chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; fever up to 101.5 ° F; swollen at the injection site; felt tired; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness at the injection site), INJECTION SITE SWELLING (swollen at the injection site), FATIGUE (felt tired), HEADACHE (headache) and PYREXIA (fever up to 101.5 ° F) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchiness at the injection site). On 06-Jan-2021, the patient experienced INJECTION SITE SWELLING (swollen at the injection site) and FATIGUE (felt tired). On 16-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever up to 101.5 ° F). On 07-Jan-2021, INJECTION SITE SWELLING (swollen at the injection site) and FATIGUE (felt tired) had resolved. On 19-Jan-2021, HEADACHE (headache) had resolved. On 21-Jan-2021, PYREXIA (fever up to 101.5 ° F) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchiness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included lipid modifying agents.
Patient was given vaccine that had been drawn up and  brought to room temp. Drawn 12:45 6/16/21. It was taken by nurse to a nursing and rehab center to give to a client of theirs. It was placed in the freezer and given the next morning of 6/17/21
patients mother picked her up from daycare at approximently 4pm 6-1-2022 and patient had a rash and hives all over her body
This spontaneous report was received from a pharmacy technician concerning a 40 year old male pharmacist. The patient's pertinent medical history, drug reactions/allergies were not provided. On 28-AUG-2013, upon opening a carton of ZOSTAVAX (Lot # J003483, expiration date 29-JUN-2014), the pharmacist found a broken vial of ZOSTAVAX and during handling of the vial, pharmacist had a cut from broken vial and minor bleeding occurred. A band-aid was put on as treatment. The patient did not seek medical attention. There were no laboratories performed. Additional information has been requested.
On the afternoon following vaccination, pt developed arm swelling, redness at injection site, accompanied by myalgias, vomiting, headache which persisted for 3 days.
Received booster @ 1318.  @ 1400,  husband requested assistance for wife's complaint of numbness/ tingling on L arm.  RN completed focused neuro assessment and significant L hand grasp, L arm and L leg weakness.  Mild facial droop; mild confusion
Pt recvd vax 19NOV92 &  4 1/2 hrs following inject pt exp nausea & became lightheaded & flushed in the face; pt was frightened of fainting and/or falling; Pt felt sick all over; pt thought that sx were consistent w/flu; 21NOV92 felt weak;
Patient arrives to the clinic with his mother referring pain on injection site on the right deltoid area, the pain started on tuesday (one day after the vaccination), he was not able to lift his arm due to the pain, the swellness had improved by wednesday but the pain was still present at the time he came to the office. The patient's mother denied any fever, loss of apetite or any other symptoms.
get a flu shot twice. Both years I caught the flu a few months later.; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involved an unknown age and gender patient who experienced get a flu shot twice both years i caught the flu a few months later (influenza) while receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious caught the flu (influenza) few months later get a flu shot twice both years following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Hard pass! I wish you'd stick to your old content that was just fun and funny."  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
I received my shot around 5pm on April 7th at the pharmacy. My left arm was a little sore and I felt a bit woozy but aside from that everything seemed okay. Approximately 5-6 hours after my vaccine my period started back up which was strange as I just finished my cycle on Friday, April 2nd. My period was pretty heavy in comparison for the first 3-4 days and then finally stopped again on Sunday, April 11th.  I am 1 week past my vaccine and everything seems fine for now and I hope it continues.
Saturday evening, I started to experience fullness in my chest that I thought may have been indigestion. Then I was also getting some right sided upper abdomen pain with it and cramping in my chest area. That persisted for about 5 days, and it was intermittent. On the 6th day I visited my doctor on 10/29/2021. They ran some test, and everything came back normal. They told me to start taking an OTC maximum again for 14 days. I was having minimal symptoms at that point. I got progressively better as time went on.
Pain in the arm location where the shot was given with some pain radiating into my shoulder and neck at times. Gets better and then pain returns and since the 2nd shot in the other arm where there was no reaction my right arm hurts again at the injection site and does not stop even taking pain reliever. I?ve also been sick with sinus aches, congestion, fever, chills, and cough that aches and sore throat on and off since the 2nd vaccination on March 31st. I feel this is lasting for a while and I?m so exhausted all the time. I don?t know if this has any relation to getting the vaccine but I?m never hardly ever sick and now I can?t go a day without pain or worse flu like symptoms.
Patient is a 52 year old male. He presented to the ER with fever, altered mental status, and weakness of extremities on 7/27 after receiving his second dose of Pfizer COVID-19 vaccine on 7/26. Patient has a history of multiple sclerosis and morbid obesity. Patient became less responsive overnight after the vaccination and could not get out of bed per H & P. He developed a fever and was taken to the ER. T-max was 102.5 degrees F while in the ER. Upon admission, patient had almost total paralysis. Patient received methylprednisolone 1 g IV x 3 doses (7/28 to 7/30) ordered by tele neurology.  Provider thinks this was likely a multiple sclerosis flare precipitated by febrile episode. Patient mental status has recovered to baseline and his weakness is improving.   Report submitted by hospital pharmacist for hospital medicine physician.
Breakthrough case admission after 3 vaccines  Pfizer 1/13/21 lot# EK4176;  Pfizer 2/3/21 lot# EL9265;  Pfizer 10/26/21 lot# FF2590
First day was achy, severe headache, vomiting and fever. Second day body aches continued. On the 4th pain hip pain was persistent and 8th day clammy, headache and achy.
Pt broke out in hives 1 hr after injection and later in the day had dizzy, weakness, body aches.
Pt began to run a fever the same day and developed cellulitis the next day on his arm after being immunized. Was given an antibiotic and the cellulitis was resolved.
Came to urgent care on 11/24 with chief complaint of right sided lower back pain that is tender to palpation. Given ketorolac 30mg IM x 1 dose & sent home with ketorolac 5mg po Q6 hours prn pain. Returned to urgent care on 11/25/12. X-ray obtained. Patient had 8/10 radiating pain. Was given diazepam 2mg po x 1. Sent home to continue ketorolac, apply heat, & stretch the muscle.
The patient was 12 years old at the time of the vaccination, however, they received the pediatric dose of pfizer for their second shot.
Left lower quadrant mastitis presenting 12/29/2020, 5 days after receiving dose #1 Pfizer Covid19 vaccine in the left deltoid.  I was seen in urgent care and treated successfully with sulfamethoxazole-trimethoprim orally twice daily for 7 days.
This spontaneous report was received via company representative from a female patient of unknown age reporting on herself. The patient's medical history included breakout of rashes "every year or so" which upon getting routine testing, occurred to be shingles. On an unknown date in September 2016, the patient was vaccinated, in a pharmacy, with the first dose of ZOSTAVAX injection (dose, site and route of administration, lot# and expiry date were not reported) for prevention of shingles. There was no information about the patient's concomitant medications reported. On an unknown date in 2016, the patient "broke out in a good size rash on her buttocks". The patient sought medical attention. Unspecified treatment was given for the adverse event. The patient recovered from the event on an unknown date in 2016. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Possible vaccine failure. Patient was hospitalized for streptococcus pneumonia after being vaccinated with Prevnar.  Nurse follow up on 06/30/04 states: "dehydration."  Follow up on 08/27/04 states: "This is not a vaccine failure, serotype was 33F."
TESTED POSITIVE FOR COVID; This spontaneous report received from a consumer concerned an 71 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total administered on 01-JAN-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2022, the patient tested positive for Covid with the Binax Now test when treated with covid-19 vaccine ad26.cov2.s (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for Covid was not reported (dose number in series 2). This report was non-serious. This case was associated with a product quality complaint: 90000214055. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
redness, swelling and itching at injection site. indurated area of about 4cm in diameter
Arm where received the injection was numb; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper arm in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced numbness of upper arm. On an unknown date, the outcome of the numbness of upper arm was recovered/resolved.   It was unknown if the reporter considered the numbness of upper arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that the patient after receiving the 1st dose of Shingrix, the arm where received the vaccination was numb, it happened on the same day and lasted for less than 24 hours. No further information was available. The reporter consented to follow up.
This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored RECOMBIVAX HB exposed to 9.7 degree for 6 hours 20 minutes (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, and 1408USA000848. Additional information has been requested.
1357 client complained of a lump in her throat feeling; sensation of having trouble swallowing; feels hot at back of neck 1358 BP 152/106  P 140  R 12 SpO2 99%   LOC A&O x 3; Skin cool, pink and dry; Resps unlabored and lungs clear-no wheeze or stridor; heart regular  and pulse strong 1405  BP 142/88  P 116  R 12  SpO2 99% Resps continue unlabored; sensation of lump in throat continues; EMS notified 1410  BP 136/84  P 108  R 12 SpO2 99%  Resps unlabored; sensation still present; pulse has an irregularity; EMS arrived; Handoff given to EMS crew; client dispositioned to local ED at Hospital
The night I had the Covid vaccine, ~ 12 hrs later, I had a sudden onset of intense itching in my right ear, that extended deep into region of Eustachian tube. This lasted ~ 1 hr  and finally subsided just before I was getting ready to take a Benadryl.  The itching returned intermittently over the next 3 weeks, and was bothersome. This was accompanied by the feeling of warmth about the ear occasionally. One incidence of tiny pains in the ear occurred.  After ~ 18 days, a gradual onset of ringing in the ears began. This worsened on day 19 , becoming twice as loud.  At this point , I deferred the second vaccine dose which was scheduled for day 19, 1/22/21.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no reported medical history. On 02-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number H01997; 02/2014), subcutaneous (dose unknown) in the arm. No other suspect therapies or concomitant medications were reported. On an unspecified date in 2013, reported as "the past few days" the patient experienced rash and itching over the entire arm where the vaccine was administered. The patient noted this rash and itching comes and goes. No treatment information was reported. The outcome of itching over the entire arm and rash over the entire arm was reported as not recovered/not resolved. The reporters relatedness of rash and itching over the entire arm to ZOSTAVAX is unknown. Additional information has been requested.
pt recvd vax & 1hr later screamed a few minutes & rt eye turned red & rt side of face turned bright splotchy red; faded in 30mins but still visible;
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Influenza vaccine Quadrivalent. Co-suspect products included ADVAIR Diskus inhalation powder (batch number 7ZP4239, expiry date 31st December 2018) for chronic obstructive pulmonary disease. Concurrent medical conditions included drug allergy (allergy to drug aspirin, codeine or statins). Concomitant products included ipratropium bromide, PLAVIX and PROAIR. In November 2017, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On 25th December 2017, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On 30th December 2017, the patient experienced acute  respiratory failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced yeast infection. The patient was treated with CIPRO. ADVAIR  Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure and yeast infection were unknown and the outcome of the acute respiratory failure and influenza were recovered/resolved. It was unknown if the reporter considered the vaccination failure, acute respiratory failure and influenza to be related to influenza vaccine Quadrivalent. The reporter considered the yeast infection to be possibly related to influenza vaccine Quadrivalent and ADVAIR Diskus. It was unknown if the reporter considered the acute respiratory failure and influenza to be related to ADVAIR Diskus. Additional details were provided as follows: Concomitant product included Beta blocker. The patient got a flu shot in November 2017 and developed the flu on Christmas day. The patient was on CIPRO and on the 5th day the patient developed acute lung failure and was hospitalized for 6 days. The patient then was placed in a nursing home for 3 weeks. When the patient took ADVAIR, (ADVAIR was started in 1999) she felt better. The patient never had pneumonia before, her dosage of ADVAIR had been increased to 500/50 started on the day of reporting. The patient rinsed her mouth with water and brushes her teeth, but she still had yeast infections. This case was considered as suspected vaccination failure, the confirmatory laboratory test and TTO (time to onset) was not reported.
Pain, redness and swelling in the left arm at injection site(s).  A mild fever that lasted about 36 hours after the vaccinations
Diluent for HIB given.  Vaccine was not given, diluent was not mixed with HIB vaccine before giving to the patient.  Patient has not had any adverse reaction to the diluent.  Notified patient's mother of error.
expired on 12-Feb-2022 and a dose was given on 14-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired on 12-Feb-2022 and a dose was given on 14-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. The Moderna had been in the refrigerator for ten days and there had been no temp excursions.
Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heavy bleeding compared to usual cycles.; Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heavy bleeding compared to usual cycles.; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 27-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 07Apr2021 15:45 (at the age of 27-years-old) as dose 1, single for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. The patient previously took almond and experienced drug hypersensitivity. Patient received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced Menstrual cycle was 15 days longer than normal after receiving vaccination, period has included abnormally heav08Apry bleeding compared to usual cycles. on 08Apr2021 08:00. No treatment was received for the events. The outcome of the events was reported as unknown.  No follow up attempts are possible. No further information is expected.
Pt recvd 2 doses of Heptavax 26JAN84 & 28FEB84 & 1 dose of Engerix-B 11OCT91 & 1 wk p/3rd dose pt devel elevated SGOT, elevated SGPT & elevated total bilirubin; no tx given; blood work up will be repeated in 1 mo;
Has a bad rash on his right wrist underneath his palm that looks like eczema; It feels like it wants to come out on his left wrist; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) and FEELING ABNORMAL (It feels like it wants to come out on his left wrist) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-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 ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) and FEELING ABNORMAL (It feels like it wants to come out on his left wrist). At the time of the report, ECZEMA (Has a bad rash on his right wrist underneath his palm that looks like eczema) had not resolved and FEELING ABNORMAL (It feels like it wants to come out on his left wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-466136 (Patient Link).
Temp-100 degrees. Rash upper left arm. Red area 6 x 5 cm.
Patient presents 1/11/06 with L arm swollen, red, hard, warm in large area distal to vaccination sites.  No streaking, margins of induration uneven.  Denies itching, reports fever.  Prescribed Keflex, Motrin and Benadryl.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. The nurse reported that on 09-MAR-2017, the patient received the first dose of GARDASIL 9(strength, dose, frequency, route of administration and expiration date were not provided) for an prophylaxis (lot # M000359 ). On 05-MAY-2017, the patient would receive the second dose of GARDASIL 9. No adverse effects were reported. No further details provided. There was no product quality complaint (PQC) involved. Additional information has been requested.