chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 23rd, explosive diarrhea; high grade fever; chill; achy body all night. On the 24th, massive headache; high grade fever; achy body; no appetite all day. On the 25th, low grade fever; headaches; achy body in the morning; sweat like crazy and body aches were going away in the afternoon. I had a small meal at the end of the day. On the 26th, all the symptoms were gone except my left upper arm is still red, swollen and hot.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/2/2021. Patient contacted physician office on 8/9/2021 stating had a positive COVID HOME test on 8/8/2021 with a three day history of sore throat, headache, congestion, coughing also noted to have oxygen level of 81 and fever of 101.9. Patient was retested on 8/10/2021 and was positive. Patient presented to ED on 8/10/2021 with complaints of shortness of breath.  On presentation SpO2 100% on room air without significant tachypnea, but with mild bilateral wheezes. Patient received Imdevimab+casirivimab and was discharged home @ 1645. Patient presented back to ED at 2011 in  respiratory distress with increased work of breathing, accessory muscle use, and transient hypoxia. Noted O2 sats of 74% on room air, and placed on high-flow nasal cannula. Patient improved rapidly overnight coming down to just 2 L NC by the following morning. Patient stated she felt better as well denying SOB, fevers or chills but reporting some cough. Patient O2 needs had decreased to 4 L on ambulation by 8/13. She was discharged on home with home O2 on 8/13. She was prescribed dexamethasone to complete a total of 10 days of therapy for COVID and cefdinir to complete 5 days of therapy for suspected overlying bacterial PNA. Patient presented to ED on 8/14/2021 due to shortness of breath. She was  transferred to ICU 8/15 due to acute hypoxic respiratory failure due to COVID-19 pneumonia and found to have secondary bacterial pna.  Patient returned to the floor in hosptial but subsequently bounced back to the ICU 8/25 and intubated 8/26.  Patient continued to deteriorate and palliative care was consulted.  8/31 decision was made by family to pursue DNR/AND.  Patient passed away peacefully at 8:54PM on 8/31/2021.
severe cramping; really bad period after receiving vaccine; This is a spontaneous report received from a non-contactable consumer via a Pfizer sales representative. A female patient of an unspecified age received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on 29Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified birth control that takes away her period, she has been on it for 2+ years. The patient experienced severe cramping and really bad period on an unspecified date after receiving vaccine 15 days ago. The outcome of the events was unknown. The patient thinks the events are correlated to the vaccine.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
He came to our pharmacy & the staff gave him another shot (2nd dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He came to our pharmacy & the staff gave him another shot (2nd dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He came to our pharmacy & the staff gave him another shot (2nd dose)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He came to our pharmacy & the staff gave him another shot (2nd dose)) 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.  No treatment information was reported.
Placed in the freezer mistakenly with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a patient of unknown demographics who received vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] and placed in the freezer mistakenly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (with an unknown dose, route, frequency, formulation, strength) lot u6936aa in unknown administration site.  On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (with an unknown dose, route, frequency, formulation, strength) lot 1a671m in unknown administration site.  On an unknown date the patient developed a non-serious event "placed in the freezer mistakenly with no reported adverse event" (product storage error) (unknown latency) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and TYPHOID VI POLYSACCHARIDE VACCINE.  It was reported" Caller is requesting a temperature excursion for the following: menquadfi and Typhim Vi. Cause: Placed in the freezer mistakenly. Lowest Temp: frozen -5F Time exposed to temp: 15 hours Opened or Unopened products: unopened."  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and TYPHOID VACCINE (TYPHIM VI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Placed in the freezer mistakenly with no reported adverse event).  At time of reporting, the outcome was Unknown for the event placed in the freezer mistakenly with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After immunization listed below, developed (15 min later) wheezing, lip swelling, respiratory distress, hypoxia. Required epinephrine, albuterol, BENADRYL, prednisone, H2 blocker. Oxygen. Required hospitalization. L arm urticaria.  Records received 10/12/09.  Dates of Service 9/22/09-9/23/09.  Assessment:  Anaphylaxis.  Pt. seen for well child exam and received vaccinations.  5-10 min. later she c/o not feeling well, developed a cough, was thrusting her tongue, and had difficulty breathing as evidenced by abdominal and suprasternal retractions.  Child's lips became swollen, her mouth was foaming with a mucous like substance.  A diffuse erythematous rash developed as well as a welt on her left upper arm.  She was treated in the PMD's office with epinepherine x 2, supplemental oxygen and albuterol.  In the ED that patient received Benadryl, famotidine, solumedrol and albuterol nebs.  The Pt. was monitored in the hospital for one day, and at discharge had minimal evidence of swelling around her lips, no signs of rash or urticaria, no respiratory distress and was feeling well. ICD 9 Codes:  458.0, 493.90, 493.91, 682.0, 995.0, 995.20, 458.0, 477.9, 478.19, 479.25, 493.90,. 493.91, 495.8, 682.0, 691.5, 692.9, 696.9, 706.0, 782.1, 786.09, 785.09, 788.09, 786.2, 787.01, 787.02, 787.5, 995.0, 995.20, 995.3, V15.09, V15.09.
5 inch diameter slightly raised, reddened area, non-fluctuant, non tender right anterior thigh.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin", notes: Known allergies: Ceftin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2 week of covid vaccination. He received Paxlovid as antiviral drug as treatment of COVID-19 started on 03Jul2022 to 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives at day 2 treated with OTC medication like benadry.  Day 4 reported shortness of breath and patient being seen in the ED.
Elevated resting heart rate, heart palpitations, racing heartbeat, extreme chills which sometimes lasted 3 hours.
This case was reported by a nurse via call center representative and described the occurrence of acute respiratory tract infection in a patient who received HAVRIX for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, PENTACEL for prophylaxis and PREVNAR for prophylaxis.  On 17th January 2019, the patient received HAVRIX, Hepatitis B vaccine, PENTACEL and PREVNAR. On 25th February 2019, 39 days after receiving HAVRIX and Hepatitis B vaccine, the patient experienced acute respiratory tract infection (serious criteria GSK medically significant), acute bronchitis, vomiting and nasal congestion. On 13th March 2019, the patient experienced fever, cough, runny nose and sneezing. On an unknown date, the outcome of the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing were unknown. It was unknown if the reporter considered the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing to be related to HAVRIX and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. On 25th February 2019, the patient came back and was experiencing congestion and vomiting, no fever and was diagnosed with acute respiratory infection. When the patient came back in on 13th March 2019, 55 days after receiving HAVRIX and Hepatitis B vaccine, the patient was experiencing fever, cough, runny nose, sneezing and was diagnosed with acute bronchitis. The reporter was unsure if the patient was still experiencing these symptoms. The reporter gave permission for follow up. It was unknown if the reporter considered the acute respiratory tract infection, vomiting, nasal congestion, acute bronchitis, fever, cough, runny nose and sneezing to be related to PENTACEL and PREVNAR vaccine.
Sore arm and rash at injection site.  Fatigue, aches.  Persisted for 2 days.  Improved after that.
I started to not feel well around 8 am the next day. At 9 I noticed I had a fever (mostly low grade but spiked to 101.8 shortly before breaking), chills, weakness, and felt overly tired. From about 8 am until 7 pm last night I could not get warm. I managed my symptoms with ibuprofen and slept for a good portion of the day. My fever finally broke around 7 pm last night.
4 hours after injection- arm started aching. 12 hours after injection - trouble falling asleep. 18 hours after injection woke up with : fever (100.9) headache, and muscle ache. 18.5 hours after injection took 200 mg ibuprofen. 21.5 hours after injection - severe fatigue and blurry vision. 25 hours after injection laid down for short nap, but was awoken 4.5 hrs later by my alarm. I rarely sleep like this during the daytime ! 2 days after injection I finally felt normal.
Nervous; Warmness inside her body; Desperation; Anxiety attack/feelings of anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety attack/feelings of anxiety), NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ANXIETY (Anxiety attack/feelings of anxiety). On an unknown date, the patient experienced NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation). At the time of the report, ANXIETY (Anxiety attack/feelings of anxiety), NERVOUSNESS (Nervous), FEELING HOT (Warmness inside her body) and FEELING OF DESPAIR (Desperation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication includes anxiety pills.   The patient went to ER and she had  a fear before vaccination.
ongoing AE started 4/26 and continues through today (4/28); 4/26 around 11:30pm  Unable to sleep due to extreme discomfort.  Contemplated going to hospital. Fever: temperature reached 101.9 with severe body aches (joint and muscle). My normal body temp is 97.2. Heart racing; Whole body: extreme fatigue and weakness,  bouts of sharp pain in legs and back; Near shot location: extreme soreness in arm with limited range of motion in arm. 4/27: Fever:  continued to have temperature above 101 with severe body aches (joint and muscle).  After I took Tylenol at 1:00pm, temp dropped to 100.3. My normal body temp is 97.2. Heart racing; Whole body: extreme fatigue and weakness,   Arms feel like they are burning; Near shot location: an additional symptom of soreness and pain in left armpit and breast.  and pain shooting down my left arm; loss of appetite; 4/27: Repeat of 4/26 with exception that temp holding steady at 100.3 (with Tylenol)
Information has been received from a 65 year old female who on 08-JUL-2009 was vaccinated with "1 dose of PNEUMOVAX 23 and "a" dose of ZOSTAVAX (Merck) (MSD) (dose, route and lot# not reported). Concomitant therapy included gonadotropin, chorionic. The patient mentioned that she began the "HCG diet" in June, 2009. She underwent a 9 days of liver and colon cleansing period. On 06-JUL-2009 she began the new phase of the diet that required her to inject 0.02 cc of HCG hormone subcutaneously into her abdomen. Her weight on 06-JUL-2009 was 163 pounds. Starting on 09-JUL-2009 she was restricted to 500 calories/day for the remaining 3 weeks of the diet. On 08-JUL-2009 she received PNEUMOVAX 23 and ZOSTAVAX (Merck). Then on 10-JUL-2009 her weight was 168 pounds. She also mentioned that she developed a slight red area at the injection site. She stated that she had bloodwork completed prior to beginning the diet. At the time of reporting, the patient had not recovered. No further information is available.
STORAGE IN REFRIGERATOR ( 2°C - 8°C ) UP TO 30 DAYS. (VACCINE USED AFTER 10-16-2021 )
I found out I was pregnant via a Positive home Pregnancy test June 21, 2021. The pregnancy was also confirmed on June 26, 2021.  Starting July 10 thru July 14, 2021, I became sick with significant diarrhea, upset stomach, nausea, and heartburn. I did not have a fever, vomiting, head cold, headache, muscle aches, sore throat, not I had come in contact with anyone who was COVID+.  On July 26,  2021, I had my first ultrasound at which time my preganancy appeared  to be measuring two weeks earlier at 6 weeks, 4 days gestation, with the estimated delivery date 3.17.22.  According to the last menstrual period I had, I should have measured 9 weeks and 5 days, with estimated delivery date 2.24.22. On August 2, 2021, I had my Second ultrasound where it was discovered that there was no heartbeat and the decision to have a D&C was made, scheduled and performed on 8.6.2021 by OBGYN.
Irregular taste, BP 185/108, 179/100 (hx of HTN) No txment Completed 45 minute observation with no signs/symptoms adverse reaction on leaving Received 2nd injection 01/11/21 with no sign/symptom  adverse reaction
bruising in the area of injection of vaccine; tingling in the area of injection of the vaccine; discomfort; ncreasing markings where the injection took place over 3 square inches in area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area). At the time of the report, VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
My wife and kids had it before I did. Starting 07/05/2022, I developed fatigue, sore throat, muscle aches and body soreness. By saturday, 07/09/2022, I decided to take an At-Home COVID-19 test which came back positive. Then, the symptoms have been consistent, except I have developed nasal congestion and sinus pressure. By saturday I was feeling a little better but still present. I tested myself earlier today (07/14/2022) and was still positive. I am feeling mostly better but I still am having fatigue and nasal congestion. I was able to speak to my PCP on 07/13/2022 and they recommended Paxlovid. However, since I was already starting to feel better I declined it.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of ROTATEQ lot# L020861 with expiration date 25-JAN-2017, orally (dose was not reported). Administered doses of ROTATEQ experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003962: US-009507513-1612USA008786:
Shortly after receiving the vaccine he experienced disorientation - did not recognize where he was, who he was, who he was with.  This lasted 15-30 minutes and then he returned to normal.
A pharmacist reported the occurrence of an injection site reaction in an 18 month old female who received Infanrix for prophylaxis. The subject had no known drug allergies or adverse experiences following previous immunizations. Concurrent conditions and medications were not specified. On 4/10/02, the subject received her fourth injection of Infanrix (530A2) into the left deltoid. On the same day, the subject received her fourth injection of Hib-titer into the right deltoid. One day later, the subject developed an injection site reaction characterized by soreness, redness, and a 5cm by 7cm area of induration. The reporter considered the injection site reaction to be related to Infanrix administration. This report has been linked to reports A1389698A, A0389699A, A0389701a, and A0365783A due to same reporter.
This patient developed body aches, left arm ache, multiple swollen glands, left clavicular , left anterior cervical. No axillary nodes. The patient incapacitated by arm pain 1 day, slowly improved over 3 days.
Monovalent Covid19 vaccine was administered as booster dose instead of Bivalent Covid19 vaccine
- Sore & warm to touch (subsided). - Blisters around the injection site. - Pus running out of the blisters.
and felt a little bit sore; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced and felt a little bit sore on an unspecified date and mentioned that her daughter got the first dose of vaccine with Moderna and tested positive, they wanted to know if how many days before they can take the second shot and are they still eligible for the 2nd dose. The clinical outcome of the event was reported as unknown.   Information on the Lot/batch number has been requested.
Pt reported lightheadedness that started 8 minutes after receiving vaccine, which persisted beyond the 15-minute waiting period. He was monitored for approx. 1 hour, with persistent but not worsening symptoms. No symptoms of anaphylaxis. Blood pressure noted to be elevated, but no intervention given. No history of hypertension. He was discharged from our facility with continued lightheadedness but stable vitals, and sent home to rest. There was no medical indication for any additional treatment.
The pt experienced a syncopal episode 5 minutes following vax which lasted 15 seconds. The pt recovered fully following 10 minutes of observation.