chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling in left armpit lymph node.Swelling and water retention in surrounding area; 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, expiry date was unknown) via an unknown route in the left arm on 14Feb2021, at 07:45 AM, (at the age of 42 years) as a single dose for COVID-19 immunisation. Patient did not have medical history. The patient had no allergies. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC) and chondroitin (within 2 weeks of the vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262, expiry date was unknown) via an unknown route in the left arm on 28Jan2021 at 05:00 PM (at the age of 41 years) as a single dose for COVID-19 immunization. On 02Feb2021, the patient had covid test (covid test type post vaccination: Nasal Swab) and result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021 at 04:00 AM the patient experienced swelling in left armpit lymph node, swelling and water retention in surrounding area. Patient did not receive any treatment for the adverse event. 1st dose administered on 28Jan2021 and 2nd dose administered on 14Feb2021 to patient, which is Inappropriate schedule of vaccine administered. The outcome of the event swelling in left armpit lymph node, swelling and water retention in surrounding area was recovering.  Information about batch number has been requested.
On March 3, 2022, I had a sharp pain behind my left eye. I went to go sit down and passed out. The ambulance was called and received a brain scan. The brain scan showed I had two aneurysms and one of them ruptured. The doctor put coils in both aneurysms.  I was in ICU for two weeks, and a total of nineteen days in the hospital. I was out of work for three months.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-FEB-2016 the patient was vaccinated with MMRII (dosing details were not reported) lot # L015282 with an expiry date 30-APR-2017 which was improperly stored at 47 F for a time frame of less than an hour. There was no previous temperature excursion. No information was provided regarding concomitant medications. No adverse effects were reported. There was no product quality complaint involved This is one of the two reports received from the same reporter. Additional information has been requested.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case is for 45th patient out of 77 patients reported.  No concomitant medication information was provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Grand Mal seizure Severe dizziness with nausea for about 30 seconds accompanied by falling. According to first hand witnesses my hands and feet went stiff, I was making gurgling noises with my mouth, I was unresponsive. I urinated on myself while unresponsive. The shaking and stiffness lasted about 1.5 minutes. I then remained unresponsive for approximately ten minutes afterwards.  911 was called by my 20 and 15 yr olds who witnessed the event. EMTS arrived and suggested transport, but I denied due to being tired, not wanting to transport, and felt I could follow up with my primary physician.  I ended up seeing a neurologist and lost my driver's license for 90 days.
pt recv vax & devel a grapefruit sized area of redness & swelling @ the inj site;pt also exp dizziness & palpitations;pt recovered;
Headache, Fever, chills, muscle spasms, left arm pain, left hand contracture onset one hour post vaccination administration. Resolved after 400mg Ibuprofen administered. Pt returned to office after onset of symptoms. Tylenol 650mg administered and patient symptoms continued to improve. Patient remained in office from 3:15-4:45 and then discharged home. Phone call by MD at 9:00pm and symptoms completely resolved.
tongue tingled; half her mouth had a tingling feeling; half her mouth had numbness; flu-like symptoms; arm ached; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA ORAL (tongue tingled), PARAESTHESIA ORAL (half her mouth had a tingling feeling), HYPOAESTHESIA ORAL (half her mouth had numbness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (arm ached) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA ORAL (tongue tingled), PARAESTHESIA ORAL (half her mouth had a tingling feeling), HYPOAESTHESIA ORAL (half her mouth had numbness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (arm ached). On 02-Mar-2021, PARAESTHESIA ORAL (tongue tingled) and PARAESTHESIA ORAL (half her mouth had a tingling feeling) had resolved, HYPOAESTHESIA ORAL (half her mouth had numbness) outcome was unknown. On 03-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. In March 2021, PAIN IN EXTREMITY (arm ached) had resolved. 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 concomitant medications were given Treatment information provided as Benadryl, rest and sleep
patient received Pentacel without reconstituting HIB component of the vaccine/ NO AE; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from the other health professional .  This case involves a 6-months-old male patient to whom nurse administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6395AA, expiry date: 24-Apr-2021, via an intramuscular route in right quadricep) without reconstituting with HIB component of the vaccine (product preparation issue) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU), HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique(latency: same day).  At the time of reporting, no adverse event was reported.  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.
pt devel fever 104-105 few hrs p/vax sleepy; improved p/24hrs
H1N1 - Left arm - allergic reaction - open sore at injection site, rash on entire left arm, neck, fever.
Shingles, Acyclovir 800 MG,  Prednisone, First pain 3/18/2021, blisters appeared 4/1/2021
1) Initially -30 mins after vaccine administered - "Electrical-like" tingling started in chest and face.  then cascaded throughout entire body.   2) Following - Hives and rashes would appear randomly on neck, chest, inner thigh, inner forearm, and feet/ankles. Occurred nightly for about 2 weeks and was resolved by Benadryl, followed by having them every other night or so for several weeks.  Reactions gradually reduced in frequency after about 6 weeks.  3) Currently, very infrequently, will experience random tingling/itchiness in different spots of body.  Benadryl/Zyrtec will resolve.
J96.00 ACUTE RESPIRATORY FAILURE 12/26/2021 METABOLIC ENCEPHALOPATHY
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were unknown. In May 2017 (reported as "within the past week (prior to 12-MAY-2017)"), the patient was vaccinated with a dose of VARIVAX injection, lot # M039318 with expiry date 20-SEP-2018, subcutaneously (exact dose was not reported) for prevention of varicella. The vaccine was administered together with sterile diluent (MERCK) injection, lot # M034911 with expiry date 05-MAY-2019 (exact dose was not reported). On an unknown date in May 2017, 3 to 4 days following the administration of VARIVAX and sterile diluent (MERCK), the patient experienced a severe injection site reaction consisting of redness, swelling, warmth and discomfort at the injection site. The patient sought medical attention by visiting the physician. The reaction was diagnosed as possible cellulitis and was treated with an unspecified antibiotic. The outcome of the events and causal relationship between the events and suspect therapies were not provided. The reporting nurse requested a lot check on the administered products. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009116.
Patient developed an itchy red rash with bumps on various parts of body including head and torso two days following vaccination.  Patient self treated with diphenhydramine and the reaction resolved after 3 days
Information has been received from a consumer concerning her 16 year old daughter with penicillin allergy, asthma and some allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL and with the second dose on 04-Oct-2007. Concomitant therapy included FLOVENT, Albuterol and a prescription drug cough medicine. On 21-JUL-2007 the patient experienced itchiness, redness and swelling of hands and feet. On 05-OCT-2007, after second vaccination the patient experienced hives all around both knees with causes itching and redness. The hives subsequently spread to  her feet, and then to her entired body including her face. The patient subsequently developed bronchitis, felt weak all the time and had "never ending headaches". At the time of report, the patient was doing better but she had "no stamina" and she continued to experience coughing spasms and brochitis periodically.  Also, whenever her extremities, such as her hand or feet are subjected to coldness or cold temperatures, they turn red and she experienced itchness. The patient was recovering. No additional information is expected.
This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mood disorder, stress, hives (during stress) and migraine (during stress). Concurrent medical conditions included allergy. Concomitant products included SHINGRIX and lamotrigine. In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the keratosis was unknown and the outcome of the eye crusting and eyelid rash were not recovered/not resolved and the outcome of the pain, pruritus and rash were recovering/resolving and the outcome of the allergy aggravated and toothache were unchanged. The reporter considered the keratosis, eye crusting, pain, pruritus, allergy aggravated, rash, toothache and eyelid rash to be possibly related to SHINGRIX. Additional details were provided as follows: In end of January 2018, the patient received 1st dose of SHINGRIX and experienced same events as after the 2nd dose, (refer case US2018078743). Approximately 2 weeks after receiving 2nd dose of SHINGRIX, the patient experienced a crusty rash on her eyelids, and rash on forehead and behind the ear. The patient experienced more general allergies than before SHINGRIX therapy. The patient saw a dermatologist and a diagnosis of keratosis was made and a cortisone cream helped in alleviating the skin issues of rash and crustiness on the eyelid. The permission was given to send a letter requesting physician information.
Patient called the next AM stating she had 101 fever and all over body aches. No other complaints. Patient taking OTC DAYQUIL and stated she would call back if she had any further issues.
Patient said that she had pus on the injection site and it was red and about 1-2 inches. She went to ER but Dr. suggested her to keep an eye on it no treatment was given.
Back of lt arm, red raised and itching. Site of varicella vaccine give 4/22/08. Instructed by Dr Benadryl PO
The mother of the patient called in and left a voicemail on a nurses phone here at the office at approximately 5:30 pm. I checked the voicemail and return the mothers call to see what was happening to the child. The mother stated that the child was having facial swelling in his temporal area on his face and a rash was developing. I told the mother that any possible reaction need to be seen by a healthcare provider and I recommended for her to take the child to the emergency room. Upon requesting the emergency room noted from the visit, the documentation from the ARNP who treated the child in the ER noted a rash on the child's face contributed to a possible allergic reaction to the Hepatitis A vaccine. The patient was treated with BENADRYL PO and given a prescription for oral steroids to take at home. The ER noted that the child was stable and discharged. I contacted the mother on 04/16/2018 to check on the child. The mother stated that he was fine and they did not fill his prescription for the oral steroids because his symptoms resided.
Patient received 2nd dose of shingles vaccine in March of 2019. On July 23, 2019 contacted provided with the following complaint. Patient believes that he has shingles. Has had shingles in the past, this seems worse. Pain started 1.5weeks. Rash developed over the weekend. Rash to left buttocks and spreading down his legs. +red patches, +fluid filled blisters, +drainage, +tender to touch, +burning sensation, +5-8/10 pain, +abdominal pain and +body aches. Denies fever, nausea, fatigue, weakness, or HA.
One hour after the flu shot injection, my left upper arm (deltoid area) started to swell, felt warm to touch and achy. Today, the injection site is red, hot, and swollen. I think it is a reaction to the flu shot
The pt has a GI tube and was vomiting (green) liquid in the GI tube. The pt experienced a fever of 99.9 in the middle of the night when mother checked on the pt. The pt seemed tired on the second day. Unable to tolerate tube feeding.
Woke up morning of Monday, January 25,2021 at 230am for work and felt nauseous, had chills and body aches and hurt to the touch all over. My head felt heavy. I had to leave work early and took off the next day due to not feeling well
Severe tinnitus in right ear (about 8/9 out of 10); next day diminished to 5/6; settled at about 2/3
My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.
Headache; Dizziness; Nausea; This is a spontaneous report from a contactable other health professional.  A 56-year-old female patient received bnt162b2 (BNT162B2) via intramuscular in right arm on 17Dec2020 at single dose for vaccination. There were no medical history or concomitant medications.  The patient experienced headache, dizziness, nausea all on 17Dec2020. The reporter described that immediately after patient was administered the COVID-19 vaccine injection she was handed the paperwork, stood up and had sudden onset headache, dizziness and nausea. As of time of the report the headache had subsided slightly but came and went in waves. The dizziness and nausea remain persistent. She reported the seriousness criteria as probably medically significant or somewhere between not serious and medically significant. Patient was currently under observation in the ED (emergency department), but had not been admitted to the hospital. The patient had been in the ED for over 30 minutes at time of report, so patient did not believe that these events are vagal. The reporter called to report these events and to ask for recommendations on how to respond to these events relative to this product. The reporter verified that there had been no relevant testing, imaging, lab work or investigations done at this time. The outcome of the event headache was recovering while for all other events was not recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, headache, dizziness and nausea, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Had a syncopal event; A spontaneous report was received from a health care provider who is also the patient, a male of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syncopal episode.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 17 Jan 2021, after receiving the vaccine, the patient had a syncopal episode.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event, syncopal episode, was considered unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Syncope occurred one day (same day) after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
10/27/09 11:00 A difficulty focusing, vision blurred, confusion, knew people's face but unable to recall name. Aware something not right and can remember episode. Lasted app. 1 hour with several days afterwards feeling confused with vision change. Tingling of hands. Went to ER.
pt looked flushed on 4DEC94 aorund 4PM; Sunday 4DEC94 evening noticed light rash all over face; 5DEC94 morning bright red bumps covered entire body which lasted 2 1/2 wks; face started peeling @ this time; had fever x 3 hrs; scratching face
This spontaneous report was received from a pharmacist referring to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-AUG-2016, the patient was vaccinated with M-M-R II (Lot number, expiration date and dose were not provided) intramuscular instead of subcutaneously. There was no concomitant medication reported. No untoward effects were noted. Additional information has been requested.
Information has been received from a registered nurse concerning a 9 year old male who in January 1997, was vaccinated with varicella vaccine. In January/February the pt was exposed to a severe breakout at school. In approximately February 2001, the pt developed greater than 100 lesions all over the body, face, torso, and mucal membranes on throat. The pt received acyclovir treament. It was also reported that the pt's sibling had similar experiences. Additional info has been requested.
Massive Head and body aches. Body chills and nausea. Chest pain. Fatigue.