chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
random metallic smell; This is a spontaneous report from a contactable physician (patient herself). A female patient of an unspecified age received bnt162b2 (lot number: EK5730; Expiration date: 31Mar2021), via an unspecified route of administration on 17Dec2020 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. About a half hour later, the patient experienced random metallic smell on 17Dec2020. The outcome of event was unknown.
Dizziness, lightheaded, tachycardia, tinnitus since May 08.  2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08.  First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx:  Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort.  Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09.  W/u (-). DX:  dizziness.
I woke up this morning with a lymph node in my neck shoulder area that was swollen and sore and affecting that shoulder on that side. Just alittle pain. I have had no treatment
Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to strawberries. Patient was given 1 epi pen at 11:07am in the left thigh at the clinic. EMS transport  Patient is a 63 y/o F with h/o environmental allergies and asthma who presents to the ED via EMS for evaluation of an allergic rxn that began at 1030 today. Pt was at hospital and had just received her first COVID vaccine when she developed a facial rash and swelling to her tongue and throat. She also c/o dizziness. She was given Epi, Solumedrol, and Benadryl via EMS with improvement. Pt currently receives an allergy shot monthly for tx of her environmental allergies. She has never used an Epi pen previously. Pt denies fever.
Chills, Nausea, Cold Sweat, Uncontrollable shaking, Headache.
Previously healthy patient received his second flu vaccine approx 0830 the morning of event. He had no significant reaction with the first flu vaccine given 10/15/20. Via ER records: Daycare personnel reported patient on stomach on floor, not breathing, turning blue.  Patient stimulated, no CPR needed, and seemed to recover. When EMS arrived, patient breathing (approx 1:30pm). Reported as likely less than 1 min not breathing. Exam normal in ER. Dx as BRUE and released after 2 hr observation.
PATIENTS RECEIVED A DOSE OF THE VACCINE HAVING TEMPERATURE EXCURSIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D12A, and expiry: UNKNOWN) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced patients received a dose of the vaccine having temperature excursions, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patients received a dose of the vaccine having temperature excursions and incorrect product storage was not reported. This report was non-serious.
Broke out with rash that had blister-like bumps. It occurred on legs and arms. Inflammation levels were high.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-OCT-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
The patients left deltoid is swollen, hot to touch, red with extreme pain 4cm by 7cm. The patient is unable to move arm without elevating pain.
Two days after receiving booster dose, patient experienced a "measles-like" rash  on her neck, stomach, back, and at injection site. By day 6, rash had resolved.
First 18 hours arm was extremely painful. Next day arm was swollen, red, hot and painful. The pain extended to shoulder.
Pain, redness, soreness, swelling at injection site, headache, muscle aches, fever, shivering, fatigue.
A Moderna booster was given to an unauthorized age group. A typical 0.25mL booster dose was given. No adverse reactions have been reported so far.  They received Pfizer for their primary series.  More than 5 months had pasted since the primary series, but they should have received the Pfizer for their booster.
7/3 had fever 101.8 otherwise well 7/4 at 3 am seen in ER after shaking episode with egar walled back. T 103.8 Dx; possible febrile seizure. 7/5 seen in office, reported temp at home 102.8 but 99 ax in office after motrin tx.  dx: exudative tonsillitis
C/O nausea and dizziness. Declined acc evaluation. Agreed to additional monitoring. Voiced improvement and ready to go home.
Cyanosis in hands, fingernails, lips, feet, weakness, faster heart beat & breathing. All lasted about 10-15 minutes. Happened again the next night at the same time. Four hours later, he got a 102 fever. This did not happen the next night or any time during the day.
suspected shingles; painful rash; skin burning; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (23Mar2021), this case now contains all required information to be considered valid.  A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 26Jan2021 15:00 (Lot Number: EL8982; Expiration Date: May2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 29 years).  The patient's medical history and concomitant medications were not reported. The patient experienced painful rash and skin burning on 29Jan2021 14:00 and he stated that he had suspected shingles on an unspecified date. Outcome of the events was unknown.
Severe aches, sore (like the flu), temp (101), nightmares, overall 'acheyness" (like the flu)
Pt was vaccinated with the first and second doses of varicella virus vaccine live on 09/14/1998 and 10/19/1998. On 07/16/1999 laboratory evaluation revealed a lack of response.
Pt received pneumonia vaccine on 9/19/2014. C/O severe arm pain on the evening of 9/19/14 and all day 9/20/14. She took hydrocodone 5/325 2 three times daily. This took the edge off of her pain but did not relieve it. Also used warm and cold compresses. No swelling or redness noted. Quarter size bruise at injection site. Pt on COUMADIN.
Morbilliform/measles-like rash for about 36 hours. Self resolved.  Resembled the rash I get from Amoxicillin allergy. Preceded by fever (101.8)/chills for 36 hours. Resolved, took tylenol to control
Soon after my mom got her Moderna booster, she had a sore arm and felt flu-like symptoms, which we expected. However, over the next few days she began to feel very weak and fatigued and did not feel well. Most concerning , which is still ongoing, she started to break out in multiple purpura all over her arms, and actual blood would come out of some of them. We did not go to her doctor at that time, but I attribute it to the shot, as she was not breaking out with this prior to the shot. She continued to break out on her arms and legs with these purpura, and still is. She has not regained the vitality she had before the booster, and has had increased body pain since the booster, as well.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M041213 with expiration date 22-JUN-2019 and lot # M037770 with expiration date 01-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007308.
Client received her 1st dose of COVID vaccine (Pfizer COVID vaccine on 11/23/21 lot: FK5127). Client's mother reported that client has no known allergies and no chronic conditions. Client's mother reported, "24 hours after her daughter's COVID vaccine that she was standing and that she fell two times." The client denied losing consciousness and dizziness. Client's mother did not report the reaction to her daughter's Pediatrician. Client's mother is requesting for her daughter to receive the Pfizer Pediatric COVID vaccine 2nd dose.  RN submitted a medical consult via text to Vaccine Operations and approval via text from Dr. was obtained for client to receive Pfizer Pediatric COVID vaccine 2nd dose. RN educated client's mother to have client stay 30 minutes after her Pfizer Pediatric COVID vaccine and educated on ER precautions and when to follow up with daughter's Pediatrician, if her daughter experiences the same symptoms. Client's mother verbalized understanding. Client received Pfizer Pediatric COVID vaccine 2nd dose lot: FK5618 exp: 01/28/22.  Client completed 30 minutes observation with no adverse reactions and left facility at 4:35PM.
Patient got half of a dose; liquid came out between needle and syringe; A spontaneous report was received from a nurse concerning a patient of unknown age, gender, race and ethnicity who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "patient got half of a dose" and "liquid came out between needle and syringe". The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, patient received half of a dose of the mRNA vaccine because liquid came out between needle and syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event, "patient got half of a dose" and "liquid came out between needle and syringe" was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered and Device connection issue.
SERIOUS SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious side effects. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Patient's first dose of Moderna is reported in electronic records as given on 04/07/2021 and second dose Moderna reported as given on 04/30/2021. This makes the patient's second dose of Moderna given too early and invalid. Multiple attempts were made to contact patient by phone to them know of need for new second dose and was unable to make contact.
11/14/09 101 fever, nausea, aching, chills, ears, glands, throat swelled. 11/16/09 Dr office-antibiotics. 11/18/09 severe diarrhea, chills, dry cough, sore throat. 11/25-Dr office-no improvement in ears/throat (numbness/sore). 11/29/09 dizzy-walking sideways, mouth, hands, feet burning-given prednisone. 12/4 worse, Dr sent me to ER (no knee reflex) feared Guillain Barre. 12/4/09 spinal tap, blood work-1 day and night (ER and hospital)-neurologist office call. 12/10/09 EMG and more blood work-NEURONTIN prescribed. 1/7/10 neurologist visit-numbness almost all gone.
Patient reported feeling lightheaded, having blurry vision, and a burning sensation in the location of the injection.
BOTH FEET SWOLLEN; GASSY/BLOATED FEELING; EXTREME HEADACHE; BOTH LEGS CRAMPING; THROAT CHOKING; MUCUS PRODUCTION FROM ALLERGY; SORE THROAT; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: eucalyptus globulus oil/menthol. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced mucus production from allergy. On 12-APR-2021, the subject experienced both legs cramping. On 12-APR-2021, the subject experienced throat choking. On 14-APR-2021, the subject experienced both feet swollen. On 14-APR-2021, the subject experienced gassy/bloated feeling. On 14-APR-2021, the subject experienced extreme headache. On 14-APR-2021 18:00, treatment medications included: acetylsalicylic acid. On 15-APR-2021 08:00, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both legs cramping on APR-2021, sore throat, throat choking, and mucus production from allergy on 12-APR-2021, and both feet swollen, gassy/bloated feeling, and extreme headache on 15-APR-2021. This report was non-serious.
This case was reported by a healthcare professional  and described the occurrence of hepatitis B antigen positive in a 45-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included diabetes and renal failure.  The subject was hoping to received a kidney transplant.  Concurrent medications included EPOGEN, ZEMPLAR, CYMBALTA, NEXIUM, LYRICA, REQUIP and RENAGEL.  On 30 April 2008 the subject received 1st dose of ENGERIX B at 40 mcg in the right arm.  On 5 May 2008, 5 days after vaccination with ENGERIX B, the subject was found to be hepatitis B antigen positive.  Three more blood levels taken on unspecified dates after this were all negative.  The reporter was concerned because the subject is being evaluated to receive a kidney transplant and the reporter is now being told that the subject needs to have a liver biopsy due to the positive antigen result.  At the time of reporting the outcome of the event was unspecified.
Patient is under the age of 18 and was provided Moderna vaccine.  Per CDC guidance and in consultation with medical director, the patient has been counseled that  a second dose of Moderna vaccine off-label is the recommended second dose. Patient is doing well post vaccination.
pt's arm swelled considerable p/receiving vax, lg area of erythema, hot locally, said needed to take off watch because of swelling that extended to finger tips, very sore, nauseated, t100; pt advised to use APAP, elevate extremity;
sore throat; coughing; body shakes; stomach hurts; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), COUGH (coughing), TREMOR (body shakes), ABDOMINAL PAIN UPPER (stomach hurts) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On 27-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), COUGH (coughing), TREMOR (body shakes), ABDOMINAL PAIN UPPER (stomach hurts) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat), COUGH (coughing), TREMOR (body shakes), ABDOMINAL PAIN UPPER (stomach hurts) and CHILLS (chills) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications was reported as the patient took blood pressure and thyroid hormones medications.  No laboratory details was mentioned. Treatment information was provided as the patient took benadryl   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: TCR addded
Influenza vaccine given  in error on 11/15/22.   Had already received influenza vaccine on 10/13/22.   Monitored and no reaction occurred .
Report mild numbness of the left arm with tingling to left hand that is intermittent lasting 5-10 minutes. Denies weakness or limited ROM of the left extremity. Treatment: Reports rub hand and shake arm. Outcome: Continues to have intermittent episodes of numbness and tingling of left extremity.
Rash on lt arm & lt chest area injection site was left arm occurred 2 hrs p/;
Patient was very nervous to take the intramuscular vaccine. After I applied the vaccine, she waited in the room, her brother and sister were taking  the vaccines as well.  After all had their vaccines, she was standing and preparing to leave when she mention to her mother she was  drowse in a joke way. I start talking to her, asking if she was serious or joking, because I would recommend her to wait  if she was drowse. As I talked to her, she started to faint and fall. Me and her mother hold her to avoid the fall. I put her lay down on the floor. She recovered in few seconds. I kept observing her signs and breathing. She was fine after that.
A non-serious spontaneous report of received half dose in one nostril was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. After receiving FLUMIST in one nostril, the patient did not receive more. The patient only received one half in one nostril on 20-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt recv vax on 8/26/98; 4.5 hrs later pt exp fever (103 degrees) and prolonged (>1 hr) local seizure.  Pt tx=Dilantin, Ativan, Phenobarbital w/ hospital admission.
Left Arm pain, underarm pain; neck pain.; feeling like I have a sinus cold; Left Arm pain, underarm pain; shoulder pain; Feeling very tired; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 08:00 (Lot number: FD8448) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. The patient took concomitant medications. The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 15Aug2021 09:00, outcome "not recovered" and all described as "Left Arm pain, underarm pain"; NECK PAIN (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "neck pain."; NASOPHARYNGITIS (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "feeling like I have a sinus cold"; ARTHRALGIA (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "shoulder pain"; FATIGUE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Feeling very tired"; HEADACHE (non-serious) with onset 15Aug2021 09:00, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of axillary pain, neck pain, nasopharyngitis, pain in extremity, arthralgia, fatigue, headache.  Additional information: Patient did not administered other vaccine prior to Covid-19 vaccination. Patient was not tested positive since vaccination.  No follow-up attempts are possible. No further information is expected.