chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates have been extended. Patient received expired dose from the lot number:059H21A. No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Patient identifiers added
patient received vaccine 5/3/21. patient states she had no symptoms or issues until about Saturday 5/8/21. She states that she had started developing redness and swelling in the injection area on saturday. She said that it has not gotten worse since then, it is just still there. Patient was offered OTC remedies and directed to her doctor for further evaluation if symptoms continue or progress to make sure that the area is not infected
Patient felt light headed and sweaty and faint after immunization.  We elevated feet and gave him a drink with sugar and after a few moments he started feeling better.
on 3/34/21 woke up with more arm tenderness than day before. At around 1:00pm 3/24/21 I started to have bad diarrhea out of nowhere, about a hour later I got a mild fever of about 99.8 with some fatigue. Took a nap and felt fine after that.  3/29/21 I woke up to a rash around injection site. A little itchy no other symptoms went away in two days.   4/20/21 Woke up to body aches, chills, fever and sore arm. Fever ranged from 99.9-102.8 all day used ibuprofen to treat the fever and body aches. Fever broke sometime in the middle of the night woke up drenched in sweat.  4/21/21 Woke up to my arm being really sore and very red. Arm is red, feverish, and a bit swollen. I had a fever on and off all day stayed strong at 99.9 almost the entire day. Broke around 5:00AM.  4/22/21 Woke up to the redness having spread down my arm a little further. Had some nausea and mild vomitting. I went to the dr to make sure there was no allergic reaction.
I received the first Pfizer shot on Thursday, January 21.  On Wednesday, January 27, I had an intense metallic taste in my mouth.  I had a covid test on January 29 which was negative.  It is now the end of March and I still have metal mouth.  My mouth tastes like metal, and everything I eat or drink has a metal overlay over what I can taste.  Either I am getting used to it or it may have abetted a little.  I really hope it goes away.
Information has been received from a health professional concerning a 29 year old male who on 01/10/2002 was vaccinated with a dose of varicella virus vaccine live. On 01/11/2002 the pt experienced a mild fever, slightly swollen glands and muscle aches. On 01/14/2002 the pt developed 4-5 red spots on his face and chest. Unspecified medical attention was sought. Additional info has been requested.
Fever and Body aches, chills, nausea.  Took Tylenol and rested
I wore a new black t shirt and I developed a rash in the distribution of the t shirt.
Swelling; Redness; minor Pain; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, vaccine location: left arm), via an unspecified route of administration from 29Jan2021 12:45 PM to 29Jan2021 12:45 PM at a single dose for COVID-19 immunisation. The patient medical history included COVID-19 (if covid prior vaccination: Yes). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included nortriptyline, levothyroxine and celecoxib (CELEXA) and other vaccine same date product (Pfizer product, lot number=EL3247), on 29Jan2021 (dose number= 01, vaccine location=left arm). Patient previously took allopurinol, Bactrim and experienced Allergies. Since the vaccination, Patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date. The patient experienced Swelling, Redness, minor Pain (non-serious) on 31Jan2021. The outcome of events was not-recovered. Information on the lot/batch number has been requested.
Significant increase in tinnitus starting about 10 days after the injection. First observed in right ear and then in the left ear. This is a long time 20 year sufferer of tinnitus. The observation is a very significant change in the level experienced.  Concerned about having the second injection and impact it would have on quality of life if this does not subside.
This study case was received from the investigator in a trial on 04 June 2014. A 41 year-old male subject (date of birth not reported) with no reported past medical history had received on an unspecified day in September 2008 a ACAM2000 (lot number, route and site of administration not reported) and 2096 days later was found to have on 29 May 2014 a positive rapid Troponin I. No symptoms were noted and no other adverse events were reported. He did do a rigorous hike on 25 May 2014. The subject had a normal ECG on 29 May 2014. Action taken was none. No further information was available at the time of the report. The subject's outcome was still present, no treatment (not recovered). According to the investigator, the event of elevated Troponin was considered mild, other important medical event and remotely related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Arm hurt; Didn't feel well; Made her sick; 1st dose of Shingrix a year ago; This case was reported by a pharmacist and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell, sickness and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell, sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell and sickness to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and arm hurt, just did not feel well and it made sick.  The patient the 1st dose of Shingrix a year ago and mentioned that had a rough time with the 1st dose and was probably part of the reason why had not returned for the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up. No vaccine details available at the time of the call. This case linked with US2020AMR257399, US2020AMR257416, US2020AMR257400 and US2020256891, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR257399:same reporter_individual pt US-GLAXOSMITHKLINE-US2020AMR257416:same reporter_some patients (sick, 2nd dose) US-GLAXOSMITHKLINE-US2020AMR257400:same reporter_some patients (sick, 1st dose) US-GLAXOSMITHKLINE-US2020256891:same reporter_some patients (late)
thought they had Covid; arm is sore; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of after about 9 hours later. At the time of the report, SUSPECTED COVID-19 (thought they had Covid) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.      Concomitant medications details were not reported by the reporter.  Patient received first dose on 31-Jan-2021 (Batch number: 010M20A), second dose on 28-Feb-2021 (Batch number: 013A21A) and first booster dose on 22-Oct-2021 (Batch number: 012F21A) of moderna shots. Reportedly, Patient had other Moderna shots and had headaches.  Patient received Advil as an treatment medication after about 9 hours later and headache lasted until yesterday.   This case was linked to MOD-2022-663899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2022: Follow-up document contains updated patient demographics, events added and narrative updated accordingly.
fever/fever ranging from 101 F to 102.5 F; This is a spontaneous report from a Pfizer-sponsored Program COVAX support from a contactable consumer (patient)   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 04Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Mar2021, the day after vaccination the patient experienced fever ranging from 101 F to 102.5 F. At the time of the reporting event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt given 3rd dose Pfizer after having a primary series of Moderna.  No issues post vaccination
Approximately 15 minutes after the vaccine was given, the patient felt clammy & sweaty & looked flushed. She stated that she felt like she was going to pass out. The nurse practitioner & medical assistant took the patient's blood pressure, pulse & pulse ox. Her BP & HR were high, pulse ox was normal - no wheezing. After 45 min of observation, the symptoms started to subside & returned twice. She was advised to head to the ER.
Chicken pox outbreak; This case was reported by a consumer and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 days after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was not recovered/not resolved.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient broke out with Chickenpox after receiving Shingrix vaccine.  The patient trying to ascertain if it's contagious. The patient had approximately 40-50 pox sores at various degrees or healing and still breaking out with new pox places daily. Initially started breaking out 12 days after the vaccination. The reporter asked if was there any treatment other the over the counter meds such as antihistamines and asked how long can expect this to continue.
Arm soreness, fatigue, and mild body aches that started the day after vaccination and lasted about a day.   About 1 week later, developed underarm pain - possible related to lymphadenopathy? though no palpable lymph nodes, and mild itching at the injection site. Itching lasted less than a day. Underarm pain lasted 4-5 days.
Sore arm, bad taste in mouth, Nashua, dizziness, body aches, fever
Mild headache (Day 2); Injection site soreness (Day 1 and Day 2); This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date was unknown), intramuscularly on the left arm on 18Dec2020 at 13:15 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant at the time of vaccination. 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. On 18Dec2020 at 16:00, the patient experienced injection site soreness (day 1 and day 2) and mild headache (day 2) on 19Dec2020. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events (AE). The patient recovered from both the events on an unspecified date.
Dark purple nickel-sized bruise at injection site, pain wraps all the way around bicep, hives about 3 inches from injection site - this morning the size of a nickel, now the size of a half dollar bill.
Pt presents to MD office c/o chills, sore throat, & stiff neck; Pt did have some stiffness of the neck w/inability to feel the neck to the chin; Meningismus or cerebritis secondary to rxn to Td; cannot rule out meningitis;
Mom noticed small redness to RT on 2/25/04 which spread up to 10cm x 65cm. No striae noted on 2/27/04.
Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   The patient's past medical history included multiple sclerosis. Concomitant products included Herpes zoster (Shingrix).   On 20th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: On 14th March 2019, the patient received first dose of Shingrix concomitantly. The patient experienced fever of 101 degree C after 2nd dose of Shingrix.  The health care professional noted that the fever of 101 has lasted for over 24 hours after dose 2. This case was linked to case US2019092274 for dose 1 of the same patient.      Lab Comments: Lab test performed in May 2019
She stated that her shoulder hurt for a couple weeks and that she believes that the immunization was shot too high. She mentioned this to her doctor when she had an unrelated appointment and they stated that the shot may have hit her tendon and given her a mild case of tendonitis.
pt recvd vax 930AM & woke 1PM had high pitched scream for 2 hrs; mom called clinic then called MD;
Fainted after second dose of vaccine, on April 19, 2021 treated by on-site paramedic.  Was referred to Emergency Room. On June 3, 2021 after noticing an abnormally high heart rate I went to an Urgent Care clinic.  The attending physician immediately sent me to the local Emergency Room.  I was admitted, and the ER and the Dr and staff ran a multitude of tests, including those to determine enlarged heart, blood clots, etc. that might be associated with the Pfizer COVID-19 vaccine.  I was discharged without a definitive diagnosis and was referred to my general physician with The Clinic.  Dr. ordered a heart monitor,  and she prescribed Propranolol, but that did not work, so a few weeks later, Dr. prescribed Metoprolol, which I have been on for the past 6 months.  I am now living in another area and since my condition has not improved, my GP has referred me to a Cardiac Specialist with a local health care facility.  PLEASE NOTE:  The sticker that the Vaccine clinic placed on my COVID-19 Vaccination Record Card has two overlapping Pfizer Lot numbers!  I have a photo of the card if you would like to see it.  So I really don't know which lot number I received for my second dose on April 19, 2021.
Allergic reaction to first dose of COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to first dose of COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details was not reported.  The patient received co-suspect Humira at a dose of 40 mg/0.4 ml (40 milligram solution for injection in pre-filled pen) with the citrate free formulation (40 mg, frequency :once in 2 weeks).  It was unknown if the patient was enrolled in a COVID-19 vaccine trial or not.  The reporter's causality for the event of allergic reaction to first dose of COVID vaccine was not provided with the co-suspect product Humira.  No treatment medications were reported.
Patient was given the wrong formulation of Pfizer vaccine.  She was given 0.3ml of Purple Cap (age 12+) Pfizer rather than the appropriate Orange Cap Pfizer (ages 5-11) dosage.
Left side of my face; Under my eyes; Around my cheeks; On my jaw; Welts on my face; Eye looked like I had a black eye; It was all red; Rash on my face; This spontaneous case was reported by a patient and describes the occurrence of RASH (Left side of my face), RASH (Under my eyes), RASH (Around my cheeks), RASH (On my jaw) and URTICARIA (Welts on my face) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Left side of my face), RASH (Under my eyes), RASH (Around my cheeks), RASH (On my jaw), URTICARIA (Welts on my face), EYE CONTUSION (Eye looked like I had a black eye), ERYTHEMA (It was all red) and RASH (Rash on my face). The patient was treated with HYDROCORTISONE for Rash face, at a dose of 1 dosage form. At the time of the report, RASH (Left side of my face), RASH (Under my eyes), RASH (Around my cheeks), RASH (On my jaw), URTICARIA (Welts on my face), EYE CONTUSION (Eye looked like I had a black eye), ERYTHEMA (It was all red) and RASH (Rash on my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported.   This case was linked to MOD-2021-035235 (Patient Link).
Right arm became limited movement (only move 45 degrees) two hours after injection with significant swelling front and back of the arm; hot to touch and red spotty areas.  She thought it would get better but did not contact pharmacy until October 21, 2022 because continuation of mild swelling, still warm to touch, but concern because the area remained red in different areas on the are.  Told  her to take Benadryl 50 mg every 6 - 8 hours and alternate hydrocortisone cream 1% with benadryl cream every 6 hours.  She reported on October 22nd that there was improvement; she can move are normally and continue regimen. She reported on October 23rd that area is much better and did not feel need to contact a doctor.  I did encourage to seek medical help if not resolving.  Patient had no other concerns.
Fever (103.8) and febrile seizure 12 hours after vaccines administered.
Narrative:  47 Y.O. FEMALE WITH PMH OF COPD, POLYCYTHEMIA PT, PRESENTS TO THE ED FOR COVID VACCINE REACTION S/P PFIZER VACCINE ON 04/22/2021. ASSOCIATED RASH AT INJECTION SITE DEVELOPED THE PREVIOUS NIGHT AND PROGRESSIVELY WORSENED; ALSO HAD FATIGUE AND BODY ACHES S/P INJECTION THOUGH SYMPTOMS RESOLVED. PATIENT CARED FOR IN ED AND DISCHARGED TO HOME SAME DAY.
Fever, intense migraines, dizziness, extreme fatigue, pain, nausea, eye pain
This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with unspecified doses of VARIVAX (Merck) (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored VARIVAX (Merck), so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
"Itching of palms and soles of feet, hives under her arms and back of legs with itching and blotchy and right eye swollen shut" per mother.
My daughter has had a full body rash, that nobody can identify, since the shot.  They start as little dots and change into circles after a while. She had had chest pains and pressure and is very uncomfortable
no additional AE reported; Patient received first dose of VARIVAX at the age of 36-year-old on 09-SEP-2021. Patient received a second dose on 05-OCT-2021; This spontaneous report has been received from a nurse, regarding a 36-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not provided.  On 09-SEP-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), and on 05-OCT-2021 with the second dose (inappropriate schedule of product administration), both as prophylaxis (exact doses, route of administration and anatomical locations of vaccination, lot numbers and expirations dates were not reported). No additional information was provided, and no adverse events (AEs) were reported (no adverse event).
Numbness in right arm and leg, 30 minutes, post vax. No shortness of breath or swelling. No difficulty in speech. Numbness has slowly resolved.