chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Died; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient died on 30-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medication provided.  1st dose was given on 20Sep2021 with lot number 046C21A.  Reporter states that she was fine with no illnesses prior to getting the vaccine.  Company Comment: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
pt recv vax & immed devel soreness @ the inj site & a h/a;4 to 5 days later pt exp big red hives & a burning throat;currently pt is exp itchiness, soreness & stinging @ inj site, & a burning throat;
Severe Tinnitus flare up and dizziness started approximately 12 hours after vaccine administered.  No tinnitus or dizziness in prior two weeks before receipt of the vaccine on April 8th at 2:00 pm.  Dizziness resolved after about 72 hours.  Tinnitus still present 24 hours a day, every day.  Moderately disruptive to sleep and ability to function.
No adverse event; Recieved 0.5 cc as dose 3; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Recieved 0.5 cc as dose 3) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069FZ1A, 026L20A and 017B21A) for COVID-19 prophylaxis.     Patient has not diagnosed or tested positive for COVID-19. Patient has no acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Sulfonamide allergy, Allergic rhinitis since 1990, Osteoarthritis since 2000 and Hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-1995 to an unknown date for Hypothyroidism, VITAMIN D NOS from 01-Jan-2020 to an unknown date for Vitamin D low, VITAMIN C [ASCORBIC ACID] from 01-Jan-2021 to an unknown date for an unknown indication.   On 04-Mar-2021 at 10:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021 at 10:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Nov-2021 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3).    Patient's weight was reported as 145 units not specified. Patient had not received other vaccine on same day as Moderna COVID-19 vaccine or within one month prior to any Moderna dose.  Patient received 0.25 ml dose 4 of Moderna (batch number 005M21A) on 01-Apr-2022 at 09:30 am. Patient received dose 5 of Moderna on 26-Sep-2022 at 09:00 am and experienced adverse events which were treated with Tylenol and Meloxicam.   This case was linked to MOD-2022-662826 (Patient Link).
pt recvd vax & w/in 24hhrs post vax exp a swollen,red,& hot arm (elbow to shoulder);tx w/DPH for 3-4 days & ice;sx resolved;
Having pain and swelling on left side of chest, left underarm and left side of left breast.  Painful to light touch.  Started in the early morning hours on 10/21/21. Have not been seen by PCP yet.
Significant local reaction at injection site with significant redness, warmth, slight swelling & soreness for 2 days.
Hurt for few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included stress (few years back for being out of work) and rash (went from the spine and wrapped under the armpit and stopped at the nipple). Concurrent medical conditions included nerve damage and pruritus.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had permanent nerve damage so the nipple always had a slight itchiness.  The patient did not find it too terrible, just had to wear long sleeve shirt till the rash was gone.  The patient got the vaccine recently and that actually had an hurt for a few days.  The patient could only wait now to see if it worked. Additional supportive information: The follow-up would not possible, as no contact details were available.
Indicated of headache the night after receiving the vaccine. Also reported pain at the insertion site. Today there is redness and warmer than her other arm. Employee spoke to her department coordinator and she will be sent to an occupational center for follow up. Pharmacy contract staff have their own workers compensation program.
Unable to walk,could not get himself up off of the toilet.; fell to the floor, and was on the floor for 2 hours; he was just too weak; Sore arm in the evening; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Unable to walk,could not get himself up off of the toilet.), FALL (fell to the floor, and was on the floor for 2 hours), ASTHENIA (he was just too weak) and VACCINATION SITE PAIN (Sore arm in the evening) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 25-Oct-2020 and Clot blood on 14-Nov-2020. Concomitant products included METFORMIN, APIXABAN (ELIQUIS), POTASSIUM, ATORVASTATIN, LISINOPRIL and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm in the evening). On 31-Jan-2021, the patient experienced GAIT INABILITY (Unable to walk,could not get himself up off of the toilet.), FALL (fell to the floor, and was on the floor for 2 hours) and ASTHENIA (he was just too weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Unable to walk,could not get himself up off of the toilet.), FALL (fell to the floor, and was on the floor for 2 hours), ASTHENIA (he was just too weak) and VACCINATION SITE PAIN (Sore arm in the evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-159203 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Follow up received on 26-5-21.  Adverse Event form added with details of second dose
Patient received vaccine. He has a history of fainting/becoming light headed after vaccination. He began to feel light headed and decided to lay down. Patient was given water and an ice pack. Patient was nauseous, and sweating profusely. After ~5 minutes, patient began to feel better. He waited another 15 min in the pharmacy before leaving with a driver.
pt recv vax & devel cellulitis & was hosp;the reporter noted that the sx was violet reaction;l  Annual follow-up received on 11/27/00 provided no additional data.
My thyroid numbers have been normal since removal, I test every 6 months with the same dr. My numbers where showing too much levothyroxine, so dr lowered my meds. Now I'm hypo so he has increased. I have tingling in my right butt and hip area since the shot. My diverticulitis is worse. I sleep about 13  hours a night. I have fog brain, sores on my tongue, I have had thrush. I'm always tired. Its hard for me to format words or sentences.
flue like symptoms; he got very severe diarrhea for 6 to 7 days; lost 12 pounds of weight.; fever; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Laparoscopy (laparoscopy for bowel obstruction.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
1. 10 Days after the second dose experienced itching on the back. Noticed red spots on both the armpits. ( around 14th March) 2. After about another 10 days, itching continued and rashes red spots spread over the back and noticed similar patches in the groin area as well. ( around 24th March) 3. Have not taken Aligra medication for five days. Also applied HydrocortisoneCream with Aloe for five days. 4. Even after further 15 days, no significant change observed. Additionally noticed a red patch with itching on the face under and on the side of the right eye. (around 8th April)
Fever onset acute with severe fatigue on Friday PM Feb 12. Some lightheadedness when waking up at night on Feb 12 and 13.m needed to sit on the floor to avoid falling. Rapid pulse 80-90 vs normal of 50. Fever to 102 with shaking chills daily for 4 days Feb 13-16. Total days of fever to 100 or more were from Feb 12 to Feb 23. Could not tolerate food from Feb 12 to Feb 22. Lost 7 lbs from 153 to 146. Regained appetite Feb 22.  Fever controlled with ibuprophen or Tylenol. After Feb 15.
allergic reaction; swelled up; felt cold; flu-like symptoms; dizzy; This is a spontaneous report from a contactable HCP.   A currently 24 year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE,as a single dose, for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient received the Pfizer covid vaccine last Wednesday. She says she felt cold and flu-like symptoms, dizzy, she swelled up, took a BENADRYL which calmed it down. She would like to know whether she can get the 2nd dose of the Pfizer covid vaccine after an allergic reaction to the first. The outcome of the events was not reported.  Information on the Lot/Batch number has been requested.
Never received his second dose of the vaccine; Felt as if he had the COVID-19 virus all over again; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again) and PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was contracted with COVID-19 ,5 weeks before initial vaccination).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine). At the time of the report, SUSPECTED COVID-19 (Felt as if he had the COVID-19 virus all over again) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received his second dose of the vaccine) 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.  Patient received his first dose of the Moderna vaccine. One week later, he felt as if he had the COVID-19 virus all over again, and so the patient never received his second dose of the vaccine.  Treatment information was not provided.  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.  Unlikely, that the event  COVID-19 is related to the vaccine.  Company comment: 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.  Unlikely, that the event  COVID-19 is related to the vaccine.; 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.  Unlikely, that the event  COVID-19 is related to the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive, notes: She now has tested positive for COVID rebound . 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.
Approximately 12 hours later complained of "dizziness and headaches". Rested 10 minutes, reassured, released.
Pt said arm was swollen, hot, hard and painful. Also said slight stiff neck and said was careful of using arm.
No additional AE's/PQC's reported; Temperature excursion for VARIVAX which was administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 04-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015459 with an expiration date on 20-MAY-2021, and T012550 with an expiration date on 10-APR-2022) for prophylaxis  (strength, dose, anatomical location, and route of administration were not reported).         The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of -6.8°Celsius degrees (°C) during a time frame of 3 hours and 54 minutes. The data logger was not involved.  There was no prior temperature excursion and no adverse events were reported.
About 20 minutes after receiving influenza injection, patient vomited, pt was observed for 1 hour post episode with no further adverse reaction.
menstrual irregularities; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "menstrual irregularities".  Additional information: Agent states her case number is #. Agent relays she has a caller on the line that is a HCP that has a patient that has had the 1st and 2nd dose of Pfizer Covid 19 vaccine. Agent relays that after the vaccine the patient had irregularities with her menstrual cycle. Agent relays that his question is if she can get the booster dose, is it alright for her to get that booster dose. Agent relays the callers license number.  Caller states that is a version of it. Caller is asking if the call handler can provide some information on that. Caller states this is turning into a marathon call, that just to be read the disclaimer it took over 5 minutes.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; on 4aug95 devel varicella rash w/ 10-15 spots on body;area was dry & scaling over 7aug95
in the evening, after vaccination with influenza and PPV-23, the patient developed fever and chills. she also developed redness and swelling at the site of the PPV-23 (right arm, SQ inf to delt). She missed one day of work. She is recovering; no more fever or chills, erythema is diminishing. Appears patient is recovering.
I tested positive for COVID-19 on July 2, 2022. My symptoms began on June 26, 2022 but I thought it was a sinus infection. I had energy and was not fatigued. I had nasal drainage and coughing and a sinus headache. After I tested positive I did feel very fatigued on July 3rd. I slept about 17 hours a day for at least 2 weeks. I didn't have any energy to do anything I wanted to do. The next time I tested myself was about July 10th and I tested negative. After that I was still fatigued but beginning to feel more energetic. As of today I have mild fatigue but I feel like I am on my way to recovery.
Had COVID in Oct2021. After the booster - that night I was tired, arm was sore, I woke up twice, pain in arms, chills, sweaty and drank water. Lymph nodes on the left in the armpit area. Friday am felt like death, I was crying, week, tired and chills, really thirsty all day. my muscles were sore all over like I ran a marathon. The next two days had diarrhea and couldn't eat and throw up twice from Thursday to Saturday I couldn't eat. Sunday, I got better still had diarrhea and no other symptoms still sore arm and swollen in lymph nodes and not so bad. Called the doctor on Friday on 2pm.
Body ached all over day after shot throughout to following day, and breathing was labored as I could not breathe through my nose
"Moderna COVID-19 Vaccine EUA": approximately 14 hours after receiving the vaccination I woke up with chills, a 100.7 fever, headache, fatigue, nausea, muscle aches, sweating episodes and join pain in addition to severe injection site pain.   All symptoms resolved within 24 hours besides the headaches, sweating episodes and injection site pain which resolved with 72 hours.
On 7/8/05 received Td booster. Next afternoon noticed bruise at imm site (left arm). The following day swelling occurred in a band laterally 1/2" below bruise. Band is 7"x3" today. Pt states swelling was more raised before, better now. Also had difficulty raising arm, and headaches continuing til today.
Pt called store & reported pain and swelling under armpit of left arm, with mild warmth and redness. Pt received 1st dose on 09-26 in LD and reported symptoms the following day. Told pt the location of localized swelling/irritation is abnormal and that she should have it evaluated at her local walk-in clinic. If unable to be seen immediately and it worsens, take benadryl.
Inflammation; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (Inflammation) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events include steroid.
She received her fist COVID-19 vaccine on 04/10/21 in her left arm and states she developed regional painful lymphadenopathy on da# 7 post vaccination, developed itch with an urticarial patch  (area) 3 inches in diameter and muscular pain at the vaccine site on day #15. She also develop low grade fever, which is expected. She recovered on day #20. Please could you open a reports on VAERS