chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN RIGHT PINKY  FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.
pt recvd vax & by that afternoon had a t104 & rash @ site of inject; also had a knot w/swelling; was fussy but not uncontrollable cry; seen by MD told pt was having reaction to pertussis;
"On 11/19/10 I received the Flu Mist.....12 hours after the Flu Mist was administered to me I became violently ill with diarrhea, vomiting, chills which resulted in excessive dehydration as well as extreme body, lower back & flank pain. I was seen & treated in the ER on 11/20/10 for these symptoms and was informed not to return to work until 11/24/10. Ironic, that the onset of the symptoms came on so quickly after the Flu Mist was administered to me. I also, later found out that due to my Fibromyalgia condition that I should not have been given the Flu Mist at all."
TONGUE IS PUTRID; SOUR TASTE; This spontaneous report received from a patient concerned a 62 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced tongue is putrid. On 22-MAR-2021, the subject experienced sour taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue is putrid, and sour taste. This report was non-serious.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of PEDVAXHIB (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: N001348 (expiration date 31-OCT-2019), and N004632 (expiration date: 02-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004345: US-009507513-1709USA004343: US-009507513-1709USA004047.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 21-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On monday 12/28 i started to feel  fatigue/ weakness  Body ache Headache Slight feverish On tuesday morning between 1-5am i had Fever Body ache Chills
To ED with confusion. Acute metabolic encephalopathy with underlying dementia.  COVID-19 (+)Treated with Remdesivir x 2 doses. Stopped due to elevated LFTs. Stable on room air without dyspnea.
Initial report received 08 July 2009 from a health care professional. A 27-year-old pregnant female patient with a history of a latex allergy, had received a 0.5mL injection of ADACEL (lot number, route and site not reported) on 07 July 2009. Her date of last menstrual period was not reported; however, her expected date of confinement was estimated to be 30 January 2010. She had two previous full term pregnancies with normal outcomes. She had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 19 February 2010 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from non serious to serious. According to the reporter, the patient was reported to have been in good health. She had no illness at the time of vaccination and she had not received any other vaccines within four weeks of receiving ADACEL (lot number, route, and site not reported). The patient had a history of two prior pregnancies, both which resulted in full term live births with no congenital anomalies. Her last menstrual period occurred 26 April 2009 and her estimated date of delivery had been 31 January 2010 (previously reported as 30 January 2010). Prenatal testing had been normal. On 22 August 2009, 46 days post vaccination, the patient delivered a male fetus vaginally at 22 weeks gestation weighing 296 grams with no congenital anomalies. Apgar scores were 0/0 at one and five minutes respectively; outcome was demise. The patient had not experienced any complications during labor and/or delivery. Per the reporter, it was not known if the patient had experienced any adverse events; however, the reporter further stated that the patient had not experienced any problems until delivery at 22 weeks gestation. According to the reporter, the patient recovered. The baby case (fetal death at 22 weeks) has been captured separately in case number 2010-01165.
Moderna Covid-19 vaccine administered to a 17 year old. no resulting reactions or problems noted. reported to parent and consulted CDC protocol
After the next day I felt terrible, fatigue, I stayed in bed for couple of days 2-3 days. Same symptoms like the flu. Pain all over the body.
first dose in 2018, never came for second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received back in 2018, (batch number 4FS5N and expiry date 8th March 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The registered nurse inquired how to proceed with second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Tetanus toxoid vaccine was mistakenly administered intradermally in place of Tubersol (PPD solution).  Patient developed erythema and induration (max. 60 mm diameter) at site, which is resolving.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced a "bump" at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. This is one of several cases from same source. Additional information is not expected.
Headache, Fever, CoughWheeze, NauseaVomiting, INCREASED FATIGUE, MUSCLE ACHES, CHILLS, HEADACHE, Narrative:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "71-year-old married female with past medical history significant for morbid obesity with significant intentional weight loss, type 2 diabetes mellitus, hypertension, hyperlipidemia, obstructive sleep apnea with poor compliance with CPAP, breast cancer in 2005 with no known recurrence, nonalcoholic fatty liver disease and gout presented with several-day history of word-finding difficulty consistent with expressive aphasia.  There was also some question of her being confused on presentation.  She reportedly had transient episodes of hypoglycemia at home and was positive for COVID-19 on admission without any fevers, respiratory or GI symptoms."
Broke out with a rash on upper abdomen, chest, shoulders; spread to upper arms upper buttox and legs. Itchy raised red bumps - similar to hives or a poison ivy.  Rx prednisone for 7 days, rx lotions Still an active problem three weeks later
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with an expired dose of M-M-R II recombinant Human albumin (rHA), lot # L024265 with expiration date 01-JUL-2017, for prophylaxis (route of administration was not reported). Concomitant therapies included sterile diluent (MRK). No adverse effects were reported.
Under the arm and around the injection site is kind of blueish , Bruising because of the injection; there's also some swelling; Itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Patient asked the Pharmacist about the reaction and they said it was probably bruising because of the injection. Patient would like to know when it will go away.
Fully vaccinated with COVID breakthrough infection.   Inpatient admit for a  non COVID issue, asymptomatic positive
This spontaneous report ws received from a Licensed Practical Nurse refers to a 17 year old female patient. On an unknown date, the patient was vaccinated with dose 2 of VARIVAX (Merck) and GARDASIL in the same arm and second dose of VAQTA in the other arm. The patient also received intranasal FLUMIST. On an unknown date, 24-48 hours after vaccination the patient complained of chest heaviness. The patient also developed a rash at the injection site of VARIVAX. A chest X-ray and number of unspecified tests were performed (results not provided). Patient sought medical attention: made a phone call to office and visit to emergency room. The outcome of chest heaviness and rash at the injection site was reported as recovered on an unspecified date. Additional information has been requested.
Within 5 minutes of vaccination, patient presented with warm feeling in left arm. He proceeded to feel dizzy, diaphoretic and appeared to be unconcsious with his eyes open , though he never dropped his personal belongings, nor did he fall or slump over. An ER doctor sitting next to him lightly slapped his face several times , while calling his name. Patient was alert within 15 seconds of this event.  His pulse was quite shallow.  I called 911 immediately.  We laid patient on the floor.  Rescue arrived in less than 4 minutes. They  monitored his BP, (105/65), completed and EKG, tested blood sugar with a finger stick. Patient quickly rebounded with his pulse and BP.  He drank 2 bottles of water, drank a cup of coffee and relaxed in our clinical room until his wife arrived.  It was not necessary to go to the ER or to leave with the paramedics. Patient left the pharmacy after approximately 60-75 minutes after the adverse event.
Pt w/ previously known allergy to Amoxicillin.  NO other PMH or Medications known to this writer. Immediately post vaccination, pt had a syncopal event associated w/ flushing/sweating and dizziness.  Pt reports that she has a hx of vasovagal type rxn w/ previous vaccinations/ blood draws.   Pt had requested to lie down for immunization today and this was done. Vitals: BP 85/58, HR 64, RR 16, SPO2 100% -- > @17:30 103/62, 68, 16, 100% (supine -- > 17:48 96/59, 72, 16, 100% (sitting) @17:48 pt states that she feels ok to leave, ambulated w/o difficulties.  Advised to f/u w/ PCP, assure adequate hydration.  Pt left the facility w/ roommate at her side.  Pt stable and released from the vaccination site w/ roommate.
Patient said over first 4 days her arm continued to hurt and swell.  At day 4 it was swollen "twice its normal size" so she went to the dr.  He diagnosed an infection and prescribed antibiotics.  Over the nect few days her arm has been getting better.
Pulsatile Tinnitus in the left ear started in June of 2022. I had been having headaches, but they got more frequent and more intense in September of 2022. I also had occasional pressure behind my left eye.
Redness and mild swelling on injection site. About a 3-4 inch diameter redness area.  Patient still able to ambulate and talk.  No sign of allergic reaction.
This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers on herself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Approximately in 2009 (reported as "approximately 7 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiry date were not reported) 1 injection, intramuscular. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were not reported. The pregnancy outcome was outcome pending. On an unknown date (reported as "recently"), the patient experienced "shingles-like" pain "all over, especially in her feet and thighs". No treatment was given. The patient did not seek medical attention. The outcome of "shingles-like" pain "all over, especially in her feet and thighs" was reported as not recovered/not resolved (reported as "still occurring"). The relatedness between vaccination with ZOSTAVAX and "shingles-like" pain "all over, especially in her feet and thighs" was not provided. Additional information has been requested.
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended).    Patient age reported as 7 Year and 11 Months. No concomitant medication information provided  Reporter stated that the duration of the excursions was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials was still frozen after the excursion.  It was reported that there were no adverse reactions to the Covid vaccines given and it was determined even though there was a temperature excursion one time that the vaccines was still viable and can be used until the end of the day on 17-Aug-2022.   No treatment medications were reported.
Started feeling a little light headed interm healthy , a little flushed and cold extremities 15 mins after shot. It persisited and became more constant. Allergies, mild to amoxicillin. 1615- BP 122/80, Hr 78, SpO2 99%, Respiratory rate 20. feeling a little better after laying down.
5/25/21 @ Approximately 12:03 pm, 14 year old Patient fainted while waiting in vaccination waiting area after his first COVID-19 vaccination (Pfizer).  Patient stated that he started to have ringing in the ears and some blurred vision.  Patient's father instructed patient to lay down on the three chairs in vaccination waiting area.  At this time store employee came out to assist patient and patient's father.  I (employee) came out to assist moments later when I saw what was happening (I had just finished a consultation with another patient).   We elevated patient's legs, put and ice pack under his neck, and called 911.  Patient was awake but not very talkative. Patient was very alert and talkative in Clinical Service room at the time of immunization, which was a big change from how he was immediately after fainting. Patient appeared sweaty and pale in color.  Patient's blood pressure was taken at 12:09 pm and was 88/51 pulse 53 (patient was still laying down at this time). Respiration rate was 20 breaths per minute.  At 12:12 pm blood pressure was taken again as patient appeared more responsive and talking more.  His BP was 101/63 and pulse 63.  Immediately after second blood pressure reading, EMS arrived and they took over.  Patient was responsive and drink water and sitting up at this point.  EMS checked patient out and was cleared shortly after.  EMS stated that this will not defer patient from getting his second COVID vaccination.  Before patient left he was continuing to drink water and was eating some crackers.
Pneumonia; asthma; bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "Respiratory illness" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown"; ASTHMA (non-serious), outcome "unknown"; BRONCHITIS (non-serious), outcome "unknown".  Clinical course: Patient suffered a horrible history of respiratory illness. Patient had asthma, bronchitis, and pneumonia.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
pt states that later that night after taking the vax she started shaking violently w/ the chills until 5 AM.  After the shaking subsided she had a headache, fatigue, slight fever and vomiting.   Pt took Tylenol for her symptoms.   Pt called her PCP and was told these symptoms were to be expected and to call them back is she started having any SOB.  She says her right arm is sore and she is still very tired but feels like she is getting some better.
Unbearable, excruciating pain near the injection site. Pain felt like severely damaged nerves radiating from shoulder and continuing in arm . Severe pain lasted 2-3 hours, moderate pain another 5 hours. Other symptoms included chills (15 minutes) and severe nausea (15 minutes) during the time when severe pain was present.
Within 10 seconds of administering TDAP patient experienced seizure activity lasting approximately 25 seconds.  Patient regained consciousness, was yawning continuously, complained of being hot.  Patient laid in supine position on floor and administered oxygen by mask, took multiple sets of vitals, called EMD and at 2:10P patient decided to go to urgent care on his own with help from wife.