chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a 45-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. This case was associated with a product complaint. On 23rd May 2018, the patient received SHINGRIX. On 23rd May 2018, immediately after receiving SHINGRIX, the patient experienced laceration of finger and injury associated with device. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, injury associated with device and pharmaceutical product complaint were unknown. The reporter considered the laceration of finger and injury associated with device to be almost certainly related to SHINGRIX. Additional information was received as follows: This case was reported by certified medical assistant. The office ordered the product on 27th April 2018, and stored it in the vaccine refrigerator. There were no signs of damage or leakage. They used the first 9 vials with no issues. On Wednesday a technician reached to pick up the last vial of liquid adjuvant of SHINGRIX and she cut her finger and applied a bandage. The vial was broken on the front at the bottom of the vial and there was glass in the box but none in the vial itself and also there was no liquid in the vial and the dose was not administered. The office was sending a picture of the vial via email. The Global Response Center would arrange for replacement of 1 dose. Upon an internal review following changes were done on 8th June 2018: The event injury associated with device was removed since laceration occured due to broken vial and not due to a device.; Sender's Comments: US2018096040: Previous VAERS submission in paper format
PT DESCRIBED HAVING AN " EGG-SIZED" RED SPOT COME UP ON VACCINATED ARM ON DAY 11 POST VACCINATION
One friend had a bad time with the second one, being a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "One friend had a bad time with the second one, being a sore arm."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
face swelling, hives 11:45 AM _> Rx Benadryl tachyneic, wheezing, pulse ox 77%-> Rx ALB, oxygen @ 1152-?Rx SQ Epi given 11:56 -> 12:14 paramedics arrived
Initial and follow-up information has been received from a registered nurse concerning a 65 year old female inpatient with pneumonia, and allergies to codeine, hydrocodone, and antihistamines, who on 04-SEP-2007 at 15:00 was vaccinated IM in the right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 657628/0556U).  On 06-SEP-2007 (also reported as 05-SEP-2007) the patient experienced tenderness at the injection site, a 5x5 cm (also reported as 6x6 cm) induration that was swollen, warm, red, and firm to touch (also reported as hard).  At the time of the vaccination the patient was hospitalized for pneumonia.  On 05-SEP-2007 the patient had a temperature of up to 102F and was treated with doses of TYLENOL and CELEBREX twice daily to control her temperature.  On 06-SEP-2007 the patient was reported to be doing fair in the morning and her fever had cleared.  The plan was to continue the patient on IV antibiotics, ROCEPHIN, tobramycin, increase out of bed activity, and bronchodilators.  Laboratory diagnostics were performed (results found in laboratory section).  The patient recovered on an unspecified date.  Additional information is not expected.
Rash all over her torso; A red streak appeared all down her arm; Itching at the injection site/itchy arm; Headache; Chills; Pain at the injection site/ sore; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Rash all over her torso), ERYTHEMA (A red streak appeared all down her arm), VACCINATION SITE PRURITUS (Itching at the injection site/itchy arm), HEADACHE (Headache) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site/itchy arm), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at the injection site/ sore). On 08-Apr-2021, the patient experienced RASH (Rash all over her torso) and ERYTHEMA (A red streak appeared all down her arm). On 08-Apr-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. On 10-Apr-2021, RASH (Rash all over her torso) and ERYTHEMA (A red streak appeared all down her arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site/itchy arm) and VACCINATION SITE PAIN (Pain at the injection site/ sore) had not 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.   No relevant concomitant medications were reported. No treatment information was provided.
Increased length of menstrual cycle and amount of blood. Currently on day seven of heavily bleeding during cycle and in between cycle length. Typical menstrual cycle is three to four days max and light blood flow.
Muscle pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient reported experiencing muscle pain at the injection site after receiving 1st dose of the Shingrix vaccine back in July 2020. She stated that it went away in a day and a half. The reporter did not consent to follow up. Not all information was available. For tolerance after 2nd dose refer case US2020212920.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212920:2nd dose, same patient
Vaccine given on 4-19-13. Presented to clinic on 4-22-13 with rash all over body Measle like as per doctors note. On (4-22-13).
At time of vaccine, 34 weeks 0 days pregnant.  Estimated due date 5/21/2021.  Awoke at 2:45 am on 4/11/2021 with contractions and severe nausea.  Contractions were irregular and did not exceed more than once every 10 minutes.  Contractions continued irregularly until approximately 7 am 4/11/2021.
Pt presented to medical tent with increased swelling and pain at R arm injection site post vaccination. Approximately 10 minutes later pt also complained of feeling lightheaded. VS WNL. Ice pack given. Pt stayed for monitoring for about 1 hour post vaccine and left on own with his wife and sister in law with ice pack in place on arm.
About 10 hours after the injectionj I started to feel body aches, not just at the injection site.  About 2 hours after this I found myself shivering and unable to get warm.  Took 2 Ibuprofen and went to bed. Fell asleep for over 10 hours (unusual) andwoke up this morning with the body aches but not shivering.  Also my head feels foggy and little bit of a headache
high blood pressure, extremely tired ,extreme  brain fog, pins and needles  for about 30 min I could not stand up. Rash for 14 days and counting on trunk of my body .
4/20/09 Later in the day, respiratory problems, chest pain and severe headache-slept all day 4/21/09 and condition worsened. 4/23/09 taken to emergency room.  Client say treatment received for respiratory problems. Information reported 6/22/09.  9/1/09 ER records received DOS 4/30/09. Assessment: Asthma. Patient complains of constant pain affecting the anterior chest for 14 days. Pain radiates to back. Productive cough with yellow sputum and chest pain with breathing. Trouble breathing and short of breath. Hurts to cough. Wheezing.  ICD9-Codes: 493.90 Asthma type unspecified, 786.2 Cough.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 3012S8A) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hypertension / high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE; LOSARTAN; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent t1he following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (14Jun2022) Negative; (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was reported as yes.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/02/2021. PATIENT FULLY VACCINATED ON 03/23/2021
Shingles - unk outcome at this time. Presented which shingles and nerve pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 at 12:30 as dose 1, single (Lot number: EN6200), in left arm, on 13Mar2021 at 12:30 as dose 2, single (Lot number: EN6206), in left arm, on 16Aug2021 at 15:15 as dose 3 (booster), single (Lot number: FA7485), in left arm and on 17Jan2022 at 15:30 as dose 4 (booster), single (Lot number: FJ6369), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Apr2012; ATORVASTATIN, start date: Apr2012. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Antigen Test was NEGATIVE for three days; (20Nov2022) Positive, notes: Covid-19 Tested positive on 20Nov2022 by NAAT at [Facility name withheld]; (28Nov2022) Negative, notes: Felt feverish on 28Nov2022 and Home Antigen Test became NEGATIVE; (04Dec2022) Negative, notes: Home Antigen Test became NEGATIVE on 04Dec2022; (06Dec2022) Negative, notes: Lab NAAT test at [Facility name withheld] became NEGATIVE on 06Dec2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: First covid-19 symptoms appeared on 19Dec2022 (possibly discrepant information; pending clarification). Covid-19 Tested positive on 20Nov2022 by NAAT at [Facility name withheld]. Paxlovid started on 20Nov2022. Paxlovid 5-day course finished on 24Nov2022. Home Antigen Test was NEGATIVE for three days. Felt feverish on 28Nov2022 and Home Antigen Test became NEGATIVE. Started 2nd course of Paxlovid on 01Dec2022 evening. Home Antigen Test became NEGATIVE on 04Dec2022. Finished the 2nd course of Paxlovid (5-day) in the morning of 06Dec2022. Lab NAAT test at [Facility name withheld] became NEGATIVE on 06Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, the events VACCINATION FAILURE, COVID-19 are assessed as related to the suspect drug BNT162b2, BNT162b2 omi ba.4-5.
Warm; Itches constantly; Bigger; Vaccination site erythema; Left deltoid region of non-dominant arm red; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red), PYREXIA (Feverish) and VACCINATION SITE SWELLING (Bigger) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure (Patient on Blood Pressure medication) and Thyroid therapy.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red) and PYREXIA (Feverish). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE SWELLING (Bigger) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Jan-2021, VACCINATION SITE ERYTHEMA (Left deltoid region of non-dominant arm red) and PYREXIA (Feverish) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itches constantly), VACCINATION SITE SWELLING (Bigger) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and thyroid medications. . Treatment for the event also included ice.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non significant follow up : received on 10-JUN-2021 and does not contain any new information; 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.
Red, raised 3 x 2 inch area on right deltoid.  Tender axillia tender.  Area warm to touch, itching.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age who on beginning of February 2010, was vaccinated IM with the first dose of GARDASIL (route, dose and lot # not reported). On 11-SEP-2012, the patient was vaccinated IM with the third dose of GARDASIL (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
slowed down; Tested positive; headache; muscle aches; body aches; chills; weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and FEELING ABNORMAL (slowed down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and HEADACHE (headache). On 17-Feb-2021, the patient experienced FEELING ABNORMAL (slowed down) and COVID-19 (Tested positive). On 17-Feb-2021, MYALGIA (muscle aches), PAIN (body aches), CHILLS (chills), ASTHENIA (weakness) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (slowed down) and COVID-19 (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
In evening of the day of the vaccines, he had fever up to 103 F, decreased oral intake, diarrhea, and irritability. Diarrhea continued over the next 3 days, with increased irritability on 6/9. Family presented to Emergency Department 6/9, he received IV fluids, discharged to home. On 6/10, diarrhea continued, irritability worsened, he had abdominal fullness pain, was hospitalized for an ileus seen on abdominal film.
Loss of consciousness @ 6.5 hrs post vac Severe headache, chills, fever, and vomiting from 8 to 26 hours post vac.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 at 12:30 as dose 1, single (Lot number: EM9809), in left arm, on 01Mar2021 at 12:30 as dose 2, single (Lot number: EM6203), in left arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ZOCOR, start date: 29Jun2022, stop date: 29Jun2022; PRINIVIL; COREG; VITAMIN D3. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline", notes: known allergies: tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29Jun2022) positive, notes: Tested positive for Covid on 29Jun2022; (06Jul2022) Negative, notes: tested negative on 06Jul2022; (09Jul2022) positive, notes: tested positive again on 09Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical details: Tested positive for Covid on 29Jun2022, took PAXLOVID for 5 days, tested negative on 06Jul2022. Symptoms returned again on 08Jul2022, tested positive again on 09Jul2022. The events did not result in emergency room visit, physician office visit.
Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling; Painful  arm area / sore arm above and underneath; Flu-like; Sweats; Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules; Neck sniff; Nodules are tender; Fever up to 101.9 degrees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats) and NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and BP (BLOOD PRESSURE) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.9 degrees f (High) high.         This case was linked to US-MODERNATX, INC.-MOD-2021-076321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076321:Dose 1
I took two regular aspirin before bed the night of getting the shot in anticipation of the usual flu-like side effects of all of the Covid shots I've had previously the day after vaccination. For a couple of weeks prior, I had been experiencing bouts of tachycardia and shortness of breath after exertion. The morning after the shot, I got out of bed feeling fine and went to the bathroom. Upon standing up from the toilet, my heart began to pound, my legs were weak, and I felt like I was going to faint. I managed to get to the sink to wash my hands, but was feeling very anxious. I got back to the bed just in time to collapse on it. For the rest of the day, I was in and out of consciousness or asleep (not sure which). Each time I tried to stand and walk, my heart would race, I could hear it pounding, and I had to sit down or brace myself on a counter before collapsing again. Bending over increased these symptoms significantly. By the next morning, there was some improvement and I was able to carefully take a shower and get dressed (I have a shower bench and used it) but spent the rest of that day sitting because I still felt I might collapse and I still had tachycardia upon any change in position. Since then my balance has improved, but still get tachycardia and shortness of breath.