chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccinator thought there was vaccine in the syringe when in fact there was nothing in the syringe being used. The Patient received less than 0.5cc of air. Patient came back to our clinic the same day and received 0.5cc of Moderna in left arm.
Patient experienced a swollen and red arm (lower than injection site) with swollen throat and normal breathing other than some gasping while talking- Went to the ER 3/25/2023 (several days later) due to arm still being swollen. Was prescribed benadryl, pepcid, prednisone, and an epi-pen.
pt recv vax & subsequent lab eval revealed that pt was core antibody pos; No further details were provided;
Patient possibly received no dose of vaccine at administration (syringe potentially empty).  After inventory was performed, extra dose was in vial.  No effects of having vaccine at 24, and 72 hours of receiving injection.
Received Tdap and later that night, he developed chills, headache, bilateral elbow pain. No rash, sore throat or dyspnea.
Pt was given GARDASIL #2 on 11-17-09. She returned to the clinic on 11/23/09 & had a positive Pregnancy test.
Patient developed bilateral subcutaneous tender nodules after each vaccine site in each arm, which did not spontaneously resolve and needed to be surgically addressed. Cultures were sterile.
Experienced fever and chills starting at 10:30pm . Took temperature at 11:00pm  to find temperature at 101 degrees. Took Tylenol to break fever at 11:30pm. Fever broke at 12:50 am. Woke up at 6:30 am with a headache.
Gilliam barre syndrome; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) (seriousness criterion hospitalization). The patient was hospitalized from 01-Mar-2021 to 07-Mar-2021 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by patient. Treatment of this event was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Acute onset of lethargy, extreme fatigue, chest pain, agitation, tremors, chills, lack of appetite, muscle aches, mild dizziness and lack of coordination 11 days after vaccination (9/7/21)  Symptoms were somewhat intermittent and have improved after 2 days. Fatigue was consistent.  I visited the emergency room the morning of the 13th day after the vaccination (9/9/21) due to the chest pain and fatigue/lethargy being very concerning.  Symptoms persisted throughout the day today (9/9) but seem to have improved this evening.  No fever was noted during the event (oral thermometer used).  No respiratory involvement.
Started running fever and had aches approx. 12:00am until approx. 10am next day. Also had nausea all next day.
Tinnitus set in about 3 weeks after the 2nd vaccine. Loud ringing noise, and also an ocean or machine noise.
Moderna COVID- 19 Vaccine EUA: After vaccination patient reported dizziness and lightheadedness. Vital signs stable except pulse 106 beats per minute and blood pressure 145/94 mmHg. No loss of consciousness, rash, respiratory symptoms, or gastrointestinal symptoms reported. Repeat vital signs five minutes later all within normal ranges. Patient observed for a total of 45 minutes after vaccine administration. Symptoms resolved, no new symptoms developed, and patient left vaccine adminsitration clinic stable.
Received COVID vaccine x2 doses, Pfizer. Last dose was on 02/26/21.  On 09/04/2021 admitted to hospital, not COVID related. Does report abdominal pain, no other symptoms.  Positive for COVID on 09/14/2021, still hospitalized
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 07-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (lot # K026365 with expiration date: 15-MAR-2015), (strength, frequency and anatomical location were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The age group adult selected as per vaccine specification.  The reporter asked, Shingle shot side effects how long do they last.
The day after vaccine given, pt developed induration/swelling/warmth. Mild erythema that lasted at least 4 days-pt seen at approx day 5; area approx 2.5 cm diameter.
Client stated she developed some itching and a flat rash on the vaccinated arm about one week after the injection.  She did not contact a medical provider as she does currently not have one.  She denied taking any medications to treat the symptoms.
worsened localized injection site reaction and fever, reaction and fever disapated within a few days.
She had the vaccine, had a headache, had nausea, headache pain that still persists.  She does not have any rashes to the vaccine site.  She just have the headache that does not want to go away.  When she put the needle in she felt like she had a very large needle and felt pain which radiates from her neck and all the way down her arm.   She took ibuprofen for the symptoms, but did not call her doctor.   She is also have pain in her  muscles as well.  She did not want to take much as she wanted to have her body fight the reactions
Positive COVID test on 1/31/2022 and expired on 2/25/2022.
no adverse event; Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, 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 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 28-JUN-2023 that expired 17-JUN-2023).    No concomitant medication was reported.  No treatment information was reported.
Pt. called pharmacy to report slight head since vaccine was administered in the morning. Pt. took Vicodin and headache resolved.
Fever, chills Treated with Tylenol and Aleve. Resolved 12 hours after start of symptoms.
mild pain in the injection shoulder; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced mild pain in the injection shoulder. On an unknown date in Feb2021, the patient performed the nasal swab test which showed negative result. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient had tested for covid post vaccination. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
shortness of breath, weakness, fatigue, racing heartbeat within 2 days of vaccine (previous vaccines were Pfeiser, this one was Moderna)
Within 24 hours of injection, arm pit swelled and it felt like a lump had formed.  However, in massaging the area, no real lump was found. I would describe the feeling as having a golf ball in my arm pit,  close to the left breast.  Swelling was visible.
Information has been received from a medical assistant concerning a 35 year old female with genital herpes who on 27-NOV-2006 and 29-JAN-2007 was vaccinated IM with 0.5 ml of Gardasil (Lot #653978/0955F and 654741/0013U). Concomitant therapy included Valtrex as needed. On 30-JAN-2007 the patient experienced vertigo and nausea. The vertigo and nausea resolved on its own by 2 PM. Medical attention was sought. Additional information has been requested.
Hot at injection site; Itching at injection site; Rash  at injection site; Painful at injection site; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Rash  at injection site), VACCINATION SITE PAIN (Painful at injection site) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-Apr-2021 contains non-significant information.
Patient experienced nausea, vomiting, and chills few hours after he received the influenza and pneumococcal vaccines. States he has had similar reaction in the past with the influenza vaccine. Patient only received one dose of ZOFRAN 4mg Iv and feel completely well the next day.
Patient received COVID vaccine covid vaccine. A couple days later she started to experience tingling and numbness in her left arm. This is the arm she received the shot in. She has also had a loss of feeling in that arm. She received her shot on 3/18/21. as of 4/19 the symptoms have not changed.
pt c/o of mild h/a since vax given & swelling & redness w/tenderness of vax site where Td was given; fever 101.1;
Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.
Swollen painful thigh which was noticed the following evening and worsened, which looked like a cellulitis.
Red, bull's eye rash that grew over time, swollen and lumpy arm, hot and itchy.  Lasted about 10 days.
approx 1wk p/vax pt exp stomach cramps, low grade fever (99-100), myalgia, myasthenia, twitching of the chest & legs & soreness @ the balls of both feet;this is 1 of 2 pt from this site to have an adverse exp p/vax;
I was exclusively breastfeeding at the time of receiving both doses. My 4 month old son developed diarrhea on February 1st and it lasted 2 weeks. Lab work/stool studies were negative for any bacterial or viral infections.
Arm hard, red, swollen and hot to the touch at injection site. Nausea,  vomiting,  dizzy, lightheaded,  disoriented and extreme fatigue.
Administered Pfizer COVID vaccine, 1 minute post administration, while in Observation, patient experienced lightheadedness/"heat" sensation. VS: 130/88, O2 sat 100% RA, P 88. Ice pack applied, patient reported less anxiety and feeling better. Released to home in care of parents.
Pt was brought to paramedic station with c/o migraine.  BP taken 144/88.  Pt states she is dealing with increased anxiety today due to stress of vaccine and grandparent death today.  Pt states she feels this is the reason for elevated BP and doesn't want any additional treatment.  Advised to monitor BP for trends indicating HTN
This spontaneous report was received from a medical assistant and refers to a 226-day-old (32 weeks and 2 days) patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the third dose of ROTATEQ (lot # M026491, expiration date: 28-FEB-2018) (dose was not reported), orally. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Headache, Fever, NauseaVomiting, mouth sores Narrative:  Other Relevant History:
Infant administered Rotateq then given Pediarix and then HIB. Pt cried with each IM dose but before Prevnar administered infant stopped crying was completely still, eyes open and staring with circumoral cyanosis noted. No movement or stiffness of extremities noted. Infant responded by crying when nurse picked him up and shook shoulders and started to look around. Episode did not last longer than 15 seconds but pt did remain pale for 5 minutes. Child was transported to Medical Center for observation and evaluation.
3days after shot. Muscle, nerve spasms went on steroid, gabapentin, LYRICA, had EMG-EMG states acute brachial neuritis none feeling in thumb, 2st finger (left).
12/22 arm soreness, 12/23 headache, dizziness, body ache, abdominal pain. symptoms lasted until 1/2/21. Ibprofen and increased fluid whiched helped alliviate some of the symptoms
Patient reports itchy, raised red rash on chest and back x 1 week, states began 8 days after receiving Covid vaccine.  Reports rash is worse with moisture and heat.  Has been using zyrtec, hydrocortisone and H2 blocker - help but rash returns without continued use of each, per Pt.   Denies any airway involvement, SOB, blistering/draining areas.
Feeling tired; Upper body aches; Headache; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 11:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 COVID vaccine. Patient did not receive any other medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Mar2021 at 11:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 12:00, the patient experienced feeling tired, upper body aches and headache. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of feeling tired, upper body aches and headache and included treatment with ADVIL from an unknown start date to an unknown stop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling tired, upper body aches and headache were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Patient complained of a metallic after taste starting the day after the vaccine and lasting 3 days.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to five female patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 26-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 10/11/2021. PATIENT FULLY VACCINATED ON 04/16/2021.
2-3 days following vaccination right arm swelling for several days.  Resolved, felt weak with headache.  Nausea; emesis x2; diarrhea; no appetite 2 days after vaccination.  Continues with diarrhea.  Was given Phenergan by FNP on visit on 12/3/2007.  Blood pressure 78/56; pulse 100; no fever.
Fever chills 12 hours after shot, lymphadema in umderarm 48 hours later