chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 50 year old male who on 05/25/04 was vaccinated IM in his deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  On 05/25/04, "later that evening" he began feeling soreness and tenderness in the injection arm. He returned to the clinic "today" on 05/26/04 with erythema and warmness from the deltoid region to about 4cm below his elbow of the injection arm. The arm was also warm to touch and had "a little" edema in the elbow area. There were no systemic effects present. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided.  Additional information has been requested.
Patient presented to this clinic with her younger brother to complete his shots.  It started the evening after she got her shots and she felt pressure in her head for 5 days. She just wasn't hungry just didn't feel good. She denies any nausea or vomiting, just pressure in her head and some dizziness.  No weakness or numbness of any extremity and no problems with her speech.  Mom relates that she may have ran a low grade fever but didn't check it with a thermometer just to her touch. Mom relates that she has had other shots in Saudi Arabia but unable to get any shot record.  Shots have been started in September 21st 2015. with most of the same shots given then.
Case number PHEH2014US022580, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 40 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error.
Mom called and LM stating pt had temp 103.5 when he left the office 12/17/18. Mom gave ibuprofen and about 2 hours later he had temp of 102-something. Around 11pm he had temp of 104.5, mom started to call nurse triage 12/17/18 and pt had febrile seizure. Mom took pt to hospital. Mom said they are home now and he is fine. Mom sched f/u for Thurs 12/20/18. 12/20/18 providers note from ER f/u-he start running fever after visit. He had temp 104.5 that night. His eye rolled in the back of head and arms jerked. He went to ED. He had normal exam. He has not had fever medication today. He seems fine.
After the first shot, had migraine for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 18:15 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hormonal Migraines (Timing doesn't coincide with this), Depression/Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: PAXIL [PIROXICAM]. The following information was reported: MIGRAINE (non-serious), outcome "recovering", described as "After the first shot, had migraine for 2 days".  Additional information: After the first shot, had migraine for 2 days. Patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. Known allergies: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Urticaria diarrhea > within 24 hrs vaccines, tx with antihistamines, ? infectious diarrhea with resultant urticaria.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received an improperly stored dose of VARIVAX (lot# M023382, expiration date 11-MAY-2018; lot# M023382, expiration date 04-MAY-2018) (dose, frequency and route were unknown). The vaccines (lot# M023382, expiration date 11-MAY-2018) were exposure to -15 to -10 degree centigrade for 13 hours 48 minutes. The vaccines (lot# M023382, expiration date 04-MAY-2018) were exposure to -15 to -10 degree centigrade for 14 hours 5 minutes. There was no previous temperature excursion reported. The improper storage of vaccines was not found by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.; Sender's Comments: US-009507513-1612USA014219:
Vomiting, diarrhea, diaper rash: yeast wouldn't eat 2 weeks.  Curled up in fetal position, sotmach distended. Started losing weight: looks dehydrated, but isn't , had to put on baby food, tantrums: doesn't want anyone to touch her or around her. Stares into space, stopped talking, stopped running and playing with others, sleeplessness. Follow up 02/04/05: She has recovered from some but it triggered the onset of celiac disease. As per annual follow up report: still has leaky gut symptoms, she has improved with a gluten free/castin free diet, but still has frequent loose bowels.
A large red welt appeared at injection site, was slightly warm to touch, slightly sore, and a little itchy. First noticed it the morning of February 11, was quite red and raised. Still present today (February 13), though not as visible. Massage therapist treated it with muscle cream to reduce swelling and itching.
patient received PROQUAD in July and then MMR II third dose accidently today; This spontaneous report as received from a physician referring to a 5-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (strength, route, lot# and expiration date were not reported) for prophylaxis.   The reporter stated that the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, lot# and expiration date were not reported) on an unknown date in July 2020 for prophylaxis. Then, on 08-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 3, 0.5 milliliter (Incorrect dose administered). The outcome of the event was not reported.
I developed a red itchy rash that spread across my scalp, face, ears, neck, back, shoulders, chest, stomach, arms and legs.  I took a methyprednisolone pack, benedryl, zyrtec and famotadine, which had very limited success.  I went to the ER on 10/16, as recommended by my doctor because my face was covered with hives (looked like sunburn) and my eyes were puffy and starting to close.  The ER treated me with iv benadryl and steroids.  The rash improved after this treatment but remain to this day, approximately 1 week after vaccination.  I continue on the benadryl, zyrtec and famotadine.  I will finish the steroid pack tomorrow.
Body aches; Pain at the site of injection; Fever; Tired; just want to sleep; This is a spontaneous report from a contactable consumer (patient spouse). A 73-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) via an unspecified route of administration on an unspecified date (age at the vaccination 73-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, Caller stated, caller and her husband had a few side effects after receiving the second dose of the Pfizer COVID-19 vaccine 10 days ago. Nothing severe. The first dose was no problem and had body aches, pain at the site of injection, fever and really bad fatigue. The fatigue is getting better but still there and feel so tired we just want to sleep. Caller wants to know any data on how long the fatigue should last. Caller had heard generally within 2-3 days side effects starts to lessen. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a licensed practical nurse concerning a 45-year-old patient who on 21-APR-2008 was inadvertently vaccinated subcutaneously with 0.65 mL dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). This was not a case of product confusion, but related to an order written as "varicella vaccine." No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Client reports he has shingles starting in the area of where he received his bivalent moderna vaccine on the left upper arm and spreading on the left side of his chest.   He went to a dermatologists who diagnosed him with shingles.  He said he has had shingles before and it does not look like or feel painful like shingles.  He said two of his co-workers who have received the bivalent have recently been diagnosed with shingles also (starting on the same arm they received the bivalent vaccine. He wanted this reported.)
Temperature 101.4, paleness, headache, sleepy. Had Tylenol and laid on couch and was ok after that. Once fever broke, child was fine; no further problems.
the patient was inadverently administered a dose of MMR II by intramuscular injection instead of subcutaneous injection; No adverse effects were reported; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender.      The patient's pertinent medical history and drug reaction or allergies were not reported.  On 05-MAY-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R036583, expiration date reported as 17-FEB-2020, but upon internal validation established as 17-DEC-2020 for prophylaxis (dosage was not reported) by intramuscular injection instead of subcutaneous injection (incorrect route of product administration). No adverse effects were reported. Vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (M-M-R II) was reconstituted with sterile diluent.
1st dose: Mild soreness at injection site for ~12hrs  2nd dose: Mild soreness at injections site for ~12hrs At ~hr6 symptoms started: At ~hr6-hr42: fever (99.8F-100.6F) chills sweating mild confusion muscle/joint aches insomnia fatigue nausea/vomiting loss of appetite  Took liquid NyQuil/DayQuil per package instructions and increased fluid/electrolyte intake   At ~hr48: Condition greatly improved.  Minor headache and fatigue.  Appetite slowly returning.  Temperature still slightly high (98.8F vs 98.3F normally)
9 days after receiving Dtap, Prevnar and MMR, developed erythema multiforme minor
info was recv fr person in MD ofc concerning pt who was vax & subsequently pt exp chickenpox. addl info requested
03:00 pm Monday the 18th got a little feverish that night fever, aches, chills and headache. It was lessened with ibuprofen but not gotten rid of with it. The next day, I had a sore throat too, and I went to Urgent Care and got COVID-19, and flu test done at 08:30 am. By the 20th the fever was mostly gone but I still had a low-grade fever. Headache was mostly gone but I had a sore throat, and by the 22nd the sore throat went away on its own. The diagnosis Nonspecific virus, and symptom treatment with ibuprofen as needed.
pt recvd vax 11AM & 235PM same day pt noticed to have head drooping, drooling from mouth, limpness, & unresponsiveness for about 20 minutes; trembling noted while enroute to clinic, t103.5 R;
The first day there was a persistent cough. The 2nd day I had congestion, a persistent cough, very tired, a complete loss of appetite and I did not eat for a day. I contacted my doctor after completing a COVID-19 home test and testing positive. My doctor prescribed Paxlovid. By the end of the 5th day of the Paxlovid, all symptoms were gone. I had completely. I had not had a cold since COVID-19 started. On the Sunday before I got sick, I believe I contracted COVID-19 in a public restroom.
On 2/18/21 my arm turned red, warm and itchy.  Later that day, I experienced dull pains down to my hand.  I took an aspirin which helped the alleviate the dull pains.  The blotchy red, warm, itchy flare up sporadically continued for five consecutive days until I no longer experienced this side effect.
Headache, Myalgia & NauseaVomiting Per patient report: " I had my second COVID shot on yesterday [4/15] and I'm not feeling well. ... I have a very bad headache and I'm very achy with some nausea."
Patient had some inflammation at injection site. I instructed patient to start taking BENADRYL 25 mg every 6 hours routinely. I told her to continue to monitor site and to call us or her primary care physician if it gets worse.
Patient had a reactivation of herpes zoster on the face. She had tingling off and on on the right side of face after the first dose 5 months ago.  After the second dose she awoke the next day with painful grouped blisters on the right lateral cheek and right side of glabella and discomfort in the right er.
Angular cheilitis, aphthous ulcers, glossitis began two days after shot and is still ongoing.  Lips are continuously peeling.  Breathing was restricted somewhat as throat was swollen.  first prescribed Nystatin 100000 unitsml and took 3 days via teladoc.  Then went to internist Dr who prescribed Magic Mouth wash for pain and prednisone tabs to reduce swelling (began 4/22).  Swelling is reduced but Angular chelitis and lips continue to peel.  Dr recommended to not get second shot.
Starting day after injection my arm was extremely sore, red and a little swollen. This lasted two days. Then it slowly decreased for a about 2 days. It appeared to be going away then it flared up again. It is red, sore, and itchy. It gets worse during the day as I move around then is a bit better in the morning.
Patient came back to office 1 1/2 weeks later and reported that rash started soon after receiving vaccine. Has papular rash to entire face, erythematous, c/o itching and burning, has progressively gotten worse over past 1 1/2 weeks. Denies any other new products/food that may have caused reaction.
The pt complained of nausea and vomiting. No soreness in arm after receiving vax.
Administration error: A 48 year old female patient receives second booster doses of the Pfizer vaccine, which does not meet the age requirements to receive the booster dose according to CDC department of health guidelines.
Patient began to experience soreness and swelling of the arm that the immunizations were administered in. Soreness and swelling increased over several days until patient went to the emergency room and followed up with her primary care physician.
Fatigue      "I am tired, thirsty, have some nasal congestion, and I've been peeing a lot" POC in triage read "high" ? Skin Problem     "I have some boils on my arm"      History of Present Illness:  This is a 49y.o. male with past medical history of DM2, HTN, HLD, GERD who presented to ED on 1/9/21 for generalized fatigue and axillary skin rash.  Patient notes that 12/24/21, he experienced 24 hours of fevers, chills, and myalgias.  Since, that he has noticed progressive generalized fatigue.  He notes that for the past few weeks, he has not been using his insulin.  His home regimen consists of Lantus 80 units qHS and regular insulin 20 units TID.  He states he ran out of insulin.  Since this, he has noted increased thirst, and increased water intake.  In addition, he has noticed polyuria.  He has not been checking his home sugars either, as his glucometer is broken.  Denies fevers, chills, chest pain, shortness of breath, abdominal pain, nausea, vomiting, constipation, diarrhea.
Stomach virus; COVID-19; Hot; Lump on arm after Covid-19 vaccination; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2021, the patient experienced COVID-19 (COVID-19). In May 2021, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). In 2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling). In 2021, VACCINATION SITE WARMTH (Hot), GASTROENTERITIS VIRAL (Stomach virus), VACCINATION SITE MASS (Lump on arm after Covid-19 vaccination) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events with Humira and for the event of stomach virus with Moderna vaccine.  The reporter assessed the events of Covid-19, vaccination site warmth, vaccination site swelling and vaccination site mass to be possibly related to Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt experienced severe abdominal pain after receiving second rabies vax. He was seen in ER and released with the dx of abdominal pain. The reporter did not if vaccine was given for pre-exposure or post-exposure to rabies. It was unknown if human rabies immune globulin was given with the 1st rabies shot. Follow-up information is pending.
Patient complained of itching at injection site. When site was observed by patient Mother, site found to be red, swollen and warm to the touch. Patient brought to office for observation of site. Provider recommended Loratidine and cool compresses to site. Return to clinic woth worsening s/s.
This spontaneous report as received from a health professional refers to two unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ oral (lot# K022993, expiry date: 20-JUL-2016) (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Initial unsolicited report received from nurse on 16-July-2018. This case involves a patient (age and gender not reported) who was vaccinated with an extra dose of MENACTRA 0.5 ml intramuscularly in left arm on 11 July 2018 instead of Meningococcal vaccine B (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines). It was reported that 2 doses of MENACTRA were given at scheduled times. This was a 3rd dose given in error. Patient was supposed to receive meningococcal B but received another MENACTRA vaccine. Patient received second dose on 02 April 2018. It was an actual medication error due to extra dose administered and wrong vaccine administered. Patient was doing fine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.
Became un responsive was in a coma for two weeks on a ventilator for two weeks in icu for six weeks in the hospital for 3 months . Was unable to speak .still is unable to walk.