chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she cut her hand open by accident a week after the first shot.; This is a spontaneous report from a contactable consumer or other non hcp (consumer).   A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267) via an unspecified route of administration on 26Feb2021, left arm as 1st dose, single dose (at 39-years-old) for COVID-19 immunization. The patient's medical history included ankylosing spondylitis, Hashimoto disease, autoimmune disease. The patient's mom had a heart condition and they tested her and her heart was good. The patient's concomitant medication included tetanus vaccine on right arm. The patient previous vaccine included flu vaccine for immunization and experienced Guillain-Barre syndrome. She had a flu shot, she did get Guillain-Barre, so she was a little skeptical of the Covid shot, she was told it was safe. She did get Guillain-Barre, it was very mild, they thought she would be ok with this one. It was mentioned that the patient required emergency room and physician office and patient received vaccinations prior (within 4 weeks) to the first administration date of the suspect vaccine. On an unknown date in May-2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative and streptobacillus infection: negative. On an unknown date the patient cut her hand open by accident a week after the first shot. It was in between the first and second shot. She remembered she was pissed off because she cut her hand open and she asked if she was allowed to get it and they said better get it than not. She got it 04Mar2021 at the hospital because they had to stitch up her hand. She got it in her right arm because she cut her left. The outcome of event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
RLQ abdominal pain; less intense now than when it began but it still persists. We recommend that they be evaluated in an ER because this a/e is not common with the vaccine and there is need to rule out other causes of patient's symptoms such as appendicitis or other abdominal emergencies. Pt went to see doctor today as we rec'd and MD thinks is gallstones and patient will be having an ultrasound tomorrow.
9 days post immun, pt had temp 102, rash/achiness lasting x 2 days; now appears recovered;
rashes on upper torso; Headache; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes on upper torso), HEADACHE (Headache) and PYREXIA (Felt feverish) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Felt feverish). On 01-May-2021, the patient experienced RASH (rashes on upper torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 21-Apr-2021, HEADACHE (Headache) and PYREXIA (Felt feverish) had resolved. At the time of the report, RASH (rashes on upper torso) outcome was unknown.            Concomitant product information was not provided.   This case was linked to MOD-2021-101557 (Patient Link).
The first dose, I felt completely fine, just a sore arm.  The second dose, I felt very run down for 3-4 weeks afterward and forgetful.  On 3/28/21 at 0930 I developed sudden cardiac sx (chest pressure radiating down my left arm and dizziness to the point of nearly losing consciousness). I was transported to the ER via ambulance with Tachycardia and HTN.  While in Hospital emergency room, I had one run in the ER that they caught on strip and as a result, I was dx w SVT and d/c to home and to follow up with my PCP the next day.  Which I did and was prescribed Cardizem for when I had episodes. The days following the initial episode I had several episodes that negatively impacted my daily life, work (I couldn't work) and family. I could barely function. I was taking cold showers every couple of hours to elicit a vagal response to bring my heart rate down and manage the chest pain. The episodes would suddenly come on, without any precipitating events/stressful situations. They would begin with intense dizziness to the point of nearly passing out, sitting or standing and then I would feel my heart racing in my chest.  Out of complete and utter exhaustion, I went to ER on 3/31/21 and kept overnight observation.  While at ER I was told it was not SVT but sinus Tachycardia.  I was d/c to home on 4/1/21. The 2 weeks following being discharged from hospital, I had worsening, persistent, brain fog/memory impairment.  I had a Zio patch that found sinus rhythm.
April 7,2009 employee came in to clinic reporting right arm where tdap was adminstired for the last week was red, swollen,and painful at site of injection with tingleing down her arms to fingers for the past week. No signs of reaction at present time. Patient stated took Ibuprofen through out pass week. Recommend ibuprofen prn
Bloody diarrhea for nearly 6 days after second injection. Blood tapered off after day 6 but is still occurring.
Within a weeks time we had to take her to the emergency room for severe abdominal pain. Her plight has been virtually chronic ever since. We have had multiple encounters with medical professionals who have been left dumbfounded by her symptoms if muscular fatigue, abdominal pain, hot and cold flashes, headaches an back pain. Has caused missed school which resulted in alternative education, and missed work for parents.
Evening of vaccine and most of following night, I had severe diarrhea, continuing into next day. The day after that, I could not hold food down and still can?t.
Patient is outside of the age range, but was overdue to complete vaccination series. No other adverse reactions reported.
Client describes having significant redness that extended down her arm and it became swollen. This lasted a few days.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 12-OCT-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot# K008883; expiration date 20-SEP-2015) subcutaneous (dose was not reported). The registered nurse stated that this was the only dose of ZOSTAVAX that this patient has ever been administered. No adverse effect was reported. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Severely red, itchy, swollen eyes, inside and out. Took antihistamine (Claritin), NSAID (Naproxen), and flushed frequently with TheraTears.
Fatigue; Injection site pain; Runny nose; Cold-like symptoms; This is a spontaneous report from a contactable physician (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 11Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient previously took codeine and amoxicillin and experienced allergy. The patient received multivitamins within 2 weeks of vaccination. On 12Jan2021, the patient experienced fatigue, injection site pain, runny nose and cold-like symptoms. The patient took OTC (over the counter) cold medication as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect.
Volume difference in syringe from first dose and second dose; A spontaneous report was received from a consumer concerning a 69 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medication error of volume difference in syringe from 1st and 2nd dose/MedDRA PT: inappropriate dose of vaccine administered.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included tamsulosin, clonazepam, apixaban and metoprolol.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) on 13 Jan 2021.  On 10 Feb 2021, approximately 29 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported that he was told by one person at the facility that both doses were the same; however, he reported that the person who administered the second dose told him that the second dose was a lot higher than the first dose because it was a booster dose and that she showed him the volume difference in the syringe from the first dose and what she would be administering.  The patient reported that the amount in the syringe for the second dose was significantly more, but he did not remember the amount from the syringe.  The patient was told by a third person at the facility that both doses were the same.  The patient did not experience any side effects yet but was concerned and confused if he received a potential overdose.  Treatment for the event included none.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was resolved.; Reporter's Comments: This is a case of 69-year-old male patient who was administered volume difference in syringe from 1st and 2nd dose (inappropriate dose of vaccine administered) for mRNA-1273 vaccine Lot # 041L20A. There was no associated adverse event reported for the event of inappropriate dose of vaccine administered.
Significant joint and muscle pain x 2 weeks + weeks from left side of neck, shoulder, hip, foot.  All left side of her body.
I experienced soreness in the arm where I received the vaccines the night I got them. The pain was excruciating and I could not lift or move my arm that night and I also could not sleep. My entire body was sweating and then I was freezing and couldn't get warm. I experienced soreness for the next 3 days. My armpit was very sore as well. On day 4, I notice a lump/swelling in my armpit with pain in my shoulder and radiating up to the left side of my neck. The soreness of the arm has subsided, but the lump in my underarm has not.
Erythema at injection site and spread distally down (R) arm fever 101.9 achy flu like 10/20/18 10/22 red raised warm blotches over (R) upper arm fever 10/21 started antihistamine RTC for hive like lesions.
pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for Allergy.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product included birth control (unspecified) medication taken daily via oral route from 1995. No treatment medication reported by reporter.   This case was linked to MOD-2021-405454, MOD-2021-407018 (Patient Link).
About 1 month after second dose, a very sudden onset of memory loss.   MRI of brain was normal.  Both neurologist and neuropsychologist determined mild memory loss.
Pain in arm started about a half hour after shot was given. Then about 2 hours after shot there was a burning sensation and tingling down arm into the fingers. It is now 18 days later and my arm is getting worse. There's still burning, tingling and numbness down my arm into my fingers. My arm feels heavy.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfur drugs) and Heart disorder. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), METOPROLOL TARTRATE (LOPRESSOR), FUROSEMIDE (LASIX [FUROSEMIDE]), METHENAMINE HIPPURATE (HIPREX [METHENAMINE HIPPURATE]) and GABAPENTIN (NEURONTIN) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-393117, MOD-2021-393118 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Non-Significant Follow up received on 24-Nov-2021 which contains updated contact information. On 06-Jan-2022: Follow up received on 07-Jan-2022 included: Patient demographics, Medical history, Concomitant medications, Vaccine start date and Lot Number were updated.
Mother called to report large "boil" on thigh where HIB/HEP administered. Area with increased redness. Rx'd Augmentin and Benadryl per MD.
Guillain-Barre symptoms including extreme weakness in legs, vertigo, overall body weakness and fatigue, difficulty swallowing.  Doctors did not know what was wrong with me at first, ruling out MS and spinal cord issues with MRIs. On 6/23/2021 Dr. examined me and found that I had no reflexes. On 6/24/2021 Dr. also examined me and found the same lack of reflexes. Both doctors communicated this to my neurologist Dr. who ordered 7 rounds of plasmapheresis. I felt a little better during this process which lasted 2 1/2 weeks (every other day excluding weekends) but two days after the last treatment all of my GBS symptoms came back.  I am now worse than ever
Patient was accidentally given an undiluted dose of Pfizer vaccine, bottle was new.  No adverse events or symptoms reported at this time.
half of face is paralyzed; vision blurry and can't see; eyes hurt and are burning; eyes hurt and are burning; vision blurry and can't see; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation (reported as does not want to die) in Pharmacy. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Lot number: W0L61 or W0161) at age of 57 years old on 18Apr2021 at right arm for Covid-19 immunization. Caller state she received the first and second shot Covid. Clarified that she is referring to the Pfizer Covid vaccine. She got the shot last Sunday, a week ago. Patient experienced half of face is parlayzed: States that it is the left side or the right, she doesn't even know any more. It started the same day she got the vaccine, last Sunday 09May2021. It is getting worse. No treatment (nothing) for it. Also reported hard to read (lot number) because her eyes hurt and are burning. Caller states that she cannot see and that her eyes hurt very bad and they are burning. She cannot see and her vision is blurry (all on 09May2021). Wanted to know what to do. Outcome of the events was not recovered.
Fever, swelling of arm. This lasted for a week. Assessed by MD and told there was no concern. Patient had this same vaccine last year with no side effects.
pt recv 2 doses of vax & it was reported that DEC96 and FEB97 pt varicella antibody titer revealed a borderline result of 1:4;4wk later pt was retested & it was determined that the pt was non-immune;
13FEB92 pt was given MMR/HIB; MD was called & told pt was in the ER w/t104 & sz;
traumatic death; palpitations; weight loss; His teeth changed colors within a few months of receiving the vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL DEATH (traumatic death), PALPITATIONS (palpitations) and WEIGHT DECREASED (weight loss) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not had relevant medical history/conditions, allergy, concomitant diseases and risk factor. No previous COVID-19 diagnosed.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL DEATH (traumatic death) (seriousness criteria death and medically significant), PALPITATIONS (palpitations) (seriousness criterion medically significant), WEIGHT DECREASED (weight loss) (seriousness criterion medically significant) and TOOTH DISCOLOURATION (His teeth changed colors within a few months of receiving the vaccine.). The patient died on 23-May-2023. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, PALPITATIONS (palpitations), WEIGHT DECREASED (weight loss) and TOOTH DISCOLOURATION (His teeth changed colors within a few months of receiving the vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. She stated that an autopsy was done upon the death of her father. However, the results of the autopsy did not show any significant medically related cause of death.  Treatment details was not reported by the reporter. Company comment This spontaneous case concerns an 86-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of weight decreased and palpitations; unexpected, serious (fatal, medically significant) event of accidental death (reported as traumatic death). The events occurred after the first dose of mRNA-1273. It was reported that soon after he received the first dose, he started experiencing heart palpitations, extreme weight loss and could not get up. It was reported that the vaccine destroyed the patient's health from day 1. His teeth changed colors within a few months of receiving the vaccine. It was reported that the patient died approximately 2 years after the vaccine and an autopsy was performed, however, the results of the autopsy did not show any significant medically related cause of death. No further clinical information was provided for review. The patient's advanced age could be a confounder for accidental death. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: Unknown cause of death
Dizzy; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8730) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetic. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 07Apr2021, outcome "unknown", described as "Dizzy"; PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter reported that, the patient was dizzy and had a sore arm.  Reporter suggested patient to take one Tylenol. No further details provided about whether her husband took a Tylenol or not. Reported stated that, the patient was diabetic, which he was under control. The reporter stated the patient had a medication prescribed to him for his diabetes, but no new medicines. The reporter stated that the patient hardly takes the diabetic medication as it was controlled with diet, his blood sugar was under 100. Reporter stated patient blood sugar did not go up when he got the vaccine, like they know other diabetics that did. Reporter stated that the patient blood sugar goes maybe up to 125 if he eats a cookie once in a while, but he stays away from those things. Reporter stated that his sugar stayed low, like 90, when he got home. Reporter stated that one friend of theirs, his sugar skyrocketed, and he takes insulin. Reporter stated patient takes a pill if his blood sugar was higher than 130, which it hasn't been in a while. Reporter stated that their friend's blood sugar rose to 480 something, reporter was scared when patient got his vaccine  No follow-up attempts are possible. No further information is expected.
Soreness in body; Congestion in nose; Congestion in throat; Nausea; Itching in random spots on body; Headache; just overall felt terrible.; Soreness in neck area; Soreness in injection arm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included Localized epidermolyisis bullosa simplex from an unspecified date. Concomitant medications included terbinafine (LAMISIL), ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; ergocalciferol; iron; nicotinamide; pyridoxine hydrochloride; retinol; riboflavin; thiamine hydrochloride; tocopheryl acetate (CENTRUM) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient experienced soreness in injection arm, side and neck area. On 02Apr2021 the patient experienced a headache and nausea and just overall felt terrible. Over the next few days, soreness in body, congestion in nose and throat, and itching in random spots on body. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of neck pain, general body pain, nose congestion, throat constriction, nausea, painful arm, itching, headache, feeling miserable was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.