chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed a 10 x 6 cm area of erythema and induration on right thigh and a 4 x 2 area of erythema and induration on left thigh.
Pt was pale, sweating, complaining of dizziness. Few minutes after he was given Hepatitis A vaccine.  Epinephrine 1:1000 wat given sc.  He recovered quickly.
red/hot/itchy/hard lump on upper arm where vaccination was administered, headache day of vaccination
Patient developed immediate burning when the needle was inserted and the burning radiated down the arm.  All through the evening and the next day patient continued to have paresthesias and hypoesthesia in the arm and hands.  Immediately after the injection she began to feel dizzy but drank gatoraid once she got home and began to feel better.  Within an hour she started to have some mild numbness around her mouth and tongue.  The next day she still has some mild numbness around the mouth and some tingling of her tongue.  She has had similar issues before due to fibromyalgia and has had a malar rash that comes and goes and has tested positive for lupus in the past.
Pt recvd vax 12MAY92 & 30MAY92 pt devel rash on trunk described as erythema multiforme; t100-101;
8 days after injection, approximate 2X2 red area appeared L arm at  injection site.  Site feels warm to touch and is raised
After his MMR/Varicella, he experienced immediate fever, continual crying episodes, severe, explosive, chronic diarrhea and ever since has NOT had a solid stool. He could not fall asleep unless he was held, in the swing, or driving in the car (required movement).
Past lot that had also been expired that was administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients). Number was reported as 80777027398.  Patient age was reported as 48 years 10 months.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient  between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
started going through one of her cycles of lupus where she had headaches and dystonia; dystonia in her shoulders and neck; Malaise; headache; sinus infection; This is a spontaneous report from a contactable consumer.   A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included Attention deficit hyperactivity disorder (ADHD) from an unknown date and unknown if ongoing, lupus from an unknown date and unknown if ongoing.    She got her first Pfizer covid vaccine and for 5 days after, had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck and these symptoms will last for 15 days.  The headache then turned into a sinus infection and as a result of all this, she missed her second dose.  Her doctor told her to reschedule and told her to schedule two weeks away which would be today but she is about to start a new medication for her ADHD and to do that she has to come off of her other one which is a stimulant.  She doesn't want to start a new medication right now with the problems that might come up along with getting the second shot and any side effects that she might have.  She is frozen, just not sure what to do.  She has heard if you only get one dose, it is 80% effective. She is concerned if she only gets one dose, she'll be prevented from flying or doing other things because having the vaccine might be required but she has missed the window for getting the second shot so she doesn't know what to do. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I tested positive for COVID-19 5/28/22. I had a fever of 101-101.5, body aches, headache, and lethargy. The fever lasted for 4 days and the fatigue lasted for about 8 days.
Fever, Swallow in the site of injection, Warm and tenderness, Drowsy and severe headache.
Patient seemed nervous about obtaining a vaccine. After administration, patient stated that he has fainted during vaccination before. Roughly 1-2 minutes after receiving vaccine, patient fainted. He regained consciousness after another minute or two, and asked for some water, which was provided by his father. After another minute or so, the patient stated he felt better, stood on his own and walked unassisted. The entire incident lasted 5 minutes.
The injection was painful immediately. Pain Got worse, deep ache soreness , proceeded into more widespread shoulder pain and stiffness , eventually became completely frozen shoulder
This spontaneous report was received from a nurse via field representative and referred to a female patient of unknown race who was 23 years old at the time of the report. On an unknown dates, the patient received the first two doses of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported). The patient did not intend to finish the series as on an unspecified date she performed pap smear test which was HPV positive. The patient sought medical attention but no treatment was given for adverse event. Therapy with GARDASIL reported as discontinued. The outcome of human papilloma virus test positive was reported as recovering/resolving at the time of the report. Relatedness between the event and therapy with GARDASIL was not reported. Additional information has been requested.
Patient given two doses of varicella by mistake (Varicella and PROQUAD given).
Chills for 2 1/2 days, nausea, BP decreased to 100/55 (2 days), light-headedness and dizzy but no fever.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received Moderna vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 1:01 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 1:01 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
After 1 month of getting my 5th Pfizer Booster shot I came down with Bronchitis on 11/25/2022 in the morning with a sore throat. Later on I had chest congestions and cough. I went to the urgent care on 12/03/2022. In the urgent care I tested negative for COVID-19, FLU, and RSV. They prescribed me with albuterol and promethazine as per needed. I was advised to take the cough syrup at night. I haven't recovered fully yet but my cough has decreased.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year-old female patient, who was allergic to amoxicillin and pollen and had no illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 23-JAN-2014 at 3:50 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents declined to revaccinate. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown (recovery date was written though, as 22-APR-2014). This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
On day 10,  noticed a red patch at the injection site, swollen, hard, warm to the touch. Over the following few days, the redness area gets larger and now it covers the whole upper arm. It itches may be twice a day, the swelling is reduced but the redness is persists. I am not overly concerned, but would like to know what's going on. I hope it goes back to normal over the coming few days before i receive the second dose on March 19th.
Joint inflammation; neck lymph nodes are enlarged; heart rate has been fast; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "Joint inflammation"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "neck lymph nodes are enlarged"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart rate has been fast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clarified had joint inflammation, like joints feel irritated as if has some sort of arthritis, seems to aggravate it, that's one thing. The other thing, which caller stated is probably already documented because when caller has mammogram as a female they ask if you have had a COVID vaccine within the last 6 months to let know, because sometimes lymph nodes will appear enlarged, and caller's neck lymph nodes are enlarged again, stated that is a common side effect. Felt important to mention that, but caller is looking at a form and sees the joint issue mentioned but doesn't seem lymph nodes mentioned, but caller stated that should be a well-known side effect, it is well known in radiology department, so that should be there. Caller does see fast heart rate listed, and stated caller's heart rate has been fast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a 20 month old male pt who was vaccinated with a dose of varicella virus vaccine live (645292/0202N). One day prior to chickenpox break through, on 11/12/03 the pt developed a fever. The pt presented to the MD office on 11/13/03, with 5-6 "pox" over torso, and some on arm and face. It was noted that the pt had no treatment. It was also noted that the pt's outcome was not recovered. The nurse also stated that the varicella virus vaccine live had a temperature exposure during a hurricane and this was the vaccine that had the break through. No product quality complaint was involved. It was noted that a female (WAES # 0401USA00731) and a male (WAES # 0401USA00732) pt from the same source, had similar experiences. Additional information has been requested.
After I had the shot within 12 hours I got very sick with high fever, chills so bad my teeth were chattering, nausea, migraine, sweating which lasted 2 full days. And then for past 6 months my periods have started to become very heavy for the first two days which I?m switching out tampons every hour which is very frustrating since I work at the hospital. Then in June I had my period middle of the month which lasts about 5-6 days then exactly a week and half later I started my period again which I have never had irregular periods ever always on time except when I was pregnant with my two children. And now it?s August and I finally have my period again which again frustrating never have had a problem until after the vaccine
Vaccines given 12/10/21. On 12/15/21, pt with decreased intake and inconsolability ; went to ER and abdominal US indicated intussusception.  Barium enema tolerated well nd patient was discharged from the hospital the next  day.
Patient has a reaction 3 inches lower than the injection site. It is a 3 inch diameter circle red welt, painful, and warm to the touch. Recommended patient monitor site and if it gets worse contact a doctor. It looks like a typical site reaction but it is lower than where the vaccine was injected.
1/26 - Developed fever of tmax 102.8F (resolved on 1/28); having persistent fatigue, body aches, headache, decreased appetite. On 1/28 had four episodes of diarrhea; also developed herpes vesicular dermatitis to right and left upper and lower lips, right upper gum, and right cheek.
pt recv vax 7JUN96 & devel zoster consisting of a papular-vesicular rash in patches on lt arm, which was the arm where varicella vax given;pt had no known exposure to chickenpox or herpes zoster;VS nl, t98.1;pt to clinic 14JAN97;
Patient developed maculopapular rash over entire body 14 days after vaccine administration. Patient seen 4/18 for this rash (by MD), and unclear if vaccine-related, scabies or drug rash (was on amoxicillin for ear infection). Seen in ED on 4/20/09 for rash, diagnosed with erythema multiforme minor. Seen again on 4/24/09, with a coalescing petechial and purpuric rash, emesis, posterior cervical lymphadenopathy and diarrhea. Diagnosed at that time by senior physician with vaccine-related rubella. Dr. spoke with mom on 4/30/09 who confirmed patient's rash is almost clear, stools are becoming formed and emesis has almost completely resolved and patient is doing well. No treatment needed, just supportive care.
This literature marketed report as received from a other health professional concerning to a 77 year old female patient with breast cancer, acoustic neuroma, hearing loss and hypertension. The patient's medical history included lumpectomy and radiation therapy. On an unknown date the patient was vaccinated with VARIVAX (Merck) (manufacturer unknown) (dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient developed VZV vaccination induced granulomatous dermatitis occurring at the site of VZV vaccination. A skin biopsy specimen from the plaque on the upper aspect of her left arm was taken. Histopathological examination showed an interstitial dermal inflammatory infiltrate composed of lymphocytes, histiocytes, eosinophils, plasma cells, and numerous giant cells. There was focal dermal fibrosis and collections of perivascular plasma cells. No evidence of foreign body was noted by polarized light examination and viral cytopathic effect was not identified. A VZV immunostain was negative for VZV antigen expression. Acid-fast bacillus, Fite, and periodic acid-Schiff stains were negative for infectious organisms. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was considered to be related. Additional information has been requested.
Information has been received from a physician and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date in August 2016, the patients were vaccination with improperly stored doses (temperature: 35 F, time frame: 84 hours) of RECOMBIVAX HB (lot# L045117, expiration date not reported), dose and route of administration were not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
4pm onset "breathing funny," panting, grunting all night into next day. 12am difficulty swallowing. 102.4 temp with Tylenol every 4 hrs. "Really fussy." Seen by Dr. on 8/22 late afternoon, heart rate 180=abn.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in March 2017 (reported as since 02-MAR-2017), the patients were vaccinated with VAQTA (lot #: M039202 with expiration date: 11-MAR-2018 and lot# M047658 with expiration date 28-OCT-2017) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 0°C but less than 1°C for 59 minutes without any previous temperature excursion; this information was registered in a digital data logger. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011239: US-009507513-1703USA013304.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 09-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Severe nausea and vomiting for 12 hours and more in evening after Christmas Dinner. Loss of appetite, states appetite returning as of today, 12/28/09. No other meal participants were ill. Did not seek medical treatment. Convinced that he got this "flu" because of the vaccination 12/16/09 because he's "never had the flu" before.   Discussed H1N1 symptoms with him. Told him that the vaccine is incapable of giving him the H1N1 influenza. Advised to seek out advice from his healthcare provider, and to drink plenty of fluids.
pt. felt lightheaded and dizzy. alert and verbally responsive  v/s 97% RA 72 bpm, 18 cpm, 160/90 bp @10:30am   10:55am vital signs 97% RA, 69 bpm,  19 cpm, 150/90 BP  pt. stable symptoms improved left at 11:00am
Saw a lot of blood on the water when she was taking a shower; arthritis act up; dizzy; A spontaneous report was received from a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt dizzy, arthritis come up, and saw a lot of blood on the water when she was taking a shower.  The patient's medical history included arthritis. No relevant concomitant medications were reported.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient felt dizzy after receiving the Moderna vaccine. On 10 Feb, 2021 the patient reported that her arthritis had come up and she took two aspirins. The patient reported blood on the water while she was taking a shower.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event of dizziness and arthritis, a causal relationship cannot be excluded. Although a temporal association exist, there is still not enough information to assess the causal association between the event saw blood  and mRNA-1273 . Critical details such as the source  of blood patient's medical history is lacking. Further information has been requested
This is a spontaneous report from a contactable consumer. A 5-month-old male patient received TRUMENBA (lot number: R94916, expiration date 30Jan2019), via an unspecified route of administration on 14Feb2018 at single dose for immunisation. Patient had no medical history. Concomitant medications included hepatitis b vaccine, rotavirus vaccine, and VITAMIN D. On 14Feb2018, it was reported that the instead of giving PREVNAR 13, the MA accidentally gave meningococcal group b rlp2086 to the patient. On 15Feb2018 10:00, the patient had low grade fever, also has sore leg at injection site and was a bit fussy. It was reported that the temperature was 101.8 and the patient was receiving acetaminophen. It was reported that the medication error was a result of PREVNAR 13 and TRUMENBA having exactly the same size box; explaining that both are white and green stripe on TRUMENBA was not very visible when stored in the fridge. It was also reported that the new training staff at that time was unfamiliar with the vaccine packaging. The reporter wanted to know what they should do and what type of adverse side effect there could be. Outcome of the events was unknown.
Starting day of vaccine she had swelling of her L leg with difficulty bending the leg at the thigh and limping. She also had pain with crying. The leg swelling and difficulty walking lasted 2 days. She had low grade fever for 12 hours of 100.3
Patient with seizure activity around 1000am on the day following the administered the following vaccinations:  Hib, MMR, varicella, PVC, flu. Episode lasted approx 5 minutes per parents report and involved patients eyes rolling back, cessation of breathing, color change and limp.