chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (lymph node swelling) and pain in extremity (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 4, 2021, patient experienced lymphadenopathy (lymph node swelling) and pain in extremity (sore arm). At the time of the report, lymphadenopathy (lymph node swelling) and pain in extremity (sore arm): unresolved. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; dosing remained unchanged. No concomitant medication or treatment information reported. This case linked to MOD-2021-061138 (patient link).
right eye was totally blurry and couldn't see out of it; really bad headache on the right side of her head by her right eye; Nausea; lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 10:20 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 37 years as dose 1, single dose for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: Started when she was around 13 or 14 years old. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "not recovered", described as "really bad headache on the right side of her head by her right eye"; VISION BLURRED (non-serious) with onset 11Mar2021, outcome "recovered" (11Mar2021), described as "right eye was totally blurry and couldn't see out of it"; NAUSEA (non-serious) with onset 09Mar2021, outcome "recovering", described as "Nausea"; DIZZINESS (non-serious) with onset 09Mar2021, outcome "recovered" (10Mar2021), described as "lightheadedness". Therapeutic measures were taken as a result of headache.  additional information: Caller states that she has been alternating taking Ibuprofen and Tylenol. She clarifies that it helps a bit but then comes back and she still has a headache. Ibuprofen: Lot: OAE3317 A, Tylenol: Lot: PMA102  No follow-up attempts are possible. No further information is expected.
Initial swelling on lymph node under the left axilla with pain and warm to touch on  2-5-21. Contacted MD who prescribed Augmentin 500 mg BID for 10 days. On day 13 after vaccine the swelling went away. Joint pain began on Feb 5th including hips, knees , ankles, wrist and elbows and continues to today.  Rash began on both legs (thighs and calf) and hands. Raised rash non pustule red in color. This began approximatly 1 week post vaccine. Right hand began swelling on  2/16/21 with pain and redness. On 2/17/21 swelling increased  and increased pain. Pain in right hand and wrist is worse on 2-18-21 (pain scale 6)
began rash on diaper area 1 wk p/vax; seen by MD; elevated temp & rash was told to viral condition since this seems viral; also has runny eyes & nose;
The next morning, I noticed swelling and hardening of my lymph nodes in my left armpit. A lot of tenderness. It lasted probably a week. Each day being a little better than the first day.   After about maybe 2 weeks after the shot, I noticed that my left breast implant felt hard. It was swollen and it was very painful. I got an MRI to see what was going on and I went and saw Dr. (plastic surgeon). The swelling of the implant, it was swelling on the top of the implant. She was not familiar with this happening to anyone else. They were shocked when they saw my breast in the office. When sleeping at night, it would be so painful it would wake me up.   Right breast remained normal during these health events.
It made the bleeding worse even more; It made the bleeding worse even more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. An 18-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2022 at 10:00 as dose 3 (booster), single (Lot number: FL3209), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 1, Date: 16May2021, Time: 3:30 PM, Anatomical site of injection: Right Arm, Batch/Lot number: Pfizer 6W0182), administration date: 16May2021, for Covid-19 immunization, BNT162b2 (DOSE: 2, Date: 06Jun2021, Time: 4:30 PM, Anatomical site of injection: Right Arm, Batch/Lot number: Pfizer 6W0181), administration date: 06Jun2021 for Covid-19 immunization, reaction(s): "Everytime I got up, I would bleed everywhere, legs to floor", "My periods were always bad but never this heavy". The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "It made the bleeding worse even more".  Clinical course: Patient stated her periods were always bad but never this heavy, it all started when she was out in the (state name withheld), where she got her 2nd dose. Every time she got up, she would bleed everywhere, legs to floor and it's so much so fast, the pool cannot hold. When she got my booster, it made the bleeding worse even more. There were no prior vaccinations, Relevant Tests and Specific relevant test for Thromboembolic events with Thrombocytopenia reported.   No follow-up attempts are possible. No further information is expected.
Severe headache 2 1/2 hours after immunization followed by fever, dizziness, unusual fatigue, drowsiness, itching, some trouble breathing, attempted vomiting.
24 hours after having dose 2 he began vomiting and having low grade fever. The fever continued through Friday and did vomit again. I called the doctor on Friday and got a prescription of Zofran to help with the vomiting. He did have decreased appetite.  Then he has been having loose stool since Tuesday.  As of today he still has a little bit of an elevated temperature and some loose stools. He has also had a runny nose since last Tuesday but is much better.
T-104(R).Local rxn,pain,swelling,inc warmth @ site of inject,rash.Generalized adenopathy wheezing.Pain in joints.Inflammation of joints.Generalized rash began 30Aug90,then whelps.Saw MD when joints began swelling.Also difficult voiding
Vaccine was draw up the day prior during previous immunization activity. Administered after exceeding beyond use dating. Patient contacted to be re-vaccinated.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epidural injection (in order to mitigate back aches.). Concurrent medical conditions included Back ache.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included back injections to treat back-aches.  Treatment information was not provided by the reporter.
Child had low-grade fever, rash and some diarrhea. Mother gave Tylenol. No report that child is worse; she attended school each day. On 7/14/00, child's teacher reported she had a sore throat. She was checked but found nothing wrong. Seen in ER on 7/15/00 and dx'd with gastroenteritis. It was questionable as to whether this was an adverse reaction to Hib vaccine. Treated with Pedialyte, Phenergam suppositories as needed if severe vomiting.
pt was injected pfizer pediatric bivalent vaccine. immediately after injection, pt fainted, pt was in and out of conscious for 3-5 min and junior epinephrine was injected into left leg. patient regained consciousness and was able to conversate. pt drank and ate snack and regained composure.  911 was not called d/t guardian request, pt was able to walk around the store after snacking. pt remained in store for another 20 minutes and left.
Given a full dose instead; Having more side effects than they had with the second dose; "I think I need to go vomit right now."; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having more side effects than they had with the second dose), NAUSEA ("I think I need to go vomit right now.") and OVERDOSE (Given a full dose instead) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (Having more side effects than they had with the second dose) and NAUSEA ("I think I need to go vomit right now."). On 23-Oct-2021, the patient experienced OVERDOSE (Given a full dose instead). On 23-Oct-2021, OVERDOSE (Given a full dose instead) had resolved. At the time of the report, VACCINATION COMPLICATION (Having more side effects than they had with the second dose) had not resolved and NAUSEA ("I think I need to go vomit right now.") outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-363294, MOD-2021-362105 (Patient Link).
Fever; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 17Sep2021 at 17:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 20Aug2021 at 17:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. On 18Sep2021, the patient experienced fever and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever and vomiting was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Fever since 4:00 a.m. Friday left thigh red, swollen.
Started to feel like I had a cold. Took a home COVID-19 test and it was positive. Contacted doctor and was prescribed Paxlovid. A few weeks later I had problems breathing and went to the Emergency Room. Had a CT scan and it showed I had blood clots in my lungs. Also had an Ultrasound on both legs and their was blood clots in both legs as well.
PT CAME TO CLINIC 11-13-20 FOR UNEXPLAINED BRUISING X 3-4 DAYS AGO, LABS SHOWED THROMBOCYTOPENIA, SENT TO  ER FOR EVAL. PT DIAGNOSED WITH ITP, ER RECOMMENDS VAERS REPORT D/T THIS BEING RELATED TO MMR VACCINE.
Patient stated 15 minutes post vaccination she felt tingling to her right hand for about 4 hours. Reports palpitations 30 minutes post vaccine. Unknown duration as per patient.. Patient denies any palpitations, chest pain, or shortness of breath at time of phone interview.  At about 9pm on the  day of  vaccine  patient reports a rash all over her body.  Describes it as bumpy and very itchy, getting worse.  Patient reports taking Benadryl.  States it helped with the itching but rash is continuing to spread.  Denies respiratory complaints at time of phone interview.  Patient instructed to see her provider as soon as possible for evaluation and treatment.
no adverse event; an adult patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to an adult patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 10-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 ml, lot number: S018772, expiration date: 07-JUL-2020, for prophylaxis (route of administration was not provided) (formulation was provided as vial but upon internal validation established as prefilled syringe). No additional adverse effects were reported in the patient. No product quality complaint was reported (PQC). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018772; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient has shoulder pain with a small tissue mass consistent with ganglionic cyst. The patient had the mass surgically removed on 11/3/11.
Pt started having PVCs, pitting edema, fatigue, arm pain, brain fog and bradycardia the day after vaccination. Symptoms persisted fo 10 days before slowly starting to improved. Still c/o feeling fatigued and foggy 3 weeks later.
Headache; Sweating; Hand swelling; Injection site induration; Vaccination site cellulitis; vaccination site pruritus; injection site  erythema; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Vaccination site cellulitis), HEADACHE (Headache), HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Hand swelling) and VACCINATION SITE PRURITUS (vaccination site pruritus) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cellulitis.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Vaccination site cellulitis), VACCINATION SITE PRURITUS (vaccination site pruritus) and INJECTION SITE ERYTHEMA ( injection site  erythema). On 23-Jan-2021, the patient experienced HEADACHE (Headache), HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Hand swelling) and INJECTION SITE INDURATION (Injection site induration). On 23-Jan-2021, VACCINATION SITE PRURITUS (vaccination site pruritus) and INJECTION SITE ERYTHEMA ( injection site  erythema) had resolved. At the time of the report, VACCINATION SITE CELLULITIS (Vaccination site cellulitis), HEADACHE (Headache), HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Hand swelling) and INJECTION SITE INDURATION (Injection site induration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The injection site is clover shaped, hot and touch to hard.
Patient observed for 15 minutes after immunizations, no complaints and returned to class. Patient returned to health center 30 minutes later complaining of slight dizziness, denies dyspnea, no diaphoresis, hives or rash noted, alert and oriented x 3, ambulation stable, BP 122/70 Pulse 70. Patient observed for one hour, vital signs checked every 15 minutes, BP 120/66 P 70, BP 116/70 P 66, BP 118/70 Pulse 66. Patient remained stable no other complaints. RN, health center nurse, present during entire observation. Patient provided list of urgent care centers and emergency department addresses and phone numbers if symptoms became worse. Patient's resident assistant contacted and walked patient to dorm room, will remain with patient for a few hours and another resident assistant will check on patient later in evening. Patient voiced understanding of all education provided to include going to urgent care/emergency department if symptoms become worse. Patient called morning of 4/17/19 and stated "I'm good."
2 hrs post vax, crying, inability to step on leg of inject site pain progressed to next day, pt unable to stand @ all; Upper limbs trembling, as well as legs; pt in distress x 3 days w/gradual improvement;
28JUL97 gen tonic/clonic sz x2 w/in 1hr of vax;elevated temp to 104R;pt returned to clinic;Ibuprofen & APAP & cooling measures;last temp 100 R @ 5PM-much improved, smiling;
Mother reported that child woke up on Wednesday, September 20 with welts on one side of her face, and top of forehead, but child reported to mother she felt fine and went to school. Per mother at the end of the day the child had a rash on her hands and "all over her body".  Mother to child to local urgent care. Was evaluated but provider unable to determine the type of rash, but indicated to the mother the rash on child's hand "may have been poison ivy".  Was given steroid treatment for less than 7 days (unsure of name or duration of treatment regimen).  Mother states the child went to school the following day, September 21, as she indicated she "felt fine".  Mother states she wasn't sure how well her daughter felt or if she didn't want to miss the school field trip that day (9/21/23).  per mother, the rash on 9/21/23 was a faint rash on her face with two spots on her cheek, one on her eyelid, and a cluster on her forehead and hand, with the hand being "Itchy".  I spoke with the school nurse who indicated she did not closely observe the child as she was getting on the field trip bus, but she did not notice any large rash or cluster on the child's face or forehead.
patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jun-2022 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from the lot number 049l21a affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was reported as 3. No concomitant product reported by reporter. No adverse events occurred at time of administration or were reported thereafter. No treatment medication reported by reporter.
c/o lt arm numbness; lt side facial numbness, tongue thickness, N/V; onset 2AM 28MAY92; 28MAY 1100AM appt w/MD given DPH & observed; 1500 somewhat better still tired; 1JUN sxs inc-tingling lt arm, face; 2JUN92 tingling-limping; MD consult;
Seriousness Criteria: Other-Medically Significant. Initial information was received on 30 October 2008 from a health care professional. A female patient received an injection of FLUZONE (lot number, route, site and number of previous doses were not reported) on 28 October 2008. Four hours post vaccination the patient reported swollen lips, tight chest, shortness of breath, and congestion. The patient took two BENADRYL, symptoms decreased and the patient was back to work the following day. However, the patient's recovery status was not reported. List of Documents held by Sender: None.
This spontaneous report as received from a pharmacy technician concerning a currently 43 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Shivering (22 Apr 11:30 pm-  23 Apr12:00 am) Fever over 102 (23 Apr 6:00 am- 23 Apr 11:00 pm) Nausea (22 Apr 11:30 pm- 24 Apr 7:30 am) Lack of appetite (22 Apr 11:30 pm- 24 Apr 11:00 am) Dizziness when standing (22 Apr 11:30 pm- 23 Apr 11:00 pm)
MMR #1 given 10-12. Arthralgias, fever, general malaise for 3 days 10-22. Evaluated 10-24, negative for mononucleosis. Rash, maculopapular, diffuse 10-26 (resolution of flu-like symptoms at time of rash). Still with rash.
PATIENT DEVELOPED MILD ABD. DISCOMFORT AFTER 1ST & 2ND DOSES WHICH PROGRESSED AFTER TEH 3RD DOSE TO SEVER ABD. PAIN, DIARRHEA, BLOODY VOMITUS AND MILF FEVER. WENT HOAG ER. WAS TOLD FOOD POISONING. GIVEN PROTNIX, METOCLOPROPAMIDE AND PANTOPREZOLE. SYMPTOMS STOPPED WITHIN 6 HRS. AFTER ER VISIT
Headache, chills, joint pain, severe fatigue, insomnia, some minor chest pain.