chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial that had been punctured 24 hours and 6 minutes before administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vial that had been punctured 24 hours and 6 minutes before administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone; left arm got red/upper left forearm got red/left arm redness gone; left arm got swollen/upper left forearm got swollen/left arm swelling gone down; fever (went away quick); a good size black and blue mark; bruising of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a good size black and blue mark), VACCINATION SITE BRUISING (bruising of the left arm), VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), PYREXIA (fever (went away quick)) and VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) 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 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced PYREXIA (fever (went away quick)). In November 2021, the patient experienced SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down). On 07-Nov-2021, VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down) had resolved. At the time of the report, SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm) outcome was unknown and PYREXIA (fever (went away quick)) had resolved.            No Concomitant medications were reported  Patient reported that she had visited her physician on 05 NOV 2021, the doctor had her use cold compresses on her left arm and after a day it became significantly better. The reporter stated the doctor thinks the needle may have been inserted at an angle and caused the bruising of the left arm.   This case was linked to MOD-2021-381139, MOD-2021-381023 (Patient Link).
Vomited; A spontaneous report was received from a pharmacist on 11OCT2023 regarding a patient of unknown age and gender who "vomited" (PT: Vomiting) following the administration of oral Vivotif capsules (typhoid vaccine live oral Ty21A; route; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that a patient took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration.  The outcome of the reported event was unknown. The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Significant follow up information was received from the pharmacist on 20OCT2023.  It was reported that the patient had no known allergies/intolerances/sensitivities.  Reportedly, the patient vomited only once, and no treatment was taken by the patient for vomiting. Further, it was reported that the patient took the subsequent doses of Vivotif.  The patient had recovered from the reported event on an unknown date.  No action was taken with Vivotif with respect to the reported event.  Company comment: It was reported that a patient of unknown age and gender took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration. The patient had recovered from the reported event. Considering a temporal association (between the onset of the event and Vivotif intake), the causality for the event of vomiting is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient of unknown age and gender took the first dose of Vivotif and vomited after 4 hours and 30 minutes of administration. The patient had recovered from the reported event. Considering a temporal association (between the onset of the event and Vivotif intake), the causality for the event of vomiting is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
As described on first page   I have had post menopausal bleeding , a lump in right breast and heart palpitations all of which will require diagnostic testing . I firmly believe it?s related to the spike proteins in the vaccine. I wish I had never received that vaccine and I will report findings from testing
The vaccine was incorrectly administered - it was not injected Intramuscular as required - it was injected directly into the bursa of my shoulder, causing what my Physical Therapist refers to as SIRVA (shoulder injury resulting from vaccination administration) and/or frozen shoulder.  Approximately 4-5 hours after receiving the incorrectly administered vaccine, I was unable to lift or move or use my left arm at all.  Two months down the line I am requiring physical therapy 3x/week in order to regain strength, stability, range of motion and general normal use of my left arm & shoulder.  Because of the strain on my shoulder, my neck and collarbone are also negatively affected.  This has been one of the most painful episodes I have ever experienced and has caused quite a loss of activity.  I do not fully understand if this is a VAERS reportable injury or not, as it appears to have been an error in administration of the vaccine, rather than something in the actual vaccine that injured me.
rash in his left arm and then spread throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in his left arm and then spread throughout the body) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 25-Jan-2021, after receiving second dose of  mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash in his left arm and then spread throughout the body). At the time of the report, RASH (rash in his left arm and then spread throughout the body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
few of the tenants received the booster shot and have been throwing up / this patient stated that there were others; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others). At the time of the report, VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) outcome was unknown. Not Provided          No concomitant treatment was provided. No treatment medication was provided. Reporter believes that the patients are immunocompromised since she knows Moderna has not approved a booster dose, but not sure patients are immunocompromised or not.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache. On an unknown date, the outcome of the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 or 56 years. The patient received SHINGRIX in the left arm. The next day, the patient experienced soreness in the arm, swelling of the arm, lumps at the injection site, headache, migraine headache, fever, chills, dizziness, malaise, fatigue, exhaustion. The symptoms lasted for about 2 weeks and then resolved.
her left arm was inflamed; cough; her left arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical history information was given by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TIZANIDINE HYDROCHLORIDE (TIZAFLEX) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red). At the time of the report, VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
developed Covid and had to be hospitalized; This is a spontaneous report from a contactable consumer. A 52-years-old male patient (husband) received first dose of BNT162B2 (BNT162B2), formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced developed covid and had to be hospitalized, (covid-19) on 26Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: developed covid after 7 days of first vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
1/20/2021 @ 08:25 AM: Chills, body ache and fatigue. Symptoms for one day, next day was feeling well. Verbalized he is recovered.
Ocular migraine, bright lights in one eye for various lengths of time; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a non-contactable consumer, the patient. A 72-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199), via an unspecified route administration in the right arm on 01Mar2021 (at the age of 72-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the right arm on 12Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the second dose on 01Mar2021 (day 17) after the first dose (characterised as inappropriate schedule of vaccine administered). On 02Mar2021 the patient experienced ocular migraine, bright lights in one eye for various lengths. The patient did not receive any treatment for ocular migraine. The event of ocular migraine resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of ocular migraine was not recovered.  No follow-up attempts are possible. No further information is expected.
Several pts devel "delayed swelling & itching following received of vax w/lot #4968119. Reporter not able to specify # of pts. More info to follow when available.
Skin rash on both arms proximal and distal to antecubital fossa, both legs proximal and distal to popliteal fossa, right neck (side of injection).
After receiving my vaccines, I went home and went to sleep because I work nights. My arm was in pain which I expected. When I woke up, I felt like I had a cold, so I only worked a short shift. I went in at 04:00AM instead of 12:00AM. When I was getting ready for work the following night, while taking a shower, I noticed that under my left arm was swollen. When I checked it out after getting out of the shower, I noticed a large lump under my arm. On 10/28/2022, I went to a local clinic because the lump was still there and was still swollen. The physician there told me that it was a normal reaction and advised that I take TYLENOL and use warm compresses. I currently still have slight swelling, but it has gone down significantly, and it is no longer concerning.
w/in 1 hr p/vax slept 8 hrs; could not awaken to feed; was limp; no temp & then later t101 R- p/8 hrs appeared OK;
CLOUDY HEAD; TIREDNESS; ABDOMINAL CRAMPS; CLOUDY VISION/HAZINESS/ BLURRED VISION; DIZZINESS WHEN STANDING AND WALKING; .This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included double pneumonia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 13:24 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2021, the subject experienced cloudy vision /haziness/ blurred vision. On 30-APR-2021, the subject experienced dizziness when standing and walking. On 01-MAY-2021, the subject experienced cloudy head. On 01-MAY-2021, the subject experienced tiredness. On 01-MAY-2021, the subject experienced abdominal cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramps on 01-MAY-2021, had not recovered from cloudy vision /haziness/ blurred vision, and dizziness when standing and walking, and the outcome of tiredness and cloudy head was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
A physician reported that a 4 year old female received her first dose of Prevnar on 1/4/01, at the age of 34 months. Medical history includes nephrotic syndrome and immunosuppressive therapy with FK 506 (tacrolimus). On 6/23/02, the child was hospitalized. A blood culture was performed; Streptococcal pneumoniae serotype 6B was isolated. Diagnoses of pneumococcal bacteremia (without focus) and pneumococcal peritonitis were made. She survived and was discharged from the hospital on 6/26/02. As of the date this was reported, no additional information was available.
The next morning, he had a severe sore throat that felt like strep throat, severe tiredness  and then turned into a massive runny nose  and then a cough.   He was Lethargic for several days.  He hasn't been to school, so we don't know how he could have gotten massive cold like symptoms.  Its been several days and no one else has gotten sick who has been around him, so we don't think it was a cold but must have come from the shot.
Situation: 33M s/p vaccination had c/o nausea, dizziness and became diaphoretic.  Background: Patient here for first dose vaccine and was monitored for 15 mins after being vaccinated.   Assessment:  ? 1530: patient stated he felt dizzy. RN assessed patient was diaphoretic. ? 1532: 78/40 (sitting). Juice given. Placed on gurney. Ambulance called.  ? 1536: 105/67 (lying flat) ? 1540: 104/69 (sitting). Patient refused ambulance and cancelled. ? 1556: 108/76 (sitting, feet dangling)  Recommendation: The patient improved after closer monitoring. No further recommendations.
0.25 ml from 2 vials with the same lot number was pulled up and administered as one dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.25 ml from 2 vials with the same lot number was pulled up and administered as one dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.25 ml from 2 vials with the same lot number was pulled up and administered as one dose). At the time of the report, INCORRECT DOSE ADMINISTERED (0.25 ml from 2 vials with the same lot number was pulled up and administered as one dose) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up information was received on 01-Apr-2021 contains no new information.; Reporter's Comments: This report refers to a case of Inappropriate dose of vaccine administered for mRNA-1273, lot # 040A21A with no associated AEs.
Patient went home and after 2 hours had a very severe sore throat and itchy burning sensation in her eyes.
vaccine expired on 7/13/2022  use for clinic on 7/15/2022 no reports of adverse reaction as of 7/26/2022
Initial misuse report received on 14 October 2013 from a health care professional. A 12 years old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that FLUZONE ID was given to the patient of 12 years. List of documents held by sender: none.
Patient completed vaccine consent form as never having had a COVID vaccine before, and not having any vaccine in the last 14 days.  When reporting the administered Janssen vaccine, it was discovered that she had received a Pfizer COVID vaccine on 8/2/21.  Upon questioning patient, she admitted to lying on the consent form and in conversation.  She needed to be fully vaccinated to attend her daughter's graduation in 16 days, and could not wait for 2nd dose of Pfizer.  Patient reported no side effects when leaving pharmacy 15 min after administration of Janssen vaccine.  She was advised to report any adverse reaction if any should occur.
Body aches, sensitive skin, dizziness, nausea and fever that spiked to 103.1
pt started having headache and body aches first, then fever 100.6 and chills and a red face
Fever up to 104 degrees checked axillary, convulsions, shaking, screaming, fever began at 3:00 am on 10.28.10, convulsions/shaking lasted 20-30 min.
pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318 and expiration dates were not reported), via an unspecified route of administration in left arm on 12Feb2021 at 12:30 PM, as single dose for COVID-19 immunisation. The medical history included R hip arthritis and allergy codeine causes nausea and vomiting. The concomitant medication included naproxen, ibuprofen, calcium, vit D and glucosamine. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9261 and expiration dates were not reported), via an unspecified route of administration in right arm on 21Jan2021 at 06:30 PM, at single dose for COVID-19 immunisation. On 13Feb2021 at 12:00 PM, patient experienced pain and swelling of left axillary lymph node. No any other vaccine administered in four weeks. The corrective treatment was not required for the AE. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the patients event was recovering.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Mild, Additional Details: Patient passed out hit his head while dropping to the ground. Paramedic was called and came. He was fine after, but called a ride to get him to be on the safe side.
Tongue numb - Still numb today.  I want to know if my tongue will ever recover. Throat swelled. - Took Benadryl. Right arm pain for 4 days. Bad headach for 3 days.
Alopecia Areata developing in September 2021 with no other health indications. Balding has spread to 90% of scalp and 25% of body. Adverse reactions to vaccine #2 and to booster - high fever, sweats, heavy vomiting, fatigue