chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age who on 01-JUL-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot # 667912/0933Z) (dose and route not reported) that was expired. It was reported that the expiration date on the vial label was smudged and illegible. The vaccine expired on 25-Feb-2012, this date was obtained from the Order Management Center. No adverse effects were reported. A PQC was involved. The pharmacist reported that the affected vial had been previously opened, and that multiple doses have been withdrawn from the vial. No outer packaging remained with the vial. The expiration date on the label was smudged and illegible, the pharmacist stated that she did not whether that occurred prior to receipt of the vial by the pharmacy or during storage, handling and administration of the product. Primary vial label was affected. It was reported that lot number was legible, expiration was not legible. No other vials from the lot were available to check. No boxes were available to check the affected vial contained lot number 667912/0933Z. The product was received "a long time ago". Crimp and stopper of the multidose vial looked intact and appeared as they normally do; doses of vaccine had been administered previously. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 034F21A, 0071321A and 002M20A) for COVID-19 vaccination. The patient had no any allergies. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2022, the patient experienced COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant product reported by reporter. Agent asked if they had previously received a Moderna Covid 19 vaccine and caller stated they both did. Patient received 2 primary series and 2 booster doses. No treatment medication reported by reporter. Company comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID 19. The event occurred approximately 4 months after the fourth dose of mRNA-1273. As reported, the patient tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-638959 (Patient Link). Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID 19. The event occurred approximately 4 months after the fourth dose of mRNA-1273. As reported, the patient tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient required hospitalization for COVID-19 after receiving  2- Moderna vaccines plus one Moderna booster
pt recvd vax;exp a vasovagal rxn p/ engerix;no true LOC & no sz activity;felt fatigue;2nd dose given w/out incident;
Right after I got the injection I felt my right hand tingle. I assumed it was because I was squeezing it so I dismissed that. However later around 7:45 my right side of my face felt like it would if I had gotten nova Caine and was wearing off kind of tingly but my face moves fine. I then read that other hospitals stopped the injections because of something possibly  like this and I did begin to worry.  The sensation is not strong it is only on my right side. My face moves ok just feels like when your foot goes to sleep but very mild .
He received the pnemococcal vaccine Feb 24 at 4 pm. He had a headache and severe back and stomach pain February 24 at 6 pm. He was pain free and illness free before 4 pm nothing was wrong with him before he got the vaccine.
Received flu vaccine on 10/14/2008 while pregnant. Delivered baby girl (breech). Mother believes her daughter's learning disabilities (autism spectrum, ADHD) are related to mercury in the flu vaccine she received while pregnant. Client states has reports that document both she and daughter were diagnosed with mercury poisoning and client still has mercury in her urine.
Felt fatigue and low fever 12 hours after shot. Felt ok the next morning, and then low fever and fatigue again 24 hours after the injection. Arm sore at injection site for a week. Fever and most symptoms (other than sore arm) gone within 48 hours.
Persistant screaming/crying (over 3 hrs), injection site reaction with local adenopathy starting within a few hrs after immunization.
Had 2nd dose of SHINGRIX vaccine about 10:40 a.m. By noon I had a headache and deep shuddering, shaking shivers (much more physical than a chill). Lunch tasted off; I was not hungry. I had no appetite for dinner and what I ate tasted off. Through the night I felt fever and deep shuddering, shaking shivers. My arms and legs felt unusually heavy. I got up in the morning and did not feel well. I knew that eating breakfast would be difficult but went to the kitchen with my husband to begin making it and try to stay on schedule. I was standing at the kitchen counter slicing bananas for cereal and took one sip of orange juice when a massive wave of ill-feeling descended on me. I felt light-headed and nauseated.   I leaned over the sink to possibly vomit. I then fainted and hit my head on the cupboard knobs and the floor and was unconscious for minutes according to my husband who called 911. I was taken by ambulance to Hospital Emergency Room for treatment and diagnosis of syncope, scalp laceration, hematoma of right scalp, jaw scrape, concussion, and brain bleed (subarachnoid hemorrhage). Because of the brain bleed and possible need for brain surgery, I was transferred by ambulance to Medical Center ICU because they have neurosurgeons. Brain bleed did not worsen and brain surgery was not needed according to doctors. I still have continuous headache which varies in intensity, very sore scalp/skull, and vertigo.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: Patient stated and experience throat swelling, white ulcers in back of throat and difficulty breathing in the day following vaccination. She reported she took 2 benadryl and that resolved symptoms.
Approx 2 weeks after booster vaccination I began having hives, urticaria, and dermatographia. I completed a course of steroids with minimal relief, I was given a 2nd course of steroids, again with no change. The symptoms are well controlled with the use of antihistamines including allegra and famotidine 20mg daily. Symptoms return quickly when the medications wears off.
3x4 c 1cm tender, firm, redness x 2 days tx with ibuprofen.
Shingles; Back Pain; Back rash; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), BACK PAIN (Back Pain), RASH (Back rash) and FATIGUE (Fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer, Hypertension, Shingles and Fracture (Fractures in back). Concomitant products included LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID, LOSARTAN, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), BACLOFEN, MELOXICAM (MOBIC), VALACICLOVIR HYDROCHLORIDE (VALTREX), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), IBANDRONATE SODIUM (BONIVA), FLUORESCEIN SODIUM, LIDOCAINE HYDROCHLORIDE (LIDOCAINE & FLUORESCEIN MINIMS), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and PREDNISONE for an unknown indication.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 20-Feb-2021, the patient experienced FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced BACK PAIN (Back Pain) and RASH (Back rash). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), BACK PAIN (Back Pain), RASH (Back rash) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called 10/21/18 to inform pharmacy that the PNEUMOVAX 23 vaccine received on 10/19/18 has resulted in swelling of her arm and has now progressed down to her arm to her elbow (left arm). Taken some BENADRYL and ADVIL and has been icing and will call her doctor on Monday 10/22/18.
Felt dizzy; Very hot to touch; very bright red; sore arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), VACCINATION SITE WARMTH (Very hot to touch), VACCINATION SITE ERYTHEMA (very bright red) and VACCINATION SITE PAIN (sore arm for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included TRAMADOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, ATORVASTATIN, CITALOPRAM, BUSPIRONE and VITAMIN D NOS for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 2 days). On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot to touch) and VACCINATION SITE ERYTHEMA (very bright red). On 06-Feb-2021, the patient experienced DIZZINESS (Felt dizzy). At the time of the report, DIZZINESS (Felt dizzy), VACCINATION SITE WARMTH (Very hot to touch), VACCINATION SITE ERYTHEMA (very bright red) and VACCINATION SITE PAIN (sore arm for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   Reporter did not allow further contact
Received Hep A, PENTACEL & Flu (0.25) at 1 year PE 1/21/11. 24 hours after developed morbilliform rash ? R/T Hep A (noted as LAV (<1%) on insert for Hep A.
red, swollen arm @ inj site; hot & sore to the touch; cold compresses on site;
I contracted Covid19 and experienced symptoms of muted sense taste and smell, lack of concentration/brain fog, congestion, myalgia, fatigue,  shortness of breathe, slight cough due to congestion. I began taking prednisone for the inflammation in my sinuses to prevent it from moving into my lungs. I was prescribed and took anti-viral ( did not have prescription bottle still) by my primary care physician. My symptoms are in the process of resolving and I am feeling more like myself.
Broke out an allergic reaction with hives; Broke out an allergic reaction with hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): A male 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: URTICARIA (non-serious), DRUG HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "Broke out an allergic reaction with hives". The event "broke out an allergic reaction with hives" and "broke out an allergic reaction with hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, drug hypersensitivity.  Additional Information: coronavirus Pfizer vaccine received by one of our associates during the normal course of business. Members mother reports withheld is allergic to the Coronavirus Pfizer Vaccine son is broken out into an allergic reaction with hives that is why has gotten Dupixent.  Was aware did not want to speak with Registered Pharmacist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
balancing; like all around moving; little tired; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balancing), VERTIGO (like all around moving), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). On 03-Mar-2021, the patient experienced BALANCE DISORDER (balancing), VERTIGO (like all around moving) and FATIGUE (little tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever chills and Headache, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (balancing), VERTIGO (like all around moving), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and FATIGUE (little tired) outcome was unknown.            Concomitant medications details were not reported by the reporter.
Irregular period. June I had lighter period than normal. 07/02/2021 my period started lighter than normal. Then I had spotting. Which then turned into a period for 15 days. Went to see a doctor. Took tests and everything came back normal as far as possible STD?s. Not pregnant, no abnormal pap.   August 2021 I had my period for one day. Light spotting. 08/01/21.
Coordination disturbance, excessive diarrhea, high fever, rash and hives, hyperactivity, extreme behavioral changes.
11am - sore arm 7pm - chills/fever & chest pain 8pm  - increased chest pain 4/18 1pm - increased chest pain, fatigue, chills 11pm - unbearable chest pain 4/19 7am - leave for Emergency Room. Go from ER to Hospital. Diagnosed with Myocarditis.
Mild fever; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and PYREXIA (Mild fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (Heart condition), Thyroid disorder (Thyroid), Diabetes, Hives (Chronic hives), Immune disorder (NOS) (Immune condition), Kidney disorder (Kidney condition) and Blood pressure high (high blood pressure).    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced PYREXIA (Mild fever). In November 2021, VERTIGO (Vertigo) had resolved. At the time of the report, PYREXIA (Mild fever) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
5/11/21:  SEVERE ABDOMINAL PAIN & CRAMPING BLOATING CHILLS & ACHING 8PM  5/12/21:  ER SEVERE ABDOMINAL PAIN DISCOMFORT ON URINATION CHILLS & ACHING AT ER: CT ABDOMEN PELVIS WITH I CONTRAST ONLY/BLOOD WORK RESULT: ENLARGEMENT OF ENDOMETRIAL STRIPE/PROMINENT BILATERAL ILIAC LYMPH NODES MEASURING UP TO 1.1CM/HIGH BLOOD PRESSURE  6/1/21:   DR.  ULTRASOUND (PELVIS)  8/9/21:  DR.  SEVERE ABDOMINAL PAIN BLOATING BLOOD WORK   8/18/21:  CARE ULTRASOUND  9/20/21:  DR.  FOLLOW-UP CT  10/1/21:  DR.  CT RESULTS ? OVARIAN CYSTS, SWOLLEN LYMPH NODE MAMMOGRAM BLOOD WORK  10/8/21:  DR.  COLONOSCOPY ? NO PROBLEMS  10/11/21:  DR.  WORSE PAIN ULTRASOUND ? 2 OVARIAN CYSTS ARE BIGGER, PLUS 3RD CYST ENDOMETRIAL FLUID IN CANAL BLOOD WORK FOR CA125 & OVA1  10/21/21:  DR.  BLOOD WORK RESULTS ? POSSIBLE CANCER REFERRED TO DR. AT HOSPITAL  11/8/21:  DR.  BILATERAL OVARIAN CYSTS HIGH BLOOD PRESSURE  12/8/21:  DR. HOSPITAL TOTAL HYSTERECTOMY ENDOMETRIOSIS FOUND THROUGHOUT & REMOVED CERVIX, UTERUS, & BILATERAL FALLOPIAN TUBES & OVARIES REMOVED BILATERAL SALPINGO-OOPHORECTOMY  1/4/22:  HOSPITAL RESULTS ? NO CANCER PRESENT FORGETFULNESS CONFUSION BRAIN FOG HIGH BLOOD PRESSURE CHEST PAIN OR HEAVINESS BLOODWORK   1/10/22:  DR.  CHEST PAIN HIGH BLOOD PRESSURE BRAIN FOG FORGETFULNESS CONFUSION ORDERED CCTA REFERRED TO DR.  CHANGED BLOOD PRESSURE MEDICATION   2/2/22: HOSPITAL CCTA (HEART SCAN) ? NO HEART PROBLEMS   2/25/22:  DR.  BRAIN FOG FORGETFULNESS CONFUSION CHEST PAIN HIGH BLOOD PRESSURE ORDERED BRAIN MRI, BLOOD WORK & NEUROPSYCHOLOGICAL  EVALUATION
Had a sore arm starting around 9am. Around 3am I woke up freezing and shivering uncontrollably. This co tinued until about 7 or 8 am.  Currently At 130pm 24hrs after receiving my body aches, mild headache, and pretty tired.
Pt devel rash head to toe; 21JUN91 no fever, seen by Md on 21JUN91;
Blood pressure was low; Chills; Shaking/ shaking throughout her entire body; Given an menveo and menactra injection today; received both vaccines on left arm; This case was reported by a nurse via call center representative and described the occurrence of low blood pressure in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 26th March 2021, the patient received Menveo and MENACTRA. On 26th March 2021, 3 hrs after receiving Menveo, the patient experienced low blood pressure, chills, tremor, overdose and vaccine administered at inappropriate site. On an unknown date, the outcome of the low blood pressure, chills and tremor were recovered/resolved and the outcome of the overdose and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the low blood pressure, chills and tremor to be related to Menveo.  Additional details were provided as follows: The patient was given an menveo and menactra injection, both in the left arm which led to overdose and vaccine administered at inappropriate site. After getting the injections, 3 hours later she had shaking throughout her entire body, chills and when she went to the emergency room her blood pressure was low. The patient was not admitted. The reporter consented to follow up.
Got the shot and went to bed when I got off work and when I woke up the next morning I couldn?t move and every single one of my joints felt like the were stuck and would not move without extreme pain. I was stuck in the same position I went to sleep in my other half had to roll me in and out of bed and carry me to the bathroom and this continued for three days and intermittently now ever since the first and last dose of this vaccine!!!
Chills; I get really bad for hours during the day and during the night.; Cannot get out of the bed. I am so cold; This is a spontaneous report from a contactable consumer (patient).  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EN6204), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP6955) at the age of 63-years-old as single dose for covid-19 immunisation.  Medical history included diabetes, hypertension and chronic obstructive pulmonary disease (COPD) from an unknown date. The patient's concomitant medications were not reported.  The patient stated she had the Pfizer vaccine on 05Mar2021 and 25Mar2021 and she did not have any soreness or any kind of reaction. But since during the last 2 weeks in Apr2021 it started where she had chills, really bad chills, she was not running fever. But she got really bad for hours during the day and during the night. She cannot get out of the bed. she was so cold. She asked if that could be from the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient had fever, entire arm turned red, hot to touch, and painful. Patient received antibiotic shot and prescription Bactrim to take by mouth.
Sore arm/arm is still a little sore; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6742), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Oct2022 at 20:00, outcome "recovering", described as "Sore arm/arm is still a little sore"; CHILLS (non-serious) with onset 13Oct2022 at 20:00, outcome "recovered" (14Oct2022). Therapeutic measures were not taken as a result of pain in extremity, chills.  Additional information: No prior vaccination for COVID-19. No post vaccination if the patient tested for COVID-19. No known allergies and other medical history. Sore arm and chills starting approximately 9 hours after vaccination at 20:00. The arm is still a little sore but the chills went away overnight on 14Oct2022. The outcome of the events was reported as recovering.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325922 same reporter/patient, different AE/dose;US-PFIZER INC-202101578176 same reporter/patient, different AE/dose;US-PFIZER INC-202200792194 same reporter/patient, different AE/dose;
Significant pain in days following the administration of vaccine. Pain has continued for 12 days following and is still significant on day 12 although slightly better. Pt also now has pain in jaw on same side. Not sure if related.