chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling to right thigh. 1.1 inches x 1.1 inches. Increased redness. Area tender to touch. Skin intact. No drainage noted. Ice pack applied to area. Will continue to monitor.
Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration), EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022 at 1:31 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Jul-2022 at 1:31 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). At the time of the report, PRODUCT STORAGE ERROR (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration), EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and OVERDOSE (Patient received a booster dose of Moderna COVID vaccine (0.5 ml Dose reported)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was initially stored in the refrigerator on 02-Jun-2022.  No adverse events noted at this time.  The vial did not undergo any temperature excursions.  No treatment information were provided.
Pt recvd Engerix-B on 1JUN92 & 2 days later blood tested per hosp policy & was Hep B surface antigen  pos & antibody neg; there were no adverse consequences;
The pt received immunizations around 4:00 PM on 4/10/03. By that evening the child was complaining of left leg discomfort. On 4/11 the discomfort, erythema and induration had increased. By 4/12/03 the pain was from the groin to below the knee and the child was not placing all weight on the left leg. He was seen at the local ER and dx with a cellulitis of the left thigh S/P immunizations. Keflex was prescribed. He was seen at our office 4/14/03 in follow-up and was improving. As of 4/15/03 the sx are vastly improved. At no time was a fever present.
Severe headache persisted for 3 days accompanied by fever 102.7 and stomach cramping.
Nausea and fainting.  Collapsed for two minutes.  Woken by nurse.
Pressing on chest causing shortness of breath; extreme fatigue; stomach discomfort; nausea, headaches, no appetite; chills; diarrhea, 2 days later false positive for Covid. Three days later for next 4 days, tested negative each time for Covid. Since vaccine 1 to 3 weeks later fatigue, no appetite, suicidal thoughts as if my endorphins were temporarily deleted but endorphins returned 24 hours later. Due to the extreme side affects, 1/22/21, I will not receive my 2nd Moderna vaccine.
This spontaneous report was received from a nurse refers to a 4 years old female patient with unspecified pertinent medical history or drug reactions/allergies. On 07-NOV-2012, the patient, who was younger than nine years old, was vaccinated with a dose of GARDASIL (0022AE exp 28-SEP-2012) (dose and route was not reported). No other co-suspects were reported. No concomitant medications were reported. The patient experienced no adverse effect. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Local erythema approximately 3 cm at injection site, not painful. 24 hours after no treatment required.
Information has been received from a physician concerning a 28 year old female patient who on 20-MAY-2011 was vaccinated in the right arm with a first dose of GARDASIL (lot # not reported). Concomitant therapy included PAXIL, ethinyl estradiol (+) etonogestrel (MSD), SKELAXIN, lidocaine and cyanocobalamin administered by the patient's rheumatologist. The patient contacted the physician (via telephone) on 24-MAY-2011 and reported that she had pain in her right shoulder joint. The patient was given PERCOCET for pain and was still feeling pain in the right shoulder on 26-MAY-2011. The patient was scheduled to get a sedimentation rate to look for markers of inflammation. Additional information has been requested.
APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7,  BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL.  I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 as dose number unknown, single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SYNTHROID; WIXELA INHUB. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Positive 19Jul2022; (23Jul2022) Negative, notes: negative 23Jul2022; (27Jul2022) Positive, notes: positive again 27Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Rebound COVID infection. Positive 19Jul2022, negative 23Jul2022, positive again 27Jul2022. Very mild symptoms both times
Tinnitus started on 04/23 2021. I never had tinnitus and it started 2 days after the 2nd vaccine. The doctor said we will wait for couple months to see if goes away. It did not cure. I still have tinnitus and hence want to report this. I also had fever, fatigue, etc, which was cured but tinnitus is still persistent.
Had Diarrhea for 2 days and a headache for 3 days right after the shot.  Then On October 16, I had a stroke
Case number PHEH2014US025175 is an initial spontaneous report received from a consumer on 12 Dec 2014. This report refers to a 57 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1412401) intramuscularly on 31 Oct 2014. On the same day, 2 hours after vaccination, he lost all of his hearing in his left ear and it did not return. He had tests and an Ear Nose Throat (ENT) specialist prescribed him oral prednisone along with 3 prednisone shots in his ear. The final outcome of the event was unknown. The seriousness of the event was not reported, but the event was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the event was not reported.
REDNESS WITH MILD ITCHING AT THE SITE. THE REDNESS AND SWELLING IS THE SIZE OF A MASON JAR LID. THERE IS A KNOT IN THE MIDDLE OF THE REDNESS WHERE THE INJECTION WAS GIVEN. ALL REPORTED BY THE PATIENT OVER THE PHONE.
Vaccine adm. 8/20/17, 04:15 PM in right arm. Patient was standing while Dad was holding. Patient started to cry/shake (was afraid) while wiping site with alcohol pad. Shaking increased when wiping was completed and syringe was picked up for adm. Dad held tightly injection completed using a 5/8" needle (small arm). Patient was shaking and crying then Dad let go. He was very upset, crying then fell to the floor his eyes remained open and he had muscle tightness. We continued to talk to him. Patient appeared to lose consciousness for about 2 seconds and doesn't remember falling. Patient recovered and remained in store about 15 minutes. Appeared fine. (Possible seizure ?? parent observation) (syncope with muscle stiffness/jerk RPh. observation).
Started with continuous ringing sound(mild) in right ear, 3hours after pfizer covid-19 2nd shot.  It decreased intensiveness, but still happening sporadically. It is kind of beat around 10 times per minute. No quality of life issues.
fever 103-APAP, amoxicillin tid;wheezing-albuterol nebulizer pediapred;
HEADACHE; EXTREME NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme nausea. On MAR-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 had not recovered from headache, fatigue, and extreme nausea. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reaction/allergies were provided. On an unknown date, the patient was vaccinated with GARDASIL INJ (dose, route and lot number not provided). The medical assistant reported that on an unspecified date, the patient received a dose of GARDASIL that was stored improperly. No adverse effects were reported. Additional information has been requested.
Woke up in the night with c/o headache, malaise and soreness in the arm COVID vaccine administered.
Patient received the influenza vaccination on 9/08 when she woke up on 9/09 area where Influenza vaccination was given was red, swollen, and sore.
Info has been received from a CMA concerning a 28 year old black female pt with no allergies and an unremarkable medical history, who on 2/26/05, at 11:00, was vaccinated, SC, in the right arm with a 0.5ml 1st dose of varicella virus vaccine live. There was no concomitant medication or illness at the time of vaccination. On 3/15/05, the pt developed breakthrough, which the physician had noted to be "serious". It was noted that the number of lesions on the pt's body is unknown. The pt had a CBC performed (no results were provided). It was noted at the time of this report, that the pt still had lesions on her body and her current status is recovering. There was no product quality complaint reported. Unspecified medical attention was sought. Follow-up info indicated that on 3/14/05 (previously reported as 3/15/05), the pt developed varicella rash, achiness, fatigue and fever. On 3/16/05, she was seen in the office and the varicella rash was confirmed and was resolving at the follow-up visit on 3/25/05. The pt recovered and the date of recovery was reported as 3/26/05. No further info is available.
Patient reported a rash developed on entire body 2 days after receiving her second booster shot.
It is like a little sore; Under his arm there is a big swollen knot under his arm; This is a spontaneous report from a contactable consumer. The 46-year-old Male consumer reported for himself. A 46-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number may be EN6205, expiry date: unknown) via an unspecified route of administration in Arm Left on 07Mar2021 09:00 as SINGLE DOSE for covid-19 immunization at primary care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history and no concomitant medications were reported. He is a Veteran and got the vaccine on Sunday (07mar2021). On 08Mar2021 at 10:00 patient felt there is a big swollen knot under his arm. He felt like there is pressure on it when he puts his arm down. It's like on top and squeezes it. It is like a little sore. It is not hard. That is why he is thinking it is lymph nodes/glands. He does not think it is a cyst or anything and this occurred with left arm. No relevant test reported. The clinical outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting 2 hours later and two days later. On Sunday, March 7 at 9:30 pm, in the vomit expelled everything, from breakfast to dinner and it was almost intact, as if the stomach had not worked in more than 14 hours. Upset stomach, constipation, and dizziness.
March 10, 2022 I received the first dose of Shingrix. Flu like symptoms for a few days, couldn't move my arm. Well, now my skin is getting more and more sensitive, almost like my entire body is getting shingles. That type of nerve pain. Not getting the second dose. Would like compensation for my pain.
1) After the second dose of Pfizer covid 19 vaccine, my first period  was abnormal. It lasted for 4 weeks, instead of my normal 5 days. It was also heavier than normal.  2) After my second dose of Pfizer covid 19 vaccine, dark red/brown spots slowly appeared all over my body between my chest and ankles. They didn?t itch but each lasted about 9 months.
First shot on 3/14/21, 4 days after shot (starting on Mar 18), lymph nodes in right armpit swelled and caused excruciating pain. Not just sore, but very, very painful, with shooting pain going down my arm to before elbow on the underside of arm. Pain did not go away until Mar 23rd, after my doctor's office advised via telephone to use a warm compress. By Mar 25th, major pain had subsided. As of April 20, 2021, no pain. Had second shot on April 11, 2021 in same arm - very little to no lymph node swelling and no major pain. Both shots I had soreness at injection site, first shot being worse but both subsided within 2 days. The major issue was the lymph node swelling and intense pain after first shot. Please note I am breastfeeding my 2.5 year old son, and did not stop or reduce breastfeeding after either vaccination.
Bad Cough; has been really sleepy; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient has been suffering a really bad cough and has been really sleepy. Spoke to her doctor about it already and he suggested she gets tested for Covid before getting second dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting Headache Neck ache  Nasesous  Heightened depression and anxiety
Approx. 2 1/2 hours, post vax, pt developed a fever of 40.1C and had a tonic-clonic seizure X 1 minute. After seizure, had 15-20 minutes of limpness/pallor and then became very irritable for 1 hours, then much more consolable, after receiving Tylenol.
Within 24 hours experienced severe muscle weakness and pain, treated with ice and ibuprofen. when no improvement went to walk in clinic on July 2 and received medal dose park and tizanidine muscle relaxer, continued to treat with ice/ibuprofen/rest. Would have short term relief and then reoccurrence with greater pain, weakness, and involvement of foot becoming numb while ambulating, tingling in toes, radiating pain. Went to PCP today Friday July 8th after a day of working and struggling to ambulate. Received an IM injection of dexadron.
Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus. Labs in the ED consistent with DKA, dehydration, AKI, lactic acidemia, acute alcohol intoxication. Patient was started on DKA protocol boluses aggressive IV fluid hydration and insulin drip in the ICU. DKA finally resolved. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
right central retinal vein occlusion with macular edema; right central retinal vein occlusion with macular edema; congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 20-DEC-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered vision loss in right eye and intermittent graying of vision and was diagnosed with right central retinal vein occlusion with macular edema. The patient also suffered congestive heart failure. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The events of congestive heart failure and right central retinal vein occlusion with macular edema were considered to be disabling.  Upon internal review, the events of congestive heart failure and right central retinal vein occlusion with macular edema were considered to be medically significant.
still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) in a 33-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) had not resolved.        The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown.       No concomitant medication details was provided.  Patient was trying applying ice, heat pad. The medication and remedies was not subsiding the pain.
Have only had sporadic spotting for a year. The day following my second dose, I started my period. It was manageable for 8 days then got extremely heavy and painful. Still spotting and this is the 16th day.
It felt like I had postnasal drip, this is what I normally get when I am getting a cold. My wife had just tested positive for COVID-19, I thought I should test just in case, I was positive. I used a home COIVD-19 test; it did come back positive. I called to have a telehealth visit with my doctor's office. Upon discussing my symptoms, the doctor the doctor and I decided against the Paxlovid, she did prescribe Hydrocodone/homatropine cough syrup for my cough. That postnasal drip, cough went away in a day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Long QT syndrome" (unspecified if ongoing); "Cardiomyopathy" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; BENADRYL. Past drug history included: Sulfasoxizole, reaction(s): "allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received vaccine. Had other medications in 2 weeks with Levothyroxine and Benadryl. On an unknown date patient received COVID-19 treatment started on 22Jul2022 and ended on 27Jul2022 having lot number 2815213.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2 .
Developed swelling of the left arm at vaccination site after receiving Meningococcal AND HPV vaccines both in left arm on 9/26/23.  Diagnosed with left arm hematoma and cellulitis 9/29/23. Treated with clindamycin, tylenol, and ibuprofen with improvement.
Rash -> varicella zoster of symphysis pubis. Rx with Acyclovir.
approx 9 hrs later body aches, sever nausea, lethargic, depression, swollen red arm & big bump; wen to bed & cried; h/a
Initial side effects first 36 hours after injection: sore arm, muscle aches, headache and slight blurred vision.  Mild headache has remained fairly consistent all week. Mild chest congestion and cough started all the sudden on day 3, which progressed to moderate chest congestion/bronchitis and cough on day 4, with head congestion added on day 5. Today is day 7 and all congestion and cough remain.