chrisvoncsefalvay/vaers-outcomes huggingface dataset:
day 1 and 2-soreness and slight swelling at injection site.  Day 6 - circle of rash about 1.5" in diameter at injection site.  Very itchy
Localized itching, redness, soreness, throat tightness, headache. Rxd loratadine, BENADRYL, MEDROL Pak.
Information has been received from a physician concerning a 6-week-old patient who's 25-year-old mother was vaccinated with the first 0.5 mL dose of GARDASIL two days post-partum (it was noted that she was not pregnant when she received the first dose).  The patient was breast feeding.  Subsequently, the patient died at six weeks of age.  Autopsy results revealed that the patient died from suffocation.  According to the physician, the death was not related to GARDASIL.  Physician indicated that he had all dates and lot numbers of the vaccine (not reported at the time of this report).  Additional information has been requested.
Left arm swelled up after first dosage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2022 as dose 1, single (Lot number: FE3592) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack", start date: Jul2021 (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "covid " (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. The following information was reported: PERIPHERAL SWELLING (disability) with onset 2022, outcome "unknown", described as "Left arm swelled up after first dosage". The event "left arm swelled up after first dosage" required physician office visit. No covid tested post vaccination.
Red and swollen arm area below the injection site and down entire length of arm. Small knot under skin approximately 3 inches below injection site.
After vaccines, pt did not seem to be herself, quiet. Approximately 10 hours later, pt's eye were swollen, eyes and throat became very itchy.
4 months between first and second dose; feeling sick; petechias on lower abdomen and legs; swollen limph nodes under the arm; rash at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm), VACCINATION SITE RASH (rash at injection site), MALAISE (feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm) and VACCINATION SITE RASH (rash at injection site). On 23-May-2021, the patient experienced MALAISE (feeling sick). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose). At the time of the report, PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm), VACCINATION SITE RASH (rash at injection site), MALAISE (feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
Possible hypotonic-hyporesponsive episode: approximately 48 hours after receiving immunizations, patient was sleeping next to mom on his stomach with his head to the side on a firm mattress with just a sheet over it.  Mom noticed that it looked like he was not breathing and picked him up and tried to arouse him.  He remained unresponsive with decreased tone from usual (not completely floppy but significantly so, very small spontaneous movements) and closed eyes despite vigorous patting and calling his name.  Slightly pale perhaps but never blue or purple.  Mom called 911, ambulance arrived within approximately 3 minutes and baby was brought to ambulance and then Kaiser ER.  Upon her arrival to ER mom reports that baby still not very responsive for some amount of time (?30-45 minutes) after which he become more responsive, cried vigorously, back to his normal tone and movements. Observed in ER overnight.  Workup including EKG, CXR, CBC/d and lytes and blood culture was within normal limits. Slept more than usual for one day following incidient but fed vigorously, and has been awake and alert since. No fever, no symptoms of infection or other illness.  Excellent feeding with normal stool and UOP.  No known ill contacts.
a little fatigue; her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: I take blood pressure pill losartan; "reflux" (unspecified if ongoing); "overweight" (unspecified if ongoing), notes: I am overweight. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "a little fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She stated she received the first two shots, no problem, the only major thing was a little fatigue and her arm was sore. No investigations performed. She was taking a bunch of Vitamin supplements. Route of administration: Consumer stated, "They were all given as shot, is that what you are asking?". In the arm or shoulder, the part above her elbow.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214685 same patient, different drug, dose and event;US-PFIZER INC-202300214684 same patient and drug, different dose and event;US-PFIZER INC-202300214683 same patient and drug, different dose and event;US-PFIZER INC-202300214682 same patient and drug, different dose and similar event;
This spontaneous report as received from a female Doctor of pharmacy of unknown age reporting on herself. On 13-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that on 15-MAY-2014, she experienced a red area around the injection site that she described as warm and pink about three inches in diameter over the injection site. It felt like she got stung by a bee. The pharmacist also reported pain and heat. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
This nurse was notified today that incorrect vaccine was given to patient in regard of patient age. Patient noted to be 17 on prescreen and Moderna 1st does was written on top of prescreen, Call to patient, to notify primary physician and patient refused to call any physician. Stating that he is feeling fine. That patient will return for his 2nd dose of covid in 3-4 weeks.
Patient came into the vaccine clinic for booster dose. Patient had total of four doses listed on chart and vaccine card. I let Patient know he already received booster dose. Last dose on 4/4/22 was booster dose (0.25 mL), I asked the Patient if he was immunocompromised and stated he had prostate cancer which made him eligible for an additional dose. At 1318 hours, I injected the Patient IM with additional dose. Five minutes later, colleague informed he already received his additional dose. I only checked the 4th dose and not the previous dose to see he had already received an additional dose on 11/9/21. I informed the Patient, manager, pharmacist, and charge nurse.
Information has been received from a consumer concerning her 19-year-old daughter with no medical history who was vaccinated with a 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On an uspecified date, the patient experienced cyst on ovaries after all three doses of GARDASIL. The caller did not have the dates for each dose. Ultrasound was performed. The patient was not recovered by the time of this report. The patient sought medical attention. No further information is available
This spontaneous report as received from a Registered Nurse refers to a 13 month old male patient with no pertinent medical history and no drug reactions or allergies. On 27-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H007142, expiration date 21-MAR-2014) injection. Other suspect therapies included M-M-R II administered the same day. The Registered Nurse reported that on 08-JUL-2013, the patient experienced rash, blisters and bumps across face and was seen in the office on the same day and physician diagnosed it as a mild case of chickenpox. Patient did not receive treatment and laboratory tests were not performed. At the time of the report the chickenpox was reported as not recovered/not resolved. Additional information has been requested.
headache, cough congestion, sore throat, chills/body aches, and mild SOB. Patient denies any fever, palpitations, or chest pain. She recently had sinus surgery on 12/20/21 and is on Doxycycline currently, symptoms starting 12/28/21
Patient states that she developed a rash on her arms, chest and back later that evening after receiving vaccines. Provider looked at rash and prescribed medicaiton to take for the itching.
Body aches, chills, severe chest, neck, and throat pain, difficulty breathing and swallowing
Later that day large red rash larger than 50cent piece appeared then bubbly yellow bumps appeared bigger than pimple on her arm. Now there is rash under both arms.
pt recv vax @ 12noon began itching 5PM-took DPH stopped next day itch resumed still taking is doesn't take begans itching better today;took flu shot yr ago & had itching then;
88 year old female with a PMH of dementia and hypertension, who was brought in for fever and cough for few days. No SOB.  Vaccinated with JnJ in June 2021
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M023380, expiration date: 11-MAY-2016) (dose, route of administration and injection site were not provided) at the ambulatory care center. No adverse reaction was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 1 year old female patient. The patient had no concomitant medications, allergies or pertinent medical history. On 19-MAY-2016, the patient was vaccinated with the first dose in series of PROQUAD (Merck), subcutaneously, lot # M003436, expiry date 19-JUL-2017 (dose was not reported). On an unknown date in 2016, the patient experienced petechial on her chest and legs. On 06-JUN-2016, the patient came to the office where she had a fever of 102 F, the petechial was observed on her chest and legs, and she had a platelet level of 6,000 (unit not provided). The nurse practitioner reported that the patient developed thrombocytopenia. The nurse practitioner sent the patient to a hematologist. The patient was observed and her platelets were monitored. The patient received treatment for the events (also reported as "no treatment and/or medication was prescribed"). The patient was seen in the office on 15-JUN-2016, and her platelet level was 167,000 (unit not provided). The outcome of the events was reported as "improving". The relatedness between the PROQUAD (Merck) and the events was not reported. Upon internal review the event of thrombocytopenia was considered to be medically significant. Additional information has been requested.
AS SOON AS I RECEIVED MY COVID VACCINE, MY PERIOD STARTED AND IT STAYED ON FOR 5 MONTHS.
Ever since receiving vaccine, I have been unable to stay asleep for more than 1or 2 hours at a time. Also, very vivid dreams. Both of my 2 brothers are having the exact same side effects
PATIENT STATES HE CAME HOME FROM WORK. STATES HE SAT DOWN IN THE RECLINER WITH A GATORADE TO DRINK. STATES HE GOT CHOKED ON THE GATORADE AND STARTED COUGHING. STATES THAT THE NEXT THING HE REMEMBERS IS HIS WIFE TRYING TO GET HIM AWAKENED. STATES THAT HE FEELS FINE NOW. HE SAYS THAT HE FEELS TIRED BUT HAS BEEN SINCE HE HAD COVID.
Patient present to pharmacy complaining of extreme pain in upper shoulder. Says he was awoken the night of the vaccine with a very high heart rate and spiking blood pressure. he was kept awake feeling very anxious from 1am-4am approximately. He went to work the next day where the nurse there checked his pressure, heart rate and evaluated him. The nurse recommended icing the vaccination area and taking ibuprofen. Patient came to pharmacy consultation window at 4:30pm to discuss. he said the pain had subsided some with ibuprofen and he has not felt tachycardic since the event. I advised the patient that if symptoms return that he should seek a physicians evaluation.
had pain in the arm/soreness in the arm (Injection site); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Loratadine, start date: 03Mar2021, notes: I took Loratadine 10mg for my skin allergy 2days prior to my 1st dose; Steroids clobetasol propionate a topical cream, start date: Mar2021, notes: verbatim:steroids Clobetasol propionate a topical cream, Clobetasol 05% topical cream a week after the 1st shot. Vaccination history included: Bnt162b2 (1st Dose), administration date: 07Mar2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had pain in the arm/soreness in the arm (Injection site)". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: It was reported that caller call to say he received the 2nd dose of vaccine on Sunday 28Mar2021, stated he has not had any side effects aside from soreness in the arm (Injection site). He took two medications prior his 1st dose Loratadine (03Mar2021) and antihistamine (05Mar2021) taken this two times prior the 1st shot on 07Mar2021, not sure how long it will stay in his system. Stated a week after he received the 1st dose; he took steroids Clobetasol propionate a topical cream, said he is taking this in between doses. Took Advil a couple of hours after receiving the 2nd dose. Consulting if taking steroids may have an effect with the efficacy of the vaccine. Call transferred to Pfizer Medical Information. Created manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 23Apr2021 14:30 as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm on 02Apr2021, 03:30 PM as dose 1, single for covid-19 immunisation. Patients medical history was not reported. She had no known allergies. Concomitant medication included ibuprofen taken for unspecified indication, start and stop date not reported, taken in two weeks. Patient did not take any other vaccines in four weeks. On 24Apr2021 12:00 PM patient experienced extremely weak, headaches, nausea, and muscle spasms/ fatigue. The AE resulted in doctor or other healthcare professional office/clinic visit. Patient felt the side effects are not going away as fast as expected. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive any treatment for the adverse events. The outcome of events was not recovered.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501876 Same reporter/product/event, different patient
patient stated they got sick; Both of their leg collapsed; Patient stated it was hard to get up and go to the bathroom so dragged her legs to the bathroom and back to the bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient stated they got sick), LIMB DISCOMFORT (Both of their leg collapsed) and MOBILITY DECREASED (Patient stated it was hard to get up and go to the bathroom so dragged her legs to the bathroom and back to the bed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concurrent medical conditions included Chronic fatigue syndrome (chronic fatigue syndrome for 40 years and if she drives for long time she gets tired and sick.). Concomitant products included CLONAZEPAM, ZOLPIDEM TARTRATE (AMBIEN), TRAZODONE, RISPERIDONE and ZOLPIDEM for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced ILLNESS (patient stated they got sick), LIMB DISCOMFORT (Both of their leg collapsed) and MOBILITY DECREASED (Patient stated it was hard to get up and go to the bathroom so dragged her legs to the bathroom and back to the bed). On 21-Apr-2021, ILLNESS (patient stated they got sick), LIMB DISCOMFORT (Both of their leg collapsed) and MOBILITY DECREASED (Patient stated it was hard to get up and go to the bathroom so dragged her legs to the bathroom and back to the bed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she did not take any medicine to get relief from the symptoms. Patient stated that she informed her HCP and her HCP recommended her not to get the Moderna or Pfizer COVID-19 Booster vaccine. Patient then stated that they will wait on how the new variant Omicron be like then decide to go with J&J COVID-19 Vaccine Booster shot.
Varicella: Findings: Chest with fine pink papules right leg with vessicles.  Treatment: Aveeno baths and Benadryl.
Pharmacist inject full 0.5ml instead of 0.25ml booster dose. Patient was not immunocompromised
Redness, warmth and swelling developed less than 48 hours after injection. Dx: cellulitis
Info has been received from a consumer concerning her 5 year old nephew with no medical history or allergies, who on 6/28/05 was vaccinated with a 2nd dose of MMRII. There was no concomitant medication. On 7/3/05, the pt experienced a "rash, weird shape and dots all over". It was noted that "some areas were worse than others, then, they got better, cleared, then moved to another location and cleared". On 7/4/05, the pt was seen by a doctor who did not think the rash looked like a typical measles virus vaccine live reaction. The pt was dx'd with hives. It was noted that no treatment was given. No diagnostic studies were performed. Subsequently, the pt recovered. No product quality complaint was involved. Additional info is not expected.
pt recv vax; devel shingles on 18jun95;dx w/ encephalitis; adm to hosp;felt vax rxn;discharged 29jun95
So far, developed double vision in R eye.  Partially went away but now back. CT angiogram neg  mri neg Labs neg  Have ptosis in that eye. Being checked for ACh r antibodies. Result not back. Dont know if this could be related to the vaccine or not.  One MD thinks it may just be due to dry eye.
Extreme chest pain; Trouble breathing; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 17Apr2021 at 12:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of the vaccination. On 17Apr2021 at 19:00, the patient experienced extreme chest pain and trouble breathing roughly 7 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme chest pain and trouble breathing was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt started crying approx 2hr p/vax & cried cont for 7hr;MD said next immun give ped DT;
Case number PHHY2012US051997 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received trivalent inactivated influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination, she was diagnosed with multiple sclerosis. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcome were observed in the VAERS reports of pregnant women after the administration of trivalent inactivated influenza vaccine.
Syncope, resulting in fall, blow to head with contusion: blow to ribs with contusion. ER visit.
5 minutes after the administration of the vaccine, patient started to feel a bit off. 5 minutes afterwards, she had a seizure. Her husband was with her and he has helped her before with her seizures, but 911 was called just in case. 15 minutes later, paramedics arrived and she had another seizure. patient has a vagal nerve stimulation device and her husband used it several times to help her get out of the seizure.