chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflated in the pectoral area; Discomfort; pain in his joints, pains in his knees and shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FF2587) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LUNG HYPERINFLATION (non-serious) with onset 27Oct2021, outcome "not recovered", described as "inflated in the pectoral area"; DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Discomfort"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain in his joints, pains in his knees and shoulder".  Additional information included: He doesn't have health insurance or primary doctor. Would like to know what the next step is if this inflammation doesn't go away or gets worse. It has been more than 72 hours since he got the shot and had the swelling. It has not gone. He is a really healthy man. He doesn't do drugs or drink. He has a good diet and is healthy. He has no underlying conditions. This happening is worse with the second dose. That area is still swelling. Thinks it is the lymphatic that they were reading about in the brochure. He is in the country under Visa. He doesn't have PCP or medical physician if he needs to go to the Emergency Room. He is not looking for dollars. He enquired weather he needs to go to ER because of swollen lymph nodes. The report is for statistics and he wants to be transferred for his concerns.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning 4 children who were vaccinated with varicella virus vaccine live. The physician reported that a mother of a patient reported that 4 other children in a day care setting had come down with chicken pox, "even though they were previously vaccinated." In follow-up, the physician reported that according to a patient's mother, 5 children in day care had chicken pox and all of them had a varicella virus vaccine live some time ago. Additional information is not expected.
Patient reported incident on 10/24/18. States localized swelling with lump and bruising was immediately following vaccination on 10/19/18. Patient states symptoms have started to resolve somewhat and slowly improving. Patient will utilize warm compresses and OTC pain relievers as needed and contact office if worsens or no continued improvement noted.
I had a big rash and baseball sized welt on arm. I felt dizzy, lightheaded, and nauseous.
She got her vaccine, she had soreness in the muscle part of the arm.  The soreness is felt when there is arm movement up and down.  The soreness is also felt when there is movement away from the body, swinging outward from the body.  There is also discomfort when she is carrying a weight on that arm, like a 1# weight.  There is also discomfort when trying to sleep on that arm at night.  She keeps thinking it is going away, and now it's been 6 weeks now and there has been no improvement and perhaps getting worse.  She has not taken anything for it other than ice on it the first day.  Did not have any reaction to the other three previous Pfizer vaccines.
Inappropriate schedule of product administration; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was reported.
Information has been received from a licensed practical nurse concerning a 80 year old female who on November 2001, was vaccinated with a first dose of Pneumovax 23. On 09-NOV-2006 the patient was vaccinated intramuscularly, into the left upper arm, with a second dose of Pneumovax 23. On 09-NOV-2006 the patient developed injection site redness and swelling. Unspecified medical attention was sought and no treatment was required. On 11-NOV-2006 the patient recovered from injection site redness and swelling. Additional information has been requested.
Migraine aggravated; Sever Headache; Joint pains; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine aggravated), HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Nerve block (On 5 April 2021,migraine came back.) on 01-Apr-2021. Concurrent medical conditions included Migraine. Concomitant products included DEXLANSOPRAZOLE (DEXILANT) and SUCRALFATE (CARAFATE) for Acid reflux (esophageal), BOTULINUM TOXIN TYPE A (BOTOX) and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains). On 05-Apr-2021, the patient experienced MIGRAINE (Migraine aggravated). The patient was treated with RIZATRIPTAN BENZOATE (MAXALT) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine aggravated), HEADACHE (Sever Headache) and ARTHRALGIA (Joint pains) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
A non serious spontaneous report of rash has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 22-Sep-2009. An hour after receiving FLUMIST he had a rash on his chest of tiny raised bumps. There was no itching or other signs or symptoms. The following day the reporter indicated the event had resolved.
Sinusitis, cough, nasopharyngeal drainage, ongoing 5 days, starting Dec. 10, 2022, following trip to Private location.  Took OTC meds (Robitussin at bedtime and DayQuil during the day, but symtoms persisted. Texted symptoms to Drs. office on 12/14/2022.  He called later that day and advised starting OTC Mucinex, and he prescribed Amoxicillin (875mg)  1 tab twice daily for 10 days. Good response to treatment.  Back to normal after 4 days of therapy
12 hrs later: Temp 101.6, Body Aches, Headache, Unusual Fatigue, Projectile Vomiting. Lasted 6 hours. The next day just HA and Fatigue
celiac disease; pain for one year; inflammation for over one year; arthritis; diagnoses of shingles, April 2021; two doses of Shingrix in 2017, diagnosis of shingles April 2021/ suspected vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis, COVID-19 VACCINE PFIZER for prophylaxis and COVID-19 VACCINE PFIZER for prophylaxis.   Previously administered products included Zostavax (received one dose in 2012).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, COVID-19 VACCINE PFIZER, COVID-19 VACCINE PFIZER and COVID-19 VACCINE PFIZER. In April 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced celiac disease (serious criteria GSK medically significant), pain, inflammation and arthritis. On an unknown date, the outcome of the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis were unknown.   It was unknown if the reporter considered the vaccination failure, celiac disease, shingles, pain, inflammation and arthritis to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was a dispensing pharmacist and immunizer and reported this case for herself. The age at vaccination was not reported. The patient received two doses of Shingrix in 2017. The patient had celiac disease and arthritis.  The patient had appointment with a rheumatologist to identify arthritis type was in December 2021. The patient had pain and inflammation on her right side for over one year.  The patient had 2 diagnoses of shingles in April 2021 and November 2021.  The patient had received 3 doses of COVID 19 vaccine Pfizer in 2021. The patient asked, would revaccination with Shingrix be recommended for based on the medical/ clinical data available. It was unknown if the reporter considered the celiac disease, shingles and arthritis to be related to COVID 19 vaccine Pfizer. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting. This case had been linked to the case US2021AMR247056 for 2nd Shingrix outbreak.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR247056:2nd outbreak
Administered Patient vaccine 01/21/21.  Went to ED and diagnosed with the following: 1. Shortness of breath   2. Peripheral edema   3. Hypertensive urgency   4. Weight gain   5. Hypervolemia, unspecified hypervolemia type   6. Atypical chest pain     Admitted to inpatient to hospitalist but then signed AMA and left hospital.
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who was vaccinated with first (batch number: 44080AA and expiry date: 13-Jul-2013) and second dose (batch number and expiry date not reported) of MENACTRA on 06-Aug-2012 and 15-Jan-2013 respectively (dose, route and site of administration were not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered because a 17 years old patient received two doses of the suspect vaccine with too early interval. No adverse effects from the second dose according to the patient's mom. 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 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 the sender: None.
She almost immediately felt dizzy. As she was sitting for her 15 minute wait, her throat also started feeling funny, thicker. That effect went away after a short time. the dizziness still remains to this day, It got worse, then it got a little better but it is still lingering. her doctor started her on the flonase in case it was just due to the little bit of fluid in her ear, but it is not helping, She came in for her 2nd dose today, 8/25, a few weeks late to give herself more time to recover but since she is still feeling dizzy, we decided to not give the 2nd dose in case she would have a worse reaction.
Chill; fever; body aches; migraine; dizziness; soreness at injection site; headache; lymph node swollen on left arm pit area; This is a spontaneous report from a contactable other healthcare professional(patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302), intramuscularly into the left arm on 23Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. Concomitant medication included escitalopram oxalate (LEXAPRO), riboflavin (RIBOFLAVIN), multivitamins and antihistamine (unspecified). The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El0140), intramuscularly into the left arm on 02Jan2021 12:30 at a single dose for covid-19 immunization. On 23Jan2021 20:30, patient experienced chill, fever, body aches, migraine and dizziness. On 23Jan2021, patient experienced soreness at injection site, headache and lymph node swollen on the left armpit area. The patient did not receive treatment for the events reported. Outcome of events were recovering.
This spontaneous report as received from a health professional refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reports his dad is barely able to even feed himself.; Absolutely no strength; Lost control of bowels; Runny Nose; Dad is not doing well; This is a spontaneous report from a contactable consumer (patient's son). A 69-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Apr2021 (at the age of 69-year-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes. The patient was on several different medications. The son reported that his Dad had absolutely no strength, lost control of bowels, and a runny nose on an unspecified date. The son also reported that his dad was barely able to even feed himself on an unspecified date. Two weeks ago, the son's Dad was walking around fine, now it seems like he was headed to death's door. Reported that when his Dad looks at you, its like a distant stare. The consumer also mentioned that his Dad was not doing well on an unspecified date. The consumer reported he has no idea what the date was his Dad received second dose Covid Vaccine, just knows it was about the same time the caller received his first dose. The consumer also mentioned that he does not know when any of his Dad's symptoms began. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
I had fever around 100.1F, nausea, chills, sweats, a really bad headache and the worst part was neck pain/ back pain/ pain between my shoulder blades, it kept hurting so bad that I was shaking. I took Tylenol and Ibuprofen, and it took me 3 hours until I could have some relief and feel asleep. Chills fever and body aches I had for 3 days and it reached 100.7 on Christmas day. By Saturday no more fever but the pains were still there. Sunday I was fatigued and all those days I had pretty bad night sweats (about 5 nights). My nausea was so bad that one of the doctors I work with prescribed me some Phenergan that I took Christmas eve and day to help me be able to hold something in my stomach.
pt recv vax 17AUG94 & same day pt reported metallic taste in mouth immediately following the inj; also devel a flu-like synd consisting of fever, chills, nausea & fatigue;
The patient had an occurance of vertigo 57 hours after the flu vaccine was administered.  Vertigo still present as of 12/19/00, but improved. Large local reaction on arm persisted for 4 weeks.
Vaccinated with second dose 1/4/22.   LOT NUMBERS NOT DOCUMENTED.   COVID Infection breakthrough 1/16/21.   Inpatient hospital stay.
Shot was given in belt area of back. 7 days after vaccination my legs were weak and wobbly. It was more difficult to control leg movement.
Swelling, redness, tenderness, lumpiness, warmth at injection site continuing after 3 days.
Patient did not get booster and tested positive for COVID on 11/26/21; Patient did not get booster and tested positive for COVID on 11/26/21; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EP6955) as dose 1, single and administration date Apr2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 26Nov2021, outcome "recovering", DRUG INEFFECTIVE (medically significant) with onset 26Nov2021, outcome "unknown" and all described as "Patient did not get booster and tested positive for COVID on 11/26/21". It was unknown if patient was diagnosed with COVID 19 prior to vaccination. It was unknown if patient receive any other medications within 2 weeks and any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning a 68 yr old female who on 02Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N). On 03Nov04 the pt called and reported that she developed a red, swollen, and painful arm. Her left arm was 2 inches larger than the other. Unspecified medical attention was sought. The pt was treated with ice and acetaminophen (Tylenol). The pt's outcome was unk. It was also noted that in 1998 the pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00638, 0411USA00946 and 0411USA00947).
Vaccine Admin. at 10:30 AM. Pt called the office at 1:00PM with complaints of nausea, shakiness, vertigo and SOB. Pt told to go to ER & call PMD. Pt went to Medical Center and was treated with Prednisone, Benadryl and Xanax(all of this per pt). At approx. 2pm pt called back and talked to RN..pt feeling much better after ER visit and treatment given.
excessive pain in the area; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (excessive pain in the area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (excessive pain in the area). At the time of the report, VACCINATION SITE PAIN (excessive pain in the area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.
Sore arm to the point of unusable. Bad neck and headache. Sore joints and overall feeling of being unwell.
Large amount of Bleeding at time of injection. Enough to spill all over the floor and my arm and clothing. Rhen i had a severe rash weeping snd bleeding and red and bruised face and neck. Itching and hard to breathe as well as pain all over Face where rash is scabbing and oozing.
rash-patient was being treated for an ear infection as well and was on Amoxicillin for 9 days (10 day coarse), had a light rash from ATB increased rash post vaccination. Patient was given Prednisolone Suspension for 5 day treatment on 9/17/22.
Patient received Pfizer SARS-CoV-2 vaccination started experiencing throat irritation. Patients denied SOB, hives or difficulty swallowing. Patient states she had a reaction to flu vaccine in the past and had to use epi-pen. Transported to ED, treated with epinephrine 0.3mg injection, prednisone, and pepcid. Patient was released in stable condition.
increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2-3 years.  I took my prescribed blood pressure medication prior to bed time.  This morning  b/p is in normal range.  other side effects: sore arm, leg and hip pain.  This am has improved.
Arm has been burning for 2 2/2 weeks.  The injection was given up high. Also woke up with nausea which has lasted over a week.  Spent first day after injection in bed. Felt feverish and had absolutely no energy. Felt that way for about two or three days. For about a week had very little energy. My arm through the shoulder blade and in the back still has a  burning sensation.
dizziness, lightheadedness causing nausea, feeling of unbalanced when walking for 5+ days
Patient reported a bruise at the injection site about the size of a quarter that didn't resolve for over a week. She also stated that her blood pressure was elevated and she was very fatigued - she missed 2 days of work.
Child almost fainted was alert throughout the incident. Mom said he was hyperventilating. Child turned pale a little. Judy Dehm offered ammonia ampoule to smell and I offered fruit juice to drink. Child regained back the colour and felt better in few minutes (5 min), mom reported fever 104 on 6/14/06 1:30 a.m.
This morning, patient discovered that she has approx 2 inch red area around injection site, area has small blisters, warm to the touch and is hard, can feels like an egg under the skin. Patient is experiencing no pain and did not even notice the reaction until someone else pointed it out to her.  Patient said that after the immunization she was exhausted, and needed to lay down to take a nap which is unusual to her.
The next day bad pain in the arm, 103 fever, headache, nausea, body ache and for 3-day fatigue for 3-week, upper part left arm - hard knot and super painful and can feel the heat about 6 weeks. I have fully recovered from the vaccine. For COVID-19 - started feeling tired, nasal congestion, fever, headache, cough, sore throat and fatigue. Two days later I lost taste and smell till today till to date, shortness of breath, called doctor and got antibiotic and steroids on two weeks after. The cough was bad and shortness of breath.