chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 Days after receiving 1st vaccine I experienced an intense electrical/shock and/or stabbing sensation located on my left foot near outer front ankle region.  After the 1st episode an additional 2 more shock waves continued lasting a few seconds with a pain intensity level of 10.  Three consecutive stabbing sensations lasted a total of about 30 seconds leaving me feeling very nauseous.  Feels like nerve pain.  Symptoms did not return until about a week later.  Same intensity but this time continued daily with random shooting/stabbing sensations deep inside the ankle area. I've been dealing with this now for 2 solid weeks. I have had no prior injuries or complications in this region or anywhere around that part of my body. Approx. 8 1/2 hours after my 2nd vaccine I experienced several back to back shocking/stabbing sensations again in the same region warranting an emergency hospital visit. Xray of foot showed no trauma and doctor had no explanation for nerve pain. No nerve impingement characteristics identified after thorough evaluation of leg and foot. Doctor advised me to go home and take NSAIDS for a period of 2 weeks.
Approx. 2" rash aroun injection site. Warm,itching, tender and slightly elevated.
4 to 5 days after receiving vaccine, she noticed rash under left arm extending to deltoid area to elbow, itchy red. Used cortisone cream to help with itch. next morning she noticed her left lip was swollen, numbness on left upper lip and swollen face. Only lasted for around 24 hours. Notified Dr and hasn't heard much from them. Was advised to speak with Dr in regards to it and getting approval for 2nd dose. She feels better today and never seeked care for this.
2nd Moderna Dose 1/20/21 1/23/21 - numbness, tingling in legs. Seen Urgent Care. Normal DTR's, strength 1/28/21 - Improving, some leg heaviness - subjective 2/5/21 - Office visit, subjective weakness L.E. DTR diminished at patella, normal ankles normal strength Neuro referral order 2/11/21 - Neuro Eval. EMG ordered, Develop patella Reflex  2/12/21 - ER visit. Tingling Lumbar Puncture - slightly  Neurog F/U plan-prodc.
On 11/16, patient called doctor complaining of redness, swelling, and pain at site of injection. Patient asked to come to office to be evaluated. Doctor confirmed that there was a rash in area, swelling and tenderness in upper arm where flu vaccination was given. Redness on deltoid area. Swelling extends from forearm to dorsum of arm. Doctor considered as unremarkable the site of pneumonia injection. Doctor reports that patient did not have any chest pain, shortness of breath, wheezing, fever, chills, or complained of congestion. Doctor recommended rest, elevation and ice packs and taking Vicodin, but not sure whether patient actually took medicine. Patient status has been followed by phone. Progressively has improved; redness has decreased an no pain reported.
One day after the vaccine, a lump formed on the left side of my groin, along bikini line, which seemed like a swollen lymph node. Originally it was pea-sized, then the next day tripled in size and became red, hot, and very tender. Over the next week it reduced in size until it healed. Over the two days after the vaccine, I was very tired and my arm where I received the vaccine was very sore and bruised. The bruise and soreness lasted about 1.5 weeks.
Took shingles vaccine in 2014 and after looking back he believes right after the 1st vaccine he was getting headaches, quite a few of the min the morning waking up and taking Excedrin and other things.  Also getting a lot of nervous problems.  He got his doctor to prescribed cyclobenzaprine.  He started to get high blood pressure and his heart beat went up.  He always had a 40-50 heart beat all his wife and his BP was pretty normal.  After that he started to have some problems, and his doctor said that he needed to be on some BP medicine, and then had to be put on medicine.  He always walked in the woods, and took his dogs for long walks.  He started to go to the doctor every 6 months, and his heart beat was normal about 70, which they said was normal.  He told them that it was normally in the 40-50.  He found that this all started after the first vaccine, and also the elevated BP.  It is sill down to 30s with the medicine.  He wished that he had not taken that vaccine as he was in good shape and pretty healthy, and now he is not so active  He had to go to the ER a few times due to chest pains and was told that it was heartburn/indigestion.  He is now on Amlodipine and Hydrochlorothiazide.  He is also Cimetidine for his indigestion.  He takes all his medicines once a day and feels OK, but still gets the headaches fairly often like a nerve headache.  He gets them sometimes in the morning mostly and then he has decaf coffee and limits his sugar and salt.  He uses the cyclobenzaprine sparingly when he feels a little anxious, possibly every 2 months or so.    He thought it was an aging thing, but as he thought about it it had to be due to something and pin pointed it to that vaccine.  He feels good if he has dinner at 3:00 and does not have anything at night as if he does he gets indigestion.  He did have the Shingrix in 2019, and that they would call him to get the next dose, and they never did.    He has not gotten any other vaccines since the Shingles vaccine in 2019.
Patient received Janssen COVID19 vaccine at 9:30am. Upon receiving vaccine he sat down on chair to wait for 15 minutes post-vaccination. Just minutes after sitting down patient lost consciousness, fell from chair, and hit his head on a nearby countertop in room. He fell on his side on floor, EMS were called, and ice pack was placed on his head while awaiting EMS arrival.
Pt noticed red indurated area at site of ZOSTAVAX injection. Customer concerned about warmth and hardness of injection site. Went to PCP and placed on antibiotic for suspected infection. Developed in 24-48 hrs after injection. Pt reports no alcohol to site of injection. Give B-12 shots herself. I did use an alcohol wipe on her.
This spontaneous case, initially received from the other health professional (nurse) on 03-Oct-2018, concerns a 50-year-old, adult female patient. On 03-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195126 and expiry date: 30-Apr-2018]. At the time of this report, the patient had not experienced any adverse event. The reporter assessed the case as non-serious. This case 201804267 was linked to 201804266 reported by the same reporter. Follow up received from other health professional (nurse) on 30-Oct-2018: The patient's age (50 years) was added. The reporter confirmed that, the patient had not experienced any adverse event. The narrative and case comment were amended accordingly.
Approximately 13 minutes after the vaccine was administered patient reported feeling faint. She was sweaty, shaky, hyperventilating, tingling in her fingers and reported a rapid heart rate. Patient was able to speak in full sentences and answer questions. The pharmacy team immediately called 911. The pharmacist assessed the patients symptoms and determined the patient was not experiencing anaphylaxis as she was not experiencing swelling or throat closure. No emergency medications were administered. The patient layed down on her back and elevated her feet. The EMT arrived within 5 minutes and assessed the patient. Patient was taken to the emergency department.
Patient called call center on 4/28/21. Patient having flu like symptoms 1 day post covid vaccine (started 4/15/2021).  Patient unable to speak in full sentences, patient stated wheezing and having difficulty time breathing.  Advised for pt go to ED.
8" inflammation ring and 3" raised knot around injection sight.  Sight was warm, slightly itchy, tender to the touch. diarrhea, and extreme fatigue morning of 8/16.  7:25 p.m. took Zyrtec.
Vertigo; severe dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "severe dizziness". Additional information: Reporter had a quick question; reporter had a friend that just about week or so ago have the COVID Pfizer Booster, the new booster was asking for any kind of complaints of vertigo, severe dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Menveo vaccine was reconstituted with sterile diluent and administered to a patient; Menveo vaccine was reconstituted with sterile diluent and administered to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th August 2021, the patient received Menveo. On 30th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that Menveo vaccine was reconstituted with sterile diluent and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No more information about lot number, expiration date and patient details was provided. The reporter consented to follow up by email.
6 inch area of swelling at site with redness, warm, pruritus. ZOSTAVAX was given.
severe burning and was even "jumping" with the injection; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from nurse and consumer/ non health care professional via Regulatory Authority (under reference 00827108).  This case is linked to cases 2021SA345810 and 2021SA361277 (same reporter).  This case involves a 30 years old female patient who had severe burning and was even "jumping" with the injection (vaccination site pain), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127 and expiration date: 30-Jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe burning and was even "jumping" with the injection (vaccination site pain) (unknown latency) following the administration of vaccine.  It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised."  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
L supraclavicular lymph node (mobile, rubbery, tender) noticed 5/7/21. No other lymphadenopathy.
This case was reported by a contact and described the occurrence of vaccine underdose in a adult patient who received ENGERIX B pediatric (batch number ZF2L3, expiry date 19th January 2017). On an unknown date, the patient received ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. No adverse event reported.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report () was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Rec'd call from mother 2/20/02 who states that child had a fever of 104F, decreased appetite and a trunk rash following the administration of MMR vaccine on 12/5/01. Family physician called at that time and over the phone instructions given to mother.
collapses on the field and has to be resuscitated; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 29 years old  patient with unknown demographics who collapses on the field and has to be resuscitated while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.   On an unknown date the patient collapsed on the field and has to be resuscitated (syncope) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and life-threatening.  Final diagnosis was (life-threatening) collapses on the field and has to be resuscitated.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (collapses on the field and has to be resuscitated).  At time of reporting, the outcome was Unknown for the event collapses on the field and has to be resuscitated.; Sender's Comments: Sanofi Company Comment dated 03-Feb-2022: This case involves a 29 years old  patient with unknown demographics who collapses on the field and has to be resuscitated while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be excluded.  Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pt notes w/in 2 hours of received PPV23 vaccine pt developed uncontrolled vomiting then diarrhea muscle aches.
Fever, headache, body ache, tiredness All started at 8:10 am the day after I received the vaccine
Hardening of the shoulder, severe pain and numbness in the head, temperature (not fever), muscle pain almost all over the body and in the bones of the face and jaw.
Patient was vaccinated at 8:48.  Her sister was vaccinated at 8:52.  The patient was sitting next to her sister when her sister started feeling faint.  The sister was evaluated and provided water.  It was then reported to the healthcare providers that the sister feels anxious when she gets vaccines and does pass out.  While evaluating the sister and providing her water the patient became limp in her chair, dropping her personal items and laid head on her dad who was standing next to her.  Upon initial evaluation the patient started having convulsive activity affecting her head, face and shoulders.  The patient was lowered to the floor to a safe setting.  The convulsions lasted approximately 5-10 seconds.  Once convulsions were over the patient was alert and responsive.   Her vital signs were HR:92, SPO2:96%;  BP:113/78.  Paramedics were called immediately and arrived approximately at 9:10.  The patient was laying on the floor and paramedics started a complete evaluation; placing the patient onto the heart monitor, and ran another set of vital signs and a point of care blood glucose.  Vital signs, monitor reading, and blood glucose  were unremarkable.  The patient has NKA; No past medical history and is on no current medications.  Upon evaluation when the patient was helped from laying to sitting by paramedics she started to feel faint once again.  The patient was taken to the hospital for further evaluation.
Information has been received from a registered nurse concerning multiple unknown patients of unknown age. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On multiple unknown dates since "October 2015", the patients were vaccinated with improperly stored VARIVAX (lot#, expiration date, dose and route unknown) for prophylaxis. Information regarding temperature excursion of vaccine was unknown. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001263: US-009507513-1703USA001265: US-009507513-1702USA011328:
AREA WAS INFLAMED 2 X 2 INCHES WITH SOME SWELLING, FOLLOWING DAY AREA GREW WITH MORE REDNESS. ON SATURDAY AREA FORMED A BLISTER.
Pt transferred to observation area for 15 min. At 2:19 for discharge I noticed pt having some difficulty breathing. Pt  then started to have sensation of throat closing and chest tightness. Pt stated she is allergic to shellfish, peanuts, seasonal and anesthesia.   Blood pressure was 136/86-HR-100 O2 saturation 99%. AOx3 no change in mental status, stridor or wheezing noted. No N/V or abdominal pain. No dizziness or hypotension. No hives, swelling of lips, tingling, or itching noted.   Pt took her own medication of Qvar80mcg-Redinhaler @2:30pm. Stiolto Respimat inhaler 2.5mcg. @2:35pm. Also has albuterol/ EPI pen, but didn't take it.   Pt given Benadryl 50mg 2:40pm with water. Patient symptoms resolved completely by 3:45pm.   Continued to monitor pt. Pt states she is feeling better no signs or symptoms of distress noted.   Pt verbalize understanding of follow up with PMD and allergist@ Allergy and Sinus before coming for second dose. Pt taking taxi home husband was notified.
After receiving TDAP vaccination went home and noticed swelling beginning in arm. Next day, shoulder and arm were swollen and painful to the point that any mobility was limited and extremely pained. Upon reading the pamphlet provided by doctor, I noticed a warning for latex allergies when receiving this shot. As this was my first visit to the physician and my records had not arrived from the previous doctor, perhaps they were unaware of the allergy. I did not read the paper until after the shot. Swelling of arm continued to be painful throughout week - now, seven days later, swelling has decreased other than a large purple lump at injection site that is warm to the touch. I am intending to return to the doctor to have it examined.
red, pruritic rash on inguinal and upper thigh area then appeared on abdomen, back and upper arms. treatment: BENADRYL 25-50 Q6h for 24hrs. topical hydrocortisone cream. still with rash.
Her hands started to immediately swell up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Xeljanz 5mg. Vaccination history included: Covid-19 vaccine (Primary immunization completed (Manufactruer unknown)), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her hands started to immediately swell up".  Additional information: Patient advised she had stopped her Xeljanz for four days w hen she got her Covid vaccine. Her hands started to immediately swell up. Patient was prescribed Xeljanz 5mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
have not been having regular periods anymore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8737) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "childhood asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; FOLIC ACID; VITAMIN D [COLECALCIFEROL]; MULTIVITAMIN [VITAMINS NOS]. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Bactrim, reaction(s): "known allergies: bactrim". Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "have not been having regular periods anymore". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "have not been having regular periods anymore". The event "have not been having regular periods anymore" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Ever since receiving the Covid vaccines patient had not been having regular periods anymore. After her initial covid vaccine she thought it could just be a coincidence but after she received her subsequent doses it was apparent that it was related. she still has not had a period after receiving her last dose and her husband and she were hoping to have another child. Her PCP has done lab work & found no abnormal hormone levels or other factors that would indicate any other issues or early menopause etc. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Vesicular rash with scabs. Pt seen in ER. Caladryl lotion.
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.