chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left injection site arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 031A21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-336832, MOD-2021-336849, MOD-2021-336832 (Patient Link).
Narrative:  Patient called the Clinical Call Center to report he is on his 4th day of cough and congestion. Patient reports having severe shortness of breath with cough frequently. Patient reports productive cough with green sputum x 4 days, temperature normal but cannot remember the exact number, sore throat, nasal congestion, and headache. He reports testing negative for COVID-19 with home kit yesterday. He states that he has been taking Mucinex, Nebulizer treatments, and hydrating well and nothing is helping. He denies sob at rest, confusion, cp, vision changes, body aches. Patient advised to report to ED for evaluation. In ED, O2 sats in the low 90s at one point. HR was up to 121, pt received Lopressor (IV, 5mg, x2) w/ subsequent HR in low 100s. WBC 11.8K, Hgb 16.8. CMP largely unremarkable. Troponin negative. BNP 191. Covid PCR positive. EKG: Heart rate 121, A. fib, no ST elevation or depressions, occasional PVCs noted. CTA chest showing no evidence of PE, there is evidence of thrombus in left atrium, groundglass opacities in bilateral lower lobes and right upper lobe, nonobstructive nephrolithiasis less than 1 cm. Patient started on heparin drip. Patient also given morphine, Zofran, ketorolac. He received 3 days of IV Ceftriaxone and was de-escalated to Augmentin 875 mg BID X 2 more days. The patient was also treated for acute respiratory failure due to acute bacterial pneumonia. The patient did not require supplemental oxygen. He did not require any further care due to COVID-19 pneumonia. Pt admitted from 11/11/22 to 11/15/22.
The patient developed a headache the evening after her second HPV immunization. The headache has persisted since then (over one month). The headache is exacerbated intermittently, especially when around bright lights or loud noises, but is gradually improving. The patient missed four days of school the first week, and one day of school the second week. She has attended school since then, but still complains of headache, and is not able to participate in some activities such as cheer. The patient's mother notes that the patient developed similar headaches two days after her first HPV vaccine (given on 2/8/18) and now suspects that they were triggered by the HPV vaccines. Last year the patient was admitted to the hospital for unremitting headaches 3/14/2018, and was followed closely by neurology.  Those headaches lasted a total of three to four months, and eventually resolved.
(2/23/2021) Chronic constipation, flu-like symptoms, headaches (sinus). Was given enema and prescribed Miralax. Still takes it everyday.
This spontaneous report as received from a physician refers to a 52 years old female patient with asthma and morphine allergy; the patient was known to be "atopic". The patient was vaccinated with a dose of ZOSTAVAX (Lot number, dose and route not reported) on 08-MAY-2012. No other co-suspects were reported. There was no concomitant medication. Physician reported that on 18-MAY-2012, then days after receiving ZOSTAVAX, the patient developed a rash all over her body. "A part of the rash was biopsied and it came back as atopic dermatitis. The patient was treated with systemic and topical steroids and anti-histamines. At the time of the report, the outcome of atopic dermatitis was reported as not recovered/not resolved. The patient contacted the physician. Atopic dermatitis was considered to be disabling for short period of time by the reporter physician. The relatedness for atopic dermatitis was unknown for ZOSTAVAX. Additional information has been requested.
I experienced a breakthrough case of COVID-19 with fever, sore throat, headache, nasal congestion, runny nose, cough, and fatigue.
Within 20 minutes I was very sick. Weak, no appetite. This was 3 weeks ago, and I am still not feeling well.
Extreme stomach pain, chills, dizziness, headache, arm pain, rash swelling, severe exhaustion
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reported that on an unknown date, unknown number of patients were inadvertently administered ROTATEQ (unspecified dose and route) lot # K016275, expiry date 20-APR-2016. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Lost 33 lbs to date; Lost appetite; noted hair loss; This is a spontaneous report from a contactable consumer via Pfizer colleague. An elderly non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on 2021 (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included COVID-19. The patient previously received 1st dose of BNT162B2 in 2021 (lot number and expiration date were unknown) and experienced runny nose, sore throat, cough, fever, headache.  The patient's concomitant medications were not reported. After second dose, patient lost appetite, noted hair loss, and had lost 33 lbs to date, all on an unspecified date. The patient underwent lab tests and procedures which included weight: lost 33 lbs to date on an unknown date. The outcome of the events was unknown. Treatment received was unknown. The events were resulted in Doctor or other healthcare professional office/clinic visit.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Red arm; Warm arm; Little rash around IS; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS). At the time of the report, ERYTHEMA (Red arm), VACCINATION SITE WARMTH (Warm arm) and RASH (Little rash around IS) outcome was unknown. Not Provided          Reporter did not allow further contact
day p/vax had low grade fever 99.5, very sore arm w/bright red rash about 3-4 inches in size;very tired & a general sick feeling;this lasted for 3 days p/each shot;pt recv two inj 2 wk apart;also area of shot very tender & lump lasted 3 wk
Patient with hx of drug and food allergies (nuts, dilaudid and azithromycin) with no prior history of anaphylaxis was monitored for 30 minutes post COVID-19 Moderna Vaccine and reported no post-vaccine symptoms at time of discharge from urgent care.  Patient returned aproximately 45 minutes later, around 3:45p after c/o throat discomfort and sensation of throat itching/neck hives.  Pt took 50mg home benadryl prior to returning.  Patient was brought into observatory room with vitals: BP 125/83, Oxygen 99, HR 72, on exam was in no acute distress, no oropharyngeal edema, no respiratory distress with clear lungs, no wheezing, no hives visible. Pt was monitored for 20 additional minutes with improvement in symptoms and declined further monitoring.  Patient reported she has an up to date EpiPen.  She was advised low threshold for EpiPen usage and ER evaluation should patient develop any worsening symptoms. Covid Vaccine reaction clinic hotline was provided to patient. Patient agree with plan of care.
Dry heaving, lightheaded, bilateral tingling in hands, felt like they were going to pass out. Evaluated by EMS-cleared
Area of injection was warm, itchy, red and swollen the next morning and area larger by day 2.
Diarrhea; Rash; allergic reaction; irritated her skin; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 (at the age of 78-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had an allergic reaction. She had diarrhea all night and it irritated her skin. She has a rash down there. The outcome of events diarrhea, rash, irritated her skin was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
muscle aches; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) at the vaccinate age of 36 years old, as single dose for covid-19 immunisation. Patient received the first dose on Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced muscle aches on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Patient's memory has been affected so does not recall exact dates.  Patient received vaccine at job site.   Date of vaccination around 2013 or 2014.  Patient had never received a vaccine--any-- prior to that date.  Approximately 8-12 months later started to have tingling in extremitiesarms and legs.  In 2015-2016 patient was in the city and woke up in hospital. The patient was in hospital for about 6 months and then moved into nursing home after that.   Doctor thought that it was GBS, that paralysis had gone to chest and had to be on ventilator because could not breathe on her on.   Current primary is Dr just changed doctors Scheduled to go for evaluation for progression to new doctor on 12/31/19, Neurology Dr
15 year old with knee pain, received Lyme disease vaccine recombinant OSpA (LYMErix). Knee pain on and off since 08/24/2001, the medical history, concurrent illnesses, and concurrent medications were not specified.
Information has been received from a registered nurse concerning a female with "many health unspecified problems" and a dairy allergy who on 27-NOV-2007 and 25-JAN-2008 was vaccinated PO with her first and second doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine (human-bovine) (lot# 657672/0903U, lot# 657989/1838U). Concomitant drug therapy included lansoprazole (PREVACID), digoxin, acetaminophen (TYLENOL), aspirin and milk of magnesia. In 2007 and in 2008, about 1 week after vaccination, the patient experienced rectal bleeding after the first and second doses of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was subsequently admitted to a hospital. The patient sought medical attention through a visit with the "gastroenterologist who diagnosed her with colitis." The outcome was unknown at the time of this report. There was no product quality complaint. Additional information has been requested.  03/03/2008 MR received for DOS 11/2-22/2007 as well as F/U GI consult 1/30/08 with DX: Colitis.  Bloody stools began again in December. Seen by GI on 1/30/08 to r/o infection vs dairy-soy allergic colitis vs Hirschsprung's. 3/19/2008 Vax record received and updated.  Pt received 1st dose of DTap, Hib, Prevnar, IPOL, and Rotateq on 11/27/2007.
patient stated that his throat was itchy and that he was having some issues swallowing. BP 159/78 Epi Pen 0.3mg administered at 2:36 p.m. Ambulance called and transported patient to ER @ 2:45
w/in 3hr of vax pt devel swelling @ inj site;also devel lymphadenitis;treated self symptomatically & recovered p/48 to 72hr;
Patient got her shot around 11:15am and around 11:45am started feeling itchy down the arm of injection (left) and itchy in the mouth and numb in the tongue. Came to report to me (lead RPh for clinic) at 11:50am. I spoke with another staff member to get patient 50mg of benadryl. While I waited for the medicine, I inspected the patients arm, face and inside the mouth. No redness, swelling, hives or other signs/symptoms of allergic reaction. Arm looked normal, no discoloration. Same with face and inside mouth. Patient took 50mg Benadryl at 12pm. Patient also stated having sinus issues currently (before vaccination) and has had off/on reactions with flu shot and other vaccines, mainly itching in the arm that was injected and swelling at the injection site (grapefruit size). Patient reported feeling itchiness gone at 12:10pm but still having some numb tongue. By 12:23pm, patient reported feeling completely better and no more numbness in the tongue.
Pt presented with pain in his thigh where he received the Pneumovax vaccine with redness.  Physician concerned about localized reaction to vaccine vs. cellulitis.
Rash or hives covering the injection arm, plus a swollen index finger.  And soreness at injection site.
Pain in arm, not able to lift arm where injection administered, headache, site hot to touch, fever and nausea.
Pt awoke day after vaccination to severe swelling/redness. On entire upper arm and bicep area. Pain/swelling/redness was reduced w/TYLENOL and was on PNEUMOVAX arm not FLUZONE arm resolved in 2 days.
flu symptoms; lump in the shoulder at injection site; drowsiness; fever; headache; Tired; pain in left arm down to hand; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient who experienced flu symptoms, fever, headache, tired, drowsiness, pain in left arm down to hand and lump in the shoulder at injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 01-Sep-2016, the patient received a  0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot number: not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-SEP-2016 the patient developed a non-serious events flu symptoms (influenza), fever (pyrexia),  headache, tired (fatigue), drowsiness (somnolence), pain in left arm down to hand (pain in extremity) and lump in the shoulder at injection site (vaccination site mass) (latency: 1 day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (pyrexia, headache, fatigue, somnolence, pain in extremity, vaccination site mass, influenza).  At time of reporting, the outcome was Not Recovered / Not Resolved for all the event s.
pt recv vax 6NOV97 & 12NOV97 pt exp abd pain in mid epigastric area;pt did not have this adverse exp p/dose 1;pt described pain as feeling sore & hurting like a type of gas pain;MD stated cramping attributed to constipation;
A non-serious spontaneous report of ten-year-old got H1N1 and then symptoms has been received from a pharmacist/health professional concerning a ten-year-old female, subsequent to H1N1, Intranasal. No relevant medical history has been reported for this patient. The patient was administered oseltamivir phosphate within 48 hours of receiving the vaccine. On an unknown date in 2009, the patient received H1N1, Intranasal. On an unknown date in 2009, the patient experienced symptoms after receiving the vaccine. No details regarding the symptoms have been reported. The outcome of the event was unknown at the time of reporting.
Swelling of the face, lips, eyelids within 3 hours of vaccine administration.  Took benadryl orally and aspirin and within 24 hours, the swelling went down.
Itchy rash started on face, spread to top of head, and then rest of body in crops of new and old vesicles w excoriations
right vision described as "more cloudy", endorses left blindness, discharged home from vaccine clinic after observation
A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.) in a 14-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old patient was administered the Moderna COVID.19 vaccine as first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Light fever 105 orally; seen cats on the ceiling lasted approx 6 hrs; MD notified on 7APR92;
blackouts, seizures, fell, went to hospital Sunday then returned to drs office on Monday 09/12/2011 admitted to hospital on Wednesday 09/14/2011 was discharged on 09/16/2011 with no diagnosis as to what caused problem
Pt called triage line with c/o intermittent symptoms of feeling "feverish", chills, body aches, and diffuse ABD pain. Pt denies SOB, N/V/D, HA, sore throat, and/or CP at this time.  In addition, pt reports a "period of delirium for less than 20 minutes yesterday...it has to be because of the vaccine...".  Pt reports that she received her 2nd dose of the Moderna vaccine on 03/02/2021 to L deltoid.  Pt advised to seek medical attention and/or evaluation with either their PCP and/or HCP with PMG IC for symptoms.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-JAN-2016, the patient was vaccinated with improperly stored oral, ROTATEQ, 2ml, once (dose number was not provided) lot # L013206, expiry date 29-JAN-2017. No adverse effects were reported. Temperature excursion was noted at 57 Fahrenheit for 71 hours and 45 minutes, there was no previous temperature excursion. This is one of two reports receive from the same reporter. Additional information has been requested.
Blood clot in left leg.  Left leg was extremely swollen and in pain.  Initially admitted into Hospital.  The hospital administered and IV and took X-rays to verify the blood clot.  The doctor advised it was a ?very rare blood clot? and was further told I ?should never have gotten this blood clot? and there was ?no reason?.
Within 2 hours:  Itching, warmth and soreness.  After 4 hours 1? swollen, warmth red spot, continued soreness and itching.  After after 18 hours much warmer, 2? raised red area and a higher degree of soreness along with fatigue.  At 27 hours?no improvement and the  Spot is warm even through a thick t-shirt.   It is now 27.5 hours since inoculation.
Information has been received from a physician concerning a 2-month-old female who on 08-Jul-2006 was vaccinated PO with a 2.0 ml dose of Rotateq. There was no concomitant therapy. The physician reported that on 14-Jul-2006, the patient developed severe diarrhea. Unspecified medical attention was sought. On 15-Jul-2006, the patient's severe diarrhea resolved. Additional information has been requested.
soreness at the injection site after bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  Concurrent medical conditions included Cancer.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine) outcome was unknown. No concomitant medications were reported. It was reported that patient took First dose of Moderna vaccine on 04-Feb-2021, Lot number:011M20A, Dose: 0.5ml. Second dose of Moderna vaccine on 04-Mar-2021, Lot number: 003A21A, Dose: 0.5ml. Third dose of Moderna vaccine (Booster 1) on 17-Nov-2021, Lot number: 004C21A. No treatment medications were reported.   This case was linked to MOD-2022-651191 (Patient Link).
Swelling of arm 12 cm above and 10 cm below the elbow.  Elbow swelling the size of a softball.  Only small amount of swelling at the injection site.  No rash, sob, n&v, myalgia, or facial swelling.  I&D of the elbow performed in the ED.
Patient's arms swelled up the day and it was red and hard to touch after she received SHINGRIX. She had just applied ice and took BENADRYL for it. She called her doctor and he said to continue applying ice and take BENADRYL. Symptoms resolved after 3 days.
Prolonged crying nearly continuous for 7 days with agitation. On day 8 stopped and infant returned to previous happy calm disposition.