chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax 27SEP91 & devel pain @ inject site & axillary pain that night; 2nd night awoke soaked w/persipiration feeling ill; continued to feel ill 3rd day; This was 1st of series of Hep B vax;
Patient reported fever of 101 degrees and went to the ER due to previous history of seizures due to fever. Received Tylenol in the ER and fever subsided.
A 5 x 7 cm red swollen area on thigh just adjacent to a mosquito bite.
Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; Tested positive for COVID around 10AM EDT on 30Sep2021 via at home COVID test.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscularly on 07Apr2021 (Batch/Lot number was not reported) (age at vaccination: 23 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162b2 (Batch/Lot number was not reported) on 17Mar2021 for COVID-19 immunization. No other vaccine received in four weeks. The patient was tested positive for COVID around 10 am EDT on 30Sep2021 via at home COVID test (test type unknown). No treatment was received for the event. The patient was recovering from the event.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
swelling has moved to left side side of her tongue and to her left cheek.; sore throat; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on 08Feb2021 (age at the time of vaccination was not provided) as dose number unknown, single for Covid-19 immunization. The patient's medical history included Covid-19 and heart attack. Caller mentioned she had COVID and a heart attack around thanksgiving that was why she decided to get the vaccine. It was verified that this occurred prior to getting the Covid-19 vaccine. The patient's concomitant medications were not provided. The patient calling about the Covid-19 Vaccine and stated that she had the vaccine on Monday 08Feb2021. She had a sore throat yesterday on 09Feb2021, and the lymph nodes on the left side of her neck were swollen yesterday on 09Feb2021. Stated that it felt like her tongue was bothering her too on that side, and now the swelling is moving up to her cheek today on that left side; kind of looks like the mumps on 10Feb2021. She asks if she should get medical attention. She mentioned that she was hospitalized the week of thanksgiving with Covid and a heart attack. It was verified that this occurred prior to getting the Covid-19 vaccine. She declined to provide email address. Caller wanted to know if these symptoms have been associated with the vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. Information about lot/batch number has been requested.
This spontaneous report as received from a nurse refers to a female patient of unknown age. Two weeks ago, on 27-JAN-2013 the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were not reported) in the upper left arm. On an unknown date in 2013 the patient had pain in her left arm for several days. The outcome of pain in her left arm was reported as recovered on unspecified date. It was unspecified if the patient sought medical attention. Additional information is not expected.
she is HIV positive, but it's a false positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. Patient got both doses of the Covid vaccine and after getting both doses she donated blood to the red cross three weeks later. She just got a letter stating that she was HIV positive, but it was a false positive and wanted to know if anyone else has reported this. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient called in and stated she had rash, redness, swollen, local warm at the right arm injection site, like a "kiwi" size, a little bit itching, started 2-3 days after the injection, no fever.
not immunocompromised; couldn't stand up; didn't want food or liquids; she still has difficulty standing; too weak to walk; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids), DYSSTASIA (she still has difficulty standing), ASTHENIA (too weak to walk) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 032L20A and 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced NAUSEA (nauseous). In September 2021, the patient experienced DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk). On 19-Sep-2021 at 2:00 AM, the patient experienced MOBILITY DECREASED (couldn't stand up) and DECREASED APPETITE (didn't want food or liquids). On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised). At the time of the report, MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids) and NAUSEA (nauseous) outcome was unknown, DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk) had not resolved and OFF LABEL USE (not immunocompromised) had resolved.            No concomitant medications were provided. Patient treatment include she went to the emergency room where they gave her 2 bags of IV fluids. Patient is not immunocompromised but got the shot because they heard Pfizer had authorized a third shot for people over 65.   This case was linked to MOD-2021-324298 (Patient Link).
5 minutes after administration of MMR, Varivax, and Prevnar # 4, the patient had giant urticaria without wheezing, no angioedema. Resolved approximately 20-30 minutes after administration of Diphenhydramine.
Debilitating, 10/10 left arm pain, the night of the vaccine there was nausea and vomiting due to pain. Paraesthesia of the thumb, index, pointer fingers on both hands. Due to pain unable to unable to use left shoulder for 2 days, no position of comfort. Tylenol and ibuprofen made the pain bearable, 7/10, to the point it was no longer causing nausea and vomiting. 5 days out and still 3/10 pain without return to baseline function prior to injection. Also experienced 36 hours of fever, chills, myalgia, head ache
Headache, chills, nausea, body aches starting about 7 hours after the vaccination.  The side effects lasted about 36 hours and improved with ibuprofen.
Muscle pain, headache, fever, chills, shivering, stomach pain. difficulty sleeping, tiredness and weakness the following day
This case concerns a 48 year-old female patient who received AFLURIA IM (lot 01549211A) at right deltoid on 09-SEP-2009 at 07:40. The patient was not ill at the time of vaccination. The patient has a medical history of controlled hypertension. No concomitant medications were provided. On 09-SEP-2009 after AFLURIA was started, the patient developed a hard red hot area around the injection site. Per the reporter, the patient has recovered from the event. The reporter considered events as non-serious. No further information is expected.  ADDENDUM: 24-sep-2009: Patient is not pregnant. Batch Review Result received on 02-NOV-2009. Batch number: 01549211AS. Result: In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. 19-AUG-2013: Case reported to unflag the insignificant change in case approval field as the corrections made previously were medically significant, age group changed back to blank in the patient field, core unlisted for all the event changed back to blank in the vaccine relatedness field, company causality was entered as possible (per the narrative) in the company seriousness field, core unlisted was changed to unlisted int he company seriousness field, new event added in the adverse event field "hard (red spot) around the injection site". 18-JUN-2015: This case was reopened and the listedness of the individual events were reviewed. This activity was carried out as part of the company's commitant to the MHRA to improve quality and consistency of company safety database. Listedness: Listed (according to the CSI Inactivated Influenza Virus Vaccine CCDS and AFLURIA US PI).
she had skin sensitivity on back; This is a spontaneous report from a non-contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated she had skin sensitivity on back after receiving first Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt reports beginning of day 1 post COVID vaccine dose 2, she had h/a and neck pain and by the 24-hour mark everything started to occur.  Pt presents with red blotchy skin on the face and torso, swollen lips (upper and lower), oral temperature of 100.5, sore  arm with pain rating 10/10.
LEFT DELTOID AREA (WHERE INJECTION GIVEN) WAS SWOLLEN AND TENDER. NO REDNESS OR WARMTH. PT WAS GIVEN RX OF PREDNISONE PO AND INSTRUCTION TO USE WARM COMPRESS. BUT SHE DID NOT TAKE THE MED. JUST WARM COMPRESS. OVERNIGHT, SWELLING AND TENDERNESS SUBSIDED. BY 9AM IN NEXT MORNING, ALL SYMPTOMS AND SIGNS RESOLVED.
arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient
Dose 1 Moderna 01/25/2021 Lot # 029K20A  Pt currently has covid 19 8/18/2021
HAD A FEVER AT 100.7 AND WAS RESOLVED ON THE SAME DAY
today she has redness around the site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient took the Covid shot the day before (18Dec2020) and said it was ok, but on the day of the report, 19Dec2020, she has redness around the site. The patient wanted to know if she can put the ice pack around it, and also stated she should have not taken the shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Patient experienced chest pain.  He went to the ER and was diagnosed with Pericarditis.
Rash at the site of an injection; General malaise; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash and general malaise. On an unknown date, the outcome of the injection site rash and general malaise were unknown.   It was unknown if the reporter considered the injection site rash and general malaise to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had rash at the site of an injection and a feeling of general malaise afterwards. The family member reported that she followed up with her Health care professional who administered the vaccine and was not experiencing any significant or further issues. The reporter was happy to complete any necessary paperwork.
Two hours post vax, the pt experienced aches, chills, fever, and felt sick. The next day she experienced hip and knee pain.
Within 10 minutes:  much post nasal drip (mucus) and dry coughing.  48 hours later, a headache in forehead area.  2nd day, headache worse in forehead area, a "splitting" pain headache.  3rd day, a migraine with expected pain in left eye are.  I am a lifelong migraine sufferer.
Tested positive for COVID after having vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after having vaccine) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID after having vaccine). At the time of the report, COVID-19 (Tested positive for COVID after having vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was the first or second dose.  The rechallenge was not applicable as event occurred after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19) is not affected by this report.
hurts to raise my right arm up to brush my hair or drive a car; soreness in both arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose in November 2022, for tolerance of 1st dose of shingles vaccine, refer case US2023AMR067348).   In JAN-2023, the patient received the 2nd dose of Shingles vaccine. In JAN-2023, immediately after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: soreness in both arms). On an unknown date, the patient experienced mobility decreased (Verbatim: hurts to raise my right arm up to brush my hair or drive a car). The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was resolving and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.  It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR067348   Additional Information: GSK Receipt Date: 04-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that the arm was sore as soon as the shingles vaccine was administered. The patient was still having soreness in both arms. The patient stated that it was hurt to raise his/her right arm up to brush his/her hair or drive a car. The patient took Ibuprofen and held ice pack on arm as a treatment and it relieved some of soreness but not completely. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR067348:Same reporter
Wife reports patient was vaccinated on 3/30/21.  She stated patient only had blurred vision following vaccination which lasted a about 2 days.  On 4/4 family members visited and it was noted that 1 member tested positive for Covid on 4/5/21 and her spouse was home sick on 4/4/21 and was later positive on 4/5/21.  Around 4/5/21 patient began having more frequent episodes of delusion and confusion.  Speech slurred and slouched in chair.  Patient would be demanding when asking for water when water was in his hand.  Talking to her but looking at the ceiling.  She stated she thought he was having "mini strokes."  Increased weakness with standing.  Slid to floor multiple times from chair.  She reports loss of appetite and trembling.  Saw MD on 4/12.  "Could hardly breathe."  MD ordered doxycycline and an inhaler.  Patient to Hospital on 4/13/21.  Diagnosed with Covid on 4/13/21 via PCR.  Discharged from hospital to Skilled Nursing Facility on 4/16/21.  Sent back to Hospital on 4/18/21 and passed away on 5/1/21.  Wife states that death certificate indicates "Utonic Hypercapnic respiratory failure, acute/chronic CHF, hypoxemic respiratory failure and HTN, DM, prostate CA and COVID PNA.  No autopsy performed.  Medical PCP.
so close to having pneumonia; got sick after the shot; hacking cough; choking; missed the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (so close to having pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.Concomitant medications were not provided.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (so close to having pneumonia) (seriousness criterion medically significant), MALAISE (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window). At the time of the report, PNEUMONIA (so close to having pneumonia), ILLNESS (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window) had not resolved.      Treatment information was not provided.   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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.    This report also refers to a case of missed dose for mRNA-1273 (Moderna COVID-19 Vaccine) lot # unknown with no associated AEs.
Nausea 36 hours, lethargy 48hrs (still), soreness at injection site  36 hours
Received an Expired Dose of Heplisav-B; Initial Report Received on 21-Apr-2022  A registered nurse reported that 46-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported. Allergies included cyclosporine, ciprofloxacin, metronidazole (Flagyl), acetaminophen/hydrocodone (Norco), piperacillin/tazobactam (Zosyn), and sulfa antibiotics.  No concomitant medications at the time of vaccination were reported.  On 13-Apr-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934967, expiration date 11 Apr-2022, NDC # 43528-003-05) in the right deltoid. No adverse reactions were reported.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Headache, Fever, Diarrhea, NauseaVomiting, she reports temp 99.0 to 100.0 via oral thermometer Narrative:  went to primary care physician but was turned away for having elevated temperature. she was instructed to report to employee health to be evaluated/treated and to report symptoms.
rt upper arm was swollen Wednesday & Thursday & today Friday is not swollen, but very warm to touch & red; mom not aware of fever;
Tinnitus has gotten worse and worse over the last two months. I read an article today saying the vaccine could cause it. 16,000 people have reported tinnitus after getting the vaccine.
Muscle soreness at injection site (left arm); This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Mar2021 at 01:00, the patient experienced muscle soreness at injection site (left arm). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle soreness at injection site (left arm) was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.