chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist, concerning a 4 month old female patient. The patient's concurrent condition included a possibly milk protein allergy. There were no medical history or concomitant medications reported. On 20-FEB-2018, the patient was vaccinated with the first dose of ROTATEQ; furthermore, on 24-APR-2018, the patient was vaccinated with the second dose of ROTATEQ, both doses were administered orally with a lot # N004815 and expiration date 07-OCT-2018 for prophylaxis (frequency was not provided). On an unknown date in 2018 (reported as after received second dose of ROTATEQ) (discrepant information reported as on 11-APR-2018), the patient experienced hematochezia. The patient sought medical attention in the emergency room and subsequently followed up with unspecified physician. The reporter stated that the patient's mother drank a lot of milk while breastfeeding the patient. The patient did not receive any treatment and no laboratories were performed. The outcome of hematochezia was reported as recovering. The causal relationship between hematochezia and ROTATEQ was not assessed. Upon internal review, hematochezia was considered to be medically significant.
welts on hands, wrists, injection site and elbows; itchy; welts were painful; swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen). At the time of the report, URTICARIA (welts on hands, wrists, injection site and elbows), PRURITUS (itchy), RASH (welts were painful) and SWELLING (swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: No specific follow-up information recorded.
pt recvd vax & exp pain in lt arm & hand extending into lt side of neck; minute swelling; no further info could be obtained from pt because pt resigned from work;
Shingles; Blisters; Skin rashes on the other side of body; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body). At the time of the report, HERPES ZOSTER (Shingles), BLISTER (Blisters) and RASH (Skin rashes on the other side of body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided   Reporter did not allow further contact
States 2 hrs after shot, started feeling feverish, achy, eyes watery, yellow discharge - took nap, when woke up, felt worse - throat "tight", hard to swollow, chest felt tight.  Looked in mirror, lips swollen, face looked swollen.  Went to ER.  Tx was Benadryl 50mg, Solumedrol 125 mg, tobramycin eye drops.  Sent home on prednisone x 5 days, Tobradex 2 drops each eye 4x/day for 5 days and cont to use OTC Benadryl.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
DIARRHEA; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for drug use for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAY-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
48 hrs p injection, injection site bright red, hot (about 2.5" x 2.5") faded to pink after day 5 - night of day 7, had some itching - woke up day 8 post injection to recurrence of bright red, warm itchy 2.5" by 2.5" area at site of injection
Henoch Schonlein/Vasculitis; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient who experienced henoch schonlein/vasculitis, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious henoch schonlein/vasculitis (henoch-schonlein purpura) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Other relevant tests were not reported.  Final diagnosis was henoch schonlein/vasculitis.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for henoch schonlein/vasculitis.  Information on the batch number was requested.  List of documents held by sender: none.
received the first dose of Shingrix on 2019 / second dose in 18Apr2021; This case was reported by a pharmacist via and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On 18th April 2021, the patient received the 2nd dose of Shingrix. On 18th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consented to follow up.
ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Patient states the reaction started the at 9:00am the morning after immunization (1/30/20) She had aches and pains. She could not think or vocalize properly. She had numbness of the hands and developed a migraine.  The symptoms lasted until 3pm, approximately 7 hours.  She did not call or go to Doctor or Emergency room.  She called around 5:30pm and states she is feels fine other then her arm is a little sore.  She did not have any of these symptoms the first shot with the exception of the  arm soreness.
body temperature went up; Joints ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (body temperature went up) and ARTHRALGIA (Joints ache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (body temperature went up) and ARTHRALGIA (Joints ache). At the time of the report, PYREXIA (body temperature went up) and ARTHRALGIA (Joints ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
I started having vertigo and constant dizziness after one day of vaccination (first shot). I also developed loud tinnitus on my right ear. Dizziness has subsided after 3 weeks but tinnitus is still present and intensity remains the same.
Patient received 2 doses of this at the same time. Patient was monitored and will be followed up with via telephone call.
By an hour after, I could barely lift my arm. By bed time that night, I hurt all over my body. Joints, muscles etc. The next 3-4 days I could barely get out of bed. Moving was agony. I treated with Advil as I was told to. It waned a bit over the weeks, but after my second shot 3 weeks later, it reared its head back up and I'm in a constant 8/10 on my pain scale Everything hurts. Blood work normal, doctor just shrugs.
Vomiting (hour 48-72) -- > Bismuth subsalicylate 614 mg + Pedialyte.  Nausea (hour 24-72) Trigeminal autonomic cephalalgia (hour 12-72) -- > Acetaminophen 500mg, once every four hours. High Grade fever (101.4F) (hour 36-72)  Low Grade fever (99-100.7F)(hour 72-96) Vertigo (hour 36-72)  All symptoms subsided at 96 hours.
Beveled, red, and warm at site of injection the next day. And nausea two days after reviewing vaccine.
Pt presents to the Pharmacy with a swollen face, similar to allergic rxn. Eyes were puffy. spots and hives as well on skin on arms.  Occurred roughly 2 days after receiving her Pfizer 1st dose vaccine
I had nausea/dry heaves the night I received the vsccine, flu like symptoms the following day but felt fine within 36-48 hours or so. Then, 10am on the 3rd day after the shot, I had an acute pain in my upper stomach, right between/below ribs. Lasted acutely 1+ hours, almost drove to urgent care but then it passed. Still slight feeling for 1-2 more days. Not sure if reflux from dry heaves or something else but at one point was worried it was something more serious. I?m generally very healthy and active have never felt that kind /location of pain before. Also, had 2-3 moments of tinnitus (ringing in ears) in first 3-4 days after shot #2 . I did contact nurse hotline for medical center I go to and spoke with a nurse who had me take my temp which was normal  but didn?t get the call back until acute pain had passed.
This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 07-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot number and lot expiration date unknown) for prophylaxis and same day, the patient experienced dizziness for 30 minutes after GARDASIL 9 administration. The outcome of dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
I developed the following symptoms after the vaccination and during my deployment (Feb 2004-Feb 2005). Mood swings, blood pressure varies, endurance loss, muscle fatigue, flu-like symptoms, sinusitis and lower back pain.
Itching/burning/pulsating sensation all over skin, hands, ears, scalp, feet, etc., hives, dermatographia, hypersensitive skin, trouble sleeping. Prescribed Menthylprednisolone steroid tablets and Betamethasone Dipropionate cream.  Steroids seem to help, but the cream does not provide relief it is supposed to.    Started 12 days after receiving my booster shot. Has been 6 days since then.
Diarrhea; Archy; Chills; Fever; Stomach Pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain). At the time of the report, DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) was resolving. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Tylenol for pain. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Patient's mother called us around 10 am and told us that his son fainted at home after he got home after receiving his second covid shots.  Patient did stayed in our pharmacy for 15 minutes after his shot and he felt ok at that moment.  Patient was awake and was resting on bed when his mother called his.  According to his mon, he was given banana after the event.  After further inquiry, his mother mentioned that he did not eat anything in the morning, and was on empty stomach when he came to receive his shot.
Muscle twitches began in feet on 4/18 and quickly spread throughout body, affecting almost all body parts (hands, calves, buttocks, quadriceps, hamstrings, abdomen, face [a bit] and arms). I have also experienced vibration sensations in the feet and in one arm. One toe twitched and buzzed for 30 minutes straight.  I am not sure about the difference between a muscle twitch and a muscle spasm, but I might have experienced some spasms also. There are also hand tremors, which have not to my knowledge been present before. There might have been some tingling/pins and needles and burning, but I'm not sure if these were real or psychosomatic.  Symptoms come and go but are undiminished and still present on 5/15/21. I have had some soft stools but am obviously very anxious about this condition.
Counting day of vaccination as Day 1. Only mild soreness. Day 2-small red welt on left deltoid surrounding injection site. This continued to grow, red rash expanding from injection site. Sore, itching. By day 5 had gone with only bruising, but still itchy. Yesterday was Day 8. Noticed soreness and red welt was back around injection site. Today day 9 redness continued to grow-itchy and sore. Called ask HR and they recommended calling medical provider. Diagnosed with cellulitis and given 7 day course of antibiotics, claritin to help with itching. Instructions to let vaccination site know.  Will complete antibotics 01/15/2021
Watery diarrhea, stomach cramps, gas, and bloating that lasted 4 weeks!! He had to go to urgent care twice. He got stool and blood tests for bacteria and parasites that came out negative. He also got stool Calprotectin test that showed inflammation of the intestines.
Skin on back and neck hurts (feels sunburnt) Low fever 100° F Headache Chills Fatigue Arm soreness All still ongoing from 16 hours after vaccination until now (26 hours after vaccination)
Patient received H1N1 as flu mist at clinic on October 9, 2009 at 8 AM.  Patient developed fever at 101.5F Friday night.  Then developed headache and congestion on Saturday, October 10, 2009.  Presented to clinic 10/12/09.
Myalgia, Arthralgia & Fever Narrative:  employee with flu-like symptoms requiring him to miss 2 days of work
pt recv vax & exp rash, "not chicken pox but allerg react to something else;
very sick; most of my eye pain is on the side that I got the injection; ear infection; migraine; high fevers; pretty bad headache, back of my head hurt; nausea; my head was about to blow up; I was so nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine) and HEADACHE (my head was about to blow up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HEADACHE (my head was about to blow up) and NAUSEA (I was so nauseated ). On an unknown date, the patient experienced ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea). At the time of the report, ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), HEADACHE (my head was about to blow up), NAUSEA (I was so nauseated ), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea) outcome was unknown.            No Treatment medication was provided. Patient did not have joint pain other than ear and her head.  She also reported, Saturday being her worst day. Patient was using a biologic medication at the time of getting the third dose of Moderna COVID19 Vaccine and kept it on hold since then.   This case was linked to MOD-2021-303370, MOD-2021-303360 (Patient Link).
Mother called that her son broke out in red rash 5 mins after the administration. Stated that his face was "red and blotchy" raised areas. By the time arrived home, rash had disappeared. Stated son was sleeping comfortably with no breathing difficulties.
Stepped in a hole, she did not fall, but now the bottom of her foot hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: Not Provided) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Stepped in a hole, she did not fall, but now the bottom of her foot hurts.".   Additional information: She reports her dog Fraya, a large dog or granddaughter may have dug a hole. She reports she stepped in the hole while she was walking in her back yard to check on her tomatoes, she did not fall. She doesn't know what happened, if she bruised or pulled muscle in the bottom of her foot but, it hurts. She can't see it because its the bottom of her foot. It has been a little over a week since she had her last COVID vaccine and wants to know if it is safe to take something over the counter specifically, Ibuprofen, since she was previously told not to take it.  She states she spoke to the hospital where she got the vaccine but, got no answer and a pharmacist but, again, got no answer. Caller does not think that she falling in or stepping in a hole has anything to do with getting the COVID vaccine. She reports everything with her COVID vaccines went a lot easier than she expected it to. Caller reports that she understands now why she did not get an answer to her question and does not need to be transferred because she has her answer. She states her answer came from the Regional Pharmacy Director she happens to know at the hospital she use to work for, it's all politics. She is not sure if the call-handler worked in a hospital before but, it is all politics. Its a long story doesn't its all related to politics especially if your non-clinical like she was. She now understands where the directive of no Ibuprofen comes from. She feels that she has answered her own question and does not want to continue on the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Debilitating fatigue for 6 days, which occurred beginning at a progressively later hour of the day each day. Runny nose for one week. Sore arm with hardness at the injection site that resolved after two weeks.
Pt had experienced numbness, tingling and pain radiating down to hand after vaccine administered. After 7 days pt. states it got a little better, but then symptoms returned visit drs office & received sling & prednisone. Dx inflammatory capsulitis.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 08:00 as dose 1, single (Lot number: EL3246) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing), notes: known allergies shellfish. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound after 3 days of testing negative; Positive, notes: Paxlovid rebound after 3 days of testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
3 weeks plus 1 day following vaccine, i developed pain in my left calf. After having an ultrasound, two blood clots were discovered in my left leg (one DTV and one superficial). I was sent to the ER, a CT was performed, blood work was taken, and I was sent home with a prescription for Xarelto blood thinner. I have to be on this for 3 months, and we will evaluate to make sure I'm no longer at risk. My medical bills for the date of 5/3/21 were over $11,000, and my portion so far is over $3300 after insurance.
Redness, pain thigh at injection site.  Able to walk, run and climb, but limping yesterday.
Patient complained of difficulty swallowing, and scratchy throat. Epi-pen administered to right thigh,  EMS was called and transported patient to local hospital.