 2 days post vax. It was erythematous, maculopapular and pruritic. It resolved with diphenhydramine.
5JAN91 @512AM mom called ambulance child hot to touch states child stiff & eyes rolled back, twitching; seen in ER temp103R; rx Amox & APAP;