chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/30/2021 Conversation: 911 called Patient called in and said she was having sob, vomiting, chills, diarrhea and was very weak. Writer noted patient trying to catch her breath over the phone in between words.  Writer called 911 and made patient aware they were on their way. Writer spoke to Operator 23.  ED to Hosp-Admission Current  8/30/2021 - present (9 days) Hospital  Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Chief Complaint Patient presents with ? Shortness of Breath     1. Acute hypoxic respiratory failure secondary to COVID-19 infection.  Admit to general medical floor.  Start treatment with IV remdesivir, Decadron.  Check inflammatory markers.  Currently requiring 4 L supplemental oxygen, wean as tolerated to keep SaO2 greater than 90.  Check procalcitonin, has received IV Levaquin in the ER.  Hold further empiric antibiotics for now. 2. Hypertension.  Blood pressures appear well controlled, continue home regimen with atenolol, Procardia.  As needed IV hydralazine for acute control. 3. Fibromyalgia/chronic pain syndrome.  Continue Neurontin, as needed tramadol per home regimen. 4. Non-Hodgkin's lymphoma.  Follows with WellSpan heme-onc.  Monitor clinically for now. 5. Undifferentiated connective tissue disorder.  Follows with rheumatology, Dr..  On Plaquenil, prednisone and azathioprine trial. 6. Anxiety.  Continue BuSpar, duloxetine.   Pt is an 66 y.o. female. With past medical history significant for connective tissue disorder on Plaquenil, prednisone and azathioprine, non-Hodgkin's lymphoma, hypertension, fibromyalgia, chronic pain syndrome presented to the emergency room for evaluation of progressively worsening dyspnea.  Patient thinks she may have had a COVID exposure on 821, but did not obtain testing yet. She endorses subjective fevers, nausea vomiting and intermittent diarrhea.  She called her PCP, who advised her to present to the ER. On presentation, patient was found to be hypoxic on room air with O2 saturation into the 80s.  She is currently requiring 4 L supplemental oxygen.  Initial work-up is pertinent for respiratory viral panel which shows evidence of SARS-CoV-2 infection.  CBC within expected limits, BMP without any significant findings.  First troponin negative, BNP within normal limits.  D-dimer is mildly elevated, subsequent CT angiogram of the chest does not show any PE, does show bilateral infiltrates consistent with COVID-19 pneumonia.
I gave the vaccine, after the vaccine was completed. I told the patient to sit in the waiting area for 15 minutes, so we can monitor. However, less than 5 minutes, the patient was feeling dizziness. He was still conscious though. His girlfriend was next to him. He stated he was nausea, dizziness, sweating, and he wanted to pass out. We went and got him water and make sure he was okay. Afterward, we monitor him for additional 30 minutes. He felt better after he drank his water, ate a few candies, and a donut. He stated the last he ate was at 10am and only had a granola bar. We let him leave after he felt better. Before, we left him leave. We asked him if he is allergic to any type of medications and if he had ever fainted after a vaccine. He stated, he is not allergic to medication and he never fainted after a vaccine before.
Itchy, raised rash about 2? in diameter appeared on the night of the 7th day after vaccination.
first dose of SHINGRIX about two years ago; Headache; Muscle Pain; her arm is very hot; she does not feel well; most everything hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix about two years ago).   On 19-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), muscle pain (Verbatim: Muscle Pain), extremities hot feeling of (Verbatim: her arm is very hot), feeling unwell (Verbatim: she does not feel well) and general body pain (Verbatim: most everything hurts). On 19-JUN-2023, the patient experienced drug dose administration interval too long (Verbatim: first dose of SHINGRIX about two years ago). The outcome of the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.     It was unknown if the company considered the headache, muscle pain, extremities hot feeling of, feeling unwell and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received the second dose of Shingrix on Monday and was experiencing muscle pain, headache, and her arm is very hot, not feel well and most everything hurts. The reporter consented to follow up with the health care professionals (pharmacy). The patient received 2nd dose after 2 years of 1st dose, which led to lengthening of vaccination schedule.
Covid 19; Covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "many allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (04Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patients were given shots during excursions; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given shots during excursions) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given shots during excursions). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient's first and second doses were given elsewhere (Unknown product)  Concomitant medication information was not reported  Treatment information was not reported
I had fever, chills, muscle aches, slight elevated heart rate, tiredness, headache, slight stomach ache I just rested and within 24 hours I felt better
Headache, Myalgia, Fatigue. Arm pain. Arm redness. Axillary lymphadenopathy Narrative:
Information has been received from a physician concerning a 24 months old male patient who in approximately June 2009 was vaccinated with the first dose of VAQTA, IM at 12 months of age, and his second dose at 18 months of age, in approximately January 2010. Inadvertently, the patient received a third dose of VAQTA "this week", at the 24 months of age, on approximately 21-JUN-2010. No adverse effects were reported. The patient did not seek medical attention. Follow up information has been received from a physician concerning the patient with a history of cleft lip repair and no illness at the time of vaccination, who on 23-JUN-2010 at 11:00 a.m., was vaccinated IM with an "extra" dose of VAQTA (lot# 665164/1100Y) in his right thigh and a second SC dose of MMR II, in his left thigh. On approximately 26-JUN-2010, "3-4" days later, the patient had vomiting and cold. The physician considered the events to be not serious and did not require emergency room or doctor visit. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Information has been received from a physician concerning a 23 year old female with no known pertinent medical history, who on 19-JUN-2009 was vaccinated with the first dose of GARDASIL.  Lot No was not provided.  The physician reported that on 19-JUN-2009, the patient developed upper body rash after getting the first dose of GARDASIL.  On 23-JAN-2009, the patient recovered.  No laboratories diagnostic studies were performed.  The patient sought medical attention.  Additional information has been requested.
Persistent pain in arm unlike normal vaccine administration.  Painful to use arm in certain directions and to lay upon. Now taking Motrin.
Patient experienced Raynaud's phenomenon within several hours of her second vaccine.  Resolved after putting hand under warm water.  Has occurred only once before.
pt reported to sick call on 18SEP97 & 220PM w/c/o fatigue, malaise & pain in rt arm @ inj site;given APAP & bed rest;
Same day vaccinated 7/22/09 : pale, heart racing, dizziness, nauseated. 7/30/2009: Extreme anger, staring, irritable, screaming, aggressive, combative without being provoted.  08/01/2009: Temp 104, joint pain, low back pain, hand and feet pain, sore throat, headache, eyes burning. Lower grade fever (99 - 100), back pain  through 3 - 4 days. 08/06/2009: Screaming, out of control behavior, back pain 08/20/2009: back pain, pain in right foot
Joint pain; Swelling around eyes; Myalgia; Hives on left arm; This spontaneous case was received on 26-Oct-2020 from a pharmacist via Med Communications (reference number: SEQW20-04290) and concerned a 60-year-old, female patient.  The patient's concurrent condition included allergy to Mycin (erythromycin). The patient's concomitant medications were not reported.  On 23-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml; route of administration: intramuscular and anatomical location: left arm) as influenza prophylaxis. The batch number was not reported, and expiry date was 30-Jun-2021.  On 24-Oct-2020, one day after receiving Afluria Quadrivalent, the patient felt joint pain, had myalgia, swelling around eyes and hives on left arm where the vaccine was administered. The patient had been receiving influenza vaccines for the last ten years and never felt this.   On an unknown date in Oct-2020, the patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 26-Oct-2020, the patient was recovering from events. As reported, it was almost gone, and the patient was better.  The reporter did not provide a causality assessment.  The reporter assessed events as non-serious  Company comment: A 60-year-old, female patient was administered Afluria Quadrivalent vaccine. One day after receiving Afluria Quadrivalent, the patient felt arthralgia, myalgia, periorbital swelling and urticaria on left arm where the vaccine was administered. Chronology is plausible. Based on provided information, causality is assessed as possibly related for all events.; Sender's Comments: A 60-year-old, female patient was administered Afluria Quadrivalent vaccine. One day after receiving Afluria Quadrivalent, the patient felt arthralgia, myalgia, periorbital swelling and urticaria on left arm where the vaccine was administered. Chronology is plausible. Based on provided information, causality is assessed as possibly related for all events.
This spontaneous report as received from a pharmacist refers to a 50 year old male patient. On 18-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J006155 expiry 30-AUG-2014, .65 ml, subcutaneously for prevention of shingles. The patient had no drug allergies. The pharmacist reported that the patient received ZOSTAVAX and experienced injection site reactions of hardness, redness (a quarter in size) and a mass (2 inches in diameter) the next day on 19-DEC-2013. The patient did not recover from the events. The patient sought medical attention since he contacted the pharmacy. Additional information has been requested.
Heavy left arm. Chest pain. Shortness of breath.  Given Albuterol Inhaler, Wixal Inhaler and Anti Inflammatories.
I had pain at the place of injection after the several hours that stopped on the 3rd day after Vaccination, but then begun itching, swelling, redness and hardening of the injection place. I am concerned to receive a second shot of the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
dizziness; Rash on body; burning sensation on skin; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 06Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; RASH (non-serious), outcome "unknown", described as "Rash on body"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation on skin".  Additional information: Patient received first dose Pfizer Covid vaccine on 06Jan2021. States he developed an allergic reaction so he could not qualify for 2nd dose. States he developed a rash on body; burning sensation on skin, and dizziness; he stayed at home for 4-5 days. He did not see his hcp at the time but informed his hcp later on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache; lump at injection site; pain at injection site; Administration of an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose), HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site). On 28-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved. At the time of the report, HEADACHE (Headache), VACCINATION SITE MASS (lump at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            Patient is on immunotherapy drugs.  No treatment information was provided.
Time: 13 hours after administration of flu vaccine.  Patient awoke 1 hour after going to sleep and experienced episode of extreme full-body shivering.  Went on for about 1/2 to 1 hour or so and then subsided.
Lightheadedness Large Reduction of high frequency hearing Edema in left foot Chest flutters Mass in left breast
A few hours after he got the shower mom noticed his arms had red raised dots. She put steroid cream on him and gave him some Benadryl and it subsided a few hours later.
Warm; itchy at injection site; Redness at injection site; tender at injection site/Painful at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tender at injection site/Painful at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tender at injection site/Painful at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (tender at injection site/Painful at injection site) had resolved.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Received flu shot on 21 Dec 06 mother states next day arm was very red and swollen seen in ER and had local reaction and to TX with Benadryl. SX lasted approx 3 days and resolved. 5 days ago 12 weeks after flu shot, had urticarial rash, red and raised that came and went away with Benadryl, but back with warm, back and since has had sporadic urticaria on back, chest, and arm, no resp SXS.
pt recv vax 19JUN95 & devel fever & less than 20 lesions on body;
PATIENT ARRIVED AT MASS VACCINTION EVENT AND WAS GIVEN PFIZER AS A FIRST DOSE. MONTHS LATER, DURING A ROUTINE POSITIVE TEST INVESTIGATION IT WAS DISCOVERED PATIENT HAD RECEIVED FIRST DOSE MODERNA 14 DAYS PRIOR TO PFIZER VACCINATION. CONSENT PAPERWORK WAS PULLED FROM PFIZER EVENT AND PATIENT DOES NOT DISCLOSE PRIOR VACCINATION OF MODERNA.
Leg pain; Diarrhea; Fluish type symptoms; Couldn't get out of bed for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Fluish type symptoms) and BEDRIDDEN (Couldn't get out of bed for 3 days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Cancer. Concomitant products included ALPRAZOLAM (XANAX) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Fluish type symptoms) and BEDRIDDEN (Couldn't get out of bed for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BACILLUS COAGULANS, PLANTAGO OVATA HUSK (FIBERMUCIL) at an unspecified dose and frequency. On 02-Apr-2021, BEDRIDDEN (Couldn't get out of bed for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Leg pain), DIARRHOEA (Diarrhea) and INFLUENZA LIKE ILLNESS (Fluish type symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he had very bad reactions after receiving the 1st dose. Patient reports that the reactions never went away 100 percent.   This case was linked to MOD-2021-182855 (Patient Link).
20 minutes after receiving the vaccine she began to feel itching in her face and neck and became very dizzy.
Information has been received from a physician concerning a female between the age of 12 and 16, who, a "couple months ago" was vaccinated with a 0.5mL dose of Gardasil. Concomitant therapy included Menactra. Twenty-four hours after being vaccinated with Gardasil the patient experienced nausea and weakness. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
The patient states that her neuropathy was "set on fire" after receiving the first dose of the Pfizer.  She said it was extremely bad and painful in her arms below her elbow.  She was barely able to use her hands.
Patient experienced full body rash 2 days after 2nd dose of Pfizer COVID vaccine. He complained about itchiness but denied pain. Past medical history include seasonal allergies. He was on Allegra at the time of vaccination. Patient self-treated with Benadryl and got prednisone 20mg prescribed by his doctor.
GARDASIL shot on 6/5, 6/6 noticed bumps above shot area, (+) itch, 6/7 bumps spread across chest area. Patchy area on chest, red and bumpy. (+) itch Tx with hydrocortisone cream, CALADRYL cream + oatmeal baths. OTC itch cream. This is in follow-up to report (s) previously submitted on 7/16/2007. Information has been received from a consumer concerning her 24 year old daughter (also reported as 25) with no pertinent medical history or drug reactions and seasonal allergies who on 05-JUN-2007 was vaccinated with first dose of GARDASIL (lot# 656050/0245U) 0.5 ml in the left arm IM. Concomitant medication included ORTHO TRI-CYCLEN LO. The consumer reported that on 06-JUN-2007, the next day her daughter broke out in a rash all over her chest. Medical attention was not sought. At the time of reporting, the patient was recovering. Follow-up information was received from the Feedom of Information Act. The age, concomitant medication. lot number and allergies were updated. On 06-JUN-2007 bumps over the shot area was noticed and was itchy. On 07-JUN-2007 and bumps spread across the chest area. The patcy area on the chest was red, itchy and bumpy. Treatment for the rash include hydrocortisone cream, CALADRYL cream, and over the counter itch cream and oatmeal baths. The VAERS ID number is 284770. No additional information is expected.