chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient via Pfizer concerned a 61-year-old female. The patient's weight was 111.13 kilograms, and height was 163 centimeters. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 01 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. On an unspecified date, the patient experienced really sick, terrible (dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (dose number in series 2) (batch number: FG3527 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis. On 22-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). The patient received non-company suspect vaccine included: tozinameran (dose number in series 3) (batch number: GJ6665 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 27-OCT-2022 for covid-19 prophylaxis. No concomitant medications were reported. On 28-OCT-2022, the patient experienced extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue (dose number in series 3). On an unspecified date, the patient experienced huge, red area where injection was, swollen, has a lump and hot, arm really sore and painful (dose number in series 3). Hoping arm will continue getting better, but red spot started out the size of probably a quarter and now red spot was probably the size, can't think, maybe the size of a can, the circumference of a can. Painful lump in arm was never had that happen before, got sore after any kind of shot, but has never seen the red, warmth, or lump. Start date of adverse event: Doesn't think really started bothering until that night, woke up that morning sick and terrible, so guess would say arm started the next day, Saturday, 29-OCT-2022. Was bright red at first when started but was paler, so doesn't know if that means anything, as it has spread the color was pinker instead of bright red. The patient got the shot she was odd, shot didn't hurt at all, but the next day felt sick Iike with Covid, knows how that feels because caller had Covid before. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from extreme chills, severe joint pain, severe muscle pain, headache, nausea, and overall, just wiped out, extreme fatigue on 30-OCT-2022, had not recovered from huge, red area where injection was, swollen, has a lump and hot, and the outcome of revaccination with different covid-19 vaccine, really sick, terrible and arm really sore and painful was not reported. This report was non-serious.
I recieved my second covid 19 vaccine by moderna.  I still have the subtle altered taste/smell that occured after receiving the first dose a month ago (I have previously reported that).  On 1/25/21, I recieved the 2nd dose of vaccine at 10 am and felt fine all day.  Around 10pm, I started to have chills.  This rapidly evolved to whole body rigors.  My tempature spiked.  I couldn't move, I wasn't sure if I would pass out or throw up.  I had to have my wife bring me a makeshift urinal since I couldn't get out of bed.  Went from freezing to boiling, back and forth.  Felt absolutely miserable.  Around 2-3 am broke out into a cold sweat and finally started to feel better.  I was drenched in sweat througout the night.  It was a very long 4-5 hours.  The following night I felt fine although I also was drenched in sweat when I woke up.
Itching, , severe headache, swelling or lump under right armpit with severe pain,   pain in area of injection ,  chest pain  , runny nose, chills, fever, nausea, fatigue, muscle and body aches especially on right side.
1930 severe bronchitis like cough got worse until about 2130 then stopped abruptly;then chills, fever, nausea, diarrhea for a few hrs; by AM just h/a
Redness, pain at injection sight, diffuse itching, metallic taste in mouth. Resolving spontaneously with topical anti-histamine cream.
I'm not sure this is even a "reportable event"!  I have had mild tinnitus for several years, generally not noticeable except in extremely quiet settings. But 2 days after receiving J&J vaccine - (the day on which I felt the most "fatigued" and experienced some muscle aches, which responded well to ibuprofen) - I awoke with several episodes of loud ringing in my ears.  From that time until now, my continuous tinnitus is much louder than it had been.  I keep hoping it will subside!  It's more frustrating and annoying than anything else. No pain or discomfort. For this reason I have held off seeking medical treatment.  It seems like more than a coincidence to me, so I felt I should probably at least try to report it.
Approximately 8 hrs after flu vaccine, started having chills, cold sweat, extreme fatigue lasting 24 hrs. Fatigue lasted 48 hrs. Has had 2 additional flare up of symptoms since then. The latest occurred 12/30/2020
seen in MD officce 17OCT96 for rash, mom was concerned about chicken pox;dx was confirmed by MD & Zovirax was prescribed;
Patient reported to the pharmacy with a large circular black and blue mark at injection site and red skin that is warm to the touch extending from injection site down the arm toward the elbow.
Information has been received from a physician and a woman from the physician's office concerning a 4 year old white female who on 04MAY2000 was vaccinated in the left leg with a first dose of varicella virus vaccine live. On 03SEP2003 the patient developed varicella with over 100 lesions that was also described as a "full blown case of chickenpox". Unspecified medical attention was sought and it was unknown if treatment was required. At the time of report, the patient had not recovered. It was also reported that the patient's 2 month old premature sibling was given VZIG. No product quality complaint was involved. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 23-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
dropped and the whole thing shattered; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT0538, Expiration Date: 31Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "dropped and the whole thing shattered".  Additional information: Caller is a registered nurse that reported that they had a Prevnar 20 that dropped and the whole thing shattered. There was no patient involvement. No nurse involvement. She clarified that there were no needle sticks or anything like that.
pt did not get second dose until today; no additional AE reported; This spontaneous report was received from a pharmacist and refers to a currently 19-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # , 0.5 ml, lot # T027302, expiration date 12-AUG-2022 (route of administration was not provided) for prophylaxis. The patient did not get the second dose until the date of the report. No additional adverse events were reported.
The day after receiving the first dose of the Pfizer COVID-19 vaccine, the patient began to experience heavier than normal menstrual blood loss and blood clots. The patient returned in 21 days and received her 2nd dose of the vaccine and began to experience heavy clots and blood loss again along with headaches, paleness, and weakness. The patient saw a physician and was given medroxyprogesterone to decrease the bleeding on 4/15/2021. On 4/28/2021 the patient reported to an ER and was given a transfusion due to low iron levels.
expired PENTACEL vaccine that was given to the patient, with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and it was reported that expired Pentacel vaccine that was given to the patient, with no reported adverse event while receiving vaccine 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.   On 20-May-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once,  (lot: UJ435AAA ; expiry date: 20-May-2022) in the left thigh for immunization.  it was reported that there was expired pentacel vaccine that was given to the patient, with no reported adverse event (expired product administered) (onset: 20-May-2022) (latency: same day).  Action taken : not applicable.  Outcome: unknown   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.
syncope; shortness of breath; diaphoresis; LIGHTHEADEDNESS; This spontaneous report was received from a physician and refers to a female patient of unknown age. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In January 2009, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) lot number reported as "0524u" (dose, route, anatomical location, and expiration date were not reported) for prophylaxis.  On the same date, the patient experienced lightheadedness (dizziness), diaphoresis (hyperhidrosis), shortness of breath (dyspnoea), and syncope.  The patient had recovered in the office and was sent home on the same date.  The relatedness between the events of syncope, dizziness, hyperhidrosis and dyspnoea with therapy of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported.  Upon internal review, syncope was determined to be medically significant event.  Lot number "0524u" is an invalid lot number for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine.
minor side effects: felt like someone punched me in the shoulder with brass knuckles. whole body aches and fatigue and all flu-like symptoms. Major Side Effects/Adverse Side Effects: day 1- increased suicidal ideations, major depression, major fatigue, felt like all psychiatric medication stopped working. I felt suicidal. Felt like Killing myself because of it. resolved after 3-4 days. Stomache was also very upset. only ate rice and crackers and applesauce. Day 5- back ache for 2-3 days. I believe that the vaccine made the psychiatric medication  I take daily to stop working!  My concern is that other psychiatric patients may not know these side effect exist and that they will be getting this vaccine and then be found dead because of it.
This case was reported by a consumer and described the occurrence of lung infection in an adult female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified) and ADVAIR for unknown drug indication. A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR multi dose powder inhaler and Albuterol. On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown). The subject started ADVAIR and Albuterol on unspecified dates. On an unknown date, less than one year after vaccination with Influenza vaccine unspecified, and an unspecified time after starting, Fluticasone proprionate+salmeterol xinafonate (inhaled) and Albuterol, the Albuterol, the subject experienced lung infection. The subject reported "I had a flu shot but I still ended up with a lung infection. It took longer than usually to get over it. I probably don't know much, but I just know I usually don't get the flu when I get the shots. This year I had a lung infection but I don't think it was due to the flu. I didn't have any other symptoms." This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved.
CLIENT EXPERIENCED AN INFECTION AROUND HER TRANSPLANTED KIDNEY; WAS HOSPITALIZED AND TREATED WITH A BROAD SPECTRUM ANTIBIOTIC; CLIENT STATED SHE ALSO TESTED POSITIVE FOR COVID WHILE SHE WAS HOSPITALIZED.
Central Venous Sinus Thrombosis in Superior Sagittal Sinus  I arrived home at 12:38 on Sunday, 5/9, and opened the door to see my sister with facial droop, slurred speech and a contracted right hand/fingers. She was crying and immediately knew she was having a stroke. She had been trying to clasp some jewelry while getting ready for Mother's Day. She was able to walk down to the car with me no problem (no extremity involvement other than right hand/fingers). We arrived at the hospital within 10 minutes and she was a Code Stroke. A CT scan showed the clots as well as a tiny Subarachnoid bleed and she was admitted to NeuroICU. The symptoms waxed and waned for a few hours and at one point she developed the droop again, had headache and heartburn and vomited. A CT scan was repeated after some Heparin had entered her system and it was stable/not worse; subarach bleed was not changed and Heparin was continued.   She  has now been admitted for 3 days and the Heparin is complete. She is now being transitioned to oral Xaralto. She has no deficits whatsoever and has made a full recovery so far. We are still pending the results of her coagulation studies to see if she has a hereditary condition.   The doctors believe the clot is due to her Nuvaring Estrogen, which is most likely. However, I would still like to report this event just in case.
The next day after vaccination- developed pain on the right side lower hip. Never had any pain before that. Thought it was due to my daily exercise (had tried a new yoga pose that day). The pain continued- took over the counter pain killers.  Six days after the first shot, on 03/01/2021 I noticed rashes on the right side of my body- above my hips, going all the way halfway from my back to under my breasts.  It was after office hours, so I immediately bought calamine lotion and applied it. Next day, I called Urgent care Telehealth (could not get an appointment with my physician).  It was Shingles- was prescribed Acyclovir and Gabapentin. I took only the antiviral at the beginning. The pain was intense for many days, and so I took Gabapentin. I had immediate reaction - felt like the nerves in my head were bursting (around mid-night one day), then I took a Tylenol - it helped calm down the sensation. The shingles did not go away till end of April.  Went back to my physician again end of March- he prescribed Valtrex again for ten days. I had neuralgia- saw a neurologist, who prescribed Gabapentin. Took Gabapentin till mid- June 2021, slowly weaned away from it.  I took the second shot of the Covid Vaccine on 03/23/2021 while I was suffering from Shingles.  Consulted the doctor on site at Vax site, she thought it was okay to get the second dose.   After I was cured of Shingles, I noticed that I had a swelling on the right side of my neck under my jaw.  I was later diagnosed with Lymphoma on July 20, 2021.
After the second shot very tired and and sore that afternoon and evening. The next day she went to work at 9am even though she woke up with a slight headache and didnt feel very well. She thought it was pass. It didnt pass and her headache worsened. She excused herself to the back and was found with her eyes rolled back and unable to full wake. When she awakened she was in extreme body pain and was taken by ambulance to the ER. Since then she has been to the 3 times, has had several episodes of seizures, and has seen a cardiologist and neurologist which all have determine this is a side effect from the vaccine. She still sees the neurologist and has been prescribed Levetiracetam 500mg x6 tablets per day. Before the vaccine she has never passed our, complained about this type of head pain or had seizures.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 23 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA013888:
Information has been received from a physician concerning a 2 month old female infant who on an unspecified date was vaccinated orally with ROTATEQ. Concomitant vaccinations included "normal vaccinations for 2 month visit." Subsequently, after receiving ROTATEQ along with other "normal vaccines" the infant developed "petechiae" (rash) which covered her entire body. The physician took a blood test in the office that revealed low platelets. The patient was admitted to the hospital that same evening and another blood test was done that revealed the patient's platelets were normal. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Felt burn; Her arm hurt badly, achy; Muscle pain; Joint pain; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
LIGHT COLORED RASH NOTED ON PATIENT'S TRUNK WHICH BEGAN ON 9/23/08. DOES NOT APPEAR TO ITCH. NO FEVER NOTED. NO TREATMENT NECESSARY AT THIS TIME.
On 3-11-21 we conducted a COVID mass vaccination clinic, we have been administering Moderna clinics starting in December, and additionally Pfizer clinics starting in March. On this day we were administering Moderna vaccine. This patient presented for a vaccine accompanied by her mother, she had been added onto the schedule as we had unaccounted for vaccine doses and she was available. Mother had received her vaccine on this day also receiving the Moderna EUA information sheet. This nurse administered the vaccine to the patient after reviewing the procedure per protocol. This nurse did not verify age of patient prior to vaccination as she had finished the screening process at registration, also per protocol.
All symptoms began 21 hours after shot. Extreme fatigue continued for 24 hours. Body aches continued to this point over a day later along with a headache.
can no longer walk without assistance, can't do anything; no feelings in my arms, hands, feet, and half way down my chest.; no feelings in my arms, hands, feet, and half way down my chest.; trying to get facts on reversing the effects of the ZOSTERVAX; dizziness; tingling in the muscles on my arms and legs; patient was so scared she will be paralyzed by then; my health had deteriated immensely; have gone downhill fast; severe headaches; This spontaneous report has been received from a 61 years old female patient referring to herself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, route and dose details were unknown) for prophylaxis. The patient was not having any health problem when received the vaccine.        The patient stated that her health has deteriated immensely on an unknown date. On unknown dates (reported as within months), the patient started having dizziness, severe headaches, tingling in the muscles on her arms and legs. Then it was progressed to no feelings in her arms, hands, feet, and half way down her chest (hypoaesthesia). The patient had been referred to a neuromuscular specialist and had an appointment in March 2019. The patient was so scared that she would be paralyzed by then. The patient could no longer walk without assistance and could not do anything (akinesia). The patient's daughter had to come over to help the patient get a bath. The patient had gone downhill fast, and never thought this could happen to herself. The patient kept her grandchildren every day and walked 4 miles daily. The patient was trying to get facts on reversing the effects of the zoster vaccine live (ZOSTAVAX).  The outcome of the events was unknown. The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was related.  The adverse events "no feelings in her arms, hands, feet, and half way down her chest" were considered to be significant disability due to the patient could no longer walk without assistance and could not do anything. Upon internal review, the akinesia was determined to be medically significant.
Patient has had IUD for >3 years with minimal bleeding. Within 24-48 hrs after shot 1 and shot 2 patient experienced a period. Having bleeding is rare, but to bleed 3 weeks apart hasn?t happened since getting the IUD. The period after the first shot was the heaviest patient has had since getting IUD as well.
During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4. Muscle aches mostly to lower back. Felt like back was crushing
Runny nose, body aches, chills, bloating, kidney pain, sore arm, slight headache