chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt so bad after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt so bad after the shot). At the time of the report, VACCINATION SITE PAIN (Arm hurt so bad after the shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication was reported , No treatment medicatipn was reported. Reporter did not allow further contact.
Information has been received from a 21 year old female with attention deficit disorder and no medical history who was vaccinated with three doses of GARDASIL on unspecified dates. Concomitant therapy included YAZ for birth control and Concerta for attention deficit disorder. On 30-DEC-2008 the patient administered a pap smear test which came back positive for HPV. The patient sought unspecified medical attention. Additional information has been requested.
Warm red raised area, 2"x2", itched. Used Benadryl, applied several times a day for a week.
I do not believe my seeking medical attention was related to the vaccine, however I have been asked to provide this information. I have chronic back pain and had a microdiscectomy at the level of L4-5 in 2000. The day after I received the vaccine as above, I had an acute episode of severe back pain. I called for an appointment that day and was seen 3 days later in the facility. At that time, the pain seemed very much to be related to my chronic condition. I was referred for testing (lower back X-ray and subsequent MRI) and also saw a neurosurgeon in consultation. The testing was consistent with degenerative disc and facet disease in my lower spine. I am currently receiving physical therapy.
Cough; hoarseness; wheezing; closing of windpipe - unable to breathe except through nose. Cough lasted through the evening and night.  Inhaler & Vicks Rub helped to open windpipe somewhat.  Visit to doctor next morning, 10/31/2012.  Steroid injection and prescription for cough.  Told to avoid future flu shots.
Patient had already received bivalent booster on 09/03/2022. Received a second bivalent booster in error on 11/09/2022.
Patient received a dose of vaccine from a vial that had been mixed on 12/17/2021.
She got her vaccine, 4th one.  She had chills, fatigue over the weekend, but was nothing.  Then on Wednesday morning, 3/9/22, was down in her basement and was closing the exterior garage door button for it to close.  She came into the basement and the interior door was all distorted buckling to her, but it really was not.  She looked at the frame and felt that it was sticking out on her, which lasted for about 10-15 seconds.  She was busy and had children coming, and had a busy day going on and did not do anything about that, had no other symptoms of headache, dizziness or anything before or after that event.  She has been fine since that event.    The next day she was telling a friend about that who told her to call her doctor.  She has a neurologist as she has RA and has trouble walking.  She called him at a local facility and they did not get back to her, and she described what had happened.  The weekend by and by 3/14/22 she called again to see if she could talk to the doctor or get a call back.  During that conversation she asked if she should call her PCP, which she called.  She went into the records and said that she should have an eye check up.   She did that on 3/21/22 and her neurologist incidentally called and told her he would see her in June at her regular appointment and did not seem interested in her event.  The eye doctor told her that it could have possibly been a TIA in one or both eyes, but no other neurological symptoms of any kind.  She said that it could be an eye problem or ONJ which is an adverse reaction to some medications.  That doctor is going to call her regarding possibly this is what it might be.  She is concerned that it may have been that, if it was, should she be concerned and should she take further vaccines, just a lot of unanswered questions.    Eye doctor gave her instructions in the event that it happens again and to do within 5 minutes or call 911 or get to an ophthalmologist or seek medical attention.
7 days after shot i was taking shower and there was bumps on arm and it was splotches and red and itched and was hot and stayed  like that for 3 or 4 days . I also had a very bad headache. I slept the whole day. I was very tired.
received Shingrix first dose with a final volumen of 0.45ml.; first dose with a final volumen of 0.45ml.; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On 22nd September 2021, the patient received the 1st dose of Shingrix. On 22nd September 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient received shingrix first dose with a final volumen of 0.45ml, which led to incomplete dose administered and pharmaceutical product complaint. The nurse manager needs time to collect patients details. The reporter consented to follow up. This case was linked with case US2021201392, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201392:same reporter
localized pain in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 18 months old male patient who received ADACEL in place of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE by mistake (lot number, expiry date, dose, dose in series, route and site of administration were not reported) on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date in Oct-2018, the patient developed a non-serious dark circles under his eyes following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date in Oct-2018, the patient developed a non-serious running around like crazy following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine used. No lab data was reported. Final diagnosis was running around like crazy, dark circles under his eyes. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for dark circles under his eyes and as Unknown for running around like crazy. Reporter did not think that it has anything to do with the ADACEL. 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. Documents held by sender: none.
feel bad; he did not have the energy to do anything/ felt drained; his arms just feel like dead weight, does not know how to describe it, but they ache; This is a spontaneous report from a contactable consumer. A 75-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left deltoid (shoulder) on 06Jan2021 10:30 at a single dose for COVID-19 prophylaxis at a clinic. There were no medical history and concomitant medications. On 07Jan2021, patient stated that he knew that he would feel bad the next day of vaccination, but he was into the second day and he just does not feel good. Patient clarified that he felt drained. He said that he slept most of the day and went to the gym and he did not have the energy to do anything. Patient added that his arms just feel like dead weight, he does not know how to describe it, but they ache. The patient has not recovered from the events    Information on the lot/batch number has been requested.
This spontaneous report has been received from a registered nurse and concerns a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with unspecified doses of improperly stored (temperature: 48 F, time frame: less than 30 minutes) oral, ROTATEQ lot # L013193, expiry date 20-JAN-2017 or lot# L013202, expiry date 27-JAN-2017, orally (dose and strength were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored MMR II (lot number, Expiry date, dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Additional Details: Parents were with patient. says it happens every time she gets shots or blood work. possible NES and/or hypotension. says its happened in docs office before and they're testing her for pots and her sister has non epileptic seizures. She was fine after about 15 minutes. gave her a cold packet to put on the back of her neck and just monitored her for further symptoms.
Vaccine administered after stored at freezer temperature for too long. Patient advised and may get revaccinated.
patient received the first dose of Twinrix 8 months ago/Patient not received  2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received the first dose of Twinrix 8 months ago (batch no.4KF75 and expiry date 03rd January 2025)).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Twinrix 8 months ago/Patient not received  2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-31-Oct-2023 The health care professional asked how to proceed with patient vaccination. Till the time of reporting patient did not receive the 2nd dose of Twinrix which led to incomplete course of vaccination . The reporter consented to follow up.
Shortly after receiving my second dose my shoulder pain began and I had limited mobility in that arm. This was not a typical injection sight pain, it was in my shoulder joint. I feel the injection site was high almost near the top of my shoulder and my injury resulted because of this. It took over a week before I could get dressed on my own.   I still have shoulder pain with certain movements of my arm.
<10 degrees movement in flexion and abduction with left arm. Pain and aching at injection site. Site was not warm or red but firm. Possible flare of RA.
Vaccine administered on 11/4/08.  at 3am the following morning, the patient woke up with hives and a rash all over.  She also had a tingling sensation all over.  She took benadryl 50mg at 4am and again at 6:30am.  Called our office at 8:30 am 11/5/08 still with rash and hives.  Advised patient to go to local emergency room to be evaluated.
Pt noted to have vasovagal response after injection of HPV vaccine. Pt given ice pack to base of neck and sip of water. Pt complaints of nausea and noted to be pale and have a bit of perspiration to her forehead. PCP informed and BP monitored. Pt given juice and crackers with mother in room while pt recovered. Pt reports feeling better and was able to ambulate out of the clinic on her own.
Severe Migraine headaches daily, from the time I wake up till whenever I go to bed.
After the first shot I had severely foul underarm odor for about four days; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 72-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 72-years-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, administered in left arm on 04Feb2021 in four weeks as dose 1, single for covid-19 immunization. Medical history included spinal stenosis, osteoporosis, scoliosis, start and stop date unknown. Patient had Penicillin allergies. Patient took other medications in two weeks was dietary supplements. On 04Feb2021, patient experienced after the first shot i had severely foul underarm odor for about four days. Patient had not received any treatment. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Normal redness swelling soreness of arm which resolved after couple days along with other normal normal reactions, myalgia, low grade fever etc.  However about one week to the day, 12/31/20 same ~6 cm circ red itchy sore are reappeared on arm and is still here 1/5/20.  It may be starting to fade some.     Just wanted to let you know.  No action desired.
Hives began 5/20/08. Evaluated at Health Unit. Hives began on leg, advanced to torso, extremities, head. Angioedema. He obtained treatment from Dr (Allergy). He is currently taking Prednisone 20 mg, Benadryl, other antihistamines.
Narrative:  Vaccine given on 12/23/2021. On 12/27/2021, patient seen for rash to bilateral arms. He reports date of onset 4 days ago. Patient reports that this happened a "few years" ago and he was prescribed Benadryl. Pt denies taking any Benadryl this time. No treatment rendered and Pt denied SOB, throat/tongue swelling, or itching. Chart flagged for future reference.
Chills, rigors, horrible joint pain in wrists, knees, ankles, back, neck, fatigue, weakness insomnia, polyuria Q 30 minutes all night. The joint pains are my typical joint pains but much more severe.
The symptoms that I was experiencing included sore throat, sore muscles, sinus drainage, diarrhea, fever, chills and spotting when I haven?t had an actual period in almost 2 years. My symptoms started that weekend that I got my second vaccine and didn?t subside until the week after seeing a doctor to get tested for COVID-19, thinking I had it and getting prescribed medication to help alleviate some of my symptoms.
I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting). At the time of the report, MYALGIA (I'm  in bbn pain today/hurting all over/Im in oain/body aches Pain/I'm hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
DEVELOPMENT AND WORSENING OF RED RASH AND A HARD LUMP AT VACCINATION SITE. PAINFUL AND RASH SPREAD. FOLLOWING DAY FELT NAUSEOUS. BEGAN TREATMENT WITH CEPHALEXIN 500MG TID. RASH STILL SPREAD, REPEAT TRIP TO WALK IN CLINIC, RECEIVED CEFTRIAXONE INJECTION AND INCREASED CEPHALEXIN TO 500MG QID. RASH IMPROVED, PAIN IMPROVED.
Started having sharp pains in abdomen that led to lingering pain all over. Next day could barely walk the pain was so bad and ended up in the ER per my doctors orders. They did a CT and diagnosed me with appendicitis and had to get my appendix removed that night.
This spontaneous report was received from a consumer calling on behalf of her 5 year old son. The patient was vaccinated with the first dose of M-M-R II when she was 3 years old of age, MMRII Lot 1777Y, and the second dose of MMRII when he was 4 years of age, MMRII Lot 1250Z. No other co-suspects were reported. No concomitant medications were reported. The consumer stated that last year she noticed that her child was having sensory problems with loud noises, such as barking, the movie theater, and ice skating rink, in which her child would cover his ears. The consumer stated that she followed up with her son's primary health care provider who stated this is a common reaction to loud sounds. However, the consumer stated that her child never did that before. The consumer stated that her son does not have any known allergies but when he got vaccinated with PEDVAXHIB and an unspecified flu vaccine at 15 months of age, he developed hard bumps, like pimples on his face and the back of his arms. They were like "build up of thick skin". The patient's present status is reported as not recovered. No other information was provided. Additional information has been requested.
Pain in right shoulder and upper arm. Seen by PA in my primary care doctors office. I was given steroids when they did not work after 5 months I had an MRI which showed Frozen Shoulder Syndrome and a couple tears in shoulder area. Saw an Orthropedic  Surgeon given another round of steroids and am now doing Physical Therapy while symptoms persist.
Pt recvd MMR vax as a child & currently exhibited a lack of response to mumps; no further details were provided;
sore arm; This is a spontaneous report from a contactable consumer (patient) reported in response to non-hcp letter sent in cross reference case. A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Jan2021 (at the age of 64-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included none. Concomitant medications included zinc gluconate (CHELATED ZINC [ZINC GLUCONATE]); colecalciferol (VIT D3), both taken for an unspecified indication from Sep2020 and ongoing; ascorbic acid (VIT C) taken for an unspecified indication from Dec2020 and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: E11685; Expiration Date: Mar2021) in left arm on unspecified date at 08:20 hr (at the age of 63-years-old) for covid-19 immunisation and experienced fever (for 7 days, highest 101.7 F), loss of taste (LTD), headache body ache, fatigue, loss of appetite, malaise, covid-19 virus test positive (on 30Dec2020; fine now; admission to hospital due to the event: yes; no treatment received) and chills. The patient experienced sore arm on an unspecified date. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.