chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe shoulder pain/injection in left shoulder once, close to shoulder higher up; states it was not on the deltoid, it was given higher than normal; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 23Dec2020 13:30 at single dose by injection in left shoulder once, close to shoulder higher up for COVID-19 immunization. Medical history and concomitant medication were none. The patient received the shot yesterday, and her only experience she was having was severe shoulder pain, and she was wondering if it was possible to just take Aleve, they mentioned taking Tylenol, but she was wondering if Naprosyn was ok to take. Towards yesterday evening, she noticed the severe shoulder pain, she received it at 1:30 in the afternoon, and noticed probably around 9PM, all night was just pain like as if someone or else you overexert with exercise, that kind of pain. She hadn't taken anything, she wondered if it was ok to take Aleve, no one seemed to know. She stated the dose was not given on the deltoid, it was given higher than normal. The outcome of severe shoulder pain was not resolved.
NIGHT SWEATS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAY-2021, the subject experienced night sweats. On 19-MAY-2021, the subject experienced fever. On 19-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, fever, and fatigue on 19-MAY-2021. This report was non-serious.
couldn't move left arm above head initally. Dizzy, pale, tired, chills, aches, nausea then vomiting fever 102.
This spontaneous report was received from a physician via company representative, referring to a 13 year old female patient. It was reported none concomitant medications, none medical history and drug reactions or allergies were unknown. On 08-JUN-2018, the patient was vaccinated with the first dose of  GARDASIL 9 (strength, dose, administration route, lot number and expiration date were not reported) for prophylaxis (indication reported as "Human papillomaviruses (HPV) vaccination"). On 12-JUL-2018, the patient noticed blisters erupting all over the body and especially the feet. She was seen at an unspecified Urgent Care, and was diagnosed with Bullous Lichen Planus. On an unspecified date in 2018, she was seen by an unspecified dermatology specialist who performed a blister biopsy, which confirmed the diagnosis of Bullous Lichen Planus, and the patient was started on treatment with an unspecified steroid. The outcome of lichen planus was reported as resolving. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
My eyes became extremely itchy, red and swollen - they are still red and itchy today (9/25/2013).  I also developed a fever of 102.5 around 11:00 PM that evening as well.
on the night of 4/7 100.9 fever, sweating, nausea, chills, headache, fatigue went on for about two day and everything except horrible sweating, tasted vaccine
About 5 minutes after administration of the Varicella vaccine the patient began complaining of chest and throat pain. He was observed for further reaction and developed a rapidly progressive generalized macular erythematous rash as well as some slight swelling of the bilateral eyelids and lips. At no time did the patient develop wheezing or shortness of breath or any signs of hemodynamic compromise.
c/o acute onset occipital headache,  R. throat swelling, neck swelling, tongue swelling, difficulty swallowing saliva by report.  No resp difficulty.  Resp 16/min - nlabored SPO2 98%, HR 101, BP 160/85.     12:30pm  Epi 0.3mg given R. thigh via auto injector by anaphylactic type reaction.  All transport to closest ER.
Entire left side of body (shoulder, arm, leg) is in extreme pain, and unable to walk.
pt was vaccinated with covid 19 vaccine with a Janssen brand given on her left arm, intramuscular at 03:44 pm. Pt sat down on the post vaccine area and after 5 mins pt stated that she is feeling light headed and dizzy. Pt was assisted to lay down on the floor safely and legs were elevated asassistedby RN. Pt is alert oriented towel, date,time, location. Pt stated that she is nauseous and hadn't eaten anything yet. Initial vitals were taken and recorded BP 118/60 mmhg, PR55bpm, T96.0, RR 20, O2 sat 98% at room temp, BS 105. Vital signs monitoring done everything until stable, Pt refused to call 911 stated that she had history of being nauseous and lightheaded with blood draw and blood transfusion. Repeat  Vsat4:10 pm BP 120/ 70, RR 20 cpm, T97.6, PR 76. Pt was placed in  a sitting position and no complaints of dizziness, lightheadedness. NoSOB, no Chest pain as well. At4:20 RN discharged ptaccompanied by husband without any complaints. Pt statedsge appreciated our immediate care.Nyrse educator RN wasnotified as well..
pt recvd flu vax on 9NOV92 & 12 hrs later exp redness, swelling, & pain in arm of inject; joints became painful & devel a low fever & chills; sx lasted approx 2 dyas; also mild inject site pain;
Cold sore (herpes simplex virus) appeared on edge of upper lip. Patient has previously had only 1 cold sore outbreak, which was 4 years ago.
Your vaccine & 2 boosters made me very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective", "Your vaccine & 2 boosters made me very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine & 2 boosters made me very sick".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
has not been same since.  no energy,  not eating the same (decreased appetite/fighting to get him to take what he is taking), having screaming fits, also noted to have increased sleep time.  injection sites are not bothering him, slight redness noted.  normal BMs noted - 2-3 stools daily and no fever.  had similar issue after 2 mon shots but was with bad colic &  reflux at that time.
Monovalent vaccine given as booster; Inappropriate age at vaccine administration; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) in an adolescent female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration).    No concomitant medications were reported.  It was reported that the caller was the office manager. She had a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment medications were reported.
I test positive for COVID 19 on 07/26/2021, but didn't have any symptoms. I spoke with my health provider over the phone on 07/27/2021 he prescribed an antibody, Vitamin C, Zinc and D3.
5am on 9mar2021 woke up with headache . I had them for a few days at the center of my head. The 6Mar2021 - I couldn't walk to the bathroom.  My armpit glands - lymph notes were tender two after the vaccine. It got worse over time. Saw doctor in 23APr2021
After receiving my 4th Covid shot, my resting hear rate increased to 80 beats per minute. My normal resting rate is between 70 ? 70 beats per minute. The shot was the Moderna 042H22A. It took approximately 3 days for my heart rate to return to normal. I use the digital app monitor my activities and heart rate. I can provide data screen shots as needed.
Received only 1 dose of vaccine and didn't take second dose; Contracted covid 14 days after the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Contracted covid 14 days after the vaccine) and PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Aug-2021, the patient experienced COVID-19 (Contracted covid 14 days after the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose). The patient was treated with Immunotherapy (Monoclonal Antibody) for COVID-19. At the time of the report, COVID-19 (Contracted covid 14 days after the vaccine) and PRODUCT DOSE OMISSION ISSUE (Received only 1 dose of vaccine and didn't take second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient needed to skip the second dose of vaccine and wanted to get the newest vaccine due to the reason of COVID contraction after first vaccination. Patient was given monoclonal antibodies, so patient thought patient did not need second dose.  Adverse event did not caused patient to seek medical care.  Treatment included Monoclonal antibodies.
On the day following dose 3 he slept longer than usual.  He had a low-grade fever.  As the day progressed, he became very lethargic, and his fever peaked at 101.7 mid-day.  We consulted the pediatritian on 12/22/2022.   We gave him medicine at about Noon and continued as needed.  His fever decreased that afternoon but returned throughout the day.  The symptoms have continued until today.  He has been a bit more playful today.
pt recv vax;devel bumps on legs and waist;hive like welts on torso, under arms, legs; itching; low grade fever and sore mouth;
Severe, severe menstrual cramping and bleeding. Blood clots that range in size from small dime size to large clots the size of marbles. Filling an ultra tampon in 5 minutes. Going through tampon, pad, underclothes, outer clothes, and through a sweater onto car seat in less than 15 minutes. This bleeding has been going on now for 5 days. This is my first cycle since having the 2nd vaccine and I've NEVER experienced bleeding like this, especially with an IUD. It's debilitating. I literally ran out of my office and into my car after being stranded in the work bathroom for 10 minutes hoping the bleeding would slow enough to get to my car. Changing tampon and pad every 15 minutes. I can't leave the house. I am afraid to go out in public for fear of bleed through accidents. I'm traveling with extra clothes, sanitary supplies and layer up.
Subsequently post vax, the pt experienced a fever of 100.5. The pt sought unspecified medical attention.
aching joints, extreme fatigue, head ache, fever of 100.9 all night, muscle cramps in left foot, not able to sleep much because of headache, .
rash antecubital spaces & neck x 2 wk, onset 26JUN; chest tightness w/inc 3 pillow orthoapnea PND & wheezex, DOE plus cough w/forced expiration w/onset just p/onset rash unk whether resolved; sinus congestion x 2 wk; 26JUN onset bilat h/a
Can't sleep at night; pain from the shot/Pain in her left shoulder; Pain in her left shoulder. Had become very irritating and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EP7534), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: unknown), for COVID-19 Immunization, reaction(s): "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery."; Bnt162b2 (Dose: 02, Lot number: unknown), for COVID-19 Immunization, reaction(s): "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.". The following information was reported: SLEEP DISORDER (non-serious), outcome "not recovered", described as "Can't sleep at night"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain from the shot/Pain in her left shoulder"; IRRITABILITY (non-serious), outcome "not recovered", described as "Pain in her left shoulder...Had become very irritating and painful". Therapeutic measures were taken as a result of sleep disorder, vaccination site pain, irritability. Additional information: Reporter stated that she called about the Pfizer shot. Unable to clarify which type of Pfizer shot. Mentioned that she had took the Pfizer shot before she had the last booster a year ago. Is experiencing pain from the shot. Is in her left shoulder. Wanted to know if that is a side effect. Wanted to know what she can do about it. Just had the booster. Third shot: Pain in her left shoulder: Started 6 months after she got it. Had become very irritating and painful. Some people say it will go away and it has been a year and has not gone away. Was after the third shot. Treatment: Put on a pain patch and it goes away and when not use it gets worst. Can't sleep at night sometimes from the pain: About a month ago. Only hurts at night when she is laying on it the pain comes through then. Began after the third shot. Treatment: Doctor gave her some medicine to relax her. When she takes the pills for relaxing probably sleeps through the pain then. Had rotor cuff surgery (right side): Had rotor cuff surgery last year. Had it in 2022. Mentioned that she had two shots prior to the surgery. Clarified that these were all for the Pfizer shots. First Pfizer shot had no lot or expiry to provide. Second Pfizer shot had no lot or expiry to provide. Recovered completely in 2022. Treatment: Went to therapy. Sender's Comments: Linked Report(s): US-PFIZER INC-202300091711 same patient and product, different dose number and event;
Fever of 101.6 and 100.3 the next day, tired muscle aches, chills.  Ibuprofen helped (span of two days)
two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.; two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) and PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 04L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) and PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   This case was linked to MOD-2022-565188 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: No new information.
Fever, erythematous maculopapular rash, onset 9 days post-vaccination. Prolonged seizure (~30 minutes) 10 days post-vaccination. Treated with Valium and Ativan.  4/30/2008 MR received for DOS 3/31-4/1/2008 with D/C DX: Complex Febrile Seizure.  Pt transfered from local hospital with admitting dx: prolonged seizure in the setting of fever. Tmax 102.5'F. Pt presented with decreased responsiveness and shivering which escalated to generalized tonic seizure en route to hospital. Length of seizure 20-30 minutes.  Unresponsive to Valium.  Responsive to Ativan. Post-ictal sleepiness.  No further activity. W/U (-).
On 4/5/21 at 6:30 pm I had my vaccine and we waited 15 minutes at the place. When we left after 5 minutes later, I started to itch in my throat and then to cough and then my nose felt as if runny. I did not have anything, and I got red and could not pass saliva; it was difficult to breathe. I thought it was normal after the vaccine, but after my throat hurt a lot and it was painful to swallow, I realized it was not normal. I felt very tired, and I couldn't breathe.
fever 100,  pulse 100 for an hour or so, then going back down, then occurring again three times in 24 hours. Very achey, chills, flu like symptoms and sore throat, general weakness, fatigue.  24 hour duration. The next day feeling fine again.  (patient reports, flu vaccine also gives patient flu like symptoms.)
At 4:40 PM, employee began to feel throat tightening tight cough, both eyes became red, itchy. Itching on neck/back. States felt "hot". To ER 5:30 PM via EMS, received oral steroids, oral Benadryl and 1 nebulizer breathing treatment. Released from ER at 10 PM. F/U with primary care MD on 10/8/13.
bleed at the injection site; having problems with her knees; Sore arm; headache; gait a little unstable; A spontaneous report was received from a healthcare facility staff member concerning a 50-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and who experienced having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.   The patient's medical history included elevated cholesterol and thyroid disorder.  The Products known to have been used by the patient, within two weeks prior to the event, included pravastatin, levothyroxine sodium, turmeric, vitamin D, vitamin B1, ferrous sulfate and combination calcium + vitamin D3.   The patient received their first of two planned doses of mRNA-1273 (LOT # 011J20A) on 23-Dec-2020 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 23-Dec-2020.  After the injection, she began having problems with her knees.  She also experienced bleeding and soreness at the injection site.  Additionally, she reported a headache.  The arm soreness, which she treated with over-the-counter Advil, resolved after 2 days, however, she reported an increase in knee swelling, left greater than right.  She stated that her knees were not painful but that they felt heavy as if there was fluid in them.  She said the swelling was also causing her gait to be a little unstable. Patient denies history of knee issues.  She admitted to taking over-the-counter Aleve with no resolution of swelling.   Treatment for the event included over-the-counter Advil and Aleve.   There was no change planned to the dosing schedule of mRNA-1273 in response to the events, having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.  The event, her arm was sore, was considered recovered/resolved.    The outcome of the events, having problems with her knees, began to bleed at the injection site, had a headache, swelling in her knees and gait a little unstable, was not reported.   The reporter did not provide an assessment for the events, having problems with her knees, began to bleed at the injection site, her arm was sore, had a headache, swelling in her knees and gait a little unstable.; Reporter's Comments: This case concerns a 50-year-old, female patient with medical history of elevated cholesterol and thyroid disorder, who experienced NS, expected event of injection site pain, headache and unexpected event of injection site bleeding, joint swelling and gait disturbance. The events occurred the day the first dose of mRNA-1273 (LOT # 011J20A) was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician assistant concerning a 23 year old female with penicillin allergy and allergic reaction to CECLOR who on 05-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (LOT# 660387/2967U) 0.5 mL, intramuscularly in left deltoid. There was no concomitant medication. The physician assistant reported that on 05-JUN-2008, the patient experienced dizziness, lethargy, nausea and detached feeling following vaccination. The patient received the GARDASIL vaccine, walked 10 minutes through heat and then about 1 hour after vaccination experienced the dizziness, lethargy, nausea and detached feeling that lasted for 30 minutes. The patient returned to the physician assistant's office and was still experiencing some nausea 3 hours after vaccination. At the time of the report the patient was still recovering. Additional information has been requested.
Headaches - lasted 2 months then resolved. Cognitive slowing and fatigue - peaked at 2 months, improved, but still not resolved.