chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and rash under L & R arm pit. Left shoulder and arm had muscle pain. Knot at inject site, was size of marble. Had headache for 24 hrs.
Patient was administered 0.5ml instead of 0.25ml of booster 3rd dosage, patient was called on 1/18/2021 and denies any problems since vaccination. A letter was sent to patient informing what dosage was administered
Muscle pain and muscle spasms starting in neck and on entire back all the way down to lower back lasted 7 days with consistent improvement with each passing day; treated with Tylenol. Splotchy red rash on arms and part of legs, accompanied by pins and needles feeling in majority of body. Treated as an allergic reaction since symptoms were same as those from allergic reaction to Zofran. Treated with hydroxyzine and Benadryl; resolved in 24 hours. Chills causing entire body to shake lasted approximately 1 1/2 hours and resolved suddenly on its own. Feeling feverish and verified by checking temperature for 3 days after vaccination, starting day after vaccination; took Tylenol. Pain at injection site was almost same as for any other vaccination, just a bit more.
Information has been received from a physician concerning a patient who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658302/1032U). Subsequently, on an unknown date, the patient developed a persistent fever. The patient sought medical attention with an exam in the office. A "work-up" of unspecified tests has not revealed a cause of the fever. The outcome is reported as not recovered. The physician requests a lot check. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same reporter. Additional information has been requested.
Patient presented for 2nd Dose of Moderna and received Pfizer instead. Provider on-site communicated with patient.
Information has been received from a licensed vocational nurses via a company representative referring to multiple unknown patients of unknown age and gender.  Information regarding drug reactions/allergies, pertinent medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M027343 with expiration date 01-JUN-2018; dose, and route were not reported) for prophylaxis (incorrect product storage).  There were previous temperature excursion and multiple temperature excursion and time frame (details were unable to provide). No adverse effects were reported. This is one of several reports from the same reporter.  Additional information has been requested.  Sender's Comments:  US-009507513-1611USA011369.
Felt extremely cold and began to have uncontrollable shaking of entire body. Could not talk or walk jaw clenched closed + chattering - Lasted 15 minutes, then slow subsided over one hour. Had temp 100.2-101 during that time and thru out the night. Except for feeling achy and tired pt felt much better the following morning.
Abdominal pain; She mentioned that the person had a history of abdominal problems and it may have been exacerbated by the vaccine.; She mentioned that the person had a history of abdominal problems and it may have been exacerbated by the vaccine; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included history of abdominal problems. Patient's concomitant medications were not reported. On an unspecified date, the patient experienced abdominal pain and was wondering if that was related to the vaccine. The consumer mentioned that the patient had a history of abdominal problems and it may have been exacerbated by the vaccine. Caller was looking for percentages of certain side effects (fever, headache, muscle pain). Caller (stated that she used to do medical writing) mentioned an article from the magazine saying that getting the second dose on the same arm where you received the first dose would lead to worse side effects. She is wondering if this is true or if there are any recommendations regarding the site of injection, and if the side effects would be local or systemic in that case. The patient had concern about the duration of side effects, someone mentioned to her 3 days and she wanted to know whether that means 3 days after a dose of the vaccine or on the onset of the side effect. She enquired if there are any updates on the effectiveness of the Pfizer covid vaccine on the variants in other countries. She also wanted to know regarding the 95% efficacy of the covid vaccine, when does that start and any information on using Tylenol after getting the vaccine. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Before vaccination patient stated she had allergies to iron and epinephrine that caused anaphylaxis. Pt appeared anxious. Asked pt if she would like to receive vaccination in a quiet area w/ observation by EMTs, patient stated yes. Post-vaccination, pt complained of SOB, dizziness, lightheadedness, nausea, tingling to mouth. Patient appeared lethargic. Responded appropriately to questions from on-site EMTs. VS taken - HR 108, RR 24, BP 180/120, SPO2 99% RA. Pt was asked if she would like to be taken to ED for additional assessment, patient stated yes. Pt transported to ED by ambulance for further assessment.
Flu systems: body aches low grade fever(<99).  Blood pressure elevated and has not come back to normal range sense 1/15/23. Constant headache along with elevated blood pressure. Range / average measured (160/100). Dr. brought me in to office 1/19/23 gave me a blood pressure med and it lowered to normal level. Issued prescription for Verapamil er 120 Mg, it has little to no effect. I will be calling Dr's office as soon as I'm finished typing this report.
Administered the 12+ Pfizer COVID-19 Bivalent vaccine to 11 year old patient. No signs or symptoms present at the time of administration.
Severe swelling in ankles, drop of 20 beats in heart rate 1 week after vaccine
The day after the vaccination, 01/14/2021 I had ringing in my ear and felt very tired. I have a constant ringing in my  ear. Sometimes It's both ears, sometimes it's one. There are days where the ringing is loud and days were the ringing is not loud. I still have the ringing in my ear. It never went away, Even as I report this today,  06/10/2021. I feel like my hearing is getting worse because of the ringing.
Two minutes after administration of J&J vaccine, patient asked this nurse for water and said, "I feel dizzy." Patient was diaphoretic and pale. Patient remained seated in chair. Felt this was for 15 minutes. His feet were elevated, cold compress to neck, fan directed at patient. Patient never lost consciousness. Took cold water and pretzels. BP at 14:57 was 104/76. Symptoms totally resolved by 1500. Patient and mother report a history of vasovagal fainting with previous blood work/exposure to needles.
Day of vaccine patient reported one-sided (right) headache and had an episode of vomiting and diarrhea. The next day the patient stayed in bed all day. Unsure if there have been further s/e as this is just the third day after vaccination.
Arm was hurting this morning; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included unspecified blood thinner. The patient indicated that she was on a blood thinner and asked what was going to happen to her and if she should get the second dose. Her arm was hurting this morning (01Feb2021). The outcome of the event was unknown. Information on the lot/batch number has been requested.
COVID-19 / COVID Rebound; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 / COVID Rebound) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disorder thyroid (thyroid) and Drug allergy (sulfa).    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022 at 10:00 PM, the patient experienced COVID-19 (COVID-19 / COVID Rebound). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 / COVID Rebound) had not resolved. Not provided.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) 4 days after completing paxlovid. On an unknown date, SARS-CoV-2 test: positive (Positive) Covid Rebound 10 days after testing positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Vaccine administration time of suspect vaccine was reported as 01:00 PM. It was reported that Co-suspect drug Pfizer was used for the treatment of COVID-19 from 16 May 2022 to 20 May 2022. Company comment- This spontaneous case concerns a 65-year-old female patient, with no relevant medical history reported, who experienced the unexpected  COVID-19. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on vaccination date. It was reported that patient experienced COVID rebound 10 days after testing positive, 4 days after completing treatment with paxlovid. Patient tested positive at home antigen test and developed COVID symptoms as well. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history reported, who experienced the unexpected  COVID-19. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on vaccination date. It was reported that patient experienced COVID rebound 10 days after testing positive, 4 days after completing treatment with paxlovid. Patient tested positive at home antigen test and developed COVID symptoms as well. The benefit risk relationship of mRNA-1273 is not affected by this report.
4.26.22 (Left Lower ext. pain, swelling, redness, warm to touch) - PCP visit 4.29.2022 - US done (+) DVT
Blood clot in left arm confirmed by ultrasound. Additional swelling and pain in left leg but no identifiable blood clots. Swollen lymph nodes and pain since injection (Left arm = in arm, across breast, under armpit and Right = under armpit), rash for 2 days, tingling in fingers for 4 weeks, and injection site pain for 4 weeks,
A few days after her second dose of COVID-19 vaccination, patient reported onset of dizziness. Has had dizziness before, however now having dizziness daily, at higher intensity level than she has had in the past.
Severe body aches, chills, exhaustion, sleeplessness, sore throat, disorientation
Pfizer-BioNTech COVID-19 Vaccine Site of injection is sore, slightly swollen. I woke up the day after the vaccination (vaccinated yesterday at 9 AM, adverse effects began at 7 AM the day after) with a headache, mild body aches, and general fatigue.
extreme pain around injection site that has been present for 9 days, moderate headaches and frequent nausea & diarrea all have been present on & off for 9 days as well
L shoulder musculoskeletal pain x 1 day after administration.  Pain and symptoms not present for approx 2-3 days, then "joint pain" returned to L shoulder and has progressively worsened until present date.  Denies any other injury or event associated with the current pain.  ROM limited.  Pain with all movement of the L arm, worsening with specific positioning.  Pt reports taking ibuprofen "a few times in the past few weeks" but seldom in nature and "only when I needed to really use the arm."  Reports that ibuprofen reduces the pain and increases the ROM but does not completely aleviate the symptoms.  Denies using ice or heat.  Advised immediate follow-up with PMD.
Vaccine was administered after best use date (BUD) of 2.22.23. Expiration date of vial is 4.30.23. Vaccine was stored in monitored refrigerator under proper temperatures for a normal vial. Patient was notified of administration error 3/30/23.
DAY 1: BUMP, REDNESS MILD SWELLING ON LEFT ARM SHOT SITE; DAY 9: LEFT ARM SHOT SITE, RASH REDNESS SWOLLEN ON SHOT LOCATION. DAY 10 CONTINUES AS DAY 9; DAY 11 RASH INSECT BITE LIKE ON BACK, NECK & LEFT ARM, TREATED WITH OTC HYDROCORTISONE  & BENADRYL CREAM.
Headache, NauseaVomiting, Fatigue, Swollen glands, GI upset
3/17/09 Approx. 11:15am shingles vaccine administered to L arm SQ, tolerated well.  Approx. 11:30 am client complained of nausea VS taken B/P 130/90 HR=100 R=16 unlabored.  Also complained warm to face, ice pack applied to face.  B/P rechecked 170/100 L arm sitting.  EMS notified pw 911, O2 administered per face mask.  Client c/o "light headed".  EMS VS taken 160/98 HR=98 transported to hospital, per ER RN to be released.
Soreness at injection site. low grade temp 2-3 days after the shot. Gradual radiation of pain down arm into Right elbow over a 4wk period.
This spontaneous report as received from a health care worker refers to a 41 year old patient of unknown gender. Medical history and concurrent conditions were not reported. In 2004, the patient was vaccinated with PNEUMOVAX 23 dose 1, 0.5 ml. In 07-OCT-2009 the patient received the second dose of PNEUMOVAX 23. Lot number and expiration date were not reported. No adverse experience reported. Additional information has been requested.
pt recv vax 30OCT96 & same day pt exp lt arm pain, low grade fever, & flu like sx h/a & nausea;devel a rash on lt arm;f/u from MD on day 5 or 7 faint erythema surrounding inj site w/radius of 5cm;did not see peak swelling;shoulder induratio
11/17/21 presents to EC ED for "cough, shortness of breath with exertion, fatigue, and malaise". PMHx "no significant past medical history".
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were not reported) lot # L015046, expiration date 29-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Big red spot (redness) around the area. 10/27/14 shot was given. 10/28/14 about 2 inches "area". 10/29/14 about 5 inches "area".
Side effects; injection site itching; injection site pain; injection site swollen; injection site redness; A spontaneous report was received from a consumer concerning a female patient who experienced injection site pain, injection site swollen, injection site redness, injection site itching.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 07 Jan 2021, approximately two days prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient experienced injection site pain, injection site swollen, injection site redness, injection site itching. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events injection site pain, injection site swollen, injection site redness, injection site itching was unknown.
Fatigue, Headache, Pain at site of injection, Inflammation at site of injection, Pain at site of injection Took Tylenol
Earache, swollen ear, tenderness, Spot bleeding  Took tylenol, diphenhydramine
Chest Pain and HTN (200/130) Treated with Nitro SL and Paste, ASA, ondansetron, oxycodone Dx of atherosclerosis <25% in LAD.
Information has been received from a registered nurse concerning an 87 year old male who was vaccinated with a dose of ZOSTAVAX (Merck) on an unspecified date. Subsequently the patient developed a light case of shingles after receiving ZOSTAVAX (Merck). He recovered on an unspecified date. The patient sought unspecified medical attention. Follow up information was received from registered nurse who reported the 85 year old (previously reported as 87 year old) male patient with congestive heart failure (CHF) and atrial fibrillation (A-fib) was subcutaneously vaccinated with the first 0.6 ml dose of ZOSTAVAX (Merck) (lot # 656608/0032U) on 01-MAR-2007. There was no illness at time vaccination. He developed mild rash on the left side of face and forehead but complained of significant pain on 18-DEC-2008. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. By 05-JAN-2009 the patient denied pain. He was seen by and advanced registered nurse practitioner (ARNP) and treated with antiviral medication. The patient was seen on another clinic so limited information. He recovered on approximate 05-JAN-2009. Additional information is expected.
Bitten by a bat - Believed to be rabid. Initial shots given at hospital. Received right deltoid shots on 8-13-08 - Additional shots on 8-16-08, 8-20-08 and 8-27-08 - Broke out in hives after taking shot on 8-27-08 - Left arm between elbow and wrist covered in hives described as red circular wheals, near location of the bat bite. Told to take Benadryl.
PT IS COMPLAINING OF PAIN SHOOTING DOWN HER ARM TO HER PINKY.  STARTED ABOUT 2 HOURS AFTER THE VACCINE WAS GIVEN
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Severe muscle spasms and tremors throughout body continuing 19 days after first dose. Joint paint still happening occasionally.
EXTREME PAIN AT INJECTION SITE -- IMMOBILIZED ARM FOR 3 DAYS.
This spontaneous report as received from a healthcare worker (medical assistant) refers to 4 unspecified patients of unknown age and gender. On 11-NOV-2014 the patients were vaccinated with PEDVAXHIB, (lot#, dose, dose# and route unspecified) that were exposed to temperature outside the proper storage range. No adverse effect reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
On 8/15/14 one of our clinic nurses noted an extra MENVEO diluent in the box. 4 doses of this vaccine were given 8/14 by 3 different nurses. On 8/15 research was done on times vaccines were given as to know the 4 clients who may have rec'd powder only. This client was one of the four. No nurse working 8/14 could 100% recall whether they gave the vaccine in error (possibly using sterile diluent rather than diluent supplied to give it for example). All four client were notified by supervisor and recommended to revaccinate as soon as possible at no cost to them. Plan is to now band all vaccines together that come with a separate diluent and double check meds before given as to prevent this error in the future.
low grade fever; cold; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Patient got his 1st COVID vaccine and he knew it was supposed to be 3 weeks later, but the doctors scheduled him 5 weeks out so he wanted to know if that was okay, or if he would have to reschedule it. The patient had a low-grade fever and a cold, but he was able to get the second dose of the vaccine. The outcome of the events was unknown.  Follow-up (27Feb2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (26Feb2021): New information reported from a contactable consumer includes that the patient had a low-grade fever and a cold. The previous item was considered invalid as there was no adverse event. Upon receipt of current item, this case now contains all required information to be considered valid.
1. Immediately following the first dose of Moderna covid vaccine on 9/11/21 I started menstrual spotting. It happens two weeks after the last cycle (when I should be ovulating) and has not stopped occurring even today 1/18/23, over a year later. Never in my life before the vaccine had I experienced spotting of any kind. There were no other changes in my life. 2. After taking the vaccine (especially after the second dose on 10/10/21) my immune system became weaker. I did not usually get sick more than once a year, and after the vaccine I was becoming sick 1-2 times per month despite changing nothing else and eating healthy, exercising, and being sanitary. This continued until a couple of months ago, but I still get sick more than I did before.
Flu vaccine inadvertently administered by RN via IV route, not IM MD notified, per progress note:  "Patient reported having some tingling sensation in her bilateral toes and also reported having back pain.  She denies any swelling of her face, perioral tingling, difficulty breathing, chest pain or palpitations.  Denies any other symptoms.  Vital signs are stable on room air.  Patient was given 1 shot of Dilaudid to help with the pain.  Patient reports feeling better after 1 hour.  Cardiac monitor attached.  We will continue to monitor this patient.  Poison control has no specific recommendations other than supportive management.  Discussed with in charge nurse on the floor.  We will continue to monitor closely."
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-JAN-2013 ZOSTAVAX (lot# H0111048 / expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot# E010687 / expiry date February 2012)(subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573; 1303USA003575 and 1303USA003576 (same reporter link). Additional information has been requested.
Severe headache, muscle weakness, pain in joints - hands and feet, lower back pain, and sweating.