chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave a 0.25ml dose from the wrong vial (blue cap with a purple border); No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)).    No concomitant medication was provided.  The patient (child below 5 years) was given 0.25 ml from a vial that was meant for children 6 to 11 years old or as a booster dose to adults. The vial has a blue cap and a label with a purple border, not a magenta border. Treatment information was not provided.  This case was linked to MODERNATX, INC.-MOD-2022-637090 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637090:Crosslinked case CMOD22-03640
Lost her voice; Could not eat; Productive of light green mucus; Very weak; Could barely walk; Nauseous; Chills; Was throwing up; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak) and GAIT DISTURBANCE (Could barely walk) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumothorax. Concurrent medical conditions included Asthma.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak), GAIT DISTURBANCE (Could barely walk), NAUSEA (Nauseous), CHILLS (Chills) and VOMITING (Was throwing up). The patient was treated with CEFDINIR for Adverse event, at a dose of 300 milligram; PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency and IBUPROFEN for Fever and Chills, at an unspecified dose and frequency. At the time of the report, APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak), GAIT DISTURBANCE (Could barely walk), NAUSEA (Nauseous), CHILLS (Chills) and VOMITING (Was throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Body temperature: 100 (High) fever (99-100. something). On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) Covid-19 test was negative.         Medical history included unspecified disability. Reporter reported that On 09-Aug-2021, she consulted with her primary doctor and she was given a steroid and antibiotic shot.
A few months after receiving COVID vaccinations I developed swollen lymph nodes under my chin, which has progressed to my inguinal nodes and more nodes on my neck.
SHE LEFT THE AREA AND CAME BACK SHORTLY WITH RASH. THIS IS HER FIRST DOSE OF COVID VACCINE. ONSITE EMS REPSONDED.  BENADRYL WAS GIVEN.  BP 146/86  HR 86  O2 100% ON ROOM AIR.  SHE RECOVERED AND WENT HOME
Minor pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor pain at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Minor pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Severe Migraine day after with recurrence on day 3 then  recurring headaches since. This also happened with doses 2 and 3.  Also with  this vaccine I had severe pelvic floor (vaginal/bladder?) pain with urgency the day after that lessened over 3 days then was gone.
She had a little pain in the arm when she received one of the 4 shots she has had of the Pfizer-BioNTech.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a little pain in the arm when she received one of the 4 shots she has had of the Pfizer-BioNTech.".  Additional information: It was reported that patient wanted to know if it would be possible to experience some adverse events days after receiving the Bivalent formulation. She mentioned that she has already received 4 shots of the Pfizer-BioNTech Covid 19 Vaccine. But she was concerned that the new Bivalent formulation might contain Doxycycline. She wants to know if this antibiotic is part of the ingredients of the bivalent formulation. She had a little pain in the arm when she received one of the 4 shots she had of the Pfizer-BioNTech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax 14APR92 & devel fever & achiness; lab eval in NOV92 revealed anti-HBs 7.4; lab eval on 26MAR93 revealed anti-HBs 1.9; No further details were provided;
Not an adverse reaction. Medication Error Vaccine for 18 and older given to 16 yr old.
client said he felt light headed for a bit , he said it might be because he didn't sleep well.
Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Slight fever".  Additional information: Patient's mother reported that the adverse reaction to the Pfizer COVID Vaccine. While providing information caller stated that her husband and daughter got it. Her husband didn't have symptoms. Her daughter had slight fever. Caller wasn't expecting this at all. Reporter declined to go through a report for her daughter because it was minor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Over 3-1/2 hour time period after receiving vaccine, developed cough, burning sensation in eyes, throat tightness, facial itching, dizziness.  Reported to Employee Health Center where she was given diphenhydramine 25 mg.   Temperature 98.7, pulse 64, BP 130/70.  Referred to walk-in clinic for medical evaluation and  treatment.
Patient felt faint and she sat on the ground on her knees. She was pale and clammy. VS normal. No LOC. Patient has history of fainting when getting blood drawn. She felt better after resting and water.
Mother stated that the child had said the shot had really hurt when given.  When child awakened on 08/12/2010 injection site was swollen from shoulder to elbow and hardened from shoulder halfway to elbow.  Encouraged to speak with health care provided.
Extreme arm pain, muscle soreness, started at the injection site (left arm) and traveled down the arm into the wrist, pain has not subsided since injection.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 2:45 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Fever; aching body; congestion; headaches; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number EL3302), via an unspecified route of administration, administered in Arm Right on 13Jan2021 at 19:00 as a single dose for covid-19 immunization at nursing home/senior living facility. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Jan2021, the patient experienced pyrexia, aching body, congestion, and headaches. On 27Jan2021, the patient had nasal swab test for covid-19 and results are pending at the time of report. The patient also reported that she had to visit the doctor due to the events. No treatment was received for the events. The outcome of the events was reported as not recovered.   No follow-up attempts are possible. No Information for the lot/ batch cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 04-FEB-2013 the patient was vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The healthcare worker reported that patient received a dose of CERVARIX in April 2011 and a dose of GARDASIL on 04-APR-2013. No adverse effect reported. Additional information has been requested.
Following 15 minute observation period the patient stood up and complained of ?heaviness of the head and numbness of the lower extremities? from the knees down. The patient denies SOB, CP, palpitations, hyperhidrosis. PMH includes hyperthyroidism and anemia. The patient was sat down, given water and orange juice to drink. Vitals checked - normal. Normal gait. PERRLA. Even smile, no tongue deviation. Upper extremity strength testing 5/5. 4/5 weakness on flexion of the BIL hips, knees and ankles.  Following observation for an hour her symptoms were improving but did not resolve. She was able to ambulate without assistance. I recommended she visit the ED as her symptoms persist, which she did not want to do. Told her to follow up with a PCP then. She went home with her husband who drove her.
Patient presented to the pharmacy on the fourth day 8/18/18 complaining of and visibly noticeable red inflamed painful and itchy patch around injection site as well as swelling that radiated to the whole upper arm. The patient also stated that she had fever. The patient was advised to go to urgent care immediately. During the follow up conversation over the phone, the patient explained that urgent care gave her a prescription for cephalexin 500 mg, 3 times a day for 7 days. She said that she felt better that same evening - her fever, swelling, itchiness resolved and pain substantially subsided.
Sore arm , chills, body aches, nausea, diarrhea, fatigue. 72 hours
Rapid fast rate for about 7 hours starting at 1:00am the day after vaccine dose 7/23/21.  .  has been experiencing milder episodes of fast heart racing about 2-3 times a day  on 7/23,7/24/,7/25, and once today 7/26 Shortness of breath (started at 1:00am, felt better around 10:00am) has experienced once more on 7/24 shortness of breath  Chest pain left side started at 6:00am on 7/23/21 and  lasted for one day  Nausea  (zofran was given at  emergency to treat his nausea)  Tiredness still until today 7/26/21
60 yo female s/p Prevnar 13 vaccine c/o severe pain at injection site with twitching of arm muscles.
A little over a month after receiving the Pfizer Bivalent vaccine, I experienced a head tremor. I would explain it as being able to feel my heartbeat in a different way. I told my husband that I felt that my head was shaking and he agreed that it was. It started as slow large beats and progressed to small and fast. At times I am able to stop them when they happen and sometimes I cannot. If I do stop them, they come back pretty quickly. They are not painful. I contacted a nurse practitioner and she requested to get an MRI and to see a neurologist. I had to get an MRI for my brain and neck. I had the MRI's completed, and the results were a little confusing for me. The first person who read the MRI's, noted there was a spot on my brain and a lesion on my spine. The second person who read the MRI told me about the spot and lesion but was not worried. I'm seeing a neurologist on 01/10/2023 and I'm hoping that she will be able to provide actual, correct answers to me. I also tested positive for COVID-19 on 11/21/2022, but my symptoms started on 11/18/2022.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L035105, expiration date 17-MAY-2017 (dose, dose number, route and anatomical location were not reported). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
07/30/21 @20:00hrs = 1st dose/ 0 complications.  07/31/21 (2nd day/night) = 0 complications. 08/01/21 (3rd  day/night) = 0 complications.  08/02/21 (4th day, @0500hrs) = Extreme Exhaustion, even with 7 hrs of sleep prior to waking up.   The feeling is very similar to taking too much Melatonin or Benadryl.  Sleepiness, exhaustion, eyes burning, yawning, etc.
injection site pain; Very sore muscle pain in left arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer-BioNTech Covid vaccine, lot EL3249), via an unspecified route of administration in the left arm 22Jan2021 11:00 at SINGLE DOSE for Covid-19 immunisation. Medical history includes diagnosed with COVID-19 prior to vaccination. She was taking Daily women's vitamins within 2 weeks of vaccination. The patient experienced injection site pain, very sore muscle pain in left arm on 22Jan2021. No treatment was given. The outcome of events was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In September 2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On or about 18-JAN-2017, the patient was treated by a physician for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Patient rep reported swelling after flu shot. We gave her an ice pack and left a message to follow-up. I called patient on 12/12 & he reported swelling better but area is puffy. Patient did not feel as if MD visit is necessary.
The next day after my left arm got really swole and it begin to tingle.  I reached out to my PCP who advised I see a Specialist and gave an Anti-inflammatory but it did nothing.  A couple week later around 2:30am I woke up out of my sleep with severe shakes in my chest area, my arms and hands go so clammy and I felt so anxious I couldnt sit still and was pasing back and forward.  I had the sense of feeling choked.  The shakes were so bad causing me to get up and walk around.  At 4am I went for a walk in the neighborhood because I still could not stop shaking and remain still.  I was so adjitated around 6am I got up and began to drive to the beach then all of the sudden after about 20 minutes I had to pull over because my arms from elbow down went numb and I couldn't drive.  I was still so jittery and shaky but was able to make it to the ER where I was monitor for about 5 hrs. CBC and Urinalysis were done but everything seemed normal.  For about 10 days I had that shaky feeling, tightness in my chest area and just felt really crappy.  My PCP perscribed a few different Anti-anxiety meds but I had  an allergic reaction to those so I could not take any of those either. I have an appointment with the Neurologist  7/26.
Covid Diagnosis 15Oct2021; Covid Diagnosis 15Oct2021; This is a spontaneous report from a contactable other hcp. A 14-Year-old male patient received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 09Jun2021 16:00 (Batch/Lot Number: EW0185) (age at vaccination 13 years) as dose 2, single and via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0187) (age at vaccination 13 years) as dose 1, single both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior vaccination, the patient has not been diagnosed with COVID-19 and Since the vaccination, patient has been tested for COVID-19. On 15Oct2021, patient experienced Covid Diagnosis 15Oct2021. Seriousness of the event was medically significant. Adverse event resulted in physician office visit. The patient underwent lab tests and procedures which included PCR: positive on 15Oct2021 (Nasal Swab). The patient did not receive any treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Developed rashes on wrist/lower arm (right arm), right buttocks, minor rashes on left arm, forehead, thighs. Rash on right wrist developed into blisters. Only minor itching associated with rashes. Have not contacted Dr., but will call shortly to let her know. I don't believe it requires treatment. Concerned that this side affect wasn't indicated and little information available online about it. I consider myself healthy and with a strong immune system. Also concerned that I will get this reaction with 2nd vaccine, though not enough not to receive it.
Information has been received from a medical assistant referring to a 5 month old female patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Approximately 10 days after second Pfizer Covid 19 vaccine dose, I had an extremely heavy period unlike any period I?ve ever had. I had to stay home for several days because of how unusually heavy it was. The period also lasted much longer than my normal period. I was so worried about the intensity of this cycle that I called my GYN and went in for a visit. She performed a Pap smear, blood test, and ultrasound of my ovaries and uterus. Everything came back normal and my GYN said the cause of my abnormally heavy period was unknown. It wasn?t until I saw a news report of other women having changes in their cycles that I thought what I experienced might be related to the Covid vaccine.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Varivax (lot# 652557/1024R). Subsequently, the patient developed an abscess at the injection site. Follow up information from the registered nurse indicated that the patient was vaccinated with a dose of Varivax (lot # 649994/0553R). Two other patient's (WAES# 0603USA01435 and 0603USA01451) had a similar experiences following vaccination with Varivax (lot #649994/0553R). The reporter expressed a concern with the lot. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
fever shaking chills body aches over the last 20 days she has lost 17lbs, doesn't have an appetite nausea