chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 58 year old female Army reservist received an annual intramuscular influenza vaccine 10 Oct 2008. She reported site was sore that day with no remembered nausea, weakness, paresthesia, sensory changes, fevers or headaches. Over the next several days she reported an increasing dull ache to left shoulder/arm with pain lifting (unable to lift >25 lbs), throwing ball or pull arm forward when reaching back. She stated the pain was to the injection site with associated pain to anterior shoulder about midway between top of shoulder and axilla. She denied any injury or trauma. There are no visible divots or indentations to the injection site, no skin changes, lesions nodules or visible deformities to muscle group. As of 04 Sept 2009, she complains of reoccurring dull ache to left shoulder that worsens with activity (lifting, pulling as above). Evaluation by her PCP with ultrasound of injection site in Dec08/Jan09 for possible abscess was negative. She has used a chiropractor for 4 months with initial relief (few min to hours) but symptoms return.
passed out; chills; fever; headache; tiredness; Shakes; This is a spontaneous report from a contactable consumer reporting for self. A 53-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:00 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient received the first dose, administered in Arm Left on 08Mar2021 09:45 (Batch/Lot Number: EN6205). The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; iron taken for an unspecified indication, start and stop date were not reported. The patient experienced passed out, chills, shakes, fever, headache, tiredness 30Mar2021 08:30. Outcome of events was recovering.   Follow-up attempts are needed. Information on lot/Batch number was obtained.
pt recv vax;devel Bell's Palsy,lab eval showed white blood cell count=12.9 thous./CU.MM&inc neutrophils of 10,861;reporter felt Bell's Palsy related to vax;MD stated rt sided facial weakness;
24 hours after injection, at injection site left arm, swollen, red and hot to touch. Low grade fever of 99.7 for 3 days following injection. Left upper back pain, left neck pain, left jaw pain and pressure. Extreme fatique, whole body aches. Today is day 4 following vaccine and symptoms are slowly residing however the arm is still red, swollen and hot to touch.
Left arm swollen, red, itching around injection site - redness 12-x 8 cm down arm.
Fever, chills, sweating, nausea, headache, fatigue, scalp tenderness, shortness of breath .  Symptoms started on 03  APR 2021, fever resolved on 05 APR 2021, all other symptoms continue.  Injection site redness and tenderness is also present.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. It was reported that unknown number of doses of VARIVAX (lot number: J013900, expiration date 30-OCT-2015) were exposed to temperature of -14C  for a few hours and then -10.2C for less than 1 hour. It was reported that the doses might had been administered to the patient subcutaneously, 0.5ml. No adverse effect was reported. The nurse did not have patient identifiers or dates of administration available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph node in the left (arm of injection) armpit/chest for several days
Immediately after being give flu shot in upper left arm experienced pain which continually worsened.  The following day I was unable to lift my left arm, contacted my PMC at the hospital who instructed me to give the issue time to resolve treat with ice. Thursday and Friday taken off work. Contacted PMC Monday left message if not better by the end of the week she would schedule an x-ray. X-ray ordered along with PT. X-ray showed no broken bones, PT unable to schedule until mid-Nov. 11/22/17 PT unable to lift arm heat applied no relief. Limited duty work required as I was not able to climb ladders or lift arm. 10/31/18 apt w/PMC, able to lift arm with assistance however still extremely painful -level 5+ debilitating at times. MRI ordered scheduled for 1/16/18. 12/1/18 PT heat applied, moved arm with assistance causing extreme pain. 1/16 MRI completed showing .6cm bursal sided tear. PMC ordered cortisone shot, lab determined inappropriate without continual PT -PCM order topical which provided no relief. 1/17/18 EMI ordered to determine cause of numbness in left hand middle, ring and little fingers persistent before shot. Continued topical w/ice until 02/02/18 seen by Orthopedic given a Cortisone with order of continue PT w/ heat & ice. Relief that evening until 7/6/18 received second Cortisone injection w/ suggesting of PRP injection scheduled for 12/5/18. 9/26/18 tore right bicep tendon received first right arm Cortisone shot. December both shoulders causing extreme pain scheduled surgery for right shoulder along with PRP injection in left arm for 1/25/19. Pain in left arm continues at level 1-2 since PRP however movement of shoulder produces a noticeable clicking and continual use will increase pain. Comments wrt block 21:  I was seen by my PCM 3 times, Orthopedics 4 times, MRI & x-ray.  Urgent care clinic for two injections. Required to take several days off along with continual issues with shoulder.
This case was reported by healthcare professional and described the occurrence of swollen glands under arms in a 57-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. On the morning of 22-October 2008, the subject received a dose of FLUARIX (.5 unknown, unknown, left arm). On 24 October 2008. 2 days after vaccination with FLURIX, the subject experienced swollen glands under arms. ON 16 December 2008,  the subject experienced a "reoccurrence" frozen shoulder and decreased range of motion arm. A healthcare professional reported that a subject received FLUARIX on 22 October 2008 and two days later called to say that his left underarm had a swollen gland. He was treated with KEFLEX and the swelling resolved. On 16 December, his wife called this office to say that he had a "reoccurrence" and his left arm had decreased range of motion. He was treated at an orthopedic office and was told he had a frozen shoulder. He was given cortisone injections and physical therapy. The subject was treated with KEFLEX, CORTISONE and physical therapy. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related vaccination with FLUARIX. The orthopedist also mentioned to the subject's wife that this is the third case of frozen shoulder he has seen this year following flu vaccination. Additional cases see A0761286A and A0761289A.
Left arm swelled up to the size of a grapefruit Rash and Hives from top of Left arm down to the elbow Swollen lymph nodes in armpit Rash on face with tiny little ruptured capillaries Moderate headache Extreme fatigue
Mom called 7/30/16 to report dime-size local reaction to site of PCV13 vaccine given 7/29/16. No fever. No fussiness. Just red spot. Mom didn't notice until 7/30/16 AM.
AFTER IMMUNIZATIONS WERE GIVEN , PT TURNED PALE AND HAD AN EPISODE OF NEAR-SYNCOPE, PLACED ON EXAM TABLE AND OBSERVED. OBSERVED FOR 15 MIN. LUNGS CLEAR, HEART NORMAL, ABDOMEN SOFT, NO MASSES, ALERT & AWAKE, NO IRRITABILITY, NO RASH, NO JAUNDICE, NO LETHARGY. LEFT OFFICE AT 6:20 PM
Fever; Horrible Headache; Fatigue; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Horrible Headache), FATIGUE (Fatigue) and DIZZINESS (Feeling dizzy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (Horrible Headache), FATIGUE (Fatigue) and DIZZINESS (Feeling dizzy). At the time of the report, PYREXIA (Fever), HEADACHE (Horrible Headache), FATIGUE (Fatigue) and DIZZINESS (Feeling dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. T reatment information was not provided. Lab details were not provided.
Moderna / Dose Number: 4 Pfizer / BioNTech / Dose Number: 5; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 042L2UA), in left arm, on 23Feb2021 as dose 2, single (Lot number: 023M20A), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: C52E21A), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "Vascular disease." (unspecified if ongoing); "No spleen" (unspecified if ongoing); "Partial pancreatectomy" (unspecified if ongoing). Concomitant medication(s) included: METFORMINE [METFORMIN HYDROCHLORIDE], start date: 01Jan2015; EZETIMIBE & SIMVASTATIN, start date: 01Jan2003, stop date: 27Nov2022; BUPROPION, start date: 01Jan2001; LOSARTAN, start date: 01Jan2010; BABY ASPIRIN, start date: 01Jan2000; VITAMIN D 2000, start date: 01Feb2020. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022 at 14:00, outcome "unknown", described as "Moderna / Dose Number: 4 Pfizer / BioNTech / Dose Number: 5". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 27Nov2022 to 01Dec2022, the patient received Paxlovid as treatment of COVID-19. The patient had no known allergies.
A non-serious spontaneous report of four patients were administered one half FLUMIST dose was received from an other health professional concerning four children. Neither relevant medical history nor concomitant medications have been reported for this patient. The patients received one-half dose of FLUMIST in one nostril on 05-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; His whole body ache, the spinal cord is he can't even get up; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; He was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak; he had swollen arm, hand and wrist; he had swollen arm, hand and wrist; first dose was administered on 14Mar2021 and the second dose was on 03May2021; first dose was administered on 14Mar2021 and the second dose was on 03May2021; This is a spontaneous report from two contactable consumers (patient and patient's wife). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03May2021 (at the age of 57-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 (at the age of 57-year-old) for COVID-19 immunization and experienced rheumatoid arthritis, like his arthritis more severe, Joints were swollen; painful; the joints were inflamed and his arm was swollen, his hands were swollen. It was reported that the patient's first dose was administered on 14Mar2021 he was unable to take the second dose because he had to travel far from the country, and the second dose was administered on 03May2021. It was reported that his "whole body ache, the spinal cord is he can't even get up", he was in lot of pain with his knee, the both knees; can hardly walk because his knees are very weak and he had swollen arm, hand and wrist on an unspecified date. The patient took anti-inflammatory and  pain medication for the event "he was in lot of pain with his knee, the both knees; hardly walk because his knees are very weak". Outcome of events was unknown.  Information on Lot/Batch number was not available. Additional information has been requested.
Erythematous rash on chest and back. Generalize vaccinia. Pt given Benadryl and Tylenol.
In October 2021 I noticed that my right leg was swollen. It may have been swollen before that and I didn't notice it. Doppler ultrasound detected a blood clot in the right leg. I've taken Xarelto for six months, but the clot is still there. I had never had a blood clot prior to the Janssen vaccine.
about 2hrs p/vax 17MAY96 pt exp gen sz w/temp elevation 101.5 when measured 1/2 hr later;tx w/pediaprofen w/no further problems;
Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Burning, pain and warmth at the site of injection firm lump. Red rash on around the area of administration.
12mins post vaccination, pt c/o of chest heaviness. Pt escorted into triage area.  RN noted flushing/sweating. Charge RN, on-site provider notified.    @1355 BP 123/85 HR 79 SpO2 100% RR 14 Temp 97.9 . VSS, AOx4. Pt denies N/V, headache, SOB. Pt stated had not eaten prior to vaccination. Pt reclined back in chair and given apple juice per NP recommendation.  Pt stated that she had not eaten prior to vaccination.  On site provider recommended extended observation.   After extended observation (unspecified time period) Patient stated feeling better after finishing 1 cup of apple juice. Per NP, pt stable and d/c to home with friend.   Per NP, Pt developed panic w/ self-limiting chest heaviness after IZ. She was eval and found to have normal vital signs, see RN note. Pt spoke in full sentences, lungs were CTAB. Sx resolved after apple juice.    ED precautions discussed w/ pt, she v/u. Pt's friend will drive her home.    Pt informed she may receive 2nd COVID IZ, no contraindication at this time.
Pt somulent for 15hrs till12noon on 12MAY91 started crying uncontrollably;
My husband had it before me. I probably got it from him. I started feeling bad around 05/14/2022. I tested myself for COVID on 05/15/2022 which was positive. On 05/16/2022 I had a fever, bad congestion and overall feeling "crappy". I called my doctor yesterday and he ordered Paxlovid for me. Due to insurance issues I will be unable to start it until later today when it is finally filled. Today I don't have a fever, but I am still having significant congestion in my chest and coughing.
Large raised red rash at injection site, warm to touch 10 days post vaccination 3/16/21  Body aches 12 hours post vaccination
New onset cough, fatigue, headache lasted over a week so far.  Injection site soreness was expected; would not have reported except for severity of other symptoms.
4cm diameter firm, red, warm, swelling bump on left thigh, 7 cm diameter erythema around bump. Duracef 200 mg BID x 48 hour to rule out cellulitis vs DTaP reaction. Follow up visit 04/14/05- no change. Dx DTaP reaction. Motrin for pain, ice to site, encouraged walking.
pt states that within just a few hours of receiving the booster dose of Pfizer vaccine, her vaccinated arm ( deltoid area) became very painful.  She says she has excruciating pain while trying to do ADL's , if not using the arm there is a constant deep burn.  She does not know if this is in the bone or the muscle but does affect the deltoid area up into her shoulder
Flu shot given by Rph. Patient reported pain, weakness in left arm after shot and is seeing an orthopedic physician for inflamed bursa and possible rotator cuff involvement.
On Friday, September 10th the patient presented back at our office to look at the patient's arm where the injections were administered. Her arm was warm, swollen and red. Per the mother, the injection site had not improved and she was concerned about this reaction. RN drew a line around the induration and instructed mother to continue to monitor and take comfort measures if needed. One hour later, mother returned and stated that the child had a rash on her stomach. Per the mother, the rash was not there earlier in the day. On monday, 9/13/2021 the rash is still there but appears to be improving.
Bells Palsy; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2020SA296404, 2020SA296528, 2020SA296430, 2020SA296471, 2020SA296492, 2020SA296544, 2020SA296581, 2020SA296589, 2020SA296655, 2020SA296676, 2020SA296689, 2020SA296710, 2020SA296764, 2020SA296765, 2020SA296803, 2020SA296865, 2020SA296885, 2020SA296898, 2020SA296916, 2020SA296968, 2020SA296983, 2020SA297003, 2020SA297018, 2020SA297073, 2020SA296764, 2020SA296492, 2020SA296528, 2020SA297058 and 2020SA297065 (same reporter).  This case involves a female patient (age unspecified) who had bells palsy (facial paralysis) while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (four years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious bells palsy (facial paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Her neurologist told her not to get another (BBQ) (expanded term requested) one unless her immune system was compromised. She never had flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on batch number was requested for this case.; Sender's Comments: This case concerns a female patient who had facial paralysis after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not clearly defined, but assumedly is about 4 years. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Staff had found that Covid vaccine report did not match for the week.  Investigating it was found that a patient received a Regular Pfizer for her 5th dose instead of the Bivalent. No harm evident, physical or otherwise.
Received injection 1:00 pm. by 4:00 pm had difficulty breathing & slight problem swallowing. Became nauseated. No problems at injection site. Reported no problems with HPV4 #1 given 5-6-10. Was trying to make appointment to see MD.
Hospitalized with increased dyspnea and cough. generalized malaise, increased O2 use to 6L at home. Given Dexamethasone.  Remdesivir.
intense nerve pain; Headache; Chills; joint pain; This is a spontaneous report from a non-contactable other hcp (Patient). A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL9264) via an unspecified route of administration (Age at vaccination 18-year) in Left Arm on 16Feb2021 at 01:30 PM as dose 2, single for COVID-19 immunization. Medical history included Walnuts allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9261) administered in left arm as single dose on 26Jan2021 at 01:00 PM for COVID-19 immunization. The patient received no other vaccine in four weeks. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 16Feb2021 at 02:00 AM the patient experienced intense nerve pain, headache, chills, joint pain. It was reported by the patient that "she experienced intense nerve pain and joint pain all over her body. This lasted approximately 18 hours. She did not have a fever. She also experienced a constant headache and chills." The patient received no treatment for the adverse events. The clinical outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Seen in ER 30APR92 t105 has been having inc temp 102-103 since 24APR92; ER md dx ear infect ? rxn to vax;
Information has been received from a health professional concerning an elementary age male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.