chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CELLULITIS; LUMP AT INJECTION SITE; BURNING HAS SPREAD TO LYMPH NODES; SWELLING TO LYMPH NODES; BURNING AT INJECTION SITE; COVID-19; This spontaneous report received from a patient concerned a male of an unspecified age, race and ethnicity. Initial information was processed along with additional information received on 06-JUN-2022. 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, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 1 in total administered to the back of the left arm on 16-APR-2022 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2022, 3 weeks after vaccination the patient experienced covid-19 and had symptoms of fever of 102.4 F and headache.  On 04-JUN-2022, the patient woke up with reaction to injection site. The patient experienced lump in injection site with burning, and the burning was spreading to lymph nodes under and there was swelling (swelling to lymph nodes).  On an unspecified date, the patient went to urgent care and patient was diagnosed with cellulitis. Treatment medications (dates unspecified) included: cefalexin, 500 mg four times a day for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, burning at injection site, burning has spread to lymph nodes, and swelling to lymph nodes, and the outcome of covid-19 and cellulitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220609638-COVID-19 VACCINE AD26.COV2.S-CELLULITIS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 12:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.57.  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 2 PM, temp was 35 and at 9 AM temp was 34; condition of vaccine prior to vaccination was not frozen. The vaccines were moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were moved to clinic. Vaccine BUD date was 04-Feb-2021.  The vaccines were moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9 vials were moved to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was stored on cooler 1 , on 11-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 PM: 35, 1PM : 36, 2 PM : 37, 3 PM: 37.  The vials were only punctured right before administration.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extreme pain to left arm during injection. Softball sized swelling at injection site (high up on left arm) that lasted about 10 days. Continued left shoulder and injection site pain since injection, now with constant arthralgias and myalgias, neck and muscle  weakness, headaches, and fatigue.
Intermittent nausea beginning on 2/1/2021 thru today. Denies fevers, SOB, chest pain, dizziness. Able to eat and drink normally; using bathroom normally.
Had a very early menstruation within 10 days of the previous menstruation when period has been regular and tracked for years using an app. In additon it was a very heavy cycle and very painful. Now I've not had menstration for 40 days. After multiple at home pregnancy tests. I went to a physician and was tested and results are negative for pregnancy. She stated she is seeing multiple patients who are having multiple periods early or no periods and has asked me to report my experience to CDC.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016959, expiration date 12-MAR-2018 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided. The nurse reported that, on 25-MAR-2019, the patient was inadvertently vaccinated with one dose of ROTATEQ orally (dose number and anatomical locations of administration were not provided; with lot number R017932 and expiration date on 01-MAY-2020) for prophylaxis. On an unspecified date, the dose of ROTATEQ was exposed to a temperature excursion from 36 degrees Fahrenheit to 46 degrees Fahrenheit (46.4 degrees Fahrenheit) for a time frame of 6 minutes, which was detected by the Digital Data Logger. There was no previous temperature excursion. No adverse effects or product quality complaints were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA012097.
Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a post-operative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested.
Pt states sharp pain at injection site.  14:20 pt reports feeling dizzy, transported to triage for MD consult.  Pt stated  mostly better but she wanted to go home.  DC stable via wheel chair to shuttle accompanied by boyfriend.
Presented to the ED with complaints of weakness and productive cough with yellow/green sputum. He was found to be in afib RVR with HR in the 140s and hypoxic requiring supplemental O2. Admitted for hypoxemic respiratory failure, COVID PNA, afib with RVR. Tx w/abx, steroids, zinc, O2; Developed septic shock requiring emergent intubation; went into PEA arrest and expired 1/19.
aches that evening; shakes; sore left injection site arm; fever; shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering). At the time of the report, PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-407924 (Patient Link).   Reporter did not allow further contact
Patient worked the rest of her shift, but just informed me today when I passed her in the store that she had actually fainted 3 times when she got home.
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unkonwn age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, dose number, route, anatomica location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of FLUMIST administration in one nostril was received from a registered nurse concerning a 45-year-old female. The patient's medical history and concomitant medications were not reported. On 16-Oct-2009, the patient was administered FLUMIST. The patient told the nurse who administered FLUMIST "it all seen (sic) to go in the same nostril." There was no adverse event associated with this vaccine administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
On 1/15 around 6pm, I began to feel extremely fatigued (about 27 hours after my initial injection).  I began to feel severe flu-like symptoms (hot/cold chills, sensitive skin, headache, dry/scratchy throat, fever dreams) which persisted for several hours during the night. The next day (1/16), the fatigue, headache, and chills persisted (although the chills decreased). I took Dayquil before noon and that seemed to help with the symptoms, and Nyquil at night so I was able to sleep. By the following morning, I still had a mild headache and fatigue but continued to improve. I felt normal again on 1/18.   I also had stiffness, swelling, and soreness at the injection site for 3-4 days.
FAINTED; EARACHE IN BOTH EARS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808609, expiry: UNKNOWN) dose was not reported,1 total, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, COVID-19 virus test confirmed Suspected COVID-19 infection. On an unspecified date, the patient experienced earache in both ears, fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earache in both ears, fainted and Suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518581- covid-19 vaccine ad26.cov2.s -Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient got COVID shot on 2/9/21 and could not move his legs on 2/10/21 and 2/11/21, diagnosed with transient paralysis of lower extremities ICD 10 code: R29.818
pain in the bones of my eyes hurt to move them; pain in the bones of my eyes hurt to move them; nauseous; fatigued; rash on left arm; severe headache/head pain; chills; visual disturbances; Could barely walk; Pain was extremely intense; This is a spontaneous report from a contactable 59-year-old female consumer (patient) reported. A 59-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 14:30 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included drug hypersensitivity -Penicillin, allergy to chemicals -soy, erythromycins. The patient had allergies with penicillin, soy, erythromycins. The patient's concomitant medications were not reported. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021 18:30, the patient experienced three waves of adverse reactions. 1) Had pain in the bones of her eyes, hurt to move them; nauseous, fatigued lasted from Feb 27 - Mar 2. 2) March 8 had rash on left arm, 3) March 11 severe headache came on quickly. Started on the left side in the back and moved up to the top of head. Nauseated, chills, visual disturbances. Had to lay down. Could barely walk. Pain was extremely intense. Since then, she had nonstop head pain, 24/7 to varying degrees. It has only been since April 16 she have been able to work on the computer for a longer period of time and have had some ability to think. April 23 was the first time she was able to lay down at night without an ice pack as laying down has been one of her worst positions. Saw primary care physician who had another patient with similar issue but not as severe as her; went to neurologist who put her on a muscle relaxer and anti-inflammatory, did bloodwork and ordered and MRI/MRA. Have had chiropractic adjustments, too. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event with adjustments; muscle relaxer, anti-inflammatory. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 rna: negative on 22Mar2021- Nasal Swab, sars-cov-2 test: negative on 22Mar2021 Nasal Swab. Outcome of the event was not recovered, at the time of this report. Device Date was 30Apr2021 No follow-up attempts are needed. No further information is expected
Pt recvd vax on 4/17/1997 and same day exp bradycardia.
Pt recv vax on 2/25/98; post vax pt exp nausea, vomiting, vax site pain LA, weight loss; tx=Pedialyte & Tylenol #3.
Swollen lymph nodes on left side of neck and terrible sore throat only on the left side as well.
Caller received both doses of the Pfizer Covid-19 vaccine FEB2021 and started having complaints of itching that persists to this day; This is a spontaneous report from a contactable consumer. This 90-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Feb2021 as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Feb2021 as dose 2, single for COVID-19 immunization. The medical history of the patient included allergy to penicillin and previously had to go the hospital due to having a reaction to penicillin. The patient's concomitant medications were not reported. On an unknown date the patient reported complaints of itching with the Pfizer Covid-19 vaccine. The event outcome was unknown. Caller asked if she should get the third dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [enter generic Pfizer vaccine name], was not provided and would be requested during follow up.
pretty severe pain throughout entire body; pain at injection site; injection site was feverish/fever 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever and Pain.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5). At the time of the report, PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Back pain medication.  Treatment detail also included Tylenol Extra Strength for fever and pain.
difficulty sleeping, diarrhea started next morning and continues to current date.  Increase of symptoms which peaked around 2 weeks post vaccine included extreme fatigue, body aches and pains, chest pain, abnormal heartbeat & palpitations, winded easily, headaches, stomach aches & bloating, brain fog.  Cotton wool spot found in eye during a routine eye exam on 7/7/21 - triggering a positive ANA test
My booster shot has given me an adverse reaction. I have an appointment with my dr for Tuesday dec 14
This case was reported by a physician, via sales representative and described the occurrence of erythema multiforme in a 7-week-old female subject who was vaccinated with Pediarix (GlaxoSmithKline). Previous and/or concurrent vaccination included Rotateq (Merck); oral given the same day in 2008. In 2008, the subject received 1st dose of Pediarix (.5 ml, unknown). In 2008, within 24 hours after vaccination with Pediarix, the subject experienced erythema multiforme. This case was assessed as medically serious by GSK. In 2008, the erythema multiforme was resolved. The physician considered the event was probably related to vaccination with Pediarix.
Intense Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 09Apr2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00, the patient experienced intense tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event intense tinnitus was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
w/in 24 hrs p/immun, pt exp an inject site react (swelling of the leg, 3x normal size) & a fever of 102; tx included heat @ inject site & APAP;
Feeling groggier than normal; Urine was very dark brown, with a little bit of blood, and blood clots; Their urine was totally black and had blood clots; A little bit of blood in their urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced HAEMATURIA (A little bit of blood in their urine). On 18-Aug-2021, the patient experienced HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots) (seriousness criterion medically significant) and CHROMATURIA (Their urine was totally black and had blood clots). On an unknown date, the patient experienced MALAISE (Feeling groggier than normal). On 19-Aug-2021, HAEMORRHAGE URINARY TRACT (Urine was very dark brown, with a little bit of blood, and blood clots), HAEMATURIA (A little bit of blood in their urine) and CHROMATURIA (Their urine was totally black and had blood clots) had resolved. At the time of the report, MALAISE (Feeling groggier than normal) had not resolved.            Patient was not taking any daily medications. It is reported that patient was self catheterized four times a day. It is stated that as the day went on, the blood in the urine was lessening. It is stated that the patient had not taken anything to help with the symptoms.  Action taken was not applicable.   This case was linked to MOD-2021-292324, MOD-2021-292304 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
2 days after 2nd shot, noticed left underarm area was enlarged. Felt Lump. Date of shot: 4/10/2021.  Date noticed lump: 4/12/2021.