chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Chills; Headache; "I'' am well but got my second covid vaccine shot Saturday morning and have not been feeling well; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08May2021 as a single dose for COVID-19 immunisation. Medical history reported as unknown. It was unknown whether the patient had any allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received other medications within 2 weeks of vaccination. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID-19 vaccine. On 08May2021, the patient experienced sore arm, chills and headache. The patient reported that she was well but got her second COVID-19 vaccine shot on Saturday morning and had not been feeling well since Some better on that day but at the time of report she had a headache. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm, chills, not been feeling well and headache was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
1 day after 1st shot left hip lost 70% range of motion and stabbing pain. Symptoms gradually got better over 2 month period.Still don't have full mobility 5 months later most pain gone but not all.  Vaccination date 01/28/2021  1 day after 2nd dose right elbow lost 80% range of motion with severe stabbing pain when trying to straighten. Almost felt locked up. Symptoms gradually got better over 2 months but never complete went away. Still cannot completely straighten right elbow. Vaccination date 02/25/2021
(L) shoulder swelling after vaccine (PCV 13), localized inflammation, but never tender lymphangitis.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ oral liquid, orally, lot number M043836; expiration date 17-JUN-2018 or lot number M039061; expiration date 28-APR-2018  or lot number M007307; expiration date 30-NOV-2017 (strength and dose were not reported) for prophylaxis. The temperature of excursion with the ROTATEQ was between 47 to 77 Fahrenheit degrees during 5 hours. Previous temperature excursion was between 47 to 77 Fahrenheit degrees during 6 hours. The temperature of excursion was detected by a data logger. No adverse effects reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006397: US-009507513-1707USA006406.
Patient complained of headache, diarrhea, and left arm pain that is ongoing since 4/6/2021. She contacted the clinic on 4/19/2021 with her symptoms. The patient was advised to go the the ER.
10/4 pt had small amt of redness and soreness at injection site; next day redness and induration were 6cm around injection site and pt had soreness of left lateral neck and left arm to elbow
Approx 5 min after receiving HPV vaccine #2 Pt was atanding at appt desk and suddenly fell backwards and hit head on window ledge. Pt moved to exam room for evaluation. Bleeding controlled, 11/2 inch "C" shaped laceration noted to back of head. I staple placed by Physician covering for Attending. Pt was alert and oriented. Pt stated she did not have much to eat. Drink and snack given in office.
Developed possible IBS symptoms such as lactose intolerance, and low tolerance for carbohydrates, that were not present previously. Treatment so far is following a low FODMAP diet to help identify the triggers to the symptoms.
Case received from a health care professional on 08-May-2013. Case is medically confirmed. A male patient received the first dose of VARIVAX (lot no. not reported) and concomitantly the first dose of PRIORIX (MFR GSK, lot no. not reported) in Jan-2013. At the beginning of May 2013, the patient developed Herpes zoster. The patient showed rash on the left arm and back, but no pain. The patient's family had moved (land of occurrence), which possibly led to stress. Also solar irradiation was reported as reason (living near the border). At the time of this report, the patient had not recovered.
Pt received small pox vaccine on 08nov07 on L arm.  After 7 days pt had eqivicol reaction.  Pt was revaccinated on 15nov07 on R arm.  Two days after revaccination pt noticed 3 vessicles on L arm at original small pox vacine site.  The main vessicle is 5mm, the second is 3mm, and the third is 2mm.
This case was reported by a consumer (the subject) and described the occurrence of runny nose in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 13 October 2010 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right arm). On 15 October 2010, 2 days after vaccination with FLULAVAL, the subject experienced runny nose, "congested" (unknown congestion) and body pain. At the time of reporting the events were improved. The subject had felt better since 18 October 2010, but continued to be somewhat congested and had a runny nose. The subject reported that her husband had caught the symptoms from her. She believed that "the vaccine became activated once injected into her system".
Arm hurt; This is a spontaneous case initially received from other non-health professional via The Agency (reference number: SEQW20-00318) on 17-Apr-2020, concerning an adult, female patient who was 64-year-old at the time of this report.  The patient's relevant medical history and concomitant medications were not reported.  It was reported that the patient was on unspecified antidepressants in the past (start and stop dates for antidepressants were unspecified) and none of them worked.   On an unknown date, the patient had genetic test to determine the best antidepressant for her and it showed that none would work.   On an unspecified date in 2017, the patient was administered with INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.  On an unspecified date, after vaccination, the patient's arm hurt.  On an unspecified date, 3 months later, the patient recovered from the event of pain in arm'.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment to INN Flu Vaccine Seasonal.  This case is linked to cases 202003111 and 202003112, due to the same patient.  Follow up received from other non-health professional via The Agency (reference number: SEQW20-00349) on 27-Apr-2020: It was reported that the patient was on antidepressant in the past and that she had genetic test to determine the best antidepressant for her; indication for vaccine changed from influenza prophylaxis to ASKU, additional reference number added. Narrative was amended accordingly.   Non-significant follow-up information received from other non-health professional (consumer) from The Agency [reference number: SEQW20-00404] on 15-May-2020: Additional reference number added. No changes in narrative.  Company comment: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.; Sender's Comments: The patient developed pain in extremity on an unspecified date, after receiving INN Flu Vaccine Seasonal. Chronology needs more clarification. The patient's relevant medical history and concomitant medications were not reported. With information available, causal role of the suspect product is unassessable.
pt c/o itching p/shot;mom noted itching & dry flaking skin @ 3PM day p/shot-no other problems noted till 17MAR96 @ 8PM pt had fever (unk temp);mom took pt to MD 1045 18MAR96 MD dx cold & gave ATB plus DPH for itching;
Moderna doses administered past 12 hour; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna doses administered past 12 hour) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 22APR2022 dose were administered to patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior. The patient had reported any adverse reactions to the expired dose administered.  Dose administered more than 12/24 hours post puncture Number of doses/vials was 7 doses. On 31MAR2022, the vial was initially stored in the refrigerator.  No concomitant medications were reported. On 21APR2022 at 10:20 AM, the vial was first punctured and administration of vaccine on 22APR2022 at 9:30 AM, 1:15 PM, 23APR2022 at 9:50 AM, 4:05 PM The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. No treatment medications were reported.
Covid arm, extreme fatigue, nausea, diarrhea, headache, fever, body pain, joint pain
permenant lump in front of my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "permenant lump in front of my armpit". The action taken for BNT162b2 was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expired vaccine administered. Expired on 9/30, was notified on 10/13 that it was expired on 9/30, even though previously told  expiration was 70 days which was 10/14
ACUTE DVT OF LEFT FEMORAL VEIN 6/16/2021 CKD STAGE 3 (GFR 30-59), UNSPECIFIED. ACUTE DVT OF LEFT FEMORAL VEIN 6/16/2021 ANASARCA
6 days after the vaccine, experienced swelling; pain and redness at injection site; COVID arm; swelling into upper arm and armpit.
Lymph node pain; Loss of bladder control; Neckache; Fever; Chills; Headache; Lymph node swelling; Body aches; Shortness of breath on exertion; Extreme fatigue- slept 35hrs; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 24Apr2021 at 15:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and Meniere's disease. Concomitant medications include DEVA multivitamin and mineral supplements. Past drug history includes codeine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 03Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 22:30 the patient experienced fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue(slept 35 hrs). The clinical outcome of the event fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue were resolved with sequelae.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a 65 year old male with no known drug allergies who on 09-JUL-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) in his left arm. Concomitant therapy included testosterone injection. On 10-JUL-2008, the patient developed tenderness, soreness, erythema and swelling at the site of injection. The area was about 2 to 3 inches. The patient made a telephone call to a physician. No laboratory diagnostics studies were performed. The patient's tenderness, soreness, erythema and swelling at the site of injection persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the pharmacist who reported that the patient in the morning of 09-JUL-2008 was vaccinated subcutaneously with his first dose of ZOSTAVAX (Merck) (659410/0412X) in her left arm. In the morning of 10-JUL-2008 the patient developed erythema, pain, tenderness and swelling at site which size was 2 to 3 inches. The pain and tenderness increased to the point where the patient was unable to wash with cloth and the size increased. At the time of this report, the outcomes were unknown. Additional information has been requested.
Kind of sick; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Aphasia (Patient is non verbal and has been since before the vaccine). Concomitant products included DIAZEPAM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MALAISE (Kind of sick), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs include duwalpro and other OTC.  Treatment information include paracetamol and ibuprofen.   This case was linked to MOD-2021-021544 (Patient Link).
After receiving her vaccine, patient moved into our waiting/observation area at my request to wait for 15 minutes of observation. Within a few minutes I heard the patient's mom calling out for help. I quickly ran over to help. I observed the patient who was now sitting on the floor. Her eyes were wide and she looked shocked. I helped her mother to calm patient and asked her to remain seated. I asked her mom what happened and she stated patient twitched a couple of times and began to fall off of her chair at which point mom caught her.  Mom had blood on her arm and I noticed it had come from patient's ear where a couple of earrings were pulled as she fell. I asked if she wanted water and quickly provided her a bottle of water. Mom stated that patient had fainted from vaccine(s) in the past, but mom stated that this appeared to look like a seizure. Mom went to get a chocolate bar since patient had had nothing to eat and they were worried about low blood sugar. After patient looked like she was back to normal I left to administer another vaccine but asked mom to remain until she felt necessary. Mom and patient advised my tech that they were ok and they left the store.
16mos p/vax pt exp varicella rash & devel 100-200 spots on the body.
11:30 pm - started to feel chills. 2:00 am - threw up. Continued to have chills through the night.
pt recvd vax 7AUG95 & because of increasing fatigue & neurological complaints pt is being evaluated by a neurologist;MD is concerned that pt is developing signs of GBS;
Dizziness extreme, extreme pressure in head, neck and upper back and shoulder pain and stiffness.
Numb and tingling sensation, primarily in arms and face, later whole body. 50mg Benadryl has made it slightly better but it fades in and out throughout the day
From initial information received on 11/Mar/2005 from a registered nurse regarding an adverse event occurring in the USA. It was reported that a five year old male patient received his fifth dose of DAPTACEL, lot number C2131AA, administered in the deltoid on the morning of 01/Mar/2005. The route of administration was not reported. Four to six hours later, the patient's arm become red, hot, and swollen. He was treated with ice packs and antipyretics. The patient was seen by the physician on 09/Mar/2005 and again on 10/Mar/2005. At that time there did not seem to be any improvement in the reaction. The patient's recovery status was reported as unknown. Follow-up information received on 12-August-2005. The patient recovered. The reporter was unable to provide any further information.
Upon waking this morning, left thigh very sore. Also noticeable swelling in a large portion of the thigh, not just injection site. Warm to the touch (oval shaped area about 1-2? out from injection site) and pink (oval shaped, only about an inch long at widest). Complains her leg hurts.
5-6 days of redness that was warm to touch and hard ("blister like").  Ibuprofen and ice pack helped area to resolve back to normal.
Tinnitus started the day after the 2nd shot.  As of this writing (6/8/21),  the condition still exists
Pt. reported to me via telephone on 11/12/21, that she had severe swelling, redness, warmth, and pain at injection site (Right deltoid).  Pain and swelling spread into armpit.  Employee also reported a persistent fever.  She had already scheduled an appointment with her PCP.  I advised her to keep the appointment and to call me with an update.  At approximately, 1500, pt. notified me that she had been diagnosed with cellulitis and prescribed an antibiotic.  At that time, I informed her we also needed to get her to see a work comp provider.  3 other employees who received the same vaccine, same lot, had milder reactions but more than a normal response to vaccine.
Chills, fatigue, injection site pain, headache.   Lasted a few hours. Treated with acetaminophen. All symptoms resolved within 24 hrs post injection.
This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore). At the time of the report, PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. On an unknown date, the patient received first booster dose and received second booster dose on May-2022. On an unknown date, the pain went away. Treatment information was not provided by the reporter. Reporter did not allow further contact.
Patient developed an itchy, erythematous rash in the site of the injection on the left arm 12 days after vaccine
Menstruation was delayed two weeks with extrememly heavy and disabling flow and pain for 48 hours after onset.
pt's illness manifests itself in a variety of ways. The most common of these are debilitating body weakness, head tilting (torticollis) and balance issues. Early on these episodes were very sporadic in nature and would happen once every several weeks. They came on only when he was tired and were alleviated by sleep. As the illness progressed, so did the frequency and duration of the episodes. By May and June, they became an almost daily occurrence and would come on at all times of the day not just when pt was fatigued. Since January of 2003, we've seen little if any progress in pt's gross and fine motor development. In addition, pt demonstrates cognitive impairment with significant delays in both receptive and expressive language.  Episodic Symptoms: 1. General body weakness (hypotonia), 2. Head tilts (torticollis), 3. Compromised use of arms and hands, 4. Balance problems, 5. Drooling, 6. Difficulty chewing and swallowing, 7. Ptosis (droopy eyes), 8. Crossing of eyes, 9. Extreme fussiness. Not all symptoms present themselves during every episode. Sometimes there is a progression of symptoms (ie eyes off, then head tilt, then body weakness). Symptoms are alleviated, at least temporarily, by sleep. Daily Symptoms: 1. Significant receptive language delays (ie can't ID body parts or play pat-cake), 2. Significant expressive language delays (ie has 1 daily word, down from 12 in Jan), 3. Decreased body strength (ie can no longer crawl up a flight of stairs), 4. Gross Motor delays (ie cannot stand or walk unassisted),5. Balance problems, 6. Low muscle tone, 7. Fatigues easily. Pt at baseline is able to crawl, pull to stand, make steps supported by two hands and cruise along furniture. Since February 2003 pt has received weekly physical and development therapy through and early intervention program.