chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH PAIN; BLISTERS IN MOUTH AND LIPS; SEVERE NECK PAIN LIKE SWOLLEN LYMPH NODES; FEVER; VAGINAL BLEEDING; RECTAL BLEEDING; ALMOST FAINT; COULD NOT MOVE AT ALL; UNDER ARM HURT; CHILLS; ARM AND LEG PAIN; HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included no uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 26-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUN-2021, the patient experienced severe nausea, almost fainted, experienced leg pain at the point to where she could not move at all, arm and under arm hurt her terribly bad, had uncontrollable chills and headache. On 27-JUN-2021, the patient had fever 102.6, experienced chills, nausea, leg pain, headache, vaginal bleeding, rectal bleeding and continued with all above symptoms. Laboratory data included: Body temperature (NR: not provided) 102.6. On 28-JUN-2021 and on 29-JUN-2021, the patient continued symptoms and no fever. On 30-JUN-2021, the patient had fever, blisters in mouth and lips, experienced severe neck pain like swollen lymph nodes and she could not move her neck at all. On 01-JUL-2021, the patient was feeling better but the leg pain was still very painful, had headache, nausea, and stomach pain. The patient just wanted to report her symptoms, like a dummy she went to get the shot and got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rectal bleeding, almost faint, under arm hurt, chills, fever, vaginal bleeding, blisters in mouth and lips, severe neck pain like swollen lymph nodes, and could not move at all, and had not recovered from severe nausea, arm and leg pain, headache, and stomach pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708845-covid-19 vaccine ad26.cov2.s- rectal bleeding. 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).
Dose #2 given too early (at day 21) dose #1 done 4/2/21
About 2 months after the booster, I got COVID. I got night sweats and high fevers for 6 days. I had trouble breathing, my chest hurt a lot. It was extensive pressure on my chest. I was cold and shivering a lot, and about 8 days I felt better. I was non functional during this time. I could not get out of bed, I was to dizzy and fatigued. I was about to go to the hospital because I was in such bad shape, but I did not.
Fever of 101, chills, headache, body ache, swelling and red raised warm rash on arm
5/22/2018: Pt received a TDAP at a local pharmacy x 3 weeks ago. Patient is a 51 year old male, dull pain to left upper shoulder, loss of range of motion above shoulder and loss of range reaching back. Pain with motion and weight bearing and also weakness. Pt is left handed. Pt swims, but cannot freestyle right now. Can butterfly swim. Pt feels his TDAP injection was given too high in his left arm at outside pharmacy 3 weeks ago and is concerned he has SIRVA vaccine reaction with damage of his upper arm. The pain started right after his injection though the next day he did travel on a plane and use the overhead. His youngest daughter is about 3 years. He has pain reaching towards her. Pt denies injury from work though he does have hx of right shoulder pain.
Patient came into pharmacy for second dose and explained that he had a rash a day after his first dose on his left arm. Rash went away in about 3 days.
fever; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 25-month-old male patient who had fever (pyrexia), while he received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) were not provided whereas family history included the father could not get vaccinated as he got Guillen Barre. And the mother was pregnant. The father was really at risk here and he would have to leave and had already been exposed to child for a week.  Concomitant medications were none.  On 30-Oct-2020, the patient received a dose of suspect influenza quadrival A-B vaccine (prefilled syringe) (lot number: unknown and expiration date: unknown) at 0.5 ml once via intramuscular route in the right thigh for prophylactic vaccination.  On 30-Oct-2020, within 24 hours on the same day of starting the suspect vaccine therapy, patient had a fever of 103 fahrenheit (pyrexia).   since then he had been fine and again on 06-Nov-2020 (this morning) he spiked a fever of 103. the pediatrician did a fast-rapid flu test and it came back positive. the child he otherwise not sick or lethargic much, only a little were he wants to sleep.The patient was tested for COVID and came back negative.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-MAY-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (intramuscular; lot # reported as J0155222, expiration date 21-FEB-2015; dose was not reported). It was reported that PNEUMOVAX 23 did not have any previous temperature excursions. PNEUMOVAX 23 was supported with in-house expiry data. No adverse effects reported. Additional information has been requested.
FEELING WARM; CHILLS; RUNNING A FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on left arm on 20-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling warm. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced running a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, running a fever and feeling warm was not reported. This report was non-serious.
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported throat itching. Paramedic administered oral diphenhydramine twice at vaccination site. Patient then reported chest pain, shortness of breath, urticaria, and increased throat scratching. Paramedics administered epinephrine twice and methylprednisolone and transported to emergency department (ED). On arrival to the ED patient still reported chest tightness, numbness, and was tachycardic (pulse 122 beats per minute), tachypneic (26 breaths per minute), and hypertensive (blood pressure 139/85). In the ED patient experienced more difficultly breathing and epinephrine continuous infusion was started. Laryngoscopy did not document evidence of airway compromise. Patient diagnosed with possible anaphylaxis and admitted (currently still hospitalized).
Tongue discoloration; Accidental overdose (therapeutic agent); Medication error/ Drug mal-administration. Information regarding Flumist (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 12 year old male patient who experienced tongue discoloration after he received a second dose of Flumist on 17-Feb-2004. The pt received the first dose of vaccine on 05-Jan-2004. On 17-Feb-2004 the patient received a second dose of Flumist (accidental overdose/medication error). The first dose of vaccine was given on 05-Jan-2004. The doctor's office misread the flyer that accompanied the Flumist and administered the second dose since the patient had not been given a flu shot in the past. Immediately after administration of the second dose, the patient's tongue turned blue (tongue discoloration). No additional information was available at the time of this report. See related cases HQWYE568304MAR04 and HQWYE666209MAR04 both (adverse even, non-expedited). Follow Up: The reporter disclosed that a supply of lollipops of various colors, including the color of the patient's reported tongue discoloration, was available in the room where the patient waited after immediately receiving the vaccine.
Unconscious in shower/Eyes rolled back in head; Hot and sweaty; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head) in a 32-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.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head) (seriousness criterion medically significant), FEELING HOT (Hot and sweaty) and EYE MOVEMENT DISORDER (Eyes rolled back in head). At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious in shower/Eyes rolled back in head), FEELING HOT (Hot and sweaty) and EYE MOVEMENT DISORDER (Eyes rolled back in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain shot down left arm, throbbed. Pt had a swollen thumb red, possible thorn (cacti). Pt is going to a Dr (orthopedic) to follow up with thumb. Thumb unrelated to vaccine.
approx. 5 minutes after receiving the vaccine client started c/o nausea. She was given an antacid and it helped. She says by the time she got home she had a Headache that lasted off and on for 3 days. She took Excedrin and it helped.
0900 (appx) - received flu vax, intranasal 1600 (appx) - rash, itchiness on upper neck, down back to lumbar area (hives) 1645 (appx) - evaluated, administered one 25 mg diphenhydramine P.O.
Strawberry sized swelling two inches from injection site; Rash along both sides of neck; This is a spontaneous report received from a contactable patient. A 54-year-old non-pregnant female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number was En6204) via an unspecified route of administration on the left arm on 12Mar2021 at 12:00PM (at the age of 54-year-old) for Covid-19 immunisation. Medical history included epilepsy and chronic migraine, she was allergic to Penicillin, sulfa, nonsteroidal anti-inflammatory drugs (NSAIDs) and minocycline. Concomitant medications (taken within 2 weeks of vaccination) included erenumab (AIMOVIG), spironolactone, pregabalin (LYRICA), lorazepam and phentermine (PHEN), used administered for unreported indication. It was further reported that prior to vaccination, she was not diagnosed with COVID-19 and has not been tested positive for COVID-19 since having the vaccine. On 12Mar2021, she experienced strawberry sized swelling two inches from injection site and rash along both sides of neck. No therapeutic measures were taken for the events. The clinical outcome of the vaccination site swelling and neck rash was recovering. No follow-up attempts are possible. No further information is expected.
As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated lower extremity pitting edema up to hips and was found to have acute bilateral pulmonary emboli, including a large thrombus seen in the left main pulmonary artery. Also admitted to nausea, orthopnea, PND, chronic leg swelling no worse than usual, and a productive cough with creamy white sputum.
Client received J-Vax left arm on 6/3/05. She awoke with puffy swelling around eyes and eyelids and in lower chest area bilaterally. She took Benadryl and symptoms began to subside. Swelling was gone by the end of the day. She still had a headache, fatigue, lightheaded. No difficulty breathing, airway swelling, generalized pruritus.
Approx 10 minutes after injection with MMR, IPV, DTaP, pt developed throat clearing, then hives (1st at MMR site, then diffusely), then wheezing and pallor. She was treated with multiple (2) doses of 6mg Benadryl, Xopenex 0.63, dexamerh asone  4mg, epinephrine 0.15 mg and transfer to the ER by EMS where she was improved, no hypoxia and sent home with Benadryl for 5 days.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for AF, HF, t2dm, sleep apnea, obesity, htn, hospitalized 3/2/2021 for chf, worsening kidney function and end stage liver disease. discharged to hospice care. Deceased 4/14/2021
Headache, Myalgia, Arthralgia, c/o injection site sore. Told to follow up with primary carwe physician if no improvement.  Narrative:
Migraine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not taking any concomitant medications.   On 29-Jul-2021 patient woke up with a migraine. She reported that she gets it routinely around her menstrual cycle and she attributed her cycle for the reason for her migraine.
This case was reported by a nurse via call center representative and described the occurrence of lung infection in a adult male patient who received FLUARIX QUADRIVALENT (batch number LZ4S2, expiry date unknown). Concurrent medical conditions included knee injury and acne rosacea. On 23rd September 2014, the patient received FLUARIX QUADRIVALENT. On 24th September 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced lung infection (serious criteria GSK medically significant), rosacea aggravated and knee injury. On an unknown date, the outcome of the lung infection and knee injury were recovered/resolved and the outcome of the rosacea aggravated was not recovered/not resolved. It was unknown if the reporter considered the lung infection and knee injury to be related to FLUARIX QUADRIVALENT. The reporter considered the rosacea aggravated to be probably related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter stated that he had a severe reaction to FLUARIX QIV. He received the flu shot on 23rd September 2014 and the day after getting the shot he developed a lung infection that lasted for 8 months. Also he stated that an old knee injury that had occurred many years ago flared up and lasted for 11 months and his Rosacea acne was aggravated as well and was not resolved. He felt that the flu shot caused his body to have an inflammatory immune response. All issues required no hospitalization but the health care professional did seek treatment with a physician.
1st shingles vaccine / 11/29/19 / Covid 19 restrictions and lockdowns / 2nd shot until 6/9/2021; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 29th November 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. The patient did not receive 2nd shot until 9th June 2021 due to Covid-19 restrictions and lockdown. The reporter asked did he/she need another 4 to 6 months. The follow-up would not possible as no contact details were available.
pt recv vax & exp vomiting while using drug for malarial prophylaxis;1DEC95 pt started using the drug & presented  w/n/v, dizziness & weakness;
I had severe pain on my left side starting from the side of my neck all the way down to the tops of my left foot. The pain started a few hours after the vaccine severe pain lasted 3 days and has now turned into a dull pain all the way day my enitre left side same side i had the injection on. I have yet to see a dr  for the side effects
04/25/17 fever 101 degrees. Two erythematous - like vesicles; one at injection site R thigh, one on face (L cheek).
This was 5th covid booster.  Has not had covid.  The patient reports sudden and severe hand swelling and allover joint pain and fatigue after recent COVID vaccination.  She has never had any prior similar episodes.  Her COVID  booster was November 9.  She felt a little tired the day after the vaccine.  Then 2 days after the vaccine developed major pain in knees, hands, wrists.     She reports symptoms "it's like I got instant rheumatoid arthritis".   No hx of RA.     Still having pain, swelling, and weakness to both hands with difficulty making a fist.     Taking Tylenol every 8 hours, c/o pain on standing in the AM.
He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored every 5 minutes, and he was given 20 mL (50 mg) liquid Diphenhydramine. At 11:50 A.M., his heart rate dropped from 99 to 51, and he experienced a brief loss of consciousness for about 3 seconds. He also became diaphoretic and very pale at the same time. His pulse was weak but present, and his eyes rolled back in his head. 911 was immediately called, and a sternal rub was provided to help patient regain consciousness. EMS arrived at 11:56 A.M. and transported patient to the hospital for further evaluation. Patient was alert and talking upon transport.
I received my 2nd booster shot on 04/15/2022 and my adverse event started on 05/18/2022 Wednesday night, I had scratchy throat. I took a COVID test on the same day it was negative. On Thursday 05/19/2022, I felt like a cold in the morning and through the afternoon more like a flu with a lot of cough, runny nose, body ache, fatigue, no fever. and a very bad headache. I tested positive. I had a tele heath with a doctor on Friday morning and he prescribed me PAXLOVID for 5 days. I started taking it on the Friday. I still have cough and some head congestion its minor. I was very miserable on Friday. I am recovering now. I do have some symptoms but not worse.
12DEC pt fussy & afeb;did not sleep well & would wake up p/body jerked;pt had jerky motion;pt did not eat well;did not sleep well;seen by MD;
Within  10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home.  Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches.  Chills for a few hours. Got up and went about my day. Tired and anxious.
Initial and follow up information has been received from a physician and follow up information from a receptionist at the physician's office concerning a 4 year old male pt who per the physician was well at the time of vaccination, with no pertinent medical history and no allergies. On 08/22/03 the pt was vaccinated SC with a second dose, 0.5mL, of MMRII (Lot # 645405/0132N).  Concomitant therapy included vaccination in different arms on 08/22/03 with DTP and IPV. On 08/26/03 the pt presented to the MD's office with mild fever, congested nose and swollen eye lids. The parents treated the child with Tylenol. On 08/28/03 the pt presented again with fever of 103, nasal congestion, swollen tonsils with exudate, not sleeping well (also reported as difficulty sleeping) due to the congestion and slightly swollen eye lids. On follow up the physician reported that the child had been diagnosed with tonsillitis and had been treated with amoxicillin. The physician reported that "she thinks that the child is better because she has not heard back from the father of the child as of yet".  It was also reported by a receptionist at the office that "the child has recovered because she has not come back to the office again." The physician reported that she did not think that the reaction had anything to do with the MMRII.  Additional information has been requested.
This spontaneous report as received from the patient's friend concerning a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, lot#, expiry date and anatomical location were unknown) for prophylaxis. On an unknown date post vaccination, the patient felt "sick and tired" and developed a rash at the injection site. The outcome of malaise, injection site rash and fatigue was unknown. The reporter did not provide the causality between the events and ZOSTAVAX. There were no product quality complaints (PQC) involved.
fingers on left hand tingled.; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 11:45 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol and smoker. The patient had no allergy to medications, food, or other products. Concomitant medications included losartan potassium (LOSARTIN) from an unknown date and unknown if ongoing for an unknown indication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced fingers on left hand tingled for days. It was reported that the worst day three days after and subsided after a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event fingers on left hand tingled was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Seizure-like contractions of B upper extremities with loss of consciousness immediately after MMR. Lasted less than one minute. pt laid down and recovered.