chrisvoncsefalvay/vaers-outcomes huggingface dataset:
running a fever of 102F; First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021; hurting all over; left arm was sore where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hurting all over), PYREXIA (running a fever of 102F), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F214 and 93893) for COVID-19 prophylaxis.     Concurrent medical conditions included Sinus headache (has kind of been complaining of having sinus headaches and stuff), Depression (taking pills for a while now), Anxiety (taking pills for a while now), Throat discomfort and Swallowing difficult.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021). On 13-Dec-2021 at 2:30 AM, the patient experienced PYREXIA (running a fever of 102F). In December 2021, the patient experienced PAIN (hurting all over) and VACCINATION SITE PAIN (left arm was sore where he got the shot). At the time of the report, PAIN (hurting all over), VACCINATION SITE PAIN (left arm was sore where he got the shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 04-Sep-2021 and second dose on 12-Dec-2021) outcome was unknown and PYREXIA (running a fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Negative) Negative and (Positive) Positive. In December 2021, Body temperature: 102 102F.         Concomitant medications included patent has been taking unspecified pills for a while now for his depression and anxiety.  Caller stated that it has been a while, she thought at least 6 months because patient and his girlfriend they got tested twice. The first time patient was negative and his girlfriend had the virus, but then patient had it with no symptoms. Reporter was probed if her son's girlfriend had the vaccine, she responded saying that she did not think she got the vaccine.  Treatment medication was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
papular rash, extensor surfaces of arm & legs plus erythema of 1/2 of ears & all toes p/1wk;rash is maculopapular, ears peeling toes still erythematous;
the size of a naval orange; site became hard; site became swollen about the size of a cherry tomato; soreness at the injection site; red; Itching at the site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (site became hard) with VACCINATION SITE MASS (the size of a naval orange), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site). At the time of the report, VACCINATION SITE INDURATION (site became hard), VACCINATION SITE SWELLING (site became swollen about the size of a cherry tomato), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itching at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID-19 Vaccine  Pt received first dose of vaccine in December and states that she only had a sore arm. She received second dose 1/13/2021 at 0813 and had no side effects. Around 1500, she developed chest pain and wheezing. She used her albuterol inhaler (pt has asthma), which helped. That night, she developed a sore arm.  She woke 1/14/2021 around 0100-0200 from pain and was unable to go to back to sleep. She had aching in her left arm, as well as shooting pains through her arm and into palm. She took APAP 1000 mg PO x 1 and doxylamine which helped, but she was still unable to go back to sleep d/t pain. The pain expanded into her chest (especially with deep breaths), and upper back. She developed headache, sore throat, sweats and chills, shooting pain in her ear, painful and swollen left axillary lymph node, and the right side of her tongue became numb (numbness subsided after 1-2 hours). 1/14/21 morning, pt has persistent left hand pain, as well as joint pain in her feet, hips, and knees. She took another 1000 mg of APAP, which helped her pain. by 1/14 evening, she took 1000 mg APAP again and was able to sleep, although pt still endorsed sweats/chills.  1/15: Pt reports her pain is better, less severe, though now she is very fatigued and feels like she has been "hit by a truck". Her left axillary lymph node is still painful and swollen, but less painful than before.
Information has been received concerning a 75 year old male with no pertinent medical history, who on 22-OCT-2007 was vaccinated IM in the right deltoid, with a second dose of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U) (first dose administered in 1999). There was no illness at the time of vaccination. On 23-OCT-2007, at 8:00 am, the patient developed "swelling, edema, hyperemia were significant, tenderness minor." Treatment included quinolones (manufacturer not specified) for 5 days, and the patient recovered within 3 days. Additional information has been requested.
Leg pain, cramps, numbness in hands and feet, dizziness, high D dimer.
Injection was very high in my shoulder. Have been unable to raise arm or sleep due to pain.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received first dose of Pfizer COVID vaccine. Several minutes later, patient felt faint, got up to inform family to inform pharmacist, and fell to the ground
Patient given Varivax 7/5/00. He was exposed to sibling with active chickenpox from 11/1/00-11/5/00. The patient was seen on 11/21/00 with active chicken pox. He had approximately 150-200 lesions.
Started getting little tiny bumps in random places on my body that would itch extremely and then look like a hive but it went away in about 20 minutes.  Then it might be on my foot or back and do the same thing.  Had a low grade fever and started getting fever sores on my lip and took Valtrex.
Headaches, cough, extreme tiredness, congestion in head and chest for 5 days
Per 6/10/02 After hours dictation, dad states child very fussy and cried  for about 1.5 hrs after receiving the shots, but then took a bottle and laid down for 1.5 hours nap. when he awakened he appeared very pale and somewhat listless. He was reported to have a weak hand grasp and slightly less responsive than normal. He did focus and track according to Mom. Dad laid his head upon child's chest and felt his heart was beating very fast and unable to count. This episode lasted five minutes at 6;45 pm
Redness, itching, soreness, and swelling noted AM 8/9 after vaccine given in afternoon 8/7/06. Hot and nauseated off and on 8/9 and 8/10/06. Measured in ofc 8/10 at 13:30 5.5 x 8 cm red, indurated, (size decreased from yesterday per pt) 132/78 &98.4 by 8/18, only slight itch remained and down to 1cm red area.
Diarrhea and vomiting more than 10 times over 4 hours. Headache, redness and swelling at injection site. Body aches, fever and chills lasting more than 7 hours.
Approximately 5-10 minutes following administration of influenza vaccine, pt. experienced nausea; did not vomit, but observed dry-heaving. Symptom lasted approximately 10 min, then subsided completely. Called 12/09/10 - states no further problems; will mention to PCP when goes.
swollen; itchy; Huge rash on right hip almost down to the knee and spreading to the other leg; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg). At the time of the report, SWELLING (swollen), PRURITUS (itchy) and RASH (Huge rash on right hip almost down to the knee and spreading to the other leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported.
From the first day of getting the vaccine I can taste it in my mouth and nose . Taste is more profound in my nose after cycling
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 13:30 as dose 1, single (Lot number: EL9262), in left arm, on 04Mar2021 at 13:00 as dose 2, single (Lot number: EN6205), in left arm, on 24Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 05Apr2022 at 10:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 13Sep2022 at 10:00 as dose 5 (booster), single (Lot number: FM0698) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic fatigue syndrome", start date: 1989 (unspecified if ongoing), notes: Chronic fatigue syndrome diag. 1989; in remission.; "Known allergies: fake crab" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. This nurse reported similar events for 2 patients. This is the first of two reports. A 16-year-old female patient received TRUMENBA at single dose on unknown date in 2017 for immunization. Medical history and concomitant medication were not reported. On unknown date the patient experienced dizziness directly after receiving the vaccine. The patient waited in the office for 15 minutes and the dizziness dissipated. No treatment was needed. The event resolved on an unknown date in 2017.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017089890 Same rter/AE/product, different patient.
Patient experienced a heart attack 5 days after Covid 19 Injection and then a Stroke. Hospitalized for 3 weeks and had 2 months of Rehab.
Hypersensitivity and heat radiating from injection site on (L) shoulder through pectoral region and on the (L) upper back area.
J96.00 ACUTE RESPIRATORY FAILURE 1/17/2023 MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE, MODERATE    RIGHT INTERTROCHANTERIC FEMUR FX, DISPL INIT
patient had a vaso-vagal response. patient was sweaty and out of it. we called 911. EMT monitored patients vitals. patient recovered and refused to go to the ER. he reported feeling shaky and hands tingling. he walked out of the store on his own with his friend who accompanied him. I unsuccessfully attempted to reach patient the following 2 days with no contact.
Felt fatigue. Woke up 1/24/2022 with an itchy rash that looked like it was in lines, as well as, had patches of rash-like hives. Patient diagnosed with dermographia on 2/11/2022 after visiting PCP (allergist diagnosed dermographia)/urgent care.
Patient received his first dose today at approximately 10:30 AM and was placed in the observation area immediately after the vaccination. After 5 minutes the patient's parents reported to the vaccination staff that the patient was experiencing mild dizziness after the vaccine was administrated. The patient was evaluated by the physician and nurse on site and later allowed to leave when his symptoms subsided. The patient remained stable, conscious, and without any other symptoms beside mild and intermittent nausea which was resolved by the time of his departure from the site. Patient did not required any further interventions and was escorted to his parents' privately owned while without any difficulties.
Patient fainted.  After being helped into a chair, she has a small seizure / muscle spasm that lasted a brief moment and resulted in loss of bladder control.  At  no point did she have difficulty breathing or noticeable sweeling.
very high blood pressure; Dizziness/ Lightheaded; This is a spontaneous report from a contactable consumer, the patient. This 85-year-old non-pregmant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via unspecified route in the left arm on 14Feb2021 at 10:00 (at the age of 85-years-old) as a single dose for COVID-19 immunization. Medical history included High Blood Pressure, Back Surgery, and Neurological (as reported). Patient's known allergies include scallops. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccine. Concomitant medications received within two weeks included irbesartan 75, pravastatin (PRAVASTAT) 10mg, escitalopram oxalate (LEXAPRO) 5mg, and amlodipine besilate (AMLOPIN) '5m'. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) via unspecified route in the left arm on 24Jan2021 at 10:00 (at the age of 85-years-old) as a single dose for COVID-19 immunization. On 14Feb2021, the patient experienced dizziness, lightheaded, diagnoses (Dx) as very high blood pressure. The patient was kept in hospital 8 hours and was given meds to lower blood pressure. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received included blood pressure meds. The outcome of the events was recovered on unspecified date. The patient was tested for COVID post vaccination with nasal swab COVID test in Apr2021 which resulted Negative.   Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Difficulty breathing, chest pain, dyspnea on minimal exertion.  Diagnosed with diffuse pulmonary emboli involving the distal main branches as well as the proximal segmental and diffusely throughout the subsegmental branches of both lungs.  Elevated right ventricular over left ventricular ratio greater than 1.0 suggesting right-sided heart strain and increased right-sided heart pressures.  Admitted and treated with IV heparin bolus and infusion.
Received 3rd dose 6 months after 2nd dose as a precaution; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt received shots on Monday within two days a rash had formed, by Friday patient diagnosed with varicella.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: LOWER EXTREMITY MUSCLE WEAKNESS/SORENESS-Medium.
VS 147/90, HR 82 bpm, 98% RA, heart/lungs clear, rhythm regular, no stridor, no hives. Around 14 minutes after injection started to have sensation of warmth in her abdomen which she says moved down, chest tightness + dizinness, no SOB, hives or facial/lip/tongue, swelling nor sensation of the throat closing Allergies: tetanus shot (warmth, hives, sensation of throat swelling), benadryl (felt like coming out of her skin), sertraline (palpitation) PMHs anxiety, ADHD, HTN, aFIB, KIDNEY STONES,  No meds were given Symptoms resolved and pt stated she thinks its from her allergy
Severe head ache that she couldnt lift her head up. Fever, chills,
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patient at the time of the vaccination and no adverse reaction Reported since given vaccine.
Symptoms began 3 days after 2nd Pfizer vaccine. Heart palpitations, shortness of breath, extreme fatigue with mild exertion, nausea, brain fog.  Went to see PCP when symptoms did not clear up in 1.5 weeks. PCP ran multiple lab tests, imaging, and EKG and can not determine the cause of symptoms.  Symptoms have mildly improved but remain disabling. On good days I am at 50% capacity of baseline before symptoms began. PCP suggested symptoms could be due to stress/anxiety and recommended psychiatric consultation. Saw psychiatrist 3 times. The psychiatrist does not believe symptoms are related to any psychiatric issue.
I experienced Rolling Migraines for 4 to 5 days with all doses of Covid vaccine. Both Pfizer and Moderna vaccines, every COVID-19 vaccine since. I used UBRELVY to alleviate the symptoms. My Neurologist discovered that taking a steroid lessens the impact of migraines.
Pt refused flu vaccine. Was suppose to get Hep A. I drew up flu instead and administered to pt. Pt did not receive Hep A.
chills, migraine, cotton mouth, whole body muscle aches, congestion. Was woken up by chills and head. Went to shower and sat in hot shower for 25-30 minutes. got out. chills returned, got back in shower for 10 minutes. took excedrin and then went back to bed with heat blanket.
Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client  for hypotension and weakness.
inadvertently given a dose of Boostrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 53-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 22-JAN-2026) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently given a dose of Boostrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Boostrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug. The reporter consented to follow up. The case is linked with US2023132545, by same reporter; Sender's Comments:  US-GSK-US2023132545:Same reporter
Pt came back to pharmacy stating she did not feel good and had ringing in her ears.  She was took to the immunization room where she was unable to sit in a chair and was helped to to lie down.  She had  blank look on her face for a couple of seconds and then started looking around slightly confused then started talking again.  She laid there for about 5 minutes and started to feel better so she sat on the chair for about 5 minutes before EMT's arrived as a precaution.  After getting check out she left on her own accord. She stated while talking that when she gave blood in the past this has happened.
Patient went to the ER reporting: unable to raise arm, weakness and pain upon moving arm. Redness and tender at the injection site appear a day later when she came back to the ER 10/19/11 at 1035.
Patient received the vaccine about 1-2 weeks ago. She became nauseated and fatigued shortly afterward. This worsened until yesterday (3/16/21) when the patient became confused and polydipsic per the patient's mother. In the emergency department the patient had a seizure. CT showed severe brain edema with a sodium of 111. We are unsure if there is any relations to the polydipsia, fatigue, and hyponatremia with the vaccine administration itself. However there is a time relationship with the start of the symptoms.
13 hours after the 3rd vaccine, my heart starting racing at 120 beats a minute and did not stop until 36 hours later where it began to vacillate between 90-110 for another 24 hours.   I noticed periodic racing of the heart after that period and then contracted COVID and tested positive on December 26th.  My heart rate continues to be elevated and I started taking 12.5mg of Atenolol which helps.